chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: FLU3, FLU3, FLU3, FLU3, FLU3
Symptoms: Hypertension, Laboratory test abnormal, Muscle spasms, Pathology test, Pneumonia
Clinical narrative: This medically confirmed health authority report (initial receipt 20-Jul-2015) concerns a patient (fetus). On 07-Nov-2014, the patient received Afluria (influenza virus vaccine polyvalent, batch number T52208) via the mother, in-utero. On 08-Nov-2014, the patient's mother experienced leg cramps and abdominal pain and was in pre-term labor. The mother also had extremely high blood pressure and rapid heart rate upon arriving at the entrance of the ER (emergency room) (refer to case: US-BEH-2015052681). The mother gave birth to a still born 16-weeks gestation baby. The pathology of the placenta and fetus revealed chorioamnionitis of the placenta and the fetus patient developed pneumonia, which resulted in fetal death. The outcome was fetal death. VAERS case ID: 574857. Follow up (23-Sep-2015): The health authority reported the terms abdominal pain, amniotic cavity infection, delivery, heart rate increased, hypertension, muscle spasms, premature labour and still birth (NB: In context, the events belong to the mother - see US-BEH-2015052681). The patient attended the Emergency Room. Reporter's Comments: VAERS case ID: 574857. Sender's Comments: Seriousness: Serious.  Fetal death. Listedness: Unlisted. According to the CSL Inactivated Influenza Virus Vaccine CCDS, all events are unlisted. According to the Afluria PI, Pneumonia and foetal death is unlisted. Maternal drug exposure is listed as vaccination is not contraindicated in pregnancy. Causality: Not related. The time to foetal demise is not clear but approximately within days following vaccination in mother.  The maternal diagnosis was chorioamnionitis and Pneumonia in foetus which is possibly due to amniotic infection. The origin of (maternal) infection is not known but infection from vagina, colon and or urinary tract infection are plausible as opposed to vaccination. Company assessment 05-Oct-2015:  No change in assessment.
Sex: F
Vaccine: FLU3, FLU3, FLU3, FLU3, FLU3
Symptoms: Premature labour, Stillbirth
Clinical narrative: This medically confirmed health authority report (initial receipt 20-Jul-2015) concerns a patient (fetus). On 07-Nov-2014, the patient received Afluria (influenza virus vaccine polyvalent, batch number T52208) via the mother, in-utero. On 08-Nov-2014, the patient's mother experienced leg cramps and abdominal pain and was in pre-term labor. The mother also had extremely high blood pressure and rapid heart rate upon arriving at the entrance of the ER (emergency room) (refer to case: US-BEH-2015052681). The mother gave birth to a still born 16-weeks gestation baby. The pathology of the placenta and fetus revealed chorioamnionitis of the placenta and the fetus patient developed pneumonia, which resulted in fetal death. The outcome was fetal death. VAERS case ID: 574857. Follow up (23-Sep-2015): The health authority reported the terms abdominal pain, amniotic cavity infection, delivery, heart rate increased, hypertension, muscle spasms, premature labour and still birth (NB: In context, the events belong to the mother - see US-BEH-2015052681). The patient attended the Emergency Room. Reporter's Comments: VAERS case ID: 574857. Sender's Comments: Seriousness: Serious.  Fetal death. Listedness: Unlisted. According to the CSL Inactivated Influenza Virus Vaccine CCDS, all events are unlisted. According to the Afluria PI, Pneumonia and foetal death is unlisted. Maternal drug exposure is listed as vaccination is not contraindicated in pregnancy. Causality: Not related. The time to foetal demise is not clear but approximately within days following vaccination in mother.  The maternal diagnosis was chorioamnionitis and Pneumonia in foetus which is possibly due to amniotic infection. The origin of (maternal) infection is not known but infection from vagina, colon and or urinary tract infection are plausible as opposed to vaccination. Company assessment 05-Oct-2015:  No change in assessment.
Sex: F
Vaccine: FLU3, FLU3, FLU3, FLU3, FLU3
Symptoms: Abdominal pain, Amniotic cavity infection, Delivery, Foetal death, Heart rate increased
Clinical narrative: This medically confirmed health authority report (initial receipt 20-Jul-2015) concerns a patient (fetus). On 07-Nov-2014, the patient received Afluria (influenza virus vaccine polyvalent, batch number T52208) via the mother, in-utero. On 08-Nov-2014, the patient's mother experienced leg cramps and abdominal pain and was in pre-term labor. The mother also had extremely high blood pressure and rapid heart rate upon arriving at the entrance of the ER (emergency room) (refer to case: US-BEH-2015052681). The mother gave birth to a still born 16-weeks gestation baby. The pathology of the placenta and fetus revealed chorioamnionitis of the placenta and the fetus patient developed pneumonia, which resulted in fetal death. The outcome was fetal death. VAERS case ID: 574857. Follow up (23-Sep-2015): The health authority reported the terms abdominal pain, amniotic cavity infection, delivery, heart rate increased, hypertension, muscle spasms, premature labour and still birth (NB: In context, the events belong to the mother - see US-BEH-2015052681). The patient attended the Emergency Room. Reporter's Comments: VAERS case ID: 574857. Sender's Comments: Seriousness: Serious.  Fetal death. Listedness: Unlisted. According to the CSL Inactivated Influenza Virus Vaccine CCDS, all events are unlisted. According to the Afluria PI, Pneumonia and foetal death is unlisted. Maternal drug exposure is listed as vaccination is not contraindicated in pregnancy. Causality: Not related. The time to foetal demise is not clear but approximately within days following vaccination in mother.  The maternal diagnosis was chorioamnionitis and Pneumonia in foetus which is possibly due to amniotic infection. The origin of (maternal) infection is not known but infection from vagina, colon and or urinary tract infection are plausible as opposed to vaccination. Company assessment 05-Oct-2015:  No change in assessment.
