chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: MNQ
Symptoms: Hyperthyroidism
Clinical narrative: This case was reported in a literature article and described the occurrence of hyperthyroidism in a subject who received Meningococcal ACWY-CRM vaccine. On an unknown date, less than a day after receiving Meningococcal ACWY-CRM vaccine, the subject developed hyperthyroidism. Serious criteria included GSK medically significant and other: serious per reporter. The outcome of hyperthyroidism was unknown. It was unknown if the investigator considered the hyperthyroidism to be related to Meningococcal ACWY-CRM vaccine. Additional information was provided. This case was reported in a literature article and described the occurrence of hyperthyroidism in a patient aged between 0-89 years of unspecified gender who was vaccinated with MENVEO (GlaxoSmithKline). The patient was a part of the study to provide additional information on post-licensure safety, reported to Vaccine Adverse Event Reporting System (VAERS) for subjects of any age receiving MENVEO during 1 January 2010 through 31 December 2015. The study utilized the data reported to a spontaneous reporting system- VAERS, the co-administered by the Centres for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA)-to summarize reports following immunization with MENVEO. No information on patient's medical or family history or concomitant medication or concurrent condition was provided. On an unspecified date, the patient received MENVEO (administration route and site unspecified; dosages unknown; batch number not provided). [In this study, out of 1380 reports, other vaccines were also given concomitantly with MENVEO. The most commonly co-administered vaccines varied depending upon age including pneumococcal (n=9) and MMR (n=8) in children less than 2 years of age, Tdap in children aged 2-10 years (n=32), Tdap (n=776) and HPV (n=608) in adolescents (aged 11-18 years), and Tdap in adults aged 19 and older (n=43)]. On an unspecified date, between 0-734 days after vaccination, the patient developed hyperthyroidism. (In this study, day 0 set as the day of vaccination). This case has been considered serious per reporter (In this study, reports are classified as serious or non-serious, using the definition for serious based on the Code of Regulations). Treatment was unknown. The outcome of the event was not reported. The authors did not comment on the relationship between the event of hyperthyroidism and MENVEO. (VAERS personnel do not perform causality assessments regarding the relationship between a particular vaccine and a temporally-associated adverse event). The authors concluded that, "In our review of VAERS reports, findings of AEs were consistent with the data from pre licensure studies. Vaccine providers should continue to emphasize and adhere to proper administration of the vaccine." This is 1 of the 45 reported cases in the same literature article.
Sex: U
Vaccine: MNQ
Symptoms: Psychogenic seizure
Clinical narrative: This case was reported in a literature article and described the occurrence of psychogenic seizure in a subject who received Meningococcal ACWY-CRM vaccine. On an unknown date, less than a day after receiving Meningococcal ACWY-CRM vaccine, the subject developed psychogenic seizure. Serious criteria included other: serious per reporter. The outcome of psychogenic seizure was unknown. It was unknown if the investigator considered the psychogenic seizure to be related to Meningococcal ACWY-CRM vaccine. Additional information was provided. This case was reported in a literature article and described the occurrence of psychogenic seizure in a patient aged between 0-89 years of unspecified gender who was vaccinated with MENVEO (GlaxoSmithKline). The patient was a part of the study to provide additional information on post-licensure safety, reported to Vaccine Adverse Event Reporting System (VAERS) for subjects of any age receiving MENVEO during 1 January 2010 through 31 December 2015. The study utilized the data reported to a spontaneous reporting system- VAERS, the co-administered by the Centres for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA)-to summarize reports following immunization with MENVEO. No information on patient's medical or family history or concomitant medication or concurrent condition was provided. On an unspecified date, the patient received MENVEO (administration route and site unspecified; dosages unknown; batch number not provided). [In this study, out of 1380 reports, other vaccines were also given concomitantly with MENVEO. The most commonly co-administered vaccines varied depending upon age including pneumococcal (n=9) and MMR (n=8) in children less than 2 years of age, Tdap in children aged 2-10 years (n=32), Tdap (n=776) and HPV (n=608) in adolescents (aged 11-18 years), and Tdap in adults aged 19 and older (n=43)]. On an unspecified date, between 0-734 days after vaccination, the patient developed psychogenic seizure. (In this study, day 0 set as the day of vaccination). This case has been considered serious per reporter (In this study, reports are classified as serious or non-serious, using the definition for serious based on the Code of Regulations). Treatment was unknown. The outcome of the event was not reported. The authors did not comment on the relationship between the event of psychogenic seizure and MENVEO. (VAERS personnel do not perform causality assessments regarding the relationship between a particular vaccine and a temporally-associated adverse event). The authors concluded that, "In our review of VAERS reports, findings of AEs were consistent with the data from pre licensure studies. Vaccine providers should continue to emphasize and adhere to proper administration of the vaccine." This is 1 of the 45 valid cases in the same literature article.
