chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.08
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse referring to a 13 month old patient of unknown gender. The patient's pertinent medical history and concurrent conditions were not provided.    On 06-DEC-2017, the patient was vaccinated with an improperly stored dose of M-M-R II lot # M040558, expiration date on 03-OCT-2018, for prophylaxis (strength and route were not reported). Concomitantly, the vaccine was reconstituted with a properly stored sterile diluent (MERCK STERILE DILUENT). The vaccine was stored at a temperature of 50°F for a time frame of 2 hours. No adverse effects neither previous temperature excursions for the improperly stored vaccine were reported. The call was because of a data logger. This case was one of several reports received from the same reporter.; Sender's Comments: US-009507513-1801USA002511: US-009507513-1801USA002512: US-009507513-1801USA002513: US-009507513-1801USA002514: US-009507513-1801USA002515: US-009507513-1801USA002516: US-009507513-1801USA002517: US-009507513-1801USA002518: US-009507513-1801USA002519: US-009507513-1801USA002520: US-009507513-1801USA002521: US-009507513-1801USA002522: US-009507513-1801USA002510: US-009507513-1801USA002509: US-009507513-1801USA002508:
Age: 1.08
Sex: U
Vaccine: HIBV, MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a consumer via Clinic refers to a currently 23 month old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 07-MAR-2017, the patient was vaccinated with improperly stored dose of M-M-R II, recombinant human albumin (rHA) 1 dose unit (lot # M008589, Expiry date was not reported) and PEDVAXHIB 1 dose unit ( Lot # M025193, Expiry date : 21-MAR-2019) for prophylaxis. There were no previous temperature excursions recorded. It was unknown if data logger was involved. No adverse effects were reported. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1801USA000166.
Sex: F
Vaccine: HPVX
Symptoms: Death
Clinical narrative: Information has been received from the authors of the published literature article. The authors used Social Media's Public Streams Application Programming Interface (API) to collect live data. Between November of 2014 and January 2015, they systematically endeavored to select an optimal set of terms that would be parsimonious enough to be feasible yet broad enough to capture sufficient relevant information. Of the 2,000 comments, 1,887 (94.4%) were relevant to human papillomavirus (HPV). Thus, these 1,887 comments composed their final data-set. The vast majority of comments (n=1,668, 88.4%) originated from unique user accounts. Two hundred and four comments (10.8%) were from users who posted between two and five times, and 30 (1.6%) were from users who posted 10 or more times. Ninety-five (5.0%) comments were coded as having negative sentiment. These comments generally discouraged GARDASIL or GARDASIL 9 vaccination or expressed a particularly negative view toward it. Specific terms characteristic of these comments included "beware," "destroys lives," and "mystery illness." While sentiments were nearly always directly incorporated in to the comments themselves, negative sentiment could also often be inferred by the hashtags at the end of the comment. 78 (4.1%) comments explicitly claimed lack of safety. Examples of phrases included in comments describing lack of safety included "GARDASIL or GARDASIL 9 ruins live [sic]" and "girl dies shortly after receiving HPV vaccine." This case concerns to a healthy 12-year-old girl who died shortly after receiving HPV vaccine. The case was coded as lack of safety 77 (4.1%). The reporter considered death to be related to GARDASIL 9 and/or GARDASIL. Upon internal review death was considered to be a medically significant event. This is one of 2 reports derived from the same literature source, linked to case # 1801USA003508. Sender's Comments: US-009507513-1801USA003508.
Age: 23.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse referring to a 23 year-old patient of unknown gender. The patient's pertinent medical history and concurrent conditions were not provided.    On 07-DEC-2017, the patient was vaccinated with an improperly stored dose of GARDASIL 9 lot # N004799, expiration date on 15-NOV-2019 or lot #N021475, expiration date on 21-JAN-2020, for prophylaxis (strength and route were not reported). The vaccine was stored at a temperature of 50°F for a time frame of 2 hours. No adverse effects neither previous temperature excursions for the improperly stored vaccine were reported. The call was because of a data logger. This case was one of several reports received from the same reporter.; Sender's Comments: US-009507513-1801USA002510: US-009507513-1801USA002511: US-009507513-1801USA002512: US-009507513-1801USA002513: US-009507513-1801USA002515: US-009507513-1801USA002516: US-009507513-1801USA002517: US-009507513-1801USA002518: US-009507513-1801USA002519: US-009507513-1801USA002520: US-009507513-1801USA002521: US-009507513-1801USA002522: US-009507513-1801USA002509: US-009507513-1712USA010085: US-009507513-1801USA002514:
Age: 0.58
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse referring to a 7 month old patient of unknown gender. The patient's pertinent medical history and concurrent conditions were not provided. On 07-DEC-2017, the patient was vaccinated with an improperly stored dose of ROTATEQ orally, lot # M018958, expiration date on 03-MAR-2018, lot #N004815, expiration date on 07-OCT-2018 or lot #M045546, expiration date on 12-JUN-2018, for prophylaxis (strength and dose were not reported). The vaccine was stored at a temperature of 50°F for a time frame of 2 hours. No adverse effects neither previous temperature excursions for the improperly stored vaccine were reported. The call was because of a data logger. This case was one of several reports received from the same reporter. Sender's Comments: US-009507513-1801USA002510: US-009507513-1801USA002511: US-009507513-1801USA002512: US-009507513-1801USA002513: US-009507513-1801USA002515: US-009507513-1801USA002516: US-009507513-1801USA002517: US-009507513-1801USA002518: US-009507513-1801USA002519: US-009507513-1801USA002520: US-009507513-1801USA002521: US-009507513-1801USA002522: US-009507513-1712USA010085: US-009507513-1801USA002508: US-009507513-1801USA002514.
