chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 35.0
Sex: F
Vaccine: DTPHEP
Symptoms: Pneumonia, Rhinorrhoea, Secretion discharge, Vomiting
Clinical narrative: Symptoms started with feeling very heavy in top of chest, like bricks then it all locked up and I couldn't breathe. This causes coughing and gasping sometimes vomiting from coughing. After a few days like this, mucus began in chest and nose. A few more days and symptoms become flulike. Then pneumonia style begins. That devastates for a few more days. Then feeling better. Then one day cant breathe agin. The whole thing repeats. Severity has increased. Now there 8s no break for healthy spells. I feel like my child and I are dying. Literally.
Sex: U
Vaccine: FLUX
Symptoms: Congenital anomaly, Foetal exposure during pregnancy, Polydactyly
Clinical narrative: This retrospective pregnancy case was reported in a literature article and described the occurrence of polydactyly in a infant. The mother received Flu Seasonal QIV Dresden. The infant was exposed to Flu Seasonal QIV Dresden during the third trimester of pregnancy. The pregnancy resulted in a live neonate with a congenital anomaly. The infant was diagnosed with polydactyly. Serious criteria included congenital anomaly. Additional event(s) included maternal vaccine exposure and live birth. The outcome of polydactyly 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 polydactyly 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 polydactyly in an infant of unspecified gender whose mother was vaccinated with unspecified seasonal inactivated influenza vaccine (manufacturer unknown) during the third trimester of 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 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 during the 3rd trimester of pregnancy. On an unspecified date between 1 July 2010 and 6 May 2016, an unknown period after maternal vaccine exposure, the patient developed polydactyly. This case has been considered serious due to congenital anomaly. Treatment was unknown. The outcome of the event was not reported. The authors did not comment on the relationship between polydactyly 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: FLU4
Symptoms: Exposure during pregnancy, Premature labour
Clinical narrative: This prospective pregnancy case was reported in a literature article and described the occurrence of preterm labor 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 preterm labor. Serious criteria included other: serious per reporter. Additional event(s) included vaccine exposure during pregnancy. The outcome of preterm labor 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 preterm labor 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 preterm labour in a female aged above 10-years who was vaccinated with seasonal inactivated influenza vaccine (manufacturer unknown) during pregnancy. The patient was part of a 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 vaccination during pregnancy, the patient experienced preterm labour. This case has been considered as 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 preterm labour 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: FLUX
Symptoms: Congenital anomaly, Foetal exposure during pregnancy, Polydactyly
Clinical narrative: This retrospective pregnancy case was reported in a literature article and described the occurrence of polydactyly in a infant. The mother received Flu Seasonal QIV Dresden. The pregnancy resulted in a live neonate with a congenital anomaly. The infant was diagnosed with polydactyly. Serious criteria included congenital anomaly. Additional event(s) included maternal vaccine exposure and live birth. The outcome of polydactyly 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 polydactyly 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 polydactyly in an infant 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 vaccine (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 polydactyly. This case has been considered serious due to congenital anomaly. Treatment was unknown. The outcome of the event was not reported The authors did not comment on the relationship between polydactyly 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 12 valid cases in the same literature article.
Sex: F
Vaccine: FLUX
Symptoms: Exposure during pregnancy, Premature separation of placenta
Clinical narrative: This prospective pregnancy case was reported in a literature article and described the occurrence of abruptio placentae 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 abruptio placentae. Serious criteria included GSK medically significant and other: serious per reporter. Additional event(s) included vaccine exposure during pregnancy. The outcome of abruptio placentae 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 abruptio placentae 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 abruptio placentae in a female aged above 10-year who was vaccinated with unspecified seasonal inactivated influenza vaccine (manufacturer unknown) during pregnancy. The patient was part of a 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). On an unspecified date between 1 July 2010 and 6 May 2016, an unknown period after vaccine exposure during pregnancy, the patient experienced abruptio placentae. 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 abruptio placentae 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 them 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: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacy technician concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not reported. On 19-DEC-2016, the patient was vaccinated with a dose of M-M-R II (rHA) lot # L043703, expiration date: 03-NOV-2017, as prophylaxis (Strength, dose and route of administration were not reported), which experienced a temperature excursion of 61.7 Fahrenheit degrees for 1 hour. A previous temperature excursion was reported of 47.4 Fahrenheit degrees for 30 minutes. Digital data logger was involved. No adverse effects were reported. A product quality complaint was not involved. Additional information is not expected as there was no consent to contact the reporter.