Sex: U
Vaccine: HEPA, HPV4, MNQ, MNQ
Symptoms: Brain neoplasm, Brain stem glioma, Computerised tomogram, Death, Dizziness
Clinical narrative: This case was reported in a literature article and described the occurrence of glioma in a subject who received Meningococcal ACWY-CRM vaccine. On an unknown date, less than a day after receiving Meningococcal ACWY-CRM vaccine, the subject developed glioma. Serious criteria included GSK medically significant and other: serious per reporter. The outcome of glioma was unknown. It was unknown if the investigator considered the glioma to be related to Meningococcal ACWY-CRM vaccine. Additional information was provided. This case was reported in a literature article and described the occurrence of glioma in a patient aged between 0-89 years of unspecified gender who was vaccinated with MENVEO (GlaxoSmithKline). The patient was a part of the study to provide additional information on post-licensure safety, reported to Vaccine Adverse Event Reporting System (VAERS) for subjects of any age receiving MENVEO during 1 January 2010 through 31 December 2015. The study utilized the data reported to a spontaneous reporting system- VAERS, the co-administered by the Centres for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA)-to summarize reports following immunization with MENVEO. No information on patient's medical or family history or concomitant medication or concurrent condition was provided. On an unspecified date, the patient received MENVEO (administration route and site unspecified; dosages unknown; batch number not provided). [In this study, out of 1380 reports, other vaccines were also given concomitantly with MENVEO. The most commonly co-administered vaccines varied depending upon age including pneumococcal (n=9) and MMR (n=8) in children less than 2 years of age, Tdap in children aged 2-10 years (n=32), Tdap (n=776) and HPV (n=608) in adolescents (aged 11-18 years), and Tdap in adults aged 19 and older (n=43)]. On an unspecified date, between 0-734 days after vaccination, the patient developed glioma. (In this study, day 0 set as the day of vaccination). This case has been considered serious per reporter (In this study, reports are classified as serious or non-serious, using the definition for serious based on the Code of Regulations). Treatment was unknown. The outcome of the event was not reported. The authors did not comment on the relationship between the event glioma and MENVEO. (VAERS personnel do not perform causality assessments regarding the relationship between a particular vaccine and a temporally-associated adverse event). The authors concluded that, "In our review of VAERS reports, findings of AEs were consistent with the data from pre licensure studies. Vaccine providers should continue to emphasize and adhere to proper administration of the vaccine." This is 1 of the 45 reported cases in the same literature article.
Sex: U
Vaccine: HEPA, HPV4, MNQ, MNQ
Symptoms: Malaise, Nausea
Clinical narrative: This case was reported in a literature article and described the occurrence of glioma in a subject who received Meningococcal ACWY-CRM vaccine. On an unknown date, less than a day after receiving Meningococcal ACWY-CRM vaccine, the subject developed glioma. Serious criteria included GSK medically significant and other: serious per reporter. The outcome of glioma was unknown. It was unknown if the investigator considered the glioma to be related to Meningococcal ACWY-CRM vaccine. Additional information was provided. This case was reported in a literature article and described the occurrence of glioma in a patient aged between 0-89 years of unspecified gender who was vaccinated with MENVEO (GlaxoSmithKline). The patient was a part of the study to provide additional information on post-licensure safety, reported to Vaccine Adverse Event Reporting System (VAERS) for subjects of any age receiving MENVEO during 1 January 2010 through 31 December 2015. The study utilized the data reported to a spontaneous reporting system- VAERS, the co-administered by the Centres for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA)-to summarize reports following immunization with MENVEO. No information on patient's medical or family history or concomitant medication or concurrent condition was provided. On an unspecified date, the patient received MENVEO (administration route and site unspecified; dosages unknown; batch number not provided). [In this study, out of 1380 reports, other vaccines were also given concomitantly with MENVEO. The most commonly co-administered vaccines varied depending upon age including pneumococcal (n=9) and MMR (n=8) in children less than 2 years of age, Tdap in children aged 2-10 years (n=32), Tdap (n=776) and HPV (n=608) in adolescents (aged 11-18 years), and Tdap in adults aged 19 and older (n=43)]. On an unspecified date, between 0-734 days after vaccination, the patient developed glioma. (In this study, day 0 set as the day of vaccination). This case has been considered serious per reporter (In this study, reports are classified as serious or non-serious, using the definition for serious based on the Code of Regulations). Treatment was unknown. The outcome of the event was not reported. The authors did not comment on the relationship between the event glioma and MENVEO. (VAERS personnel do not perform causality assessments regarding the relationship between a particular vaccine and a temporally-associated adverse event). The authors concluded that, "In our review of VAERS reports, findings of AEs were consistent with the data from pre licensure studies. Vaccine providers should continue to emphasize and adhere to proper administration of the vaccine." This is 1 of the 45 reported cases in the same literature article.
