chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a State Immunization Official and refers to a multiple patients (exact number unspecified) of unknown age and gender. The patients' concurrent conditions, drug reactions or allergies, concomitant therapies and medical histories were not provided. On multiple unspecified dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 injection, lot # L043214, 30-AUG-2017 and lot # M028323, 26-SEP-2018 (doses and routes of administration were not reported) for prophylaxis. Administered doses of vaccines experienced the temperature excursion of 29.3 degrees Fahrenheit (F) for 2 hours 56 minutes, 28.8 F for 7 hours 6 minutes, 34.7 F for 26 minutes, 34.5 F for 27 minutes, 33.6 F for 1 hour 13 minutes, 30.6 F for 5 hours 55 minutes, 31 F for 3 hours 30 minutes, 33 F for 1 hour 59 minutes, 33.4 F for 2 hours 20 minutes, 32 F for 4 hours 15 minutes, 32 F for 3 hours 52 minutes, 32 F for 4 hours 4 minutes, 30.1 F for 4 hours 53 minutes, 31.7 F for 4 hours 5 minutes, 32.5 F for 2 hours 21 minutes, 33.2 F for 2 hours 16 minutes and 33 F for 1 hour 23 minutes. Data logger was involved. There were no previous excursions reported. There was no adverse effect reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA014170: US-009507513-1612USA014168: US-009507513-1612USA014169.
Age: 1.08
Sex: F
Vaccine: MMRV, PNC13, VARCEL
Symptoms: Extra dose administered, No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a nurse and refers to a patient of unknown gender and age. The patient's pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with a dose of M-M-R II (dose, route of administration, lot# and expiration date were not reported) instead of receiving PROQUAD. At the same time, the patient was vaccinated with a dose of VARIVAX (dose, route of administration, lot # and expiration date were not reported). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse referring to multiple patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On multiple unknown dates, the patients were vaccinated with improperly stored doses of adult and pediatric RECOMBIVAX HB for prophylaxis, (dose, route, lot# and expiration dates were not reported). No adverse effects were reported. There were no previous temperature excursions; the data logger reported: "traceable Min. and Max." There was no Product Quality Complain (PQC) involved. This is one of several reports from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1612USA012322: US-009507513-1612USA013205: US-009507513-1612USA013206: US-009507513-1612USA013207:
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse referring to multiple patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On multiple unknown dates, the patients were vaccinated with improperly stored doses of VAQTA for prophylaxis, (route, dose, lot# and expiration dates were not reported). No adverse effects were reported. There were no previous temperature excursions; the data logger reported: "traceable Min. and Max." There was no Product Quality Complain (PQC) involved. This is one of several reports from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1612USA012322: US-009507513-1612USA013204: US-009507513-1612USA013206: US-009507513-1612USA013207:
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse referring to multiple patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On multiple unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 for prophylaxis, (route, dose, lot# and expiration dates were not reported). No adverse effects were reported. There were no previous temperature excursions; the data logger reported: "traceable Min. and Max." There was no Product Quality Complain (PQC) involved. This is one of several reports from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA012322: US-009507513-1612USA013204: US-009507513-1612USA013205: US-009507513-1612USA013207.
