chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HEP
Symptoms: Extra dose administered, Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. In approximately August 2016 (it was reported that vaccines were administered on 22-AUG-2016, 23-AUG-2016, 24-AUG-2106 and 25-AUG-2016, but it was unknown which patient received doses on which date), the patient was accidentally vaccinated with 2 doses of RECOMIBVAX HB, intramuscularly, lot # M023892, expiry date 17-SEP-2017 (strength, dose and site of administration were not reported). No adverse reactions were reported. This is one of several cases received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker, referring to a 2 patients of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 16-AUG-2016, the patients were vaccinated with improperly stored M-M-R II (lot # M004899 exp. date 27-JAN-2018 rHa; lot # M008589 exp. date 16-FEB-2018 rHA; lot # L032044 exp. date 24-AUG-2017 and lot # L037356 exp. date 28-SEP-2017) (strength, dose and administration route were not provided). No adverse effects was reported and no product quality complaint was involved. It was reported that the vaccines were exposed to a temperature of "19C for 5 hours", it was data logger involved, but no previous excursions. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Pruritus
Clinical narrative: Redness and itching 3-4 days after injection.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. On 09-AUG-2016, the patient was vaccinated with a dose of improperly stored M-M-R II lot # L029266 (dose and route of administration were not reported). Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Information has been received from a nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not reported. On 07-AUG-2016, the patient was vaccinated with a dose of PNEUMVOAX 23 (dose, lot # and expiration date not reported) intramuscularly. On 21-AUG-2016, the patient was administered second dose of PNEUMOVAX 23 in error. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a medical assistant refers to patient of unknown age and gender. On 01-AUG-2016, the patient was vaccinated with improperly stored dose of M-M-R II lot # L029266 (dose and route of administration were not reported). This is one of several reports received from the same source. Additional information has been requested.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Fatigue, Injection site erythema, Mass, Pyrexia
Clinical narrative: Red lump, pain, redness at injection site. Fever and fatigue.
Age: 50.0
Sex: F
Vaccine: HEPAB
Symptoms: Dizziness, Hyperhidrosis, Vomiting
Clinical narrative: Patient was sweating, felt faint and vomited, w/in 15 minutes of administration. She recovered completely and was observed for 20 minutes after was checked up on in 14 1/2 hours at her home via phone and was feeling better.
Age: 27.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Asthenia, Blood copper decreased, Blood folate normal, Blood zinc increased, Borrelia test negative
Clinical narrative: Case number PHHY2016US093642, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 633901) website on 06 Jul 2016. This report refers to a 27 years old male patient. Past medical history included gastroesophageal reflux disease (GERD). Concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: not reported (earlier reported as invalid batch number: 42N4L) intramuscularly in left arm on 16 Oct 2014. On 29 Oct 2014, the patient experienced fever, weakness, numbness and tingling in both feet and lower extremities. The patient was worked up for mononucleosis, Lyme disease and Guillain Barre Syndrome (most likely). About that time, lumbar puncture of patient was to be pursued, symptoms spontaneously resolved. It was reported that, the symptoms lasted about 05 months. On 25 Nov 2014, laboratory data included Borrelia burgdorferi Ab negative, serum copper as 50 (units and normal range unspecified), serum zinc as 113 (units and normal range unspecified), serum folate as 16.7 (units and normal range unspecified), vitamin B12 400 (units and normal range unspecified), complete blood count (reported as within normal limits), Epstein Barr virus (EBV) nuclear antibodies as 7.59 (units and normal range unspecified), EBV capsid Ab IgG 5.829 (units and normal range unspecified), EBV capsid Ab IgM as 0059 (units and normal range unspecified), Cytomegalovirus (CMV) Ab IgG negative and CMV Ab IgM negative, hemoglobin A1C as 5.2 percent (normal range unspecified), erythrocyte sedimentation rate as 3 (units and normal range unspecified) and C reactive protein as 6.3 (units and normal range unspecified). The patient visited the emergency room. The outcome of the events Guillain Barre Syndrome, hypoaesthesia, asthenia, paraesthesia and pyrexia was reported as complete recovery on an unknown date. The seriousness of the events Guillain Barre Syndrome, hypoaesthesia, asthenia, paraesthesia and pyrexia was reported as non serious. The causality of the events was not reported. Seriousness assessment of the event Guillain Barre syndrome was upgraded to serious (medically significant) based on the NVS IME list. Seriousness assessment of the events hypoaesthesia, asthenia and paraesthesia was upgraded to serious (medically significant) based on the information available in the source document. Following an internal review done for the data received on 06 Jul 2016, following significant correction was done: The event mononucleosis syndrome was deleted from the case, the event Lyme disease was deleted from case narrative and other comments were updated. Follow up report received from quality assurance department on 25 Aug 2016: Updated suspect drug batch number information (deleted invalid batch number from product tab and narrative).