Sex: U
Vaccine: HEPA, HPV4, MNQ, MNQ
Symptoms: Glioma
Clinical narrative: This case was reported in a literature article and described the occurrence of glioma in a subject who received Meningococcal ACWY-CRM vaccine. On an unknown date, less than a day after receiving Meningococcal ACWY-CRM vaccine, the subject developed glioma. Serious criteria included GSK medically significant and other: serious per reporter. The outcome of glioma was unknown. It was unknown if the investigator considered the glioma to be related to Meningococcal ACWY-CRM vaccine. Additional information was provided. This case was reported in a literature article and described the occurrence of glioma in a patient aged between 0-89 years of unspecified gender who was vaccinated with MENVEO (GlaxoSmithKline). The patient was a part of the study to provide additional information on post-licensure safety, reported to Vaccine Adverse Event Reporting System (VAERS) for subjects of any age receiving MENVEO during 1 January 2010 through 31 December 2015. The study utilized the data reported to a spontaneous reporting system- VAERS, the co-administered by the Centres for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA)-to summarize reports following immunization with MENVEO. No information on patient's medical or family history or concomitant medication or concurrent condition was provided. On an unspecified date, the patient received MENVEO (administration route and site unspecified; dosages unknown; batch number not provided). [In this study, out of 1380 reports, other vaccines were also given concomitantly with MENVEO. The most commonly co-administered vaccines varied depending upon age including pneumococcal (n=9) and MMR (n=8) in children less than 2 years of age, Tdap in children aged 2-10 years (n=32), Tdap (n=776) and HPV (n=608) in adolescents (aged 11-18 years), and Tdap in adults aged 19 and older (n=43)]. On an unspecified date, between 0-734 days after vaccination, the patient developed glioma. (In this study, day 0 set as the day of vaccination). This case has been considered serious per reporter (In this study, reports are classified as serious or non-serious, using the definition for serious based on the Code of Regulations). Treatment was unknown. The outcome of the event was not reported. The authors did not comment on the relationship between the event glioma and MENVEO. (VAERS personnel do not perform causality assessments regarding the relationship between a particular vaccine and a temporally-associated adverse event). The authors concluded that, "In our review of VAERS reports, findings of AEs were consistent with the data from pre licensure studies. Vaccine providers should continue to emphasize and adhere to proper administration of the vaccine." This is 1 of the 45 reported cases in the same literature article.
Sex: U
Vaccine: MNQ
Symptoms: Erythema multiforme
Clinical narrative: This case was reported in a literature article and described the occurrence of erythema multiforme in a subject who received Meningococcal ACWY-CRM vaccine. On an unknown date, less than a day after receiving Meningococcal ACWY-CRM vaccine, the subject developed erythema multiforme. Serious criteria included GSK medically significant and other: serious per author. The outcome of erythema multiforme was unknown. It was unknown if the investigator considered the erythema multiforme to be related to Meningococcal ACWY-CRM vaccine. Additional information was provided. This case was reported in a literature article and described the occurrence of erythema multiforme in a patient aged between 0-89 years of unspecified gender who was vaccinated with MENVEO (GlaxoSmithKline). The patient was a part of the study to provide additional information on post-licensure safety, reported to Vaccine Adverse Event Reporting System (VAERS) for subjects of any age receiving MENVEO during 1 January 2010 through 31 December 2015. The study utilized the data reported to a spontaneous reporting system- VAERS, the co-administered by the Centres for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA)-to summarize reports following immunization with MENVEO. No information on patient's medical or family history or concomitant medication or concurrent condition was provided. On an unspecified date, the patient received MENVEO (administration route and site unspecified; dosages unknown; batch number not provided). [In this study, out of 1380 reports, other vaccines were also given concomitantly with MENVEO. The most commonly co-administered vaccines varied depending upon age including pneumococcal (n=9) and MMR (n=8) in children less than 2 years of age, Tdap in children aged 2-10 years (n=32), Tdap (n=776) and HPV (n=608) in adolescents (aged 11-18 years), and Tdap in adults aged 19 and older (n=43)]. On an unspecified date, between 0-734 days after vaccination, the patient developed erythema multiforme. (In this study, day 0 set as the day of vaccination). This case has been considered serious per reporter (In this study, reports are classified as serious or non-serious, using the definition for serious based on the Code of Regulations). Treatment was unknown. The outcome of the event was not reported. The authors did not comment on the relationship between the event of erythema multiforme and MENVEO. (VAERS personnel do not perform causality assessments regarding the relationship between a particular vaccine and a temporally-associated adverse event). The authors concluded that, "In our review of VAERS reports, findings of AEs were consistent with the data from pre licensure studies. Vaccine providers should continue to emphasize and adhere to proper administration of the vaccine." This is 1 of the 45 valid cases in the same literature article.