Age: 10.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse referring to a 10 year-old patient of unknown gender. The patient's pertinent medical history and concurrent conditions were not provided.    On 07-DEC-2017, the patient was vaccinated with an improperly stored dose of GARDASIL 9 lot # N004799, expiration date on 15-NOV-2019 or lot #N021475, expiration date on 21-JAN-2020, for prophylaxis (strength and route were not reported). The vaccine was stored at a temperature of 50°F for a time frame of 2 hours. No adverse effects neither previous temperature excursions for the improperly stored vaccine were reported. The call was because of a data logger. This case was one of several reports received from the same reporter.; Sender's Comments: US-009507513-1712USA010085: US-009507513-1801USA002511: US-009507513-1801USA002512: US-009507513-1801USA002513: US-009507513-1801USA002523: US-009507513-1801USA002515: US-009507513-1801USA002516: US-009507513-1801USA002517: US-009507513-1801USA002518: US-009507513-1801USA002519: US-009507513-1801USA002520: US-009507513-1801USA002521: US-009507513-1801USA002522: US-009507513-1801USA002509: US-009507513-1801USA002508: US-009507513-1801USA002514:
Age: 18.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse referring to a 18 year-old patient of unknown gender. The patient's pertinent medical history and concurrent conditions were not provided.    On 12-DEC-2017, the patient was vaccinated with an improperly stored dose of GARDASIL 9 lot # N004799, expiration date on 15-NOV-2019 or lot #N021475, expiration date on 21-JAN-2020, for prophylaxis (strength and route were not reported). The vaccine was stored at a temperature of 50°F for a time frame of 2 hours. No adverse effects neither previous temperature excursions for the improperly stored vaccine were reported. The call was because of a data logger. This case was one of several reports received from the same reporter. ; Sender's Comments: US-009507513-1801USA002510: US-009507513-1712USA010085: US-009507513-1801USA002512: US-009507513-1801USA002513: US-009507513-1801USA002515: US-009507513-1801USA002516: US-009507513-1801USA002517: US-009507513-1801USA002518: US-009507513-1801USA002519: US-009507513-1801USA002520: US-009507513-1801USA002521: US-009507513-1801USA002522: US-009507513-1801USA002509: US-009507513-1801USA002508: US-009507513-1801USA002514:
Age: 0.5
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse referring to a 6 month old patient of unknown gender. The patient's pertinent medical history and concurrent conditions were not provided.    On 12-DEC-2017, the patient was vaccinated with an improperly stored dose of ROTATEQ orally, lot # M018958, expiration date on 03-MAR-2018, lot #N004815, expiration date on 07-OCT-2018 or lot #M045546, expiration date on 12-JUN-2018, for prophylaxis (strength and dose were not reported). The vaccine was stored at a temperature of 50°F for a time frame of 2 hours. No adverse effects neither previous temperature excursions for the improperly stored vaccine were reported. The call was because of a data logger. This case was one of several reports received from the same reporter. ; Sender's Comments: US-009507513-1801USA002510: US-009507513-1801USA002511: US-009507513-1712USA010085: US-009507513-1801USA002513: US-009507513-1801USA002515: US-009507513-1801USA002516: US-009507513-1801USA002517: US-009507513-1801USA002518: US-009507513-1801USA002519: US-009507513-1801USA002520: US-009507513-1801USA002521: US-009507513-1801USA002522: US-009507513-1801USA002509: US-009507513-1801USA002508: US-009507513-1801USA002514:
Age: 15.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse referring to a 15 year-old patient of unknown gender. The patient's pertinent medical history and concurrent conditions were not provided.    On 13-DEC-2017, the patient was vaccinated with an improperly stored dose of GARDASIL 9 lot # N004799, expiration date on 15-NOV-2019 or lot #N021475, expiration date on 21-JAN-2020, for prophylaxis (strength and route were not reported). The vaccine was stored at a temperature of 50°F for a time frame of 2 hours. No adverse effects neither previous temperature excursions for the improperly stored vaccine were reported. The call was because of a data logger. This case was one of several reports received from the same reporter. Sender's Comments: US-009507513-1801USA002510: US-009507513-1801USA002511: US-009507513-1801USA002512: US-009507513-1712USA010085: US-009507513-1801USA002515: US-009507513-1801USA002516: US-009507513-1801USA002517: US-009507513-1801USA002518: US-009507513-1801USA002519: US-009507513-1801USA002520: US-009507513-1801USA002521: US-009507513-1801USA002522: US-009507513-1801USA002509: US-009507513-1801USA002508: US-009507513-1801USA002514:
Age: 4.0
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse referring to a 4 year old patient of unknown gender. The patient's pertinent medical history and concurrent conditions were not provided. On 13-DEC-2017, the patient was vaccinated with an improperly stored dose of M-M-R II lot # M040558, expiration date on 03-OCT-2018, for prophylaxis (strength and route were not reported). Concomitantly, the vaccine was reconstituted with a properly stored sterile diluent (MERCK). The vaccine was stored at a temperature of 50°F for a time frame of 2 hours. No adverse effects neither previous temperature excursions for the improperly stored vaccine were reported. The call was because of a data logger. This case was one of several reports received from the same reporter. Sender's Comments: US-009507513-1801USA002510: US-009507513-1801USA002511: US-009507513 1801USA002512: US-009507513-1801USA002513: US-009507513-1801USA002515: US-009507513-1801USA002516: US-009507513-1801USA002517: US-009507513-1801USA002518: US-009507513-1801USA002519: US-009507513-1801USA002520: US-009507513-1801USA002521: US-009507513-1801USA002522: US-009507513-1801USA002509: US-009507513-1801USA002508: US-009507513-1712USA010085.