Age: 0.5
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ lot # L035510,  expiration date 13-MAY-2017, oral (dose was not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 50 degrees Fahrenheit for 1 hour 18 minutes. Data logger was involved. There was also previous excursion of 60 degrees Fahrenheit for 7 hours. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant and refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant therapies, drug reactions and allergies were not provided. On 14-DEC-2016, the patient was vaccinated with one improperly stored dose of VAQTA injection, lot # M022924, expiration date 24-JAN-2018 (exact dose and route of administration were not reported). There was no adverse effect reported. Product quality complaint (PQC) was not involved. Administered dose of vaccine experienced the temperature excursion of more than 46 degrees Fahrenheit but less than 77 degrees Fahrenheit for 6 hours and 15 minutes. Data logger was involved. There were no previous temperature excursions reported. 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 State Immunization Official and refers to multiple patients (exact number unspecified) of unknown age and gender. The patients' concurrent conditions, drug reactions or allergies, concomitant therapies and medical histories were not provided. On multiple unspecified dates, the patients might have been vaccinated with improperly stored doses of ROTATEQ oral liquid, lot # L013192, expiration date: 19-JAN-2017, orally (doses were not reported) for prophylaxis. Administered doses of vaccines experienced the temperature excursion of 29.3 degrees Fahrenheit (F) for 2 hours 56 minutes, 28.8 F for 7 hours 6 minutes, 34.7 F for 26 minutes, 34.5 F for 27 minutes, 33.6 F for 1 hour 13 minutes , 30.6 F for 5 hours 55 minutes, 31 F for 3 hours 30 minutes, 33 F for 1 hour 59 minutes, 33.4 F for 2 hours 20 minutes, 32 F for 4 hours 15 minutes, 32 F for 3 hours 52 minutes, 32 F for 4 hours 4 minutes, 30.1 F for 4 hours 53 minutes, 31.7 F for 4 hours 5 minutes, 32.5 F for 2 hours 21 minutes, 33.2 F for 2 hours 16 minutes and 33 F for 1 hour 23 minutes. Digital data logger was involved. There were no previous excursions reported. There was no adverse effect reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1612USA014169: US-009507513-1612USA014170: US-009507513-1612USA009918:
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a State Immunization Official and refers to multiple patients (exact number unspecified) of unknown age and gender. The patients' concurrent conditions, drug reactions or allergies, concomitant therapies and medical histories were not provided. On multiple unspecified dates, the patients might have been vaccinated with improperly stored doses of VARIVAX injection, lot# M014908 and expiration date 25-MAR-2018, lot# M028553 and expiration date 07-JUN-2018, lot # M033907 and expiration date 20-JUL-2018 (doses and routes of administration were not reported) for prophylaxis. Administered doses of vaccines experienced the temperature excursion of 11.0 degrees Fahrenheit (F) for 12 hours 2 minutes, 9.7 F for 6 hours 38 minutes, 8.1 F for 6 hours 5 minutes, 7.2 F for 6 hours 57 minutes and 7.7 F for 2 hours 51 minutes. Data logger was involved. There were no previous excursions reported. There was no adverse effect reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1612USA009918: US-009507513-1612USA014168: US-009507513-1612USA014169:
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse concerning an unknown number of unspecified patients of unknown age and gender. The patients' concomitant medications, pertinent medical history, and drug reactions and allergies have not been provided. On unspecified dates starting on or after 29-NOV-2016, improperly stored doses of PROQUAD (dose, strength, frequency and route were unknown, lot # M032496, expiration date 02-JAN-2018) were each administered to the unspecified patients for prophylaxis. The PROQUAD was exposed between -15 Celsius and -10 Celsius for a time frame of 30 minutes. There were no previous excursions, and a data logger was in use. No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested. Sender's Comments:  US-009507513-1701USA001052.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On unknown dates, the patients were vaccinated with the improperly stored (-14 degrees Celsius for 15 hours) doses of PROQUAD (albumin status rHA, lot # M007964, expiration date 15-AUG-2017; dose and route of administration were not reported) for prophylaxis. No previous excursion and no adverse effects were reported. This is one of two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1701USA001209.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site nodule, Injection site pain
Clinical narrative: This spontaneous report received from a medical assistant referred to a 12 year old female patient. The patient's medical history, concurrent conditions and concomitant medications were not reported. The patient was vaccinated with GARDASIL 9 on 28-DEC-2015, 01-MAR-2016 and on 22-NOV-2016. Physician stated that the patient developed a knot under her skin at the injection site where {and after) she was vaccinated with the third dose of GARDASIL 9. The knot felt like a large marble that is in the muscle tissue of the patient's arm and the knot has increased in size since the patient received her third dose. Physician stated that the patient mentioned the injection site area is tender to touch. Patient did not receive any treatment for the events and the events had not recovered. Causality was not reported. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report received from medical assistant referred to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. Medical assistant reported that on 22-DEC-2016, the patient received an expired dose of RECOMBIVAX HB (lot: K022265, expiry date: 22-DEC-2016). No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report received from a nurse referred to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. The nurse reported that on an unspecified patient was administered a dose of GARDASIL 9 on an unspecified date two years ago, when he/she was 11 years old. recently, on an unspecified date, the patient was administered a dose of  GARDASIL 9. No adverse effects reported.  Additional information has been requested.