Sex: U
Vaccine: MNQ
Symptoms: Major depression
Clinical narrative: This case was reported in a literature article and described the occurrence of major depression in a subject who received Meningococcal ACWY-CRM vaccine. On an unknown date, less than a day after receiving Meningococcal ACWY-CRM vaccine, the subject developed major depression. Serious criteria included GSK medically significant and other: serious per author. The outcome of major depression was unknown. It was unknown if the investigator considered the major depression to be related to Meningococcal ACWY-CRM vaccine. Additional information was provided. This case was reported in a literature article and described the occurrence of major depression in a patient aged between 0-89 years of unspecified gender who was vaccinated with MENVEO (GlaxoSmithKline). The patient was a part of the study to provide additional information on post-licensure safety, reported to Vaccine Adverse Event Reporting System (VAERS) for subjects of any age receiving MENVEO during 1 January 2010 through 31 December 2015. The study utilized the data reported to a spontaneous reporting system- VAERS, the co-administered by the Centres for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA)-to summarize reports following immunization with MENVEO. No information on patient's medical or family history or concomitant medication or concurrent condition was provided. On an unspecified date, the patient received MENVEO (administration route and site unspecified; dosages unknown; batch number not provided). [In this study, out of 1380 reports, other vaccines were also given concomitantly with MENVEO. The most commonly co-administered vaccines varied depending upon age including pneumococcal (n=9) and MMR (n=8) in children less than 2 years of age, Tdap in children aged 2-10 years (n=32), Tdap (n=776) and HPV (n=608) in adolescents (aged 11-18 years), and Tdap in adults aged 19 and older (n=43)]. On an unspecified date, between 0-734 days after vaccination, the patient developed major depression. (In this study, day 0 set as the day of vaccination). This case has been considered serious per reporter (In this study, reports are classified as serious or non-serious, using the definition for serious based on the Code of Regulations). Treatment was unknown. The outcome of the event was not reported. The authors did not comment on the relationship between the event of major depression related to MENVEO. (VAERS personnel do not perform causality assessments regarding the relationship between a particular vaccine and a temporally-associated adverse event). The authors concluded that, "In our review of VAERS reports, findings of AEs were consistent with the data from pre licensure studies. Vaccine providers should continue to emphasize and adhere to proper administration of the vaccine." This is 1 of the 45 valid cases in the same literature article.
Age: 56.0
Sex: F
Vaccine: FLU4
Symptoms: Loss of personal independence in daily activities, Mobility decreased, Pain
Clinical narrative: Could not lift my arm in any direction. Had to have help showering, and getting dress. This was in Oct 2016, it is Mar 2017 and still cannot do all this w/o pain. Med and therapy.
Sex: F
Vaccine: TTOX, TTOX
Symptoms: Vomiting
Clinical narrative: Initial unsolicited report received from a Physician via other company Pfizer (manufacturer reference Number: 2016538292) on 02-MAR-2017. This case involves a 51 years old female patient who was vaccinated with a dose of TETANUS TOXOID (batch number, expiry date, dose and dose in series were not reported) in an unknown site on an unknown date. Patient's medical history and concomitant medications were not reported. On an unknown date, following the vaccination, the patient had developed allergic to vaccination which was symptomatized by vomiting. Laboratory investigations and corrective treatment were not reported. The outcome of event was not reported. List of documents held by sender: none.
Sex: F
Vaccine: TTOX, TTOX
Symptoms: Allergy to vaccine, Vomiting
Clinical narrative: Initial unsolicited report received from a Physician via other company Pfizer (manufacturer reference Number: 2016538292) on 02-MAR-2017. This case involves a 51 years old female patient who was vaccinated with a dose of TETANUS TOXOID (batch number, expiry date, dose and dose in series were not reported) in an unknown site on an unknown date. Patient's medical history and concomitant medications were not reported. On an unknown date, following the vaccination, the patient had developed allergic to vaccination which was symptomatized by vomiting. Laboratory investigations and corrective treatment were not reported. The outcome of event was not reported. List of documents held by sender: none.
Age: 11.0
Sex: F
Vaccine: HPV9, MEN, HPV9
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase normal, Asthenia, Blood creatinine normal, Blood urea normal
Clinical narrative: When she first got the shot her arm swelled up. She became lifeless, wanted to sleep all the time headaches, sick at stomach, Ran a fever on and off, face stayed red. I took her to several drs that didn't know what's wrong, ended up taken her to a ER they she had serum sickness from shot.
Age: 11.0
Sex: F
Vaccine: HPV9, MEN, HPV9
Symptoms: Cough, Fatigue, Influenza A virus test negative, Influenza B virus test, Influenza virus test negative
Clinical narrative: When she first got the shot her arm swelled up. She became lifeless, wanted to sleep all the time headaches, sick at stomach, Ran a fever on and off, face stayed red. I took her to several drs that didn't know what's wrong, ended up taken her to a ER they she had serum sickness from shot.