Age: 23.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse referring to a 23 year-old patient of unknown gender. The patient's pertinent medical history and concurrent conditions were not provided.    On 13-DEC-2017, the patient was vaccinated with an improperly stored dose of GARDASIL 9 lot # N004799, expiration date on 15-NOV-2019 or lot #N021475, expiration date on 21-JAN-2020, for prophylaxis (strength and route were not reported). The vaccine was stored at a temperature of 50°F for a time frame of 2 hours. No adverse effects neither previous temperature excursions for the improperly stored vaccine were reported. The call was because of a data logger. This case was one of several reports received from the same reporter. ; Sender's Comments: US-009507513-1801USA002510: US-009507513-1801USA002511: US-009507513-1801USA002512: US-009507513-1801USA002513: US-009507513-1712USA010085: US-009507513-1801USA002516: US-009507513-1801USA002517: US-009507513-1801USA002518: US-009507513-1801USA002519: US-009507513-1801USA002520: US-009507513-1801USA002521: US-009507513-1801USA002522: US-009507513-1801USA002509: US-009507513-1801USA002508: US-009507513-1801USA002514:
Age: 11.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse referring to a 11 year-old patient of unknown gender. The patient's pertinent medical history and concurrent conditions were not provided.    On 13-DEC-2017, the patient was vaccinated with an improperly stored dose of GARDASIL 9 lot # N004799, expiration date on 15-NOV-2019 or lot #N021475, expiration date on 21-JAN-2020, for prophylaxis (strength and route were not reported). The vaccine was stored at a temperature of 50°F for a time frame of 2 hours. No adverse effects neither previous temperature excursions for the improperly stored vaccine were reported. The call was because of a data logger. This case was one of several reports received from the same reporter. ; Sender's Comments: US-009507513-1801USA002510: US-009507513-1801USA002511: US-009507513-1801USA002512: US-009507513-1801USA002513: US-009507513-1801USA002515: US-009507513-1712USA010085: US-009507513-1801USA002517: US-009507513-1801USA002518: US-009507513-1801USA002519: US-009507513-1801USA002520: US-009507513-1801USA002521: US-009507513-1801USA002522: US-009507513-1801USA002509: US-009507513-1801USA002508: US-009507513-1801USA002514:
Age: 10.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse referring to a 10 year-old patient of unknown gender. The patient's pertinent medical history and concurrent conditions were not provided.    On 13-DEC-2017 , the patient was vaccinated with an improperly stored dose of GARDASIL 9 lot # N004799, expiration date on 15-NOV-2019 or lot #N021475, expiration date on 21-JAN-2020, for prophylaxis (strength and route were not reported). The vaccine was stored at a temperature of 50°F for a time frame of 2 hours. No adverse effects neither previous temperature excursions for the improperly stored vaccine were reported. The call was because of a data logger. This case was one of several reports received from the same reporter. ; Sender's Comments: US-009507513-1801USA002510: US-009507513-1801USA002511: US-009507513-1801USA002512: US-009507513-1801USA002513: US-009507513-1801USA002515: US-009507513-1801USA002516: US-009507513-1712USA010085: US-009507513-1801USA002518: US-009507513-1801USA002519: US-009507513-1801USA002520: US-009507513-1801USA002521: US-009507513-1801USA002522: US-009507513-1801USA002509: US-009507513-1801USA002508: US-009507513-1801USA002514:
Age: 3.0
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse referring to a 3 year old patient of unknown gender. The patient's pertinent medical history and concurrent conditions were not provided.    On 13-DEC-2017, the patient was vaccinated with an improperly stored dose of M-M-R II lot # M040558, expiration date on 03-OCT-2018, for prophylaxis (strength and route were not reported). Concomitantly, the vaccine was reconstituted with a properly stored sterile diluent (MERCK STERILE DILUENT). The vaccine was also stored at a temperature of 50°F for a time frame of 2 hours. No adverse effects  neither previous temperature excursions for the improperly stored vaccine were reported. The call was because of a data logger. This case was one of several reports received from the same reporter.; Sender's Comments: US-009507513-1801USA002510: US-009507513-1801USA002511: US-009507513-1801USA002512: US-009507513-1801USA002513: US-009507513-1801USA002515: US-009507513-1801USA002516: US-009507513-1801USA002517: US-009507513-1712USA010085: US-009507513-1801USA002519: US-009507513-1801USA002520: US-009507513-1801USA002521: US-009507513-1801USA002522: US-009507513-1801USA002509: US-009507513-1801USA002508: US-009507513-1801USA002514:
Age: 11.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse referring to a 11 year-old patient of unknown gender. The patient's pertinent medical history and concurrent conditions were not provided.    On 13-DEC-2017, the patient was vaccinated with an improperly stored dose of GARDASIL 9 lot # N004799, expiration date on 15-NOV-2019 or lot #N021475, expiration date on 21-JAN-2020, for prophylaxis (strength and route were not reported). The vaccine was stored at a temperature of 50°F for a time frame of 2 hours. No adverse effects neither previous temperature excursions for the improperly stored vaccine were reported. The call was because of a data logger. This case was one of several reports received from the same reporter. ; Sender's Comments: US-009507513-1801USA002510: US-009507513-1801USA002511: US-009507513-1801USA002512: US-009507513-1801USA002513: US-009507513-1801USA002515: US-009507513-1801USA002516: US-009507513-1801USA002517: US-009507513-1801USA002518: US-009507513-1712USA010085: US-009507513-1801USA002520: US-009507513-1801USA002521: US-009507513-1801USA002522: US-009507513-1801USA002509: US-009507513-1801USA002508: US-009507513-1801USA002514:
Age: 0.5
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse referring to a 7 month old patient of unknown gender. The patient's pertinent medical history and concurrent conditions were not provided.    On 13-DEC-2017, the patient was vaccinated with an improperly stored dose of ROTATEQ orally, lot # M018958, expiration date on 03-MAR-2018, lot #N004815, expiration date on 07-OCT-2018 or lot #M045546, expiration date on 12-JUN-2018, for prophylaxis (strength and dose were not reported). The vaccine was stored at a temperature of 50°F for a time frame of 2 hours. No adverse effects neither previous temperature excursions for the improperly stored vaccine were reported. The call was because of a data logger. This case was one of several reports received from the same reporter. ; Sender's Comments: US-009507513-1801USA002510: US-009507513-1801USA002511: US-009507513-1801USA002512: US-009507513-1801USA002513: US-009507513-1801USA002515: US-009507513-1801USA002516: US-009507513-1801USA002517: US-009507513-1801USA002518: US-009507513-1801USA002519: US-009507513-1712USA010085: US-009507513-1801USA002521: US-009507513-1801USA002522: US-009507513-1801USA002509: US-009507513-1801USA002508: US-009507513-1801USA002514:
Age: 11.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse referring to a 11 year-old patient of unknown gender. The patient's pertinent medical history and concurrent conditions were not provided.    On 14-DEC-2017, the patient was vaccinated with an improperly stored dose of GARDASIL 9 lot # N004799, expiration date on 15-NOV-2019 or lot #N021475, expiration date on 21-JAN-2020, for prophylaxis (strength and route were not reported). The vaccine was stored at a temperature of 50°F for a time frame of 2 hours. No adverse effects neither previous temperature excursions for the improperly stored vaccines were reported. The call was because of a data logger. This case was one of several reports received from the same reporter.; Sender's Comments: US-009507513-1801USA002510: US-009507513-1801USA002511: US-009507513-1801USA002512: US-009507513-1801USA002513: US-009507513-1801USA002515: US-009507513-1801USA002516: US-009507513-1801USA002517: US-009507513-1801USA002518: US-009507513-1801USA002519: US-009507513-1801USA002520: US-009507513-1712USA010085: US-009507513-1801USA002522: US-009507513-1801USA002509: US-009507513-1801USA002508: US-009507513-1801USA002514:
Age: 0.08
Sex: U
Vaccine: HIBV, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse referring to a 7 week old patient of unknown gender. The patient's pertinent medical history and concurrent conditions were not provided.    On 14-DEC-2017, the patient was vaccinated with an improperly stored doses of ROTATEQ orally, lot # M018958, expiration date on 03-MAR-2018, lot #N004815, expiration date on 07-OCT-2018 or lot #M045546, expiration date on 12-JUN-2018, for prophylaxis (strength and dose were not reported) and with LIQUID PEDVAXHIB lot #N004632, expiration date on 02-NOV-2019, for prophylaxis (strength, dose and route of administration were not reported). The vaccines were stored at a temperature of 50°F for a time frame of 2 hours. No adverse effects neither previous temperature excursions for the improperly stored vaccines were reported. The call was because of a data logger. This case was one of several reports received from the same reporter.; Sender's Comments: US-009507513-1801USA002510: US-009507513-1801USA002511: US-009507513-1801USA002512: US-009507513-1801USA002513: US-009507513-1801USA002515: US-009507513-1801USA002516: US-009507513-1801USA002517: US-009507513-1801USA002518: US-009507513-1801USA002519: US-009507513-1801USA002520: US-009507513-1801USA002521: US-009507513-1712USA010085: US-009507513-1801USA002509: US-009507513-1801USA002508: US-009507513-1801USA002514:
Sex: F
Vaccine: PPV
Symptoms: Injection site pain
Clinical narrative: Information has been received from a physician via a company referring to a female patient. The age of the patient was reported as "in their mid 60's" or "around 89 years of age". The patient's concurrent condition, medical history and concomitant therapy were not reported. On an unknown date, the patient was vaccinated with the first dose of PNEUMOVAX 23 (lot # N019838, expiration date 16-FEB-2019; dose, strength unknown) intramuscular in unspecified side of deltoid for prophylaxis. On 28-DEC-2017, the patient had severe pain in the injection area for a couple of days. There was no redness or swelling on the  area. At the reported time, the patient was better. The causality between pain and PNEUMOVAX 23 was unknown. This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-1801USA003160:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a medical assistant regarding three unspecified patients of unknown age and gender. The patients' medical history, drug allergies, previously drug reactions, concurrent conditions and concomitant medication were not reported. On 08-JAN-2018, the patients were vaccinated with three improperly stored doses of ROTATEQ lot number N000193 with expiration date in 20-OCT-2018 and lot number N004812 with expiration date in 04-10-2018, orally, for prophylaxis. The ROTATEQ doses were stored at a temperature range of 32 degrees Fahrenheit (°F) to 35 °F for the time frame of 6 hours and 40 minutes, and another range of 47°F to 77°F for the time frame of 1 hour and 20 minutes.There was no previous temperature excursion and the call was because of a data logger. No adverse effects reported.