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a 12-month-old patient of unknown gender. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On 04-OCT-2016, the patient received an improperly stored dose of VARIVAX injection (lot # M002063 with expiration date at 12-JAN-2018; dose and route of administration were not reported). The administered dose of vaccine was exposed to a temperature of -3.5 degrees Celsius (C) for 1 hour and 6 minutes. No previous temperature excursion was reported. Data logger was used to track the temperature. No symptoms were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information is not expected as all relevant information has been received.; Sender's Comments:  US-009507513-1610USA011133:
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a 12-month-old patient of unknown gender. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On 29-AUG-2016, the patient received an improperly stored dose of VARIVAX injection (lot # M004328 with expiration date at 26-JAN-2018; dose and route of administration were not reported). The administered dose of vaccine was exposed to a temperature of -3.5 degrees Celsius (C) for 1 hour and 6 minutes. No previous temperature excursion was reported. Data logger was used to track the temperature. No symptoms were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information is not expected as all relevant information has been received.; Sender's Comments:  US-009507513-1610USA011133:
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse concerning an unknown number of unspecified patients of unknown age and gender. The patients' concomitant medications, pertinent medical history, and drug reactions and allergies have not been provided. On unspecified dates starting on or after 29-NOV-2016, improperly stored doses of VARIVAX (dose, strength, frequency and route were unknown, lot # M004663, expiration date 25-JAN-2018) were each administered to the unspecified patients for prophylaxis. The VARIVAX was exposed between -15 Celsius and -10 Celsius for a time frame of 30 minutes. There were no previous excursions, and a data logger was in use. No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1612USA014258:
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent condition and concomitant therapy were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of PEDVAXHIB (lot # M034188, expiration date 20-MAY-2019; lot # M027883, expiration date 15-APR-2019, dose and route not reported) for prophylaxis. The doses of vaccine were improperly stored at 8.8 degrees Celsius for 30 minutes. There was no previous excursion reported. No adverse effects were reported. This is one of two reports receiving from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA011001.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On unknown dates, the patients were vaccinated with the improperly stored (-14 degrees Celsius for 15 hours) doses of VARIVAX (lot # M008173, expiration date 16-FEB-2018; dose and route of administration were not reported) for prophylaxis. No previous excursion and no adverse effects were reported. This is one of two reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1612USA015104:
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Deafness unilateral, Hypoaesthesia oral, Myalgia, Pain in extremity, Paraesthesia
Clinical narrative: Left Arm Pain (entire and not at site of injection); rash/hives running up neck into face right to left; numbing of lips (left side); tingling at left eye; loss of hearing/ringing in left ear.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash, Urticaria
Clinical narrative: Left Arm Pain (entire and not at site of injection); rash/hives running up neck into face right to left; numbing of lips (left side); tingling at left eye; loss of hearing/ringing in left ear.
Sex: U
Vaccine: FLU4
Symptoms: Cleft palate, Congenital anomaly, Foetal exposure during pregnancy
Clinical narrative: This retrospective pregnancy case was reported in a literature article and described the occurrence of cleft palate in a neonate. The mother received Flu Seasonal QIV Dresden. The pregnancy resulted in a live neonate with a congenital anomaly. The neonate was diagnosed with cleft palate. Serious criteria included GSK medically significant, congenital anomaly and other: serious per reporter. Additional event(s) included maternal vaccine exposure and live birth. The outcome of cleft palate was unknown. The outcome(s) of the additional event(s) included maternal vaccine exposure (unknown) and live birth (unknown). The investigator considered that there was a reasonable possibility that the cleft palate may have been caused by Flu Seasonal QIV Dresden. Additional information was provided. This retrospective pregnancy case was reported in this literature article and described the occurrence of cleft palate incomplete in a neonate of unspecified gender whose mother was vaccinated with unspecified seasonal inactivated influenza vaccine (manufacturer unknown) during pregnancy. The patient's mother was a part of the study that assessed the safety of seasonal inactivated influenza vaccines (IIV) and live attenuated influenza vaccines (LAIVs) in pregnant women and their infants whose reports were submitted to Vaccine Adverse Event Reporting System (VAERS) during 2010-2016. No information on patient's medical history or family history or concurrent condition or concomitant medication was provided. On an unspecified date, the patient's mother received unspecified seasonal inactivated influenza vaccine (administration route and site unspecified; dosages unknown; batch number not provided). Subsequently, the patient was exposed to the vaccine in utero. On an unspecified date between 1 July 2010 and 6 May 2016, an unknown period after maternal vaccine exposure, the patient developed cleft palate incomplete. This case has been considered serious as per the authors. Treatment was unknown. The outcome of the event was not reported. The authors did not comment on the relationship between cleft palate incomplete and unspecified seasonal inactivated influenza vaccine. However the authors stated, "VAERS also generally cannot determine whether a vaccine caused an AE." The authors concluded that "During the study period 2010-2016, the average annual number of VAERS reports following IIV in pregnancy decreased compared with the 2009-2010 pandemic period but remained higher than prior to the pandemic. Similar to the 2009-2010 period, no new or unexpected patterns in maternal or fetal outcomes were observed during 2010-2016. Maternal influenza vaccination benefits both the mother and the infant, protecting both from influenza disease. Given that the antigenic composition of these vaccines usually changes each season, the CDC and FDA will continue to monitor the safety of influenza vaccines in pregnant women." This is 1 of the 12 valid cases reported in the same literature article.