Sex: F
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to two patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On unknown dates, the patients were inadvertently vaccinated with the expired doses of PNEUMOVAX 23 (lot # J005071, expiration date 19-JAN-2015; dose and route of administration were not reported). No adverse effects were reported. Follow up information was received via phone call on 19-DEC-2016 and indicated that all telephone attempts to obtain follow up information had been unsuccessful. Follow up information was received via phone call on 19-DEC-2016 from the pharmacist. The pharmacist stated that she had forwarded the correspondence to the pharmacist at the clinic where the adverse event occurred. The reporter stated that she would follow up with that pharmacist and have her fax the information in. On 21-DEC-2016, demographic information about one patient was received and it was reported that the patient was a 65-year-old female. This is one of two report received from the same reporter. Additional information is not expected, as all required correspondence has been received. Sender's Comments: US-009507513-1610USA009284.
Age: 6.0
Sex: U
Vaccine: RV5
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 6-year-old patient of unknown gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 19-DEC-2016, the patient received a dose of ROTATEQ (orally, dose, lot# and expiration date were not provided), which was outside of the recommendations in the ROTATEQ prescribing information. No adverse effect was reported. Product quality complaint (PQC) was not involved. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: First sign was 3 small bumps on my face. No treatment because I didn't associate it at first with the shot.
Age: 46.0
Sex: F
Vaccine: FLUC4
Symptoms: Areflexia, CSF cell count normal, CSF culture negative, CSF protein normal, Ear pain
Clinical narrative: 11/23/16: seen in urgent care for bilateral ear pain and sore throat. Denied any other complaints. Strep test neg. Dx w pharyngitis.  12/5: seen in urgent care for numbness and tingling in hands and feet and weakness in all extremities x 3 days. Also c/o current HA. Exam: normal gross motor strength in all extremities. Gait unsteady. No patellar Achilles or UE reflexes. MD discussed w/ neurologist who recommended admission to hospital to r/o Guillain-Barre. Same day consult by Neurology: presents w/ tingling sensation x 1 week and difficulty walking x 5 days. Onset following febrile flu-like illness. Areflexic in bilateral upper and lower extremities. Plan for LP, nerve conduction studies and imaging. Same day LP performed. CSF cell count and protein WNL, culture neg. Per neurologist: "CSF results negative for Guillain-Barre". Suspect "some element of inflammatory polyradiculoneuropathy. The question is whether this is acute or subacute". MRI brain and C-spine WNL. Nerve conduction studies performed. "The findings although not consistent w a / Guillain-Barre like syndrome, cannot totally exclude that possibility and clinical correlation is required". 12/7: Per neurologist: continues to decline. Given lack of any other explanation, 5 days of IVIG treatment started per neurology based on clinical grounds. PT and OT initiated.  12/9: LE weakness significantly improved, much more ambulatory. 12/12: Minimal weakness, less unsteadiness, less numbness and tingling. Neurologist dx: "likely an acute /subacute progressive neuropathy very suggestive of a Guillain-Barre like syndrome". Pt recovered well. Discharged home w/ PT and OT. As of 12/27, cleared to drive by PT and neurologist. Continues to see PT and OT.
Age: 46.0
Sex: F
Vaccine: FLUC4
Symptoms: Gait disturbance, Guillain-Barre syndrome, Headache, Hypoaesthesia, Immunoglobulin therapy
Clinical narrative: 11/23/16: seen in urgent care for bilateral ear pain and sore throat. Denied any other complaints. Strep test neg. Dx w pharyngitis.  12/5: seen in urgent care for numbness and tingling in hands and feet and weakness in all extremities x 3 days. Also c/o current HA. Exam: normal gross motor strength in all extremities. Gait unsteady. No patellar Achilles or UE reflexes. MD discussed w/ neurologist who recommended admission to hospital to r/o Guillain-Barre. Same day consult by Neurology: presents w/ tingling sensation x 1 week and difficulty walking x 5 days. Onset following febrile flu-like illness. Areflexic in bilateral upper and lower extremities. Plan for LP, nerve conduction studies and imaging. Same day LP performed. CSF cell count and protein WNL, culture neg. Per neurologist: "CSF results negative for Guillain-Barre". Suspect "some element of inflammatory polyradiculoneuropathy. The question is whether this is acute or subacute". MRI brain and C-spine WNL. Nerve conduction studies performed. "The findings although not consistent w a / Guillain-Barre like syndrome, cannot totally exclude that possibility and clinical correlation is required". 12/7: Per neurologist: continues to decline. Given lack of any other explanation, 5 days of IVIG treatment started per neurology based on clinical grounds. PT and OT initiated.  12/9: LE weakness significantly improved, much more ambulatory. 12/12: Minimal weakness, less unsteadiness, less numbness and tingling. Neurologist dx: "likely an acute /subacute progressive neuropathy very suggestive of a Guillain-Barre like syndrome". Pt recovered well. Discharged home w/ PT and OT. As of 12/27, cleared to drive by PT and neurologist. Continues to see PT and OT.