Sex: M
Vaccine: PPV
Symptoms: Injection site pain
Clinical narrative: Information has been received from a physician via a company referring to a male patient. The age of the patient was reported as "in their mid 60's" or "around 89 years of age". The patient's concurrent condition, medical history and concomitant therapy were not reported. On an unknown date, the patient was vaccinated with the first dose of PNEUMOVAX 23 (lot # N019838, expiration date 16-FEB-2019; dose, strength unknown) intramuscular in unspecified side of deltoid for prophylaxis. On 28-DEC-2017, the patient had severe pain in the injection area for a couple of days. There was no redness or swelling on the area. At the reported time, the patient was better. The causality between pain and PNEUMOVAX 23 was unknown. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1801USA002540.
Sex: F
Vaccine: HPVX
Symptoms: Death
Clinical narrative: Information has been received from the authors of the published literature article. The authors used a Public Streams Application Programming Interface (API) to collect live data. Between November of 2014 and January 2015, they systematically endeavored to select an optimal set of terms that would be parsimonious enough to be feasible yet broad enough to capture sufficient relevant information. Of the 2,000 responses, 1,887 (94.4%) were relevant to human papillomavirus (HPV). Thus, these 1,887 composed their final data-set. The vast majority (n=1,668, 88.4%) originated from unique user accounts. Two hundred and four tweets (10.8%) were from users who posted between two and five times, and 30 (1.6%) were from users who posted 10 or more times. Ninety-five (5.0%) were coded as having negative sentiment. These  generally discouraged GARDASIL or GARDASIL 9 vaccination or expressed a particularly negative view toward it. Specific terms characteristic of these tweets included "beware," "destroys lives," and "mystery illness." While sentiments were nearly always directly incorporated in to the responses themselves, negative sentiment could also often be inferred by the hashtags at the end. 78 (4.1%) explicitly claimed lack of safety. Examples of phrases included in tweets describing lack of safety included "GARDASIL or GARDASIL 9 ruins live [sic]" and "girl dies shortly after receiving HPV vaccine." This case concerns to a girl who died shortly after receiving HPV vaccine. The case was coded as lack of safety 77 (4.1%). The reporter considered death to be related to GARDASIL 9 and/or GARDASIL. Upon internal review death was considered to be a medically significant event. This is one of 2 reports derived from the same literature source, linked to case # 1801USA001975. Sender's Comments: US-009507513-1801USA001975:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse, referring to a patient of unknown age and gender. The patient's historical drugs, medical history, concomitant therapies, drugs allergies and concurrent conditions were not reported. On 14-NOV-2007, the patient was vaccinated with an improperly stored dose of VARIVAX lot # N001530, expiration date 13-JAN-2019, for prophylaxis (strength, dose, route and frequency were not reported). The PROQUAD was reconstituted with a properly stored sterile diluent (MERCK STERILE DILUENT) (lot # and expiration date were unknown). The temperature excursion was of 47°F to 50°F, during 35 minutes. A previous temperature excursion was not reported. A digital data logger was involved. No adverse effects were reported. Additional information is not expected. This is one of several reports received from  the same reporter.; Sender's Comments:  US-009507513-1801USA003525: US-009507513-1801USA003520: US-009507513-1801USA003521: US-009507513-1801USA003522: US-009507513-1801USA003523: US-009507513-1801USA003524: US-009507513-1801USA003526: US-009507513-1712USA013991: US-009507513-1801USA003612:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse, referring to a patient of unknown age and gender. The patient's historical drugs, medical history, concomitant therapies, drugs allergies and concurrent conditions were not reported. On 22-NOV-2017, the patient was vaccinated with an improperly stored dose of VARIVAX lot # N001530, expiration date 13-JAN-2019, for prophylaxis (strength, dose, route and frequency were not reported). The PROQUAD was reconstituted with a properly stored sterile diluent (MERCK) lot # M034763 and expiration date 22-APR-2019. The temperature excursion was of 47°F to 50°F, during 35 minutes. A previous temperature excursion was not reported. A digital data logger was involved. No adverse effects were reported. Additional information is not expected. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1801USA003525: US-009507513-1801USA003520: US-009507513-1801USA003521: US-009507513-1801USA003522: US-009507513-1801USA003523: US-009507513-1801USA003524: US-009507513-1801USA003526: US-009507513-1712USA013991: US-009507513-1801USA003527.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Expired product administered
Clinical narrative: Expired vaccine given-EXP. Date 10/2017. Remainder of lot removed from stock. Mom/Client had left clinic when event realized. Phone call to mom to notify. Advised of need to repeat dose.