Sex: F
Vaccine: FLU3
Symptoms: Myocardial infarction
Clinical narrative: This case was reported by a nurse via other manufacturer and described the occurrence of heart attack in a 57-year-old female patient who received Influenza vaccine. Previously administered products included Acetaminophen (daily 500 mg every six hours orally), albuterol (started on 1st December 2015, inhale 2 puffs into the lungs every 6 hours as needed) and NEURONTIN (started on 17th September 2015, 300 mg 3 capsules orally tid). Concurrent medical conditions included drug allergy (with various drugs). On an unknown date, the patient received influenza vaccine at an unknown dose. On an unknown date, an unknown time after receiving Influenza vaccine, the patient experienced heart attack (serious criteria hospitalization and GSK medically significant). On an unknown date, the outcome of the heart attack was unknown. It was unknown if the reporter considered the heart attack to be related to influenza vaccine. Additional details were reported as follows: The age at vaccination was not reported. The patient also had other medications which included Primidone, LYRICA, Levothyroxine, Tramadol, Loratadine, carbidopa-levodopa, Gabapentin, Lisinopril, Benztropine mesylate, furosemide, NITROSTAT, Pramipexole dihydro, Meloxicam, VENTOLIN, polyethyl glycol powder, metoprolol tart, Aspirin, Acetaminophen, melatonin, IVP dye, Caesine, Azithromycin, codeine, cyclobenzaprine, NSAIDs, ZYRTEC, AEROBID, ENTEX lq, FLOVENT, latex, morphine, morphine and related, NIZORAL, PROVENTIL, ROXICET, saccharin, VICODIN, Aspirin, ATARAX, caffeine, contrast and other medication and muscle relaxant. The medication reported as current medication were COGENTIN, SINEMET, CLEOCIN, LASIX, NEURONTIN, SYNTHROID, LEVOTHROID, PRINIVIL, ZESTRIL, CLARITIN, Melatonin, MOBIC, LOPRESSOR, NITROSTAT, MIRALAX, MIRAPEX, LYRICA, MYSOLINE and ULTRAM. The patient received flu viral vaccine and experienced stopped heart per patient.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Myalgia, Pain in extremity
Clinical narrative: Left arm pain described as "muscle soreness" and "pulling" in days to weeks following injection, possibly due to fluvirin administration.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Pain
Clinical narrative: She started to notice increased pain and redness which has worsened through the weekend and into the following week.
Age: 54.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: He has noticed increased swelling, pain, and redness in his right upper arm since he got the shot.
Age: 11.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: His arm at the injection site she describes as being red, swollen and warm to the touch.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Irritability, Urticaria, Vomiting
Clinical narrative: Patient broke out in hives. First hives started on neck and belly and by mid day hives were all over entire body and face. Afebrile, some irritability and vomited x1.