Age: 27.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: C-reactive protein, Cytomegalovirus test, Epstein-Barr virus antibody positive, Full blood count normal, Glycosylated haemoglobin normal
Clinical narrative: Case number PHHY2016US093642, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 633901) website on 06 Jul 2016. This report refers to a 27 years old male patient. Past medical history included gastroesophageal reflux disease (GERD). Concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: not reported (earlier reported as invalid batch number: 42N4L) intramuscularly in left arm on 16 Oct 2014. On 29 Oct 2014, the patient experienced fever, weakness, numbness and tingling in both feet and lower extremities. The patient was worked up for mononucleosis, Lyme disease and Guillain Barre Syndrome (most likely). About that time, lumbar puncture of patient was to be pursued, symptoms spontaneously resolved. It was reported that, the symptoms lasted about 05 months. On 25 Nov 2014, laboratory data included Borrelia burgdorferi Ab negative, serum copper as 50 (units and normal range unspecified), serum zinc as 113 (units and normal range unspecified), serum folate as 16.7 (units and normal range unspecified), vitamin B12 400 (units and normal range unspecified), complete blood count (reported as within normal limits), Epstein Barr virus (EBV) nuclear antibodies as 7.59 (units and normal range unspecified), EBV capsid Ab IgG 5.829 (units and normal range unspecified), EBV capsid Ab IgM as 0059 (units and normal range unspecified), Cytomegalovirus (CMV) Ab IgG negative and CMV Ab IgM negative, hemoglobin A1C as 5.2 percent (normal range unspecified), erythrocyte sedimentation rate as 3 (units and normal range unspecified) and C reactive protein as 6.3 (units and normal range unspecified). The patient visited the emergency room. The outcome of the events Guillain Barre Syndrome, hypoaesthesia, asthenia, paraesthesia and pyrexia was reported as complete recovery on an unknown date. The seriousness of the events Guillain Barre Syndrome, hypoaesthesia, asthenia, paraesthesia and pyrexia was reported as non serious. The causality of the events was not reported. Seriousness assessment of the event Guillain Barre syndrome was upgraded to serious (medically significant) based on the NVS IME list. Seriousness assessment of the events hypoaesthesia, asthenia and paraesthesia was upgraded to serious (medically significant) based on the information available in the source document. Following an internal review done for the data received on 06 Jul 2016, following significant correction was done: The event mononucleosis syndrome was deleted from the case, the event Lyme disease was deleted from case narrative and other comments were updated. Follow up report received from quality assurance department on 25 Aug 2016: Updated suspect drug batch number information (deleted invalid batch number from product tab and narrative).
Age: 27.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Guillain-Barre syndrome, Hypoaesthesia, Mononucleosis heterophile test, Paraesthesia, Pyrexia
Clinical narrative: Case number PHHY2016US093642, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 633901) website on 06 Jul 2016. This report refers to a 27 years old male patient. Past medical history included gastroesophageal reflux disease (GERD). Concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: not reported (earlier reported as invalid batch number: 42N4L) intramuscularly in left arm on 16 Oct 2014. On 29 Oct 2014, the patient experienced fever, weakness, numbness and tingling in both feet and lower extremities. The patient was worked up for mononucleosis, Lyme disease and Guillain Barre Syndrome (most likely). About that time, lumbar puncture of patient was to be pursued, symptoms spontaneously resolved. It was reported that, the symptoms lasted about 05 months. On 25 Nov 2014, laboratory data included Borrelia burgdorferi Ab negative, serum copper as 50 (units and normal range unspecified), serum zinc as 113 (units and normal range unspecified), serum folate as 16.7 (units and normal range unspecified), vitamin B12 400 (units and normal range unspecified), complete blood count (reported as within normal limits), Epstein Barr virus (EBV) nuclear antibodies as 7.59 (units and normal range unspecified), EBV capsid Ab IgG 5.829 (units and normal range unspecified), EBV capsid Ab IgM as 0059 (units and normal range unspecified), Cytomegalovirus (CMV) Ab IgG negative and CMV Ab IgM negative, hemoglobin A1C as 5.2 percent (normal range unspecified), erythrocyte sedimentation rate as 3 (units and normal range unspecified) and C reactive protein as 6.3 (units and normal range unspecified). The patient visited the emergency room. The outcome of the events Guillain Barre Syndrome, hypoaesthesia, asthenia, paraesthesia and pyrexia was reported as complete recovery on an unknown date. The seriousness of the events Guillain Barre Syndrome, hypoaesthesia, asthenia, paraesthesia and pyrexia was reported as non serious. The causality of the events was not reported. Seriousness assessment of the event Guillain Barre syndrome was upgraded to serious (medically significant) based on the NVS IME list. Seriousness assessment of the events hypoaesthesia, asthenia and paraesthesia was upgraded to serious (medically significant) based on the information available in the source document. Following an internal review done for the data received on 06 Jul 2016, following significant correction was done: The event mononucleosis syndrome was deleted from the case, the event Lyme disease was deleted from case narrative and other comments were updated. Follow up report received from quality assurance department on 25 Aug 2016: Updated suspect drug batch number information (deleted invalid batch number from product tab and narrative).