Age: 9.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: She developed redness swelling and itching from the injection site on her deltoid muscle down to her elbow. The actual onset of symptoms is not clear, but her mother contacted our office on 10/30/17.
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Culture negative, Injection site swelling
Clinical narrative: This spontaneous report was received from a registered nurse, referring to a 15 year old non pregnant female patient. The patient's medical history,concurrent conditions or concomitant medication were not reported. On an unknown date in June 2017, the patient was vaccinated with GARDASIL 9 for prophylaxis (dosage information, route, lot number and expiration date were not reported). On an unknown date in "June 2017", the patient "developed a bump at the injection site weeks after administration of GARDASIL 9. The reporter stated that unspecified "months later" "the bump grew larger and larger." Additionally,"unspecified cultures were performed" and came back "negative". Subsequently, on an unspecified date to treat the bump "a debridement of the bump was performed". The outcome of injection site mass was reported as recovered on an unknown date in 2017. The causality assessment between injection site mass and therapy with GARDASIL 9 was not provided.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from Licensed Practical Nurse (LPN), referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant therapy, drug and allergy history were not provided. On 03-JAN-2018, the patient was vaccinated with the second dose of PROQUAD (recombinant human albumin (rHA )) by intramuscular route (strength and dose were not provided), lot number N021728, expiration date 06-FEB-2019, for prophylaxis. Concomitant therapies included sterile diluent (lot number M034582, expiration date 27-APR-2019).    No adverse effects were reported.
Sex: U
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pustule, Pruritus, Rash pustular, Urticaria
Clinical narrative: This is a spontaneous report from a contactable consumer reported for herself/ himself. A patient of unspecified age and gender received PREVNAR 13 on an unspecified date at single dose for immunisation . The patient medical history and concomitant medications were not reported. The patient reported that on an unspecified date, the site where got the injection was red and had like a little bit of pus in the middle (a little dot in the middle of the red), but it went away. It looked like little pus sores on legs and arms but not on body. It had like a little sore in the middle of redness where the needle went in. Lately patient found had like some kind of hives or itchy, the itching was horrible (driving patient crazy, it was so itchy).Patient went to  urgent care and diphenhydramine hydrochloride (BENADRYL) was given may be for the itching. Patient still had itching; vaccination site pustule recovered, while outcome of the other events was unknown.
Sex: F
Vaccine: PNC13
Symptoms: Laboratory test, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable Physician. An 8-month-old female patient of an unspecified ethnicity received second dose of PREVNAR 13 (lot#: S06832, expiry date: 31Aug2018), intramuscularly at left vastus lateralis on 25Oct2017 at 0.5 ml, single for immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced minimal fever in Oct2017 and second dose of vaccine was on 25Oct2017. The patient underwent lab tests and procedures which included body temperature: minimal fever in Oct2017. The outcome of the event was unknown.
Sex: F
Vaccine: PPV
Symptoms: Body temperature increased, Chest X-ray, Influenza, Pneumonia
Clinical narrative: This is a spontaneous report from a contactable consumer, who reported for herself and who was enrolled in a Pfizer-sponsored program; this report regards events part of the clinical course of the patient. A 76-year-old female patient received pneumococcal 13-val conj vac (dipht crm197 protein) (unspecified manufacturer) in Aug2017 (as reported, however patient couldn't really remember) at single dose for immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date she experienced flu and starting of pneumonia in one of her lungs, due to which was admitted to hospital from 05Jan2018 and released on 08Jan2018. The pneumonia was starting in her left lung. She went to the regular doctor first, she had a temperature of 105.9F. The doctor told her that she had to go to the hospital. It was checked her for flu which she had and X-rays of her lungs was done on an unknown date. Patient explained "she couldn't have the flu because she had the flu shot and the pneumonia shot, but she did have the flu". Patient was getting a little better every day but it was slow; events improved but were ongoing. Final outcome of the event was recovering. Information on the batch number has been requested. Pfizer is a Marketing Authorization Holder of Pneumococcal 13-Val Conj Vaccine (Dipht CRM197 Protein) in the reporter's country. This may be a duplicate report in cases where another Marketing Authorization Holder of Pneumococcal 13-Val Conj Vaccine (Dipht CRM197 Protein) has submitted the same report to the regulatory authorities.