Sex: F
Vaccine: FLU4
Symptoms: Exposure during pregnancy, Foetal death, Stillbirth
Clinical narrative: This retrospective pregnancy case was reported in a literature article and described the occurrence of fetal death in a female subject who received Flu Seasonal QIV Dresden. On an unknown date, less than a year after receiving Flu Seasonal QIV Dresden, the subject developed fetal death. Serious criteria included GSK medically significant and other: serious per reporter. Additional event(s) included vaccine exposure during pregnancy. The outcome of fetal death was unknown. The outcome(s) of the additional event(s) included vaccine exposure during pregnancy (unknown). The pregnancy ended in a stillbirth at greater than 22 weeks gestation with no apparent congenital anomaly present. The investigator considered that there was a reasonable possibility that the fetal death may have been caused by Flu Seasonal QIV Dresden. Additional information was provided. This retrospective pregnancy case was reported in this literature article and described the occurrence of foetal death in a female aged above 10-years who was vaccinated with unspecified seasonal inactivated influenza vaccine (manufacturer unknown) during pregnancy. The patient was a part of the study that assessed the safety of seasonal inactivated influenza vaccines (IIV) and live attenuated influenza vaccines (LAIVs) in pregnant women and their infants whose reports were submitted to Vaccine Adverse Event Reporting System (VAERS) during 2010-2016. No information on patient's medical or family history or concurrent condition or concomitant medication was provided. On an unspecified date, the patient received unspecified seasonal inactivated influenza vaccine (administration route and site unspecified; dosages unknown; batch number not provided) during pregnancy. On an unspecified date between 1 July 2010 and 6 May 2016, an unknown period after vaccine exposure during pregnancy, the patient had foetal death. This case has been considered serious as per the authors. Treatment was unknown. The authors did not comment on the relationship between foetal death and unspecified seasonal inactivated influenza vaccine. However the authors stated, "VAERS also generally cannot determine whether a vaccine caused an AE." The authors concluded that "During the study period 2010-2016, the average annual number of VAERS reports following IIV in pregnancy decreased compared with the 2009-2010 pandemic period but remained higher than prior to the pandemic. Similar to the 2009-2010 period, no new or unexpected patterns in maternal or fetal outcomes were observed during 2010-2016. Maternal influenza vaccination benefits both the mother and the infant, protecting both from influenza disease. Given that the antigenic composition of these vaccines usually changes each season, the CDC and FDA will continue to monitor the safety of influenza vaccines in pregnant women." This is 1 of the 12 valid cases reported in the same literature article.
Sex: F
Vaccine: FLUX
Symptoms: Exposure during pregnancy, Neoplasm
Clinical narrative: This prospective pregnancy case was reported in a literature article and described the occurrence of neoplasm in a female subject who received Flu Seasonal QIV Dresden. On an unknown date, less than a year after receiving Flu Seasonal QIV Dresden, the subject developed neoplasm. Serious criteria included other: serious per author. Additional event(s) included vaccine exposure during pregnancy. The outcome of neoplasm was unknown. The outcome(s) of the additional event(s) included vaccine exposure during pregnancy (unknown). The pregnancy was lost to follow up. The investigator considered that there was a reasonable possibility that the neoplasm may have been caused by Flu Seasonal QIV Dresden. Additional information was provided. This prospective pregnancy case was reported in a literature article and described the occurrence of neoplasia in a female aged above 10-years who was vaccinated with unspecified seasonal inactivated influenza vaccine (manufacturer unknown) during pregnancy. The patient was a part of the study that assessed the safety of seasonal inactivated influenza vaccines (IIV) and live attenuated influenza vaccines (LAIVs) in pregnant women and their infants whose reports were submitted to Vaccine Adverse Event Reporting System (VAERS) during 2010-2016. No information on patient's medical history or family history or concurrent condition or concomitant medication was provided. On an unspecified date, the patient received unspecified seasonal inactivated influenza vaccine (administration route and site unspecified; dosages unknown; batch number not provided) during pregnancy. On an unspecified date between 1 July 2010 and 6 May 2016, an unknown period after vaccine exposure during pregnancy, the patient developed neoplasia. This case has been considered serious as per the authors. Treatment was unknown. The outcome of the event was not reported. The authors did not comment on the relationship between neoplasia and unspecified seasonal inactivated influenza vaccine. However the authors stated, "VAERS also generally cannot determine whether a vaccine caused an AE." The authors concluded that "During the study period 2010-2016, the average annual number of VAERS reports following IIV in pregnancy decreased compared with the 2009-2010 pandemic period but remained higher than prior to the pandemic. Similar to the 2009-2010 period, no new or unexpected patterns in maternal or fetal outcomes were observed during 2010-2016. Maternal influenza vaccination benefits both the mother and the infant, protecting both from influenza disease. Given that the antigenic composition of these vaccines usually changes each season, the CDC and FDA will continue to monitor the safety of influenza vaccines in pregnant women." This is 1 of the 12 valid cases reported in the same literature article.