Sex: F
Vaccine: FLU3, FLU3, FLU3, FLU3, FLU3
Symptoms: Hypertension, Muscle spasms, Pneumonia, Premature labour, Stillbirth
Clinical narrative: This medically confirmed health authority report (initial receipt 20-Jul-2015) concerns a patient (fetus). On 07-Nov-2014, the patient received Afluria (influenza virus vaccine polyvalent, batch number T52208) via the mother, in-utero. On 08-Nov-2014, the patient's mother experienced leg cramps and abdominal pain and was in pre-term labor. The mother also had extremely high blood pressure and rapid heart rate upon arriving at the entrance of the ER (emergency room) (refer to case: US-BEH-2015052681). The mother gave birth to a still born 16-weeks gestation baby. The pathology of the placenta and fetus revealed chorioamnionitis of the placenta and the fetus patient developed pneumonia, which resulted in fetal death. The outcome was fetal death. VAERS case ID: 574857. Follow up (23-Sep-2015): The health authority reported the terms abdominal pain, amniotic cavity infection, delivery, heart rate increased, hypertension, muscle spasms, premature labour and still birth (NB: In context, the events belong to the mother - see US-BEH-2015052681). The patient attended the Emergency Room. Reporter's Comments: VAERS case ID: 574857. Sender's Comments: Seriousness: Serious.  Fetal death. Listedness: Unlisted. According to the CSL Inactivated Influenza Virus Vaccine CCDS, all events are unlisted. According to the Afluria PI, Pneumonia and foetal death is unlisted. Maternal drug exposure is listed as vaccination is not contraindicated in pregnancy. Causality: Not related. The time to foetal demise is not clear but approximately within days following vaccination in mother.  The maternal diagnosis was chorioamnionitis and Pneumonia in foetus which is possibly due to amniotic infection. The origin of (maternal) infection is not known but infection from vagina, colon and or urinary tract infection are plausible as opposed to vaccination. Company assessment 05-Oct-2015:  No change in assessment.
Sex: F
Vaccine: FLU3, FLU3, FLU3, FLU3, FLU3
Symptoms: Foetal exposure during pregnancy, Pathology test, Pneumonia, Premature baby death, Stillbirth
Clinical narrative: This medically confirmed health authority report (initial receipt 20-Jul-2015) concerns a patient (fetus). On 07-Nov-2014, the patient received Afluria (influenza virus vaccine polyvalent, batch number T52208) via the mother, in-utero. On 08-Nov-2014, the patient's mother experienced leg cramps and abdominal pain and was in pre-term labor. The mother also had extremely high blood pressure and rapid heart rate upon arriving at the entrance of the ER (emergency room) (refer to case: US-BEH-2015052681). The mother gave birth to a still born 16-weeks gestation baby. The pathology of the placenta and fetus revealed chorioamnionitis of the placenta and the fetus patient developed pneumonia, which resulted in fetal death. The outcome was fetal death. VAERS case ID: 574857. Follow up (23-Sep-2015): The health authority reported the terms abdominal pain, amniotic cavity infection, delivery, heart rate increased, hypertension, muscle spasms, premature labour and still birth (NB: In context, the events belong to the mother - see US-BEH-2015052681). The patient attended the Emergency Room. Reporter's Comments: VAERS case ID: 574857. Sender's Comments: Seriousness: Serious.  Fetal death. Listedness: Unlisted. According to the CSL Inactivated Influenza Virus Vaccine CCDS, all events are unlisted. According to the Afluria PI, Pneumonia and foetal death is unlisted. Maternal drug exposure is listed as vaccination is not contraindicated in pregnancy. Causality: Not related. The time to foetal demise is not clear but approximately within days following vaccination in mother.  The maternal diagnosis was chorioamnionitis and Pneumonia in foetus which is possibly due to amniotic infection. The origin of (maternal) infection is not known but infection from vagina, colon and or urinary tract infection are plausible as opposed to vaccination. Company assessment 05-Oct-2015:  No change in assessment.
Sex: F
Vaccine: FLU3, FLU3, FLU3, FLU3, FLU3
Symptoms: Abdominal pain, Abortion spontaneous, Amniotic cavity infection, Exposure during pregnancy, Foetal disorder
Clinical narrative: This medically confirmed health authority report (initial receipt 20-Jul-2015) concerns a patient (fetus). On 07-Nov-2014, the patient received Afluria (influenza virus vaccine polyvalent, batch number T52208) via the mother, in-utero. On 08-Nov-2014, the patient's mother experienced leg cramps and abdominal pain and was in pre-term labor. The mother also had extremely high blood pressure and rapid heart rate upon arriving at the entrance of the ER (emergency room) (refer to case: US-BEH-2015052681). The mother gave birth to a still born 16-weeks gestation baby. The pathology of the placenta and fetus revealed chorioamnionitis of the placenta and the fetus patient developed pneumonia, which resulted in fetal death. The outcome was fetal death. VAERS case ID: 574857. Follow up (23-Sep-2015): The health authority reported the terms abdominal pain, amniotic cavity infection, delivery, heart rate increased, hypertension, muscle spasms, premature labour and still birth (NB: In context, the events belong to the mother - see US-BEH-2015052681). The patient attended the Emergency Room. Reporter's Comments: VAERS case ID: 574857. Sender's Comments: Seriousness: Serious.  Fetal death. Listedness: Unlisted. According to the CSL Inactivated Influenza Virus Vaccine CCDS, all events are unlisted. According to the Afluria PI, Pneumonia and foetal death is unlisted. Maternal drug exposure is listed as vaccination is not contraindicated in pregnancy. Causality: Not related. The time to foetal demise is not clear but approximately within days following vaccination in mother.  The maternal diagnosis was chorioamnionitis and Pneumonia in foetus which is possibly due to amniotic infection. The origin of (maternal) infection is not known but infection from vagina, colon and or urinary tract infection are plausible as opposed to vaccination. Company assessment 05-Oct-2015:  No change in assessment.