Age: 11.0
Sex: F
Vaccine: HPV9, MEN, HPV9
Symptoms: Injection site erythema, Injection site swelling, Mononucleosis heterophile test negative, Pyrexia, Somnolence
Clinical narrative: When she first got the shot her arm swelled up. She became lifeless, wanted to sleep all the time headaches, sick at stomach, Ran a fever on and off, face stayed red. I took her to several drs that didn't know what's wrong, ended up taken her to a ER they she had serum sickness from shot.
Age: 11.0
Sex: F
Vaccine: HPV9, MEN, HPV9
Symptoms: White blood cell count normal
Clinical narrative: When she first got the shot her arm swelled up. She became lifeless, wanted to sleep all the time headaches, sick at stomach, Ran a fever on and off, face stayed red. I took her to several drs that didn't know what's wrong, ended up taken her to a ER they she had serum sickness from shot.
Age: 11.0
Sex: F
Vaccine: HPV9, MEN, HPV9
Symptoms: Erythema, Feeling abnormal, Headache, Nausea, Peripheral swelling
Clinical narrative: When she first got the shot her arm swelled up. She became lifeless, wanted to sleep all the time headaches, sick at stomach, Ran a fever on and off, face stayed red. I took her to several drs that didn't know what's wrong, ended up taken her to a ER they she had serum sickness from shot.
Age: 11.0
Sex: F
Vaccine: HPV9, MEN, HPV9
Symptoms: Pyrexia, Serum sickness, Somnolence
Clinical narrative: When she first got the shot her arm swelled up. She became lifeless, wanted to sleep all the time headaches, sick at stomach, Ran a fever on and off, face stayed red. I took her to several drs that didn't know what's wrong, ended up taken her to a ER they she had serum sickness from shot.
Age: 50.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site vesicles
Clinical narrative: Blisters at site of injection, with swelling at arm, redness, itching and severe pain. Treatment: VALTREX 1G, VISTARIL PAM 25mg, Tramadol 50mg, NEURONTIN 300mg, Doxycycline HCL 100mg.
Age: 50.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Injection site vesicles, Pain, Peripheral swelling, Pruritus
Clinical narrative: Blisters at site of injection, with swelling at arm, redness, itching and severe pain. Treatment: VALTREX 1G, VISTARIL PAM 25mg, Tramadol 50mg, NEURONTIN 300mg, Doxycycline HCL 100mg.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Dizziness, Heart rate increased, Local swelling, Pharyngeal oedema
Clinical narrative: Hives, swelling of the throat and neck area, a fast heartbeat, dizziness and general weakness.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Hives, swelling of the throat and neck area, a fast heartbeat, dizziness and general weakness.
Sex: U
Vaccine: HBHEPB, HEP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies were not reported. On 06-JUN-2008, the patient was vaccinated with COMVAX Lot #656510/0222u and expiration date: 09-OCT-2009 (dose and route of administration were not reported) and with RECOMBIVAX HB Lot #0490u (dose, route of administration, expiration date were not reported) both for prophylaxis (overdose). No adverse effects were 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 referring to an unspecified number of patients of unknown age and gender. The patients' pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided. On unknown dates, the nurse reported that the patients had received improperly stored vaccine of ROTATEQ Lot #M038846 and expiration date: 26-APR-2018 (dose and route of administration were not reported) for prophylaxis. It was reported a temperature between 0° Centigrade to 2° Centigrade during a time frame of 39 minutes. There was no previous temperature excursions and the call was because of a data logger. No symptoms reported. There was no product quality complaint involved. This was one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1702USA010188: US-009507513-1702USA010190.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from an unspecified reporter. Between 06-FEB-2017 and 07-FEB-2017, 8 doses of RECOMBIVAX HB (lot number M031574 with expiration date of 11-NOV-2018, and lot number M037248 with expiration date of 21-FEB-2019), were improperly stored with a minimum temperature of -0.2 degrees Celsius during 5 hours and 59 minutes with an alarm trigger time at 12:15 hours and alarm ambient temperature of 22.1 degrees Celsius on 06-FEB-2017, and a minimum temperature of 0.1 degrees Celsius during 5 hours and 39 minutes with an alarm trigger time at 00:37 hours and alarm ambient temperature of 21.1 degrees Celsius on 07-FEB-2017. The upper alarm limit status was "ok". As of 08-FEB-2017, the doses experienced a minimum temperature of 1.9 degrees Celsius during 19 minutes with a status reported as in progress". The most recent temperature excursion for RECOMBIVAX HB was between 0 degrees Celsius and 2 degrees Celsius for 7.5 hours. In addition, it was reported that the upper alarm limit was above 8.0 degrees Celsius for 1 hour, and the lower alarm limit was below 2.0 degrees Celsius for 15 minutes. Additional information has been requested. Sender's Comments: US-009507513-1703USA006474: US-009507513-1703USA006475: US-009507513-1703USA006476.