Age: 46.0
Sex: F
Vaccine: FLUC4
Symptoms: Influenza like illness, Muscular weakness, Nerve conduction studies normal, Neuropathy peripheral, Nuclear magnetic resonance imaging brain normal
Clinical narrative: 11/23/16: seen in urgent care for bilateral ear pain and sore throat. Denied any other complaints. Strep test neg. Dx w pharyngitis.  12/5: seen in urgent care for numbness and tingling in hands and feet and weakness in all extremities x 3 days. Also c/o current HA. Exam: normal gross motor strength in all extremities. Gait unsteady. No patellar Achilles or UE reflexes. MD discussed w/ neurologist who recommended admission to hospital to r/o Guillain-Barre. Same day consult by Neurology: presents w/ tingling sensation x 1 week and difficulty walking x 5 days. Onset following febrile flu-like illness. Areflexic in bilateral upper and lower extremities. Plan for LP, nerve conduction studies and imaging. Same day LP performed. CSF cell count and protein WNL, culture neg. Per neurologist: "CSF results negative for Guillain-Barre". Suspect "some element of inflammatory polyradiculoneuropathy. The question is whether this is acute or subacute". MRI brain and C-spine WNL. Nerve conduction studies performed. "The findings although not consistent w a / Guillain-Barre like syndrome, cannot totally exclude that possibility and clinical correlation is required". 12/7: Per neurologist: continues to decline. Given lack of any other explanation, 5 days of IVIG treatment started per neurology based on clinical grounds. PT and OT initiated.  12/9: LE weakness significantly improved, much more ambulatory. 12/12: Minimal weakness, less unsteadiness, less numbness and tingling. Neurologist dx: "likely an acute /subacute progressive neuropathy very suggestive of a Guillain-Barre like syndrome". Pt recovered well. Discharged home w/ PT and OT. As of 12/27, cleared to drive by PT and neurologist. Continues to see PT and OT.
Age: 46.0
Sex: F
Vaccine: FLUC4
Symptoms: Nuclear magnetic resonance imaging spinal normal, Oropharyngeal pain, Paraesthesia, Pharyngitis, Pyrexia
Clinical narrative: 11/23/16: seen in urgent care for bilateral ear pain and sore throat. Denied any other complaints. Strep test neg. Dx w pharyngitis.  12/5: seen in urgent care for numbness and tingling in hands and feet and weakness in all extremities x 3 days. Also c/o current HA. Exam: normal gross motor strength in all extremities. Gait unsteady. No patellar Achilles or UE reflexes. MD discussed w/ neurologist who recommended admission to hospital to r/o Guillain-Barre. Same day consult by Neurology: presents w/ tingling sensation x 1 week and difficulty walking x 5 days. Onset following febrile flu-like illness. Areflexic in bilateral upper and lower extremities. Plan for LP, nerve conduction studies and imaging. Same day LP performed. CSF cell count and protein WNL, culture neg. Per neurologist: "CSF results negative for Guillain-Barre". Suspect "some element of inflammatory polyradiculoneuropathy. The question is whether this is acute or subacute". MRI brain and C-spine WNL. Nerve conduction studies performed. "The findings although not consistent w a / Guillain-Barre like syndrome, cannot totally exclude that possibility and clinical correlation is required". 12/7: Per neurologist: continues to decline. Given lack of any other explanation, 5 days of IVIG treatment started per neurology based on clinical grounds. PT and OT initiated.  12/9: LE weakness significantly improved, much more ambulatory. 12/12: Minimal weakness, less unsteadiness, less numbness and tingling. Neurologist dx: "likely an acute /subacute progressive neuropathy very suggestive of a Guillain-Barre like syndrome". Pt recovered well. Discharged home w/ PT and OT. As of 12/27, cleared to drive by PT and neurologist. Continues to see PT and OT.