Sex: F
Vaccine: FLU3, FLU3, FLU3, FLU3, FLU3
Symptoms: Heart rate increased, Hypertension, Laboratory test abnormal, Muscle spasms, Pathology test
Clinical narrative: This medically confirmed health authority report (initial receipt 20-Jul-2015) concerns a patient (fetus). On 07-Nov-2014, the patient received Afluria (influenza virus vaccine polyvalent, batch number T52208) via the mother, in-utero. On 08-Nov-2014, the patient's mother experienced leg cramps and abdominal pain and was in pre-term labor. The mother also had extremely high blood pressure and rapid heart rate upon arriving at the entrance of the ER (emergency room) (refer to case: US-BEH-2015052681). The mother gave birth to a still born 16-weeks gestation baby. The pathology of the placenta and fetus revealed chorioamnionitis of the placenta and the fetus patient developed pneumonia, which resulted in fetal death. The outcome was fetal death. VAERS case ID: 574857. Follow up (23-Sep-2015): The health authority reported the terms abdominal pain, amniotic cavity infection, delivery, heart rate increased, hypertension, muscle spasms, premature labour and still birth (NB: In context, the events belong to the mother - see US-BEH-2015052681). The patient attended the Emergency Room. Reporter's Comments: VAERS case ID: 574857. Sender's Comments: Seriousness: Serious.  Fetal death. Listedness: Unlisted. According to the CSL Inactivated Influenza Virus Vaccine CCDS, all events are unlisted. According to the Afluria PI, Pneumonia and foetal death is unlisted. Maternal drug exposure is listed as vaccination is not contraindicated in pregnancy. Causality: Not related. The time to foetal demise is not clear but approximately within days following vaccination in mother.  The maternal diagnosis was chorioamnionitis and Pneumonia in foetus which is possibly due to amniotic infection. The origin of (maternal) infection is not known but infection from vagina, colon and or urinary tract infection are plausible as opposed to vaccination. Company assessment 05-Oct-2015:  No change in assessment.
Sex: F
Vaccine: FLU3, FLU3, FLU3, FLU3, FLU3
Symptoms: Premature baby death, Premature labour, Stillbirth
Clinical narrative: This medically confirmed health authority report (initial receipt 20-Jul-2015) concerns a patient (fetus). On 07-Nov-2014, the patient received Afluria (influenza virus vaccine polyvalent, batch number T52208) via the mother, in-utero. On 08-Nov-2014, the patient's mother experienced leg cramps and abdominal pain and was in pre-term labor. The mother also had extremely high blood pressure and rapid heart rate upon arriving at the entrance of the ER (emergency room) (refer to case: US-BEH-2015052681). The mother gave birth to a still born 16-weeks gestation baby. The pathology of the placenta and fetus revealed chorioamnionitis of the placenta and the fetus patient developed pneumonia, which resulted in fetal death. The outcome was fetal death. VAERS case ID: 574857. Follow up (23-Sep-2015): The health authority reported the terms abdominal pain, amniotic cavity infection, delivery, heart rate increased, hypertension, muscle spasms, premature labour and still birth (NB: In context, the events belong to the mother - see US-BEH-2015052681). The patient attended the Emergency Room. Reporter's Comments: VAERS case ID: 574857. Sender's Comments: Seriousness: Serious.  Fetal death. Listedness: Unlisted. According to the CSL Inactivated Influenza Virus Vaccine CCDS, all events are unlisted. According to the Afluria PI, Pneumonia and foetal death is unlisted. Maternal drug exposure is listed as vaccination is not contraindicated in pregnancy. Causality: Not related. The time to foetal demise is not clear but approximately within days following vaccination in mother.  The maternal diagnosis was chorioamnionitis and Pneumonia in foetus which is possibly due to amniotic infection. The origin of (maternal) infection is not known but infection from vagina, colon and or urinary tract infection are plausible as opposed to vaccination. Company assessment 05-Oct-2015:  No change in assessment.
Age: 22.0
Sex: F
Vaccine: SMALL, TYP, SMALL, TYP
Symptoms: Smallpox
Clinical narrative: This unsolicited case was received on 28-Sep-2015 via a third party query tool search on the VAERS database, under reference number 575964. This case involves a 22-years old female patient who received the following vaccinations on 17-Apr-2015: A dose of ACAM2000 (lot number "VV0034A", manufacturer: Sanofi Pasteur Biologics Co) in the left arm via an unknown route and a dose of TYPHIM (lot number: K11831, manufacturer: Sanofi Pasteur SA) in the right arm via intramuscular route. The patient did not take any concomitant medications. She did not have any medical history and current illnesses. The prior vaccination details were not provided. On 29-Apr-2015, 12 days post vaccination; the patient had an orthopox virus infection. Smallpox vaccine like lesions was noted to left face and inside left inferior lip. There were no laboratory investigations done and corrective treatment was not provided. The outcome of the event was not reported. Upon internal review, this case was considered serious due to important medical event: Orthopox virus infection. List of documents held by sender: none.