Sex: F
Vaccine: VARZOS
Symptoms: Agitation, Anger, Irritability
Clinical narrative: This spontaneous report was received from a female patient of unknown age, referring to herself. The patient's pertinent medical history, drug reactions or allergies and concomitant therapy were not reported. On 05-DEC-2016, the patient was vaccinated with a dose of ZOSTAVAX (dose, frequency, route of administration, lot # and expiration date were not reported). On an approximately 06-DEC-2016 (reported as the "day after"), the patient noticed she started to experience an "extreme state of agitation and irritability." The patient also reported she felt "very angry very easily" after getting the vaccine. The patient mentioned she was "doing better now". The patient inquired if there was any clinical information about "behavior changes" that could be associated with getting ZOSTAVAX. She was referred to the official Prescribing Information for ZOSTAVAX, for the available product information. The relationship between the adverse events and ZOSTAVAX was not reported. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to an unspecified number of patients of unknown age and gender. The patients' concurrent conditions, concomitant therapies or medical histories were not provided. On unknown date, the patients were vaccinated with improperly stored doses of VAQTA, lots# M027879 and M036459, expiration date 24-JAN-2018 and 18-JAN-2018 respectively (strength, dose, frequency and route of administration were not reported) for prophylaxis. It was reported that the temperature excursion was for 20 minutes at 9 degrees Celsius, according to the data logger. There was no previous temperature excursions. No adverse effects were reported. No product quality (PQC) complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1612USA013439: US-009507513-1612USA010790: US-009507513-1612USA013441: US-0095075131612USA013440:
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to an unspecified number of patients of unknown age and gender. The patients' concurrent conditions, concomitant therapies or medical histories were not provided. On unknown date, the patients were vaccinated with improperly stored doses of M-M-R II, lots# M011667 and M07259, expiration date 08-MAR-2018 and 09-FEB-2018 respectively (strength, dose, frequency and route of administration were not reported) for prophylaxis. It was reported that the temperature excursion was for 20 minutes at 9 degrees Celsius, according to the data logger. There was no previous temperature excursions. No adverse effects were reported. No product quality (PQC) complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 0.5
Sex: F
Vaccine: DTAP, HIBV, IPV, PPV
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a 6 month old patient of unknown gender. The patient's concomitant medications, pertinent medical history and drug reactions or allergies were not reported. On an unknown date, the patient was inadvertently vaccinated with a dose of PNEUMOVAX 23 lot # L024132 with expiry date 21-JAN-2017 (dose and route of administration were not reported) instead of PREVNAR 13. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a multiple unspecified patients of unknown demographics. On unknown dates, the patients were vaccinated with improperly stored GARDASIL 9 lot # M017983 with expiration date: 30-MAY-2018 for prophylaxis. Temperature/time frame: 1 C for 11 hours, 11 minutes. Prior excursion: 1 C for 16 hours. Data logger was involved. No adverse effects reported. No product quality complaint was involved. No additional information was provided. Additional information has been requested.