Age: 46.0
Sex: F
Vaccine: FLUC4
Symptoms: Streptococcus test negative
Clinical narrative: 11/23/16: seen in urgent care for bilateral ear pain and sore throat. Denied any other complaints. Strep test neg. Dx w pharyngitis.  12/5: seen in urgent care for numbness and tingling in hands and feet and weakness in all extremities x 3 days. Also c/o current HA. Exam: normal gross motor strength in all extremities. Gait unsteady. No patellar Achilles or UE reflexes. MD discussed w/ neurologist who recommended admission to hospital to r/o Guillain-Barre. Same day consult by Neurology: presents w/ tingling sensation x 1 week and difficulty walking x 5 days. Onset following febrile flu-like illness. Areflexic in bilateral upper and lower extremities. Plan for LP, nerve conduction studies and imaging. Same day LP performed. CSF cell count and protein WNL, culture neg. Per neurologist: "CSF results negative for Guillain-Barre". Suspect "some element of inflammatory polyradiculoneuropathy. The question is whether this is acute or subacute". MRI brain and C-spine WNL. Nerve conduction studies performed. "The findings although not consistent w a / Guillain-Barre like syndrome, cannot totally exclude that possibility and clinical correlation is required". 12/7: Per neurologist: continues to decline. Given lack of any other explanation, 5 days of IVIG treatment started per neurology based on clinical grounds. PT and OT initiated.  12/9: LE weakness significantly improved, much more ambulatory. 12/12: Minimal weakness, less unsteadiness, less numbness and tingling. Neurologist dx: "likely an acute /subacute progressive neuropathy very suggestive of a Guillain-Barre like syndrome". Pt recovered well. Discharged home w/ PT and OT. As of 12/27, cleared to drive by PT and neurologist. Continues to see PT and OT.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain in extremity, Pruritus, Swelling, Urticaria
Clinical narrative: Pain in arm from shoulder to elbow, itching, swelling, redness, hives.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Bursitis, Drug administered at inappropriate site, Pain
Clinical narrative: Acute bursitis - pain when lifting arm due to vaccine being injected right below the acromion rather than into the deltoid muscle. This is the first time I've ever experienced such pain during and after vaccination.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to multiple unspecified patients. No information regarding their pertinent medical history, concomitant medications, drug reactions, or allergies was provided. Since 08-SEP-201 to 12-OCT-2016, the patients were vaccinated with improperly stored doses of ROTATEQ oral liquid (orally; dose, lot# and expiration date were not provided). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 15 degrees Celsius for 3 hours and 40 minutes. There was no previous temperature excursion. Digital Data Logger was involved. This is one of several reports received from the same reporter. Follow up information was received from the medical assistant on 27-DEC-2016. She was going to fax the patients' identifiers, dates of vaccination, lot# and expiration dates. Additional information has been requested.; Sender's Comments: US-009507513-1612USA014131: US-009507513-1610USA008206: US-009507513-1612USA014130:
Age: 16.0
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse and refers to a 16 year old patient of unknown gender. The patient's concomitant medications, pertinent medical history and drug reactions or allergies were not reported. On 28-NOV-2016, the patient was vaccinated with an improperly stored dose of GARDASIL 9 injection (dose, route of administration were not reported; lot # M026306, expiry date: 30-APR-2018) for prophylaxis. The dose was exposed to the temperature of 32 degrees Fahrenheit (F) for a time frame of 26 days (from 05-NOV-2016 to 30-NOV-2016). There were no prior temperature excursions. Digital data logger was involved. No adverse effects were reported. Product quality complaint was not involved. This is one of two reports received from same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1612USA008528:.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to multiple unspecified patients. No information regarding their pertinent medical history, concomitant medications, drug reactions, or allergies was provided. From 08-SEP-201 to 12-OCT-2016, the patients were vaccinated with improperly stored doses of PEDVAXHIB injection (dose, route of administration, lot# and expiration date were not provided). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 15 degrees Celsius for 3 hours and 40 minutes. There was no previous temperature excursion. Digital Data Logger was involved. This is one of several reports received from the same reporter. Follow up information was received from the medical assistant on 27-DEC-2016. She was going to fax the patients' identifiers, dates of vaccination, lot# and expiration dates. Additional information has been requested. Sender's Comments: US-009507513-1612USA014131: US-009507513-1612USA014132: US-009507513-1610USA008206.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to multiple unspecified patients. No information regarding their pertinent medical history, concomitant medications, drug reactions, or allergies was provided. Since 08-SEP-201 to 12-OCT-2016, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB injection (dose, route of administration, lot# and expiration date were not provided). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 15 degrees Celsius for 3 hours and 40 minutes. There was no previous temperature excursion. Digital Data Logger was involved. This is one of several reports received from the same reporter. Follow up information was received from the medical assistant on 27-DEC-2016. She was going to fax the patients' identifiers, dates of vaccination, lot# and expiration dates. Additional information has been requested.; Sender's Comments: US-009507513-1610USA008206: US-009507513-1612USA014132: US-009507513-1612USA014130:
Age: 48.0
Sex: F
Vaccine: FLU4
Symptoms: Blood test, Chest pain, Chills, Dizziness, X-ray
Clinical narrative: 48 hours after vaccination, went to ER with chills, dizziness and chest pain.  Blood work and x-rays were taken.  No medications were administered.