Age: 22.0
Sex: F
Vaccine: SMALL, TYP, SMALL, TYP
Symptoms: Orthopox virus infection
Clinical narrative: This unsolicited case was received on 28-Sep-2015 via a third party query tool search on the VAERS database, under reference number 575964. This case involves a 22-years old female patient who received the following vaccinations on 17-Apr-2015: A dose of ACAM2000 (lot number "VV0034A", manufacturer: Sanofi Pasteur Biologics Co) in the left arm via an unknown route and a dose of TYPHIM (lot number: K11831, manufacturer: Sanofi Pasteur SA) in the right arm via intramuscular route. The patient did not take any concomitant medications. She did not have any medical history and current illnesses. The prior vaccination details were not provided. On 29-Apr-2015, 12 days post vaccination; the patient had an orthopox virus infection. Smallpox vaccine like lesions was noted to left face and inside left inferior lip. There were no laboratory investigations done and corrective treatment was not provided. The outcome of the event was not reported. Upon internal review, this case was considered serious due to important medical event: Orthopox virus infection. List of documents held by sender: none.
Age: 0.3
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5
Symptoms: Fontanelle bulging, Irritability, Ultrasound scan normal, VIth nerve paralysis
Clinical narrative: The initial case was missing the following minimum criteria: unspecified adverse event. Upon receipt of follow-up information on 28Sep2015, this case now contains all required information to be considered valid. This is a spontaneous report from a contactable other health professional reporting on behalf of physician via a Pfizer sales representative. An 8-month-old female patient of an unspecified ethnicity received second dose of PREVNAR 13 (Lot# L62072, Exp date 16Nov2015), intramuscular, on 12May2015 at 11:39 am, at 0.5 ml, single second dose of PENTACEL (Lot# C4772AA/C4855AA, Exp date 18Jul2016), intramuscular, on 12May2015 at 11:39 am, at 0.5 ml, and second dose of ROTATEQ (Lot# K020183, Exp date 25Jun2016), oral, on 12May2015 at 11:39 am, at 2 ml. Relevant medical history and concomitant medications were not reported. The patient previously received first dose of PREVNAR 13, PENTACEL and ROTATEQ. Within a few hours from vaccination the patient experienced fussyness, bulging fontanelle and sixth nerve palsy. The events required physician visit and recovered on an unspecified date. The patient was visited by an ophthalmologist for the sixth nerve palsy, and on 02Jun2015 esotropia, pseudostrabismus and hyperopia were noted. The reporter considered the events as related to the suspect vaccines.                    Adjudication Data Entry       Select the radio button next to any fields that need editing and enter data.   Box 7 Describe Adverse Event  (and treatment if any)
Age: 0.3
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5
Symptoms: Agitation, Fontanelle bulging, Inappropriate schedule of drug administration, Pyrexia, Ultrasound scan
Clinical narrative: The initial case was missing the following minimum criteria: unspecified adverse event. Upon receipt of follow-up information on 28Sep2015, this case now contains all required information to be considered valid. This is a spontaneous report from a contactable other health professional reporting on behalf of physician via a Pfizer sales representative. An 8-month-old female patient of an unspecified ethnicity received second dose of PREVNAR 13 (Lot# L62072, Exp date 16Nov2015), intramuscular, on 12May2015 at 11:39 am, at 0.5 ml, single second dose of PENTACEL (Lot# C4772AA/C4855AA, Exp date 18Jul2016), intramuscular, on 12May2015 at 11:39 am, at 0.5 ml, and second dose of ROTATEQ (Lot# K020183, Exp date 25Jun2016), oral, on 12May2015 at 11:39 am, at 2 ml. Relevant medical history and concomitant medications were not reported. The patient previously received first dose of PREVNAR 13, PENTACEL and ROTATEQ. Within a few hours from vaccination the patient experienced fussyness, bulging fontanelle and sixth nerve palsy. The events required physician visit and recovered on an unspecified date. The patient was visited by an ophthalmologist for the sixth nerve palsy, and on 02Jun2015 esotropia, pseudostrabismus and hyperopia were noted. The reporter considered the events as related to the suspect vaccines.                    Adjudication Data Entry       Select the radio button next to any fields that need editing and enter data.   Box 7 Describe Adverse Event  (and treatment if any)
Age: 0.3
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5
Symptoms: VIth nerve paralysis
Clinical narrative: The initial case was missing the following minimum criteria: unspecified adverse event. Upon receipt of follow-up information on 28Sep2015, this case now contains all required information to be considered valid. This is a spontaneous report from a contactable other health professional reporting on behalf of physician via a Pfizer sales representative. An 8-month-old female patient of an unspecified ethnicity received second dose of PREVNAR 13 (Lot# L62072, Exp date 16Nov2015), intramuscular, on 12May2015 at 11:39 am, at 0.5 ml, single second dose of PENTACEL (Lot# C4772AA/C4855AA, Exp date 18Jul2016), intramuscular, on 12May2015 at 11:39 am, at 0.5 ml, and second dose of ROTATEQ (Lot# K020183, Exp date 25Jun2016), oral, on 12May2015 at 11:39 am, at 2 ml. Relevant medical history and concomitant medications were not reported. The patient previously received first dose of PREVNAR 13, PENTACEL and ROTATEQ. Within a few hours from vaccination the patient experienced fussyness, bulging fontanelle and sixth nerve palsy. The events required physician visit and recovered on an unspecified date. The patient was visited by an ophthalmologist for the sixth nerve palsy, and on 02Jun2015 esotropia, pseudostrabismus and hyperopia were noted. The reporter considered the events as related to the suspect vaccines.                    Adjudication Data Entry       Select the radio button next to any fields that need editing and enter data.   Box 7 Describe Adverse Event  (and treatment if any)