Age: 27.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Red blood cell sedimentation rate normal, Vitamin B12 normal
Clinical narrative: Case number PHHY2016US093642, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 633901) website on 06 Jul 2016. This report refers to a 27 years old male patient. Past medical history included gastroesophageal reflux disease (GERD). Concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: not reported (earlier reported as invalid batch number: 42N4L) intramuscularly in left arm on 16 Oct 2014. On 29 Oct 2014, the patient experienced fever, weakness, numbness and tingling in both feet and lower extremities. The patient was worked up for mononucleosis, Lyme disease and Guillain Barre Syndrome (most likely). About that time, lumbar puncture of patient was to be pursued, symptoms spontaneously resolved. It was reported that, the symptoms lasted about 05 months. On 25 Nov 2014, laboratory data included Borrelia burgdorferi Ab negative, serum copper as 50 (units and normal range unspecified), serum zinc as 113 (units and normal range unspecified), serum folate as 16.7 (units and normal range unspecified), vitamin B12 400 (units and normal range unspecified), complete blood count (reported as within normal limits), Epstein Barr virus (EBV) nuclear antibodies as 7.59 (units and normal range unspecified), EBV capsid Ab IgG 5.829 (units and normal range unspecified), EBV capsid Ab IgM as 0059 (units and normal range unspecified), Cytomegalovirus (CMV) Ab IgG negative and CMV Ab IgM negative, hemoglobin A1C as 5.2 percent (normal range unspecified), erythrocyte sedimentation rate as 3 (units and normal range unspecified) and C reactive protein as 6.3 (units and normal range unspecified). The patient visited the emergency room. The outcome of the events Guillain Barre Syndrome, hypoaesthesia, asthenia, paraesthesia and pyrexia was reported as complete recovery on an unknown date. The seriousness of the events Guillain Barre Syndrome, hypoaesthesia, asthenia, paraesthesia and pyrexia was reported as non serious. The causality of the events was not reported. Seriousness assessment of the event Guillain Barre syndrome was upgraded to serious (medically significant) based on the NVS IME list. Seriousness assessment of the events hypoaesthesia, asthenia and paraesthesia was upgraded to serious (medically significant) based on the information available in the source document. Following an internal review done for the data received on 06 Jul 2016, following significant correction was done: The event mononucleosis syndrome was deleted from the case, the event Lyme disease was deleted from case narrative and other comments were updated. Follow up report received from quality assurance department on 25 Aug 2016: Updated suspect drug batch number information (deleted invalid batch number from product tab and narrative).
Age: 27.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Asthenia, Blood copper, Blood folate normal, Blood zinc, Borrelia test negative
Clinical narrative: Case number PHHY2016US093642, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 633901) website on 06 Jul 2016. This report refers to a 27 years old male patient. Past medical history included gastroesophageal reflux disease (GERD). Concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: not reported (earlier reported as invalid batch number: 42N4L) intramuscularly in left arm on 16 Oct 2014. On 29 Oct 2014, the patient experienced fever, weakness, numbness and tingling in both feet and lower extremities. The patient was worked up for mononucleosis, Lyme disease and Guillain