Sex: F
Vaccine: PNC13
Symptoms: Cough, Malaise, Urticaria
Clinical narrative: This is a spontaneous report from a contactable consumer reporting for herself. This female patient of unknown age and race/ethnicity received in Nov2017 a single dose of PREVNAR 13 for immunization. Medical history and concomitant medications were not reported. On an unknown date, patient has been on LYRICA for an unspecified indication and broke out in hives. In Nov2017, next day after she received vaccination, she didn't feel well and came down with a really bad cough. Outcome was not recovered. Information on the batch number has been requested.
Age: 17.0
Sex: F
Vaccine: MNQ, VARCEL
Symptoms: Hypersensitivity, Lip swelling, Pruritus, Respiratory rate increased, Swelling face
Clinical narrative: Patients mother contacted this office reporting allergic reaction, hives, itching, lip swelling. Patient sent to Emergency room. Treated with IV BENADRYL, SOLOMEDROL, PEPCID, EPI PEN. At hospital, patient had facial swelling, hives, itching, resp. increase rate, sent home with Rx for PO Prednisone, and EPI PEN.
Age: 17.0
Sex: F
Vaccine: MNQ, VARCEL
Symptoms: Urticaria
Clinical narrative: Patients mother contacted this office reporting allergic reaction, hives, itching, lip swelling. Patient sent to Emergency room. Treated with IV BENADRYL, SOLOMEDROL, PEPCID, EPI PEN. At hospital, patient had facial swelling, hives, itching, resp. increase rate, sent home with Rx for PO Prednisone, and EPI PEN.
Age: 0.25
Sex: M
Vaccine: DTAP, HIBV, IPV, PPV, RV1
Symptoms: Malaise, Mood altered, Personality change, Pyrexia
Clinical narrative: Fever of 106.1 and sick for almost 1 month. Change in mood and personality.
Age: 30.0
Sex: M
Vaccine: JEV1
Symptoms: Erythema, Peripheral swelling, Skin tightness, Skin warm, Tenderness
Clinical narrative: Member reported to the clinic after calling. His bicep was red, swollen, hot, tender, and tight. No fevers, vomiting, GI symptoms. He was brought to the Urgent care center to be seen right away.
Age: 17.0
Sex: M
Vaccine: HEP, HPV9, MENB, MNQ
Symptoms: Computerised tomogram normal, Electrocardiogram normal, Fall, Head injury, Laceration
Clinical narrative: Patient passed out fell, hit head and had seizure like activity before coming to and proceeded to try and vomit. Laceration above right eye due to fall. Patient was monitored x 1 hour prior to being sent to the emergency department for further evaluation.
Age: 17.0
Sex: M
Vaccine: HEP, HPV9, MENB, MNQ
Symptoms: Loss of consciousness, Seizure like phenomena
Clinical narrative: Patient passed out fell, hit head and had seizure like activity before coming to and proceeded to try and vomit. Laceration above right eye due to fall. Patient was monitored x 1 hour prior to being sent to the emergency department for further evaluation.
Age: 18.0
Sex: M
Vaccine: FLU4, HEPA, HPV9
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Age inappropriate vaccine administered and no adverse outcome.
Age: 53.0
Sex: M
Vaccine: FLUC4
Symptoms: Lip swelling, Swelling face
Clinical narrative: Patient woke up at 4:30 am and went to bathroom, noticed lips/face was swollen. Has a physician appointment this afternoon (1-11-2018). Shot was given on 1-10-2018 at 2:30 pm.
Age: 55.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Feeling abnormal, Headache, Injection site erythema, Injection site induration
Clinical narrative: The evening after the injection and the next day she got a headache, chills, was feverish and "felt very out of it." She also had pain and weakness in her left arm, which was followed by redness, pain, and a feeling of hardness to the skin about 3 inches above her elbow.
Age: 55.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Muscular weakness, Pain in extremity, Pyrexia
Clinical narrative: The evening after the injection and the next day she got a headache, chills, was feverish and "felt very out of it." She also had pain and weakness in her left arm, which was followed by redness, pain, and a feeling of hardness to the skin about 3 inches above her elbow.
Age: 16.0
Sex: F
Vaccine: MMRV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Patient received a dose of MMRV. Patient was out of the age range (4-12). Patient did not experience any adverse events.
Age: 77.0
Sex: F
Vaccine: PNC13
Symptoms: Cough, Electrocardiogram, Pneumonia, Wheezing, X-ray
Clinical narrative: Pneumonia - wheezing - bad cough.
Age: 25.0
Sex: F
Vaccine: HPV9
Symptoms: Drug administered to patient of inappropriate age, Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant, referring to a currently 28 years old female patient. The patient's medical history, concurrent conditions or concomitant medication were not informed. On an unknown date in approximately 2014 (reported as "when she was 25 years old"), the patient was vaccinated with the fist dose of GARDASIL 9 for prophylaxis (route and lot number not provided).  The patient was now 28 years old and she was in the office to receive the remaining doses of the GARDASIL 9 series. No adverse symptoms reported.