Age: 0.3
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5
Symptoms: Fontanelle bulging, Pyrexia, Ultrasound skull abnormal, VIth nerve paralysis
Clinical narrative: The initial case was missing the following minimum criteria: unspecified adverse event. Upon receipt of follow-up information on 28Sep2015, this case now contains all required information to be considered valid. This is a spontaneous report from a contactable other health professional reporting on behalf of physician via a Pfizer sales representative. An 8-month-old female patient of an unspecified ethnicity received second dose of PREVNAR 13 (Lot# L62072, Exp date 16Nov2015), intramuscular, on 12May2015 at 11:39 am, at 0.5 ml, single second dose of PENTACEL (Lot# C4772AA/C4855AA, Exp date 18Jul2016), intramuscular, on 12May2015 at 11:39 am, at 0.5 ml, and second dose of ROTATEQ (Lot# K020183, Exp date 25Jun2016), oral, on 12May2015 at 11:39 am, at 2 ml. Relevant medical history and concomitant medications were not reported. The patient previously received first dose of PREVNAR 13, PENTACEL and ROTATEQ. Within a few hours from vaccination the patient experienced fussyness, bulging fontanelle and sixth nerve palsy. The events required physician visit and recovered on an unspecified date. The patient was visited by an ophthalmologist for the sixth nerve palsy, and on 02Jun2015 esotropia, pseudostrabismus and hyperopia were noted. The reporter considered the events as related to the suspect vaccines.                    Adjudication Data Entry       Select the radio button next to any fields that need editing and enter data.   Box 7 Describe Adverse Event  (and treatment if any)
Age: 0.3
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5
Symptoms: Fontanelle bulging, Hypermetropia, Irritability, Pseudostrabismus, Strabismus
Clinical narrative: The initial case was missing the following minimum criteria: unspecified adverse event. Upon receipt of follow-up information on 28Sep2015, this case now contains all required information to be considered valid. This is a spontaneous report from a contactable other health professional reporting on behalf of physician via a Pfizer sales representative. An 8-month-old female patient of an unspecified ethnicity received second dose of PREVNAR 13 (Lot# L62072, Exp date 16Nov2015), intramuscular, on 12May2015 at 11:39 am, at 0.5 ml, single second dose of PENTACEL (Lot# C4772AA/C4855AA, Exp date 18Jul2016), intramuscular, on 12May2015 at 11:39 am, at 0.5 ml, and second dose of ROTATEQ (Lot# K020183, Exp date 25Jun2016), oral, on 12May2015 at 11:39 am, at 2 ml. Relevant medical history and concomitant medications were not reported. The patient previously received first dose of PREVNAR 13, PENTACEL and ROTATEQ. Within a few hours from vaccination the patient experienced fussyness, bulging fontanelle and sixth nerve palsy. The events required physician visit and recovered on an unspecified date. The patient was visited by an ophthalmologist for the sixth nerve palsy, and on 02Jun2015 esotropia, pseudostrabismus and hyperopia were noted. The reporter considered the events as related to the suspect vaccines.                    Adjudication Data Entry       Select the radio button next to any fields that need editing and enter data.   Box 7 Describe Adverse Event  (and treatment if any)
Age: 0.3
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5
Symptoms: Fontanelle bulging, Irritability, VIth nerve paralysis
Clinical narrative: The initial case was missing the following minimum criteria: unspecified adverse event. Upon receipt of follow-up information on 28Sep2015, this case now contains all required information to be considered valid. This is a spontaneous report from a contactable other health professional reporting on behalf of physician via a Pfizer sales representative. An 8-month-old female patient of an unspecified ethnicity received second dose of PREVNAR 13 (Lot# L62072, Exp date 16Nov2015), intramuscular, on 12May2015 at 11:39 am, at 0.5 ml, single second dose of PENTACEL (Lot# C4772AA/C4855AA, Exp date 18Jul2016), intramuscular, on 12May2015 at 11:39 am, at 0.5 ml, and second dose of ROTATEQ (Lot# K020183, Exp date 25Jun2016), oral, on 12May2015 at 11:39 am, at 2 ml. Relevant medical history and concomitant medications were not reported. The patient previously received first dose of PREVNAR 13, PENTACEL and ROTATEQ. Within a few hours from vaccination the patient experienced fussyness, bulging fontanelle and sixth nerve palsy. The events required physician visit and recovered on an unspecified date. The patient was visited by an ophthalmologist for the sixth nerve palsy, and on 02Jun2015 esotropia, pseudostrabismus and hyperopia were noted. The reporter considered the events as related to the suspect vaccines.                    Adjudication Data Entry       Select the radio button next to any fields that need editing and enter data.   Box 7 Describe Adverse Event  (and treatment if any)
Age: 67.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Extreme pain and swelling from shoulder to elbow. Gums began bleeding for 2 days, chills and extreme dizziness. 9/25/15 - doctor prescribed cefadroxil 500mg. Diagnosed as cellulitis.