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Abdominal pain, Dry mouth, Headache, Nausea, Poor quality sleep
Clinical narrative: Headache, poor sleep, abdominal pain, nausea, near syncopal, dry mouth.
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Presyncope
Clinical narrative: Headache, poor sleep, abdominal pain, nausea, near syncopal, dry mouth.
Age: 46.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Dyspnoea, Headache, Hyperhidrosis, Pain in extremity
Clinical narrative: 15 minutes after vaccination, became sweaty, dizzy, developed rash on neck, short of breath. BP-180/108. Given Benedryl 50mg IM. Patient was a doctor at a doctors conference and opted not to be transported since she was surrounded by knowledgeable colleagues. Symptoms settled after benedryl. I spoke with patient several days after the event. Sshe continued to have headaches and sore arm.  Has an appointment with her primary care doctor in mid December.
Age: 46.0
Sex: F
Vaccine: FLU4
Symptoms: Rash
Clinical narrative: 15 minutes after vaccination, became sweaty, dizzy, developed rash on neck, short of breath. BP-180/108. Given Benedryl 50mg IM. Patient was a doctor at a doctors conference and opted not to be transported since she was surrounded by knowledgeable colleagues. Symptoms settled after benedryl. I spoke with patient several days after the event. Sshe continued to have headaches and sore arm.  Has an appointment with her primary care doctor in mid December.
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Flushing, Injection site pain, Malaise, Pruritus, Rash erythematous
Clinical narrative: Several hours after receiving the vaccination, she began itching on both arms with a red rash, neck and face became flushed.  Injection site was also painful. She went to employee health and they sent her to urgent care.  She was told to take oral benedryl.  She felt unwell for several days and developed hives 48 hours after the injection.  Followed up with urgent care after a week. Symptoms resolved.
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: Several hours after receiving the vaccination, she began itching on both arms with a red rash, neck and face became flushed.  Injection site was also painful. She went to employee health and they sent her to urgent care.  She was told to take oral benedryl.  She felt unwell for several days and developed hives 48 hours after the injection.  Followed up with urgent care after a week. Symptoms resolved.
Age: 52.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Red, swollen, warm, non-tender area around injection site.  Went to employee health and she was told to report symptoms to the hotline. Symptoms resolved on own after several days without treatment.
Age: 46.0
Sex: F
Vaccine: UNK
Symptoms: Fatigue, Headache, Injection site bruising, Injection site swelling, Myalgia
Clinical narrative: Tired, headache, swollen injection site (left side) and bruise, muscle aches from left side radiating from neck to arm and hand.
Age: 49.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Injection site pain, Pain
Clinical narrative: Injection site has been painful and patient is not able to move arm normally without pain for 2 months. There is no visible redness or swelling at the site. Patient has not seen the doctor.  It was recommended that she be seen by her primary care doctor.
Age: 70.0
Sex: F
Vaccine: TDAP
Symptoms: Ataxia, Coordination abnormal, Diarrhoea, Gait disturbance, Gastrointestinal disorder
Clinical narrative: Developed a GI illness associated with nausea, vomiting, and diarrhea after a Tdap vaccination.  The patient is also having trouble ambulating and has a mildly ataxic gait.  She has no sensory symptoms but only motor and coordination symptoms.