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a 12-month-old patient of unknown gender. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On 16-SEP-2016, the patient received an improperly stored dose of VARIVAX injection (lot # M002063 with expiration date at 12-JAN-2018; dose and route of administration were not reported). The administered dose of vaccine was exposed to a temperature of -3.5 degrees Celsius (C) for 1 hour and 6 minutes. No previous temperature excursion was reported. Data logger was used to track the temperature. No symptoms were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information is not expected as all relevant information has been received.; Sender's Comments:  US-009507513-1610USA011133:
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a 12-month-old patient of unknown gender. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On 12-SEP-2016, the patient received an improperly stored dose of VARIVAX injection (lot # M002063 with expiration date at 12-JAN-2018; dose and route of administration were not reported). The administered dose of vaccine was exposed to a temperature of -3.5 degrees Celsius (C) for 1 hour and 6 minutes. No previous temperature excursion was reported. Data logger was used to track the temperature. No symptoms were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information is not expected as all relevant information has been received.; Sender's Comments:  US-009507513-1610USA011133:
Age: 1.08
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a 13-month-old patient of unknown gender. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On 16-SEP-2016, the patient received an improperly stored dose of VARIVAX injection (lot # M009768 with expiration date at 23-FEB-2018; dose and route of administration were not reported). The administered dose of vaccine was exposed to a temperature of -3.5 degrees Celsius (C) for 1 hour and 6 minutes. No previous temperature excursion was reported. Data logger was used to track the temperature. No symptoms were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information is not expected as all relevant information has been received.; Sender's Comments:  US-009507513-1610USA011133:
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a 12-month-old patient of unknown gender. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On 16-SEP-2016, the patient received an improperly stored dose of VARIVAX injection (lot # M009768 with expiration date at 23-FEB-2018; dose and route of administration were not reported). The administered dose of vaccine was exposed to a temperature of -3.5 degrees Celsius (C) for 1 hour and 6 minutes. No previous temperature excursion was reported. Data logger was used to track the temperature. No symptoms were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information is not expected as all relevant information has been received.; Sender's Comments:  US-009507513-1610USA011133:
Sex: M
Vaccine: PNC13
Symptoms: Arthralgia, Fatigue, Myalgia
Clinical narrative: This is a spontaneous report obtained from a non-contactable consumer (patient). A male patient of an unspecified age and rare received PREVNAR 13 single dose, on an unknown date, for immunization. Relevant medical history and concomitant medications were unknown. On an unspecified date, the patient experienced fatigue, joint and muscle pain. Clinical outcome was unknown at time of this report. No follow-up attempts possible. No further information expected.
Sex: F
Vaccine: FLU4
Symptoms: Exposure during pregnancy, Genitourinary symptom
Clinical narrative: This prospective pregnancy case was reported in a literature article and described the occurrence of genitourinary symptom in a female subject who received Flu Seasonal QIV Dresden. On an unknown date, less than a year after receiving Flu Seasonal QIV Dresden, the subject developed genitourinary symptom. Serious criteria included other: serious per author. Additional event(s) included vaccine exposure during pregnancy. The outcome of genitourinary symptom was unknown. The outcome(s) of the additional event(s) included vaccine exposure during pregnancy (unknown). The pregnancy was lost to follow up. The investigator considered that there was a reasonable possibility that the genitourinary symptom may have been caused by Flu Seasonal QIV Dresden. Additional information was provided. This prospective pregnancy case was reported in this literature article and described the occurrence of genitourinary system disorders in a female aged above 10-year who was vaccinated with unspecified seasonal inactivated influenza vaccine (manufacturer unknown) during pregnancy. The patient was a part of the study that assessed the safety of seasonal inactivated influenza vaccines (IIV) and live attenuated influenza vaccines (LAIVs) in pregnant women and their infants whose reports were submitted to Vaccine Adverse Event Reporting System (VAERS) during 2010-2016. No information on patient's medical history or family history or concurrent condition or concomitant medication was provided. On an unspecified date, the patient received unspecified seasonal inactivated influenza vaccine (administration route and site unspecified; dosages unknown; batch number not provided) during pregnancy. On an unspecified date between 1 July 2010 and 6 May 2016, an unknown period after vaccine exposure during pregnancy the patient experienced genitourinary system disorders. This case has been considered serious as per the authors. Treatment was unknown. The outcome of the event was not reported. The authors did not comment on the relationship between genitourinary system disorders and unspecified seasonal inactivated influenza vaccine. However the authors stated, "VAERS also generally cannot determine whether a vaccine caused an AE." The authors concluded that "During the study period 2010-2016, the average annual number of VAERS reports following IIV in pregnancy decreased compared with the 2009-2010 pandemic period but remained higher than prior to the pandemic. Similar to the 2009-2010 period, no new or unexpected patterns in maternal or fetal outcomes were observed during 2010-2016. Maternal influenza vaccination benefits both the mother and the infant, protecting both from influenza disease. Given that the antigenic composition of these vaccines usually changes each season, the CDC and FDA will continue to monitor the safety of influenza vaccines in pregnant women." This is 1 of the 12 valid cases reported in the same literature article.