Age: 67.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Cellulitis, Chills, Dizziness, Gingival bleeding, Injection site pain
Clinical narrative: Extreme pain and swelling from shoulder to elbow. Gums began bleeding for 2 days, chills and extreme dizziness. 9/25/15 - doctor prescribed cefadroxil 500mg. Diagnosed as cellulitis.
Age: 67.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Injection site swelling
Clinical narrative: Extreme pain and swelling from shoulder to elbow. Gums began bleeding for 2 days, chills and extreme dizziness. 9/25/15 - doctor prescribed cefadroxil 500mg. Diagnosed as cellulitis.
Age: 82.0
Sex: F
Vaccine: PPV, PPV, PPV
Symptoms: Erythema, Peripheral swelling
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 82 year old female patient. The patient's medical history included open heart surgery. On 24-SEP-2015, the patient was vaccinated with PNEUMOVAX 23 lot # K007826, expiration date 03-FEB-2016, dose 0.5 ml, subcutaneous. On 25-SEP-2015, (also reported as second day after vaccination) the patient experienced swelling in her right arm where she received PNEUMOVAX 23. On 26-SEP-2015, (also reported as third day after vaccination), a red line started to appear at her fingertips and went all the way up to her right shoulder. The patient went to an emergency room for this event where an unspecified physician diagnosed this as a local allergic reaction. The patient was not admitted to the hospital. She was treated with prednisone and doxycycline. The outcome of local allergic reaction was reported as recovered on an unknown date in 2015. Causality assessment was not provided. Additional information has been requested.
Age: 82.0
Sex: F
Vaccine: PPV, PPV, PPV
Symptoms: Erythema, Hypersensitivity, Injection site erythema, Injection site hypersensitivity, Injection site swelling
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 82 year old female patient. The patient's medical history included open heart surgery. On 24-SEP-2015, the patient was vaccinated with PNEUMOVAX 23 lot # K007826, expiration date 03-FEB-2016, dose 0.5 ml, subcutaneous. On 25-SEP-2015, (also reported as second day after vaccination) the patient experienced swelling in her right arm where she received PNEUMOVAX 23. On 26-SEP-2015, (also reported as third day after vaccination), a red line started to appear at her fingertips and went all the way up to her right shoulder. The patient went to an emergency room for this event where an unspecified physician diagnosed this as a local allergic reaction. The patient was not admitted to the hospital. She was treated with prednisone and doxycycline. The outcome of local allergic reaction was reported as recovered on an unknown date in 2015. Causality assessment was not provided. Additional information has been requested.
Age: 82.0
Sex: F
Vaccine: PPV, PPV, PPV
Symptoms: Erythema, Hypersensitivity, Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 82 year old female patient. The patient's medical history included open heart surgery. On 24-SEP-2015, the patient was vaccinated with PNEUMOVAX 23 lot # K007826, expiration date 03-FEB-2016, dose 0.5 ml, subcutaneous. On 25-SEP-2015, (also reported as second day after vaccination) the patient experienced swelling in her right arm where she received PNEUMOVAX 23. On 26-SEP-2015, (also reported as third day after vaccination), a red line started to appear at her fingertips and went all the way up to her right shoulder. The patient went to an emergency room for this event where an unspecified physician diagnosed this as a local allergic reaction. The patient was not admitted to the hospital. She was treated with prednisone and doxycycline. The outcome of local allergic reaction was reported as recovered on an unknown date in 2015. Causality assessment was not provided. Additional information has been requested.
Age: 73.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Arthralgia, Cough, Influenza like illness, Myalgia, Pain
Clinical narrative: Patient complained of bodyache, fever, cough, muscle/joints pain, and flu like symptoms.
Age: 73.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Pyrexia
Clinical narrative: Patient complained of bodyache, fever, cough, muscle/joints pain, and flu like symptoms.
Age: 73.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Activities of daily living impaired, Arthralgia, Cough, Exercise tolerance decreased, Injection site pain
Clinical narrative: Patient complained of bodyache, fever, cough, muscle/joints pain, and flu like symptoms.
Age: 73.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Joint range of motion decreased, Myalgia, Pyrexia, Sleep disorder
Clinical narrative: Patient complained of bodyache, fever, cough, muscle/joints pain, and flu like symptoms.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Nasal congestion, Oropharyngeal pain, Pharyngeal oedema, Pyrexia
Clinical narrative: Sore throat; throat swelling; runny nose; nasal/sinus congestion; low grade fevers; headaches.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Rhinorrhoea, Sinus congestion
Clinical narrative: Sore throat; throat swelling; runny nose; nasal/sinus congestion; low grade fevers; headaches.
Age: 70.0
Sex: F
Vaccine: FLUX
Symptoms: Headache, Nausea, Pain, Pyrexia
Clinical narrative: Fever, body aches, nausea, headache.
Age: 36.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Pruritus generalised, Urticaria
Clinical narrative: Hives, Redness, itching all over face, neck and trunk.
Age: 54.0
Sex: F
Vaccine: FLU4
Symptoms: Abdominal pain upper, Diarrhoea, Nausea
Clinical narrative: Severe stomach cramps and diarrhea last 4 hours with associated nausea.