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Registered Nurse referring to an unspecified number of patients of unknown age and gender. The patients' pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided. On unknown dates, the nurse reported that an unspecified number of patients had received improperly stored vaccine of RECOMBIVAX HB Lot #M035487 and expiration date: 23-FEB-2019 (dose and route of administration were not reported) for prophylaxis. It was reported a temperature between 0° centigrade to 2° centigrade during a time frame of 39 minutes. There was no previous temperature excursions and the call was because of a data logger. No symptoms reported. There was no product quality complaint involved. This was one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1702USA006249: US-009507513-1702USA010190:
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Registered Nurse referring to an unspecified number of patients of unknown age and gender. The patients' pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided. On unknown dates, the nurse reported that the patients had received improperly stored vaccine of GARDASIL 9 Lot #M034195 and expiration date: 29-APR-2019 (dose and route of administration were not reported) for prophylaxis. It was reported a temperature between 0° centigrade to 2° centigrade during a time frame of 39 minutes. There was no previous temperature excursions and the call was because of a data logger. No symptoms were reported. There was no product quality complaint involved. This was one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1702USA006249: US-009507513-1702USA010188:
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from a nurse referring to unspecified patients of unknown age and gender. The patients' medical history, concurrent condition and concomitant therapy were not provided. The patients were vaccinated with the following improperly stored doses of PROQUAD (dose and route unknown) for prophylaxis: on 30-JAN-2017, 3 doses with lot# M031565 and expiration date 24-DEC-2017; on 31-JAN-2017, 1 dose with lot# M031568 and expiration date 24-DEC-2017; on 01-FEB-2017, 1 dose with lot# M001152 and expiration date 05-JUL-2017; on 02-FEB-2017, 2 doses with lot# M031565 and expiration date 24-DEC-2017, 2 doses with lot# M031568 and expiration date 24-DEC-2017, on 03-FEB-2017, 2 doses with M031565 and expiration date 24-DEC-2017, 1 dose with M031568 and expiration date 24-DEC-2017, 1 dose with M018638 with expiration date 11-OCT-2017; on 06-FEB-2017, 3 doses with M031565 with expiration date 24-DEC-2017, 1 dose with M031568 with expiration date 24-DEC-2017; on 07-FEB-2017, 1 dose with M031568 with expiration date 24-DEC-2017, 1 dose with M031568 with expiration date 24-DEC-2017, 2 dose with M035145 with expiration date 30-JAN-2018; on 08-FEB-2017, 3 doses with M035145 with expiration date 30-JAN-2018; on 10-FEB-2017, 1 dose with M031568 with expiration date 24-DEC-2017, 1 dose with M035145 with expiration date 30-JAN-2018; on 14-FEB-2017, 2 doses of M035145 with expiration date 30-JAN-2018; on 15-FEB-2017, 3 doses of M035145 with expiration date 30-JAN-2018; on 16-FEB-2017, 1 doses of M035145 with expiration date 30-JAN-2018; on 17-FEB-2017, 2 doses of M035145 with expiration date 30-JAN-2018. The temperature excursions that PROQUAD experienced were as follows: lot# M031565 with expiration date 24-DEC-2017, lot# M031568 with expiration date 24-DEC-2017 and lot# M001152 with expiration date 05-JUL-2017 at -3 to 61 degrees Fahrenheit (F) for 27.5 hours on 28-JAN-2017; lot# M035145 with expiration date 30-JAN-2018 and lot# M018638 with expiration date 11-OCT-2017 at -3 to 61 degrees F for 27.5 hours on 28-JAN-2017 and at -11 to 48 degrees F for 4 hours on 17-FEB-2017. It was also reported that the vaccine also experienced the following temperature excursion previously: > 14 but < 46 degrees F (>-10 but < 8 degrees centigrade (C)) for 23 hours 30 minutes; also: >46 but < 77 degrees F (>8 but < 25 degrees C) for 12 hours 45 minutes. This is one of two reports received from the same reporter. Additional information is not expected as there is no consent to contact the reporter.; Sender's Comments: US-009507513-1703USA003861:
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from the patient's daughter referring to her 85 year old mother. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX subcutaneous (strength, dose number, anatomical location, lot number and expiration date were not provided) for prophylaxis. On an unknown date, the patient developed shingles after vaccination with ZOSTAVAX. No product quality complaint was involved. At the time of the report, the outcome of herpes zoster was not reported. The reporter did not assess the relatedness between the event and suspect therapy. Additional information has been requested.