Sex: U
Vaccine: FLU4
Symptoms: Congenital anomaly, Foetal exposure during pregnancy, Laryngomalacia
Clinical narrative: This retrospective pregnancy case was reported in a literature article and described the occurrence of laryngomalacia in a neonate. The mother received Flu Seasonal QIV Dresden. The pregnancy resulted in a live neonate with a congenital anomaly. The neonate was diagnosed with laryngomalacia. Serious criteria included GSK medically significant, congenital anomaly and other: serious per reporter. Additional event(s) included maternal vaccine exposure and live birth. The outcome of laryngomalacia was unknown. The outcome(s) of the additional event(s) included maternal vaccine exposure (unknown) and live birth (unknown). The investigator considered that there was a reasonable possibility that the laryngomalacia may have been caused by Flu Seasonal QIV Dresden. Additional information was provided. This retrospective pregnancy case was reported in this literature article and described the occurrence of laryngomalacia in a neonate of unspecified gender whose mother was vaccinated with unspecified seasonal inactivated influenza vaccine (manufacturer unknown) during pregnancy. The patient's mother was a part of the study that assessed the safety of seasonal inactivated influenza vaccines (IIV) and live attenuated influenza vaccines (LAIVs) in pregnant women and their infants whose reports were submitted to Vaccine Adverse Event Reporting System (VAERS) during 2010-2016. No information on patient's medical history or family history or concurrent condition or concomitant medication was provided. On an unspecified date, the patient's mother received unspecified seasonal inactivated influenza vaccine (administration route and site unspecified; dosages unknown; batch number not provided). Subsequently, the patient was exposed to the vaccine in utero. On an unspecified date between 1 July 2010 and 6 May 2016, an unknown period after maternal vaccine exposure, the patient developed laryngomalacia. This case has been considered serious as per the authors. Treatment was unknown. The outcome of the event was not reported. The authors did not comment on the relationship between laryngomalacia and unspecified seasonal inactivated influenza vaccine. However the authors stated, "VAERS also generally cannot determine whether a vaccine caused an AE." The authors concluded that "During the study period 2010-2016, the average annual number of VAERS reports following IIV in pregnancy decreased compared with the 2009-2010 pandemic period but remained higher than prior to the pandemic. Similar to the 2009-2010 period, no new or unexpected patterns in maternal or fetal outcomes were observed during 2010-2016. Maternal influenza vaccination benefits both the mother and the infant, protecting both from influenza disease. Given that the antigenic composition of these vaccines usually changes each season, the CDC and FDA will continue to monitor the safety of influenza vaccines in pregnant women." This is 1 of the 12 valid cases reported in the same literature article.
Age: 38.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Injection site pain, Pain, Pain in extremity, X-ray normal
Clinical narrative: Constant pain, somewhat throbbing in my right arm, particularly at injection site, upper right arm. Wondering if injection site was done too far up on my right arm, and was injected into the deltoid?  This pain has been occurring since the actual date of the flu shot being administered, on 10/20/2016 and has not subsided.
Age: 38.0
Sex: F
Vaccine: TDAP
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Persistently sore upper arm with shoulder mobility abnormalities.
Age: 0.0
Sex: M
Vaccine: HEP
Symptoms: Circulatory collapse, Resuscitation, Shock
Clinical narrative: Vascular Collapse / Shock  Treated with code blue procedures.
Age: 28.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Eye pain, Injection site inflammation, Injection site swelling, Iritis, Malaise
Clinical narrative: I had the normal inflammation/swelling at the injection site 1-2 days after receiving the vaccine. Then about a week after the injection (12/04/16) I started having left eye pain/pressure and light sensitivity. A couple days later I had fever and malaise. My eye got really red and painful and extremely light sensitive. The eye doctor thought it was viral pink eye at first but it developed into a full blown iritis. About a week and a half after starting on steroids for the iritis I got a vesicular rash on my mouth/nose. I was prescribed valacyclovir for suspected shingles iritis.
Age: 28.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Ocular discomfort, Ocular hyperaemia, Ophthalmic herpes zoster, Ophthalmological examination, Oral mucosal eruption
Clinical narrative: I had the normal inflammation/swelling at the injection site 1-2 days after receiving the vaccine. Then about a week after the injection (12/04/16) I started having left eye pain/pressure and light sensitivity. A couple days later I had fever and malaise. My eye got really red and painful and extremely light sensitive. The eye doctor thought it was viral pink eye at first but it developed into a full blown iritis. About a week and a half after starting on steroids for the iritis I got a vesicular rash on my mouth/nose. I was prescribed valacyclovir for suspected shingles iritis.