Age: 50.0
Sex: F
Vaccine: FLUX
Symptoms: Swelling, Urticaria
Clinical narrative: Swelling. Hives.
Age: 29.0
Sex: M
Vaccine: FLU4
Symptoms: Abdominal pain, Diarrhoea, Headache, Vomiting
Clinical narrative: Headache, abd pain, vomited once, diarrhea.
Age: 58.0
Sex: M
Vaccine: FLU4, PPV, TDAP, VARZOS
Symptoms: Inflammation, Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: Arm inflamed, sore, swollen, fever.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Gait disturbance, Pain in extremity
Clinical narrative: Not sure if connected or not but suddenly had pain in my left foot. So severe, could barely walk on it.  Only hurt when putting pressure on foot.  I received my shot in my left arm.  It is now approx. 20hrs later and it's going away.  I took Advil immediately and took more during the evening.  I didn't realize until I took a shower this morning and remove the bandaid on my left arm that the symptoms started after my flu shot.  It doesn't make sense but I did not step on anything or do anything that would make my foot so sore and now it's going away.
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Hypoaesthesia
Clinical narrative: Numbness down back of L arm.
Age: 31.0
Sex: F
Vaccine: FLUX
Symptoms: Back pain, Blood pressure increased, Chest pain, Dysphonia, Fatigue
Clinical narrative: Sudden nausea followed with throat swelling which restricted my airway. This lasted for approximately 3-5 minutes. Blood pressure elevated then dropped to 101/53. After a minutes rest in standing BP 99/68. Through out the day experienced fatugued, exhaustion. Around 2:00 PM body began shaking and my heart rate ranged from 103 beats per minute to 117 beats per minute. I was treated in the emergency room for an allergic reaction around 3:00 PM. Heart rate remained elevated ranging from 92-111 bpm through out the evening. I began experiencing back pain while in the Emergency Room and that went away around 4:00 AM the next morning. On 10-7-15 at 6:30 AM Heart Rate 77 bpm. I have a sore wind pipe, mild hoarseness, and chest feels sore.
Age: 31.0
Sex: F
Vaccine: FLUX
Symptoms: Heart rate increased, Hypersensitivity, Nausea, Oropharyngeal pain, Pharyngeal oedema
Clinical narrative: Sudden nausea followed with throat swelling which restricted my airway. This lasted for approximately 3-5 minutes. Blood pressure elevated then dropped to 101/53. After a minutes rest in standing BP 99/68. Through out the day experienced fatugued, exhaustion. Around 2:00 PM body began shaking and my heart rate ranged from 103 beats per minute to 117 beats per minute. I was treated in the emergency room for an allergic reaction around 3:00 PM. Heart rate remained elevated ranging from 92-111 bpm through out the evening. I began experiencing back pain while in the Emergency Room and that went away around 4:00 AM the next morning. On 10-7-15 at 6:30 AM Heart Rate 77 bpm. I have a sore wind pipe, mild hoarseness, and chest feels sore.
Age: 31.0
Sex: F
Vaccine: FLUX
Symptoms: Tremor
Clinical narrative: Sudden nausea followed with throat swelling which restricted my airway. This lasted for approximately 3-5 minutes. Blood pressure elevated then dropped to 101/53. After a minutes rest in standing BP 99/68. Through out the day experienced fatugued, exhaustion. Around 2:00 PM body began shaking and my heart rate ranged from 103 beats per minute to 117 beats per minute. I was treated in the emergency room for an allergic reaction around 3:00 PM. Heart rate remained elevated ranging from 92-111 bpm through out the evening. I began experiencing back pain while in the Emergency Room and that went away around 4:00 AM the next morning. On 10-7-15 at 6:30 AM Heart Rate 77 bpm. I have a sore wind pipe, mild hoarseness, and chest feels sore.
Age: 64.0
Sex: M
Vaccine: FLU3
Symptoms: Chest discomfort, Injection site erythema, Pruritus
Clinical narrative: Patient came back the next day stating they had a itchy arm, felt like their chest was tight, and had redness at the site of injection.
Age: 0.66
Sex: M
Vaccine: DTAP, PNC13, RV5
Symptoms: Extra dose administered, Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Received extra (4th) dose of Rotateq and 4th dose of DTaP given too early. No adverse symptoms noted. Parents communicated desire for event to be reported.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site induration, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Injection site swelling, itching, hot to touch, hard.
Age: 45.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site bruising, Injection site reaction, Injection site swelling, Injection site warmth, Rash erythematous
Clinical narrative: The symptoms that I experienced the day following the flu shot was a red rash/bruising on the arm where I received the flu shot from the shot site to my lower elbow.  The arm was hot to the touch and was slightly inflated.  I went to the emergency room the evening of October 1st, 2015 to have it treated in case it was a severe reaction. Since then, the arm has returned to normal.
Age: 31.0
Sex: M
Vaccine: FLU3, TDAP
Symptoms: Fall
Clinical narrative: Patient was sitting on bench and fell over, but conscious.  Patient was given some sugar to take as patient is diabetic.  Patient recovered over 15 minutes and choose to walk out the store with family member.
Age: 48.0
Sex: M
Vaccine: FLUC3
Symptoms: Cardiovascular examination, Chest discomfort, Dizziness, Feeling hot, Myalgia
Clinical narrative: "I am a very brittle Diabetic. I came into work and got the flu shot around 12 and felt fine. I started lifting cases of water and soda, then went to work at the cash register.  At around 1:00 pm I started feeling dizzy and noted chest tightness across my chest and shoulder blades (Like muscle aches). I became warm all over and went to the restroom to put cold water on my face and neck. I went back to where they were giving the flu shots and asked them if this is normal and the nurse said no and walked me down to be evaluated in the ER."