Age: 78.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Blood test normal, Computerised tomogram normal, Dyspnoea
Clinical narrative: Information has been received from an office manager via a company representative referring to a 78 year old male patient. The patient's pertinent medical history and drug allergies were not provided. There was no concomitant medication reported. On 16-FEB-2017, the patient was vaccinated with ZOSTAVAX (lot number and expiration date unknown) 0.65 ml, subcutaneously for prevention of herpes zoster. On 17-FEB-2017, the patient experienced difficulty breathing and "could not fill his lungs". On 20-FEB-2017, the patient came in for office visit due to difficulty breathing and was given DECADRON 8/4 mg. On 22-FEB-2017, the patient went to unspecified emergency room for difficulty breathing. Unspecified Blood work and a computerized axial tomography (CAT) scan was done at the emergency room and everything was fine. The outcome of the event was reported as not recovered. The causal relationship between ZOSTAVAX and the event was not provided. Additional information has been requested.
Age: 78.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Blood test, Dyspnoea, Nuclear magnetic resonance imaging, Thinking abnormal, X-ray
Clinical narrative: Information has been received from an office manager via a company representative referring to a 78 year old male patient. The patient's pertinent medical history and drug allergies were not provided. There was no concomitant medication reported. On 16-FEB-2017, the patient was vaccinated with ZOSTAVAX (lot number and expiration date unknown) 0.65 ml, subcutaneously for prevention of herpes zoster. On 17-FEB-2017, the patient experienced difficulty breathing and "could not fill his lungs". On 20-FEB-2017, the patient came in for office visit due to difficulty breathing and was given DECADRON 8/4 mg. On 22-FEB-2017, the patient went to unspecified emergency room for difficulty breathing. Unspecified Blood work and a computerized axial tomography (CAT) scan was done at the emergency room and everything was fine. The outcome of the event was reported as not recovered. The causal relationship between ZOSTAVAX and the event was not provided. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a vaccine coordinator concerning an unspecified number of unspecified patients of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided. On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX (lot # M035687, expiration date 10-AUG-2018) (strength, dose, frequency and route were not reported) for prophylaxis. It was reported that the vaccines were exposed to a temperature between 5 fahrenheit degree and 14 fahrenheit degree during a time frame of 927 hours and another temperature between 14 fahrenheit degree and 46 fahrenheit degree during a time frame of 34 hours. After two excursions, the patients had administered the vaccine. Data logger was involved. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to 12 unspecified patients (age and gender unknown). No information regarding the patients' concurrent conditions, medical history, drug reactions or allergies, and concomitant therapies was provided. The reporter stated that, on unspecified dates, the patients were vaccinated with improperly stored doses (incorrect product storage) of PROQUAD (lot# M037012, expiration date 21-FEB-2018) (strength, dose, frequency, route of administration and anatomical location were not reported) for prophylaxis. The vaccine doses were exposed to a temperature excursion greater than 5 and less than 14 degrees Fahrenheit (also reported as ">-15 but <-10 degrees Celsius") for 1 hour and 40 minutes and 2 hours in two different time frames; digital data logger was involved. No adverse effects were reported. There was not product quality complain (PQC) reported. This is one of two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1703USA001634.
Sex: U
Vaccine: PPV
Symptoms: Erythema, Pain
Clinical narrative: This spontaneous report was received from a pharmacist via other company Pfizer and refers to a patient of unknown demographics. Information on past drugs, medical history and concurrent conditions were not provided. On an unknown date, the patient was vaccinated with PNEUMOVAX 23, (route, dose and lot number were not reported) for prophylaxis. Information on concomitant medications were not provided. On an unknown date, the patient experienced pain and redness. The outcome of pain and redness was unknown. Causality of events with respect to PNEUMOVAX 23 was not provided. It was reported that there was no product complaint and no medical information request. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse practitioner referring to unknown number of patients of unknown age and gender. The patient's concurrent conditions, concomitant medication and medical history were not provided. On an unspecified date, the patients were vaccinated improperly stored VARIVAX (lot # L050560, expiration date: 14-DEC-2017; lot# M034584, expiration date: 27-JUL-2018; lot# M036292, expiration date: 17-AUG-2018; lot# M038858, expiration date: 14-SEP-2018; lot# reported as " M040137", expiration date: 28-SEP-2018; lot# reported as " M041081",  expiration date: 05-OCT-2018; lot# reported as " M038857", expiration date: 14-SEP-2018; lot# M038226, expiration date: 07-SEP-2018; lot# M037643, expiration date: 01-SEP-2018; lot# M027885, expiration date: 30-JUN-2018; dose and route unknown) for prophylaxis. The VARIVAX was stored at 10 Fahrenheit for 3024 hours. There was no previous temperature excursion. Data logger was not involved. No adverse effects were reported. No product quality complaint was involved. This is one of two reports received from the same source. Additional information has been requested.; Sender's Comments: US-009507513-1702USA012126:
Sex: F
Vaccine: HPV4
Symptoms: Dizziness
Clinical narrative: This spontaneous report was received from a physician via a company representative referring to a female patient of unknown age. The patient's medical history and concurrent conditions were not reported. On 07-NOV-2015, the patient was vaccinated with a dose of GARDASIL, intramuscular (lot # and expiry date were not reported) for prophylaxis. Other co-suspect or concomitant medications were not reported. On 07-NOV-2015, the patient felt faint (dizziness). The patient did not seek medical attention and did not receive any treatment. The outcome of dizziness was reported as recovered/resolved on 07-NOV-2015. The physician did not rate causal relationship. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: This spontaneous report has received from a physician via company representative referring to a female patient of unknown age. The patient's medical history, concurrent conditions and concomitant therapies were unknown. On an unknown date the patient was vaccinated with a does of ZOSTAVAX (dose, lot# and expiration were not reported) subcutaneously for prevent shingles.  On an unknown date the patient experienced "pain and swelling at the injection site for five days". The patient contacted physician, but no treatment was given. The outcome of injection site pain and swelling was recovered. Causality was not provided. Additional information is not expected because the reporter does not want to be contacted further.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from an unspecified reporter. Between 06-FEB-2017 and 07-FEB-2017, 9 doses of ROTATEQ (lot number M016918 with expiration date of 15-FEB-2018, and lot number reported as M31553 with expiration date of 19-MAR-2018), were improperly stored with a minimum temperature of -0.2 degrees Celsius during 5 hours and 59 minutes with an alarm trigger time at 12:15 hours and alarm ambient temperature of 22.1 degrees Celsius on 06-FEB-2017, and a minimum temperature of 0.1 degrees Celsius during 5 hours and 39 minutes with an alarm trigger time at 00:37 hours and alarm ambient temperature of 21.1 degrees Celsius on 07-FEB-2017. The upper alarm limit status was "ok". As of 08-FEB-2017, the doses experienced a minimum temperature of 1.9 degrees Celsius during 19 minutes with a status reported as in progress". The most recent temperature excursion for ROTATEQ was between 0 degrees Celsius and 2 degrees Celsius for 7.5 hours. In addition, it was reported that the upper alarm limit was above 8.0 degrees Celsius for 1 hour, and the lower alarm limit was below 2.0 degrees Celsius for 15 minutes. Additional information has been requested. Sender's Comments: US-009507513-1702USA007965: US-009507513-1703USA006475: US-009507513-1703USA006476.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from an unspecified reporter. Between 06-FEB-2017 and 07-FEB-2017, 23 doses of GARDASIL 9 (lot number M009378 with expiration date of 23-APR-2018, lot number L037554 with expiration date of 25-DEC-2017, and lot number M035486 with expiration date of 05-JUN-2019), were improperly stored with a minimum temperature of -0.2 degrees Celsius during 5 hours and 59 minutes with an alarm trigger time at 12:15 hours and alarm ambient temperature of 22.1 degrees Celsius on 06-FEB-2017, and a minimum temperature of 0.1 degrees Celsius during 5 hours and 39 minutes with an alarm trigger time at 00:37 hours and alarm ambient temperature of 21.1 degrees Celsius on 07-FEB-2017. The upper alarm limit status was "ok". As of 08-FEB-2017, the doses experienced a minimum temperature of 1.9 degrees Celsius during 19 minutes with a status reported as in progress". The most recent temperature excursion for GARDASIL 9 was between 0 degrees Celsius and 2 degrees Celsius for 7.5 hours. In addition, it was reported that the upper alarm limit was above 8.0 degrees Celsius for 1 hour, and the lower alarm limit was below 2.0 degrees Celsius for 15 minutes. Additional information has been requested. Sender's Comments: US-009507513-1703USA006474: US-009507513-1702USA007965: US-009507513-1703USA006476.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from an unspecified reporter. Between 06-FEB-2017 and 07-FEB-2017, 15 doses of VAQTA (lot number M036459 with expiration date of 18-JAN 2018, and lot number M033611 with expiration date of 02-MAR-2018), were improperly stored with a minimum temperature of -0.2 degrees Celsius during 5 hours and 59 minutes with an alarm trigger time at 12:15 hours and alarm ambient temperature of 22.1 degrees Celsius on 06-FEB-2017, and a minimum temperature of 0.1 degrees Celsius during 5 hours and 39 minutes with an alarm trigger time at 00:37 hours and alarm ambient temperature of 21.1 degrees Celsius on 07-FEB-2017. The upper alarm limit status was "ok". As of 08-FEB-2017, the doses experienced a minimum temperature of 1.9 degrees Celsius during 19 minutes with a status reported as in progress". The most recent temperature excursion for VAQTA was between 0 degrees Celsius and 2 degrees Celsius for 7.5 hours. In addition, it was reported that the upper alarm limit was above 8.0 degrees Celsius for 1 hour, and the lower alarm limit was below 2.0 degrees Celsius for 15 minutes. Additional information has been requested. Sender's Comments: US-009507513-1703USA006474: US-009507513-1703USA006475: US-009507513-1702USA007965.