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report has been received from a licensed practical nurse (LPN) regarding a patient of unknown age and gender. The patient's medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided. On 02-JAN-2018, the patient was inadvertently vaccinated with one dose of expired ROTATEQ oral liquid ( dose not reported, lot # M007301, expiration date 19-NOV-2017) for prophylaxis. No adverse effects were reported. Additionally, no product quality complaint (PQC) was involved.
Sex: F
Vaccine: HEPA
Symptoms: Device leakage, Exposure via skin contact, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to herself (female patient of unknown age). There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. The medical assistant reported that on an unknown date, she had touched a VAQTA vial, lot # N023953, expiry date 05-NOV-2018, for prophylaxis that was leaking and the product touched her skin directly. No adverse experiences were reported. Product Quality Complaint (PQC) was filed. Lot number N023953 has been verified to be a valid lot number for VAQTA.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 03-JAN-2017, the patient was vaccinated with VARIVAX lot # N019127, intramuscular route instead of subcutaneous. The vaccine was reconstituted with sterile diluent. No adverse effects were reported.
Age: 54.0
Sex: M
Vaccine: FLU3
Symptoms: Ageusia, Anosmia, Sinusitis
Clinical narrative: This initial spontaneous case was received on 17-Oct-2017 from a pharmacist, concerning a male patient of unspecified age. The patient's medical history included sinus infection. On 27-Oct-2016, the patient was administered with FLUVIRIN (dose:0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number, expiry date: not reported). On an unspecified date, after the vaccination, the patient experienced change in taste in mouth and lost his ability to taste things for about 2 weeks and ability to smell. It was reported that, the patient had never the taste of metallic. It was reported that, the patient had sinus infection and went to ENT. The outcome of the event loss of smell was not recovered, and outcome of the events loss of taste and sinus infection reported as recovered, the outcome of the event taste changed was not reported. The reporter assessed the events as non-serious.
Age: 72.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site pain
Clinical narrative: Severe pain to right deltoid x3+ weeks.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Mobility decreased, Pain in extremity, Peripheral swelling
Clinical narrative: Patient reports extreme swelling and pain that causes impaired mobility of her arm. She states that the swelling spreaded to her elbow and she had to place ice packs for 6 hours the day she recieved the vaccine. She has taken ibuprofen and vicoden. She called the pharmacy the following morning and was counseled to continue using cold packs, and take aleve instead of ibuprofen and also to take benadryl, and monitor the swelling.
Age: 78.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash, Injection site swelling
Clinical narrative: Rash on the injection site about 12x13cm with palpable swelling. +itchiness, red, swelling; had the vaccine pcv 13 1/8/18.
Age: 56.0
Sex: M
Vaccine: HEPAB, JEV1, MMR
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Client was to receive RABAVERT, dose 3 in the series. Instead, Ixiaro Japanese Encephalitis vaccine was given in its place. The client did not have an adverse reaction to any vaccine.
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site abscess, Injection site cellulitis, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Left upper arm with redness, swelling, and hot to touch. Cellulitis and abscess of upper arm. Treated with CEFDINIR SUSPENSION  250 mg/5 mL Suspension for Reconstitution 6 mL PO twice daily; for 10 days Quantity: 120 Milliliter, 0 refills.
Age: 39.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Has pain in arm and fever, fever subsided with TYLENOL and MOTRIN, still has pain in arm 2 days later, told patient it was probably the pneumonia shot causing pain in arm told patient if it doesn't go away in a few days, may need to see dr to be evaluated.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Swelling and redness at injection site.
Age: 56.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site vesicles
Clinical narrative: Two days after receiving the injection, patient complained of fever, itching, pain and swelling at the injection site, redness and what look like little blisters around site. 1/11/18 -patient reports no fever but continues to have pain, redness and swelling. Site was assessed by the provider and recommended treatment was KEFLEX 500 mg 1 po tid for 10 days #30, BENADRYL 25 mg use as directed for itching (over the counter), and either MOTRIN or TYLENOL for pain (over the counter).
Age: 56.0
Sex: F
Vaccine: TDAP
Symptoms: Pyrexia
Clinical narrative: Two days after receiving the injection, patient complained of fever, itching, pain and swelling at the injection site, redness and what look like little blisters around site. 1/11/18 -patient reports no fever but continues to have pain, redness and swelling. Site was assessed by the provider and recommended treatment was KEFLEX 500 mg 1 po tid for 10 days #30, BENADRYL 25 mg use as directed for itching (over the counter), and either MOTRIN or TYLENOL for pain (over the counter).
Age: 24.0
Sex: F
Vaccine: FLU4
Symptoms: Underdose
Clinical narrative: Patient given IIV (PF) Pediatric 0.25cc dose instead of the proper IIV (PF) adult 0.5cc dosage at time of vaccination.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Urticaria
Clinical narrative: Developed hives after receiving 4 mo vaccines. Have persisted for about 3 days.
Age: 13.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Diarrhoea, Fatigue, Full blood count normal, Headache, Insomnia
Clinical narrative: Diarrhea, headache, insomnia, malaise, fatigue, and low grade fever started the day after the vaccine and continues.