Age: 70.0
Sex: F
Vaccine: TDAP
Symptoms: Immunoglobulin therapy, Lumbar puncture, Motor dysfunction, Nausea, Specialist consultation
Clinical narrative: Developed a GI illness associated with nausea, vomiting, and diarrhea after a Tdap vaccination.  The patient is also having trouble ambulating and has a mildly ataxic gait.  She has no sensory symptoms but only motor and coordination symptoms.
Age: 70.0
Sex: F
Vaccine: TDAP
Symptoms: Vomiting
Clinical narrative: Developed a GI illness associated with nausea, vomiting, and diarrhea after a Tdap vaccination.  The patient is also having trouble ambulating and has a mildly ataxic gait.  She has no sensory symptoms but only motor and coordination symptoms.
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Injection site pain, Joint instability, Sleep disorder
Clinical narrative: Left shoulder and deltoid pain right after injection, left shoulder and deltoid pain radiating to left elbow reported on 10-22-16, pain continues. Complaints of upper arm at injection site always sore and decrease range of motion on 11-10-16, anti-inflammatory and ice not helping, pain manageable but wakes her up occasionally at night reported on 11-17-16, PT ordered 11-17-16, reported to PT that it feels better if she holds her arm close to her body, diagnosed by PT the her left shoulder pain is due to instability on 12-16-16.
Sex: U
Vaccine: HEPA
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This solicited report was received from a registered nurse via a Merck Access Program employee (also reported as company employee) refers to a patient of unknown age and gender enrolled in a patient support program entitled "Merck Access Program". There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date, the patient was vaccinated with their first dose of VAQTA intramuscularly (dose, lot # and expiration date were not reported). On an unknown date about two months later, the patient was vaccinated with their second dose of VAQTA intramuscularly (dose, lot # and expiration date were not reported). Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: 5 DTaP reaction; not infectious. Right upper arm, not crossing joints; several on erythema, warm, mildly tender. No focal nodes, radius pulse 2X, UE w/full strength, from.
Age: 12.0
Sex: F
Vaccine: DTAP
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Patient needed a TDaP but was given a DAPTACEL. No adverse effects have been found or reported. Patient was seen for well child check up on 12-28-16.
Age: 18.0
Sex: M
Vaccine: FLU4, MENB
Symptoms: Injection site oedema, Lymph node pain
Clinical narrative: Tender (L) axillary lymph nodes and edema (L) deltoid muscle.
Age: 3.0
Sex: M
Vaccine: FLU4
Symptoms: Cough, Crying, Fall, Hypotonia
Clinical narrative: Twin given flu shot, about 15 min. later eating candy cane - neighbor noticed he put hands in air and fell on face. Mom picked up and ran to porch shaking him - seemed limp. He coughed and responded within 1 min. crying. Did not cough anything out. 16:20 - Talked with Mom - said was doing fine.
Age: 0.17
Sex: F
Vaccine: RVX
Symptoms: Incorrect route of drug administration
Clinical narrative: Gave Oral vac. pt's LT Thigh (IM).
Age: 70.0
Sex: M
Vaccine: PNC13
Symptoms: Blood test, Head discomfort, Headache, Injection site pain, Lymphadenopathy
Clinical narrative: Next day had soreness at injection site and shoulder. Swollen gland under arm (left). Soreness lasted about 3 days. Itchiness on side od body started a week ago. At same time had night sweats on 2 consecutive days and went away. On 2nd/3rd day stiffness on neck and pressure on back of head. Headache is very uncomfortable. Have to take TYLENOL/ADVIL (600mg) every day. Feels better to a degree but not sure if it is just because of the medicine. Had doctor visit on 12/27 and blood work was done. Spoke to nurse who was not sure problems were vax related and pt might be developing cranial disease. Today doctor called back and said to wait for symptoms to go away. Today feels a little better but pt taking so much ADVIL so not sure how much pain/soreness still is there.
Age: 70.0
Sex: M
Vaccine: PNC13
Symptoms: Musculoskeletal stiffness, Night sweats, Pruritus
Clinical narrative: Next day had soreness at injection site and shoulder. Swollen gland under arm (left). Soreness lasted about 3 days. Itchiness on side od body started a week ago. At same time had night sweats on 2 consecutive days and went away. On 2nd/3rd day stiffness on neck and pressure on back of head. Headache is very uncomfortable. Have to take TYLENOL/ADVIL (600mg) every day. Feels better to a degree but not sure if it is just because of the medicine. Had doctor visit on 12/27 and blood work was done. Spoke to nurse who was not sure problems were vax related and pt might be developing cranial disease. Today doctor called back and said to wait for symptoms to go away. Today feels a little better but pt taking so much ADVIL so not sure how much pain/soreness still is there.
Age: 48.0
Sex: F
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: Hives 24 hours after vaccination.
Age: 5.0
Sex: F
Vaccine: VARCEL
Symptoms: Blood test, Burning sensation, Contusion, Culture, Injection site erythema
Clinical narrative: My daughter started off with a little bruise and complained of burning. I thought it was just some bruising from the vaccination and thought nothing of it. Later her arm swelled and had a raised rash that over night turned into blisters. The site was warm, pink/red, warm, rashy and blistery.
Age: 5.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site rash, Injection site swelling, Injection site vesicles, Injection site warmth, Urine analysis
Clinical narrative: My daughter started off with a little bruise and complained of burning. I thought it was just some bruising from the vaccination and thought nothing of it. Later her arm swelled and had a raised rash that over night turned into blisters. The site was warm, pink/red, warm, rashy and blistery.
Age: 66.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Headache, Injection site erythema, Injection site pruritus, Injection site swelling, Pruritus
Clinical narrative: Swelling and redness below injection site to the elbow with an itching sensation around the swelling which radiated down the arm to the wrist. The swelling was the size of my palm/fist. Onset of a mild headache. Applied ice to the swelling and took acetaminophen tablets prior to bed. The next AM the itching stopped with the swelling subsiding and the redness dissipated. The mild headache is continuing.
Age: 66.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Injection site erythema, Injection site swelling, Myalgia
Clinical narrative: Swelling and redness below injection site to the elbow with an itching sensation around the swelling which radiated down the arm to the wrist. The swelling was the size of my palm/fist. Onset of a mild headache. Applied ice to the swelling and took acetaminophen tablets prior to bed. The next AM the itching stopped with the swelling subsiding and the redness dissipated. The mild headache is continuing.
Age: 66.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Headache, Injection site erythema, Injection site pruritus, Injection site swelling, Pruritus
Clinical narrative: Patient states that he had muscle aches with redness and swelling at the site down to arm.
Age: 66.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Injection site erythema, Injection site swelling, Myalgia
Clinical narrative: Patient states that he had muscle aches with redness and swelling at the site down to arm.
Age: 14.0
Sex: F
Vaccine: FLU4, HPV9
Symptoms: Blood culture negative, C-reactive protein increased, Chills, Cytomegalovirus test positive, Hypotension
Clinical narrative: Developed fever and chills, tmax 103.  near-syncope episode in office 12/22/16, admitted to Hospital for tachycardia and hypotension despite fluids administered.
Age: 14.0
Sex: F
Vaccine: FLU4, HPV9
Symptoms: Influenza virus test negative, Presyncope, Pyrexia, Red blood cell sedimentation rate normal, Streptococcus test negative
Clinical narrative: Developed fever and chills, tmax 103.  near-syncope episode in office 12/22/16, admitted to Hospital for tachycardia and hypotension despite fluids administered.
Age: 14.0
Sex: F
Vaccine: FLU4, HPV9
Symptoms: Tachycardia, Viral test negative, White blood cell count normal
Clinical narrative: Developed fever and chills, tmax 103.  near-syncope episode in office 12/22/16, admitted to Hospital for tachycardia and hypotension despite fluids administered.
Age: 35.0
Sex: M
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Injection site pain, Pain
Clinical narrative: Muscle pain in left arm, deltoid. Pain localized at site of injection. Pain has continued even presently, increase. I am a very active person. I am no longer able to work out my biceps or triceps without pain. The pain is not getting better, it is getting worse.
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Hypoaesthesia, Injection site swelling, Paraesthesia
Clinical narrative: Patient had numbness, tingling down left arm up to 3 weeks after the administration. Patient also had swelling (grape size lump) near injection site for almost 3 weeks.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician refers to an unspecified number of patients of an unknown age and gender. The patients relevant medical history, concurrent condition and concomitant medication were not reported. On unknown dates, the patients were vaccinated with unspecified improperly stored doses (at a temperature of 10 degrees Fahrenheit (F) for 1 hour) PROQUAD for prophylaxis  (lot # M029595 and expiration date of 10-DEC-2017) (strength, dosage schedule, anatomical location and route were not reported). No adverse effects were provided.  No Product Quality Complaint (PQC) was involved. This is one of several reports received from the same reporter. As of 16-DEC-2016, all telephone attempts to obtain follow-up information have been unsuccessful. Additional information has been requested. ; Sender's Comments: US-009507513-1610USA010337: US-009507513-1610USA010777:, MERCK 1610USA010778:Mfr number
Sex: F
Vaccine: PPV
Symptoms: Urticaria
Clinical narrative: Information has been received from a Nurse Practitioner (NP) via company representative concerning to herself, a non pregnant female patient over "65" year old. No medical history or concurrent conditions were reported. Concomitant therapies included PREVNAR 13 vaccine. The reporter stated that on an unknown date, after receiving a PNEUMOVAX (strength, dose, route of administration, lot # and expiration date were not reported) for prophylaxis, she got the PREVNAR 13 vaccine, on an unknown date and subsequently got hives on her body. No product quality compliance was involved. At the reporting time, the outcome of hives was unknown. The relatedness between hives and PNEUMOVAX was not 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 Medical assistant referring to an unspecified patient of unknown age and gender. The patient's concurrent conditions, medical history, drug reaction, allergies and concomitant medication were not reported. On an unspecific date the patient was administered with improperly stored ROTATEQ (lot # M018957, expiration date 22-NOV-2017)(strength and dose were not provided) orally for prophylaxis.  It was reported that the temperature excursion was for for a total of 10 hours and was exposed to 1.36 C, according to the data logger. There was no previous temperature excursion. No adverse effects were reported. No product quality complaint was involved. Additional information has been requested.
Age: 1.75
Sex: F
Vaccine: DTAPIPVHIB, FLU4, PNC13
Symptoms: Blood chloride normal, Blood creatinine decreased, Blood glucose normal, Blood potassium normal, Blood sodium normal
Clinical narrative: Henoch Schonlein purpura 12.23.16 following vaccines 12.14.16. URI SX/cough SX approximately 12.16.16. Platelets stable, trace blood UA.
Age: 1.75
Sex: F
Vaccine: DTAPIPVHIB, FLU4, PNC13
Symptoms: Blood urea normal, Blood urine present, Carbon dioxide normal, Cough, Haematocrit normal
Clinical narrative: Henoch Schonlein purpura 12.23.16 following vaccines 12.14.16. URI SX/cough SX approximately 12.16.16. Platelets stable, trace blood UA.
Age: 1.75
Sex: F
Vaccine: DTAPIPVHIB, FLU4, PNC13
Symptoms: Haemoglobin normal, Henoch-Schonlein purpura, Platelet count normal, Upper respiratory tract infection, White blood cell count normal
Clinical narrative: Henoch Schonlein purpura 12.23.16 following vaccines 12.14.16. URI SX/cough SX approximately 12.16.16. Platelets stable, trace blood UA.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Patient has been experiencing Left arm pain since receiving vaccine.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Axillary pain
Clinical narrative: Reported soreness in armpit area.
Age: 1.08
Sex: F
Vaccine: FLU4, HEPA, MMR, PNC13, VARCEL
Symptoms: Body temperature increased, Influenza virus test negative, Staphylococcus test negative
Clinical narrative: Child developed temp 104.5.
Age: 1.25
Sex: M
Vaccine: FLU4, MMR, VARCEL
Symptoms: Blister, Erythema, Local swelling
Clinical narrative: Red raised area measuring 2.5cm x 1cm with smaller blisters-2 inside.
Age: 19.0
Sex: F
Vaccine: FLU4, HPV4
Symptoms: Injection site erythema, Injection site nodule, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Pt. reports tenderness at site next day. By the second day reports swelling, tenderness, feverish at site. Per pt. unable to sleep on that arm. Swelling continued to increase and redness started after 3-4 days. Presented to clinic 12-29-16 with area red, feverish, and knot at injection site.
Age: 19.0
Sex: F
Vaccine: FLU4, HPV4
Symptoms: Sleep disorder
Clinical narrative: Pt. reports tenderness at site next day. By the second day reports swelling, tenderness, feverish at site. Per pt. unable to sleep on that arm. Swelling continued to increase and redness started after 3-4 days. Presented to clinic 12-29-16 with area red, feverish, and knot at injection site.