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Hypersensitivity, Urticaria
Clinical narrative: Broke out in hives covering face, chest and arms. Benadryl eased the symptoms.
Sex: M
Vaccine: TDAP
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Patient did not experience any adverse events from this vaccine administration.  A newborn infant was mistakenly given a Tdap vaccination instead of a Hepatitis B vaccination.
Age: 48.0
Sex: M
Vaccine: FLUX
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: Chills, severe body aches, 103 degree fever over 12 hours, symptoms gradually diminishing over next 12.
Age: 28.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Erythema, Lymphadenopathy, Pain, Pyrexia
Clinical narrative: Pain, redness, red bands down arm, fever X1 day and swollen lymphnodes X1 day.
Age: 71.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Erythema
Clinical narrative: Red area softball-size. I instructed patient to apply ice, and take an ibuprofen.
Age: 61.0
Sex: F
Vaccine: FLUX
Symptoms: Chills, Cough, Ocular hyperaemia, Rhinorrhoea, Swelling face
Clinical narrative: Running nose, red eyes, chills, cough, swollen face.
Age: 10.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Back pain, Hypoaesthesia, Limb discomfort, Neck pain, Paraesthesia
Clinical narrative: About 3 minutes after Gardasil was given patient stated that she felt as if a bunch of shots were sticking her in her left neck.  Vital Signs were rechecked and WNL.  Patient then stated that her posterior middle back started to feel the same way.  I had her lay down.  Vital Signs were WNL, and provider was notified.  Once provider was at the bedside she began to have left arm numbness right leg numbness and tingling with complaints of her right leg beginning heavy to left on assessment.  Patient was able to move all extremities and denied pain on touch and movement.  Ice pack was applied to affected areas and patient was given water.  Patient recovered in less than 20 minutes.
Age: 57.0
Sex: F
Vaccine: FLUX
Symptoms: Burning sensation, Cough, Dysphagia, Flushing, Headache
Clinical narrative: Raw throat, coughing, headache, throat then started to get hard to swallow, face and neck turned all flush, eyes burned all over body ache, lips went numb.
Age: 57.0
Sex: F
Vaccine: FLUX
Symptoms: Hypoaesthesia oral, Pain, Pharyngeal erythema
Clinical narrative: Raw throat, coughing, headache, throat then started to get hard to swallow, face and neck turned all flush, eyes burned all over body ache, lips went numb.
Age: 7.0
Sex: M
Vaccine: FLU3
Symptoms: Pain in extremity, Rash, Skin warm
Clinical narrative: Patient received vaccine on 9-28 around 4:30pm. Mother noticed rash on 9-29 around 6pm. Patient states that his arm was warm and painful. Mom states that it still has not started to go down.
Age: 54.0
Sex: F
Vaccine: HEPAB, MNQ
Symptoms: Arthralgia, Asthenia, Chest pain, Dizziness, Dizziness postural
Clinical narrative: Initial unsolicited report received from a nurse on 21 September 2015. This case involves a 54-year-old female patient who was vaccinated with a first dose MENACTRA (batch number: U5049AA, expiration date: 19 August 2016, dose was not reported) intramuscularly in right deltoid and a dose of TWINRIX (batch number: HZ9Z9, expiration date, dose were not reported) intramuscularly in left deltoid on 17 August 2015. Previously in January 2015 and February 2015, the patient received a dose of TWINRIX. The patient did not receive MENACTRA previously. The patient's pre-existing physician diagnosed allergies, birth defects, medical conditions reported as no known drug allergies (NKDA), Chronic low back pain, hypertension, numbness in feet, borderline diabetes, cardiac murmur, allergic rhinitis, sciatica. The patient's illness at time of vaccination reported as chronic low back pain, chills. Concomitant medication was not reported. On 18 August 2015 (Friday) in evening, one day following the vaccination, the patient experienced pain and swelling in right upper arm. On same Friday night patient scratched the site, with some "pus" coming out. Had pain in right throat, right shoulder and right chest which started on 18 August 2015 (Friday) night. On 19 August 2015 (Saturday) and 20 August 2015 (Sunday), the patient had a fever. On an unspecified date, the patient had 16 cm long, 10 cm wide warm, red, hard area at injection site, on her right upper arm pain causing weakness of her right arm. The patient had some hard lumps on both arms and left leg and her fingers. The patient had joint pain in all her joints. Felt low energy, has muscle weakness to her legs and arms, dizziness, eye weakness and dizziness when she stands up suddenly. The patient had required ER or doctor visit. The patient had normal blood pressure limits. Other laboratory investigation and corrective treatment were not reported. On an unspecified date, the patient recovered from hard lumps on both arms and left leg and fingers except on her right upper arm was not recovered. The patient had joint pain in all her joints, all resolved except in her elbows. The patient not recovered from pain in right throat, right shoulder and right chest. The outcome of the events eye weakness, low energy, weakness of her right arm, muscle weakness to her legs, pain and swelling in her right upper arm starting, 16 cm long, 10 cm wide warm, red at injection site on her right upper arm, scratched the site, with some pus, lumps right upper arm, fever, dizziness, hard area at injection site on her right upper arm were unknown. Upon internal review, company assessed the event of eye weakness as serious and important medical event. List of documents held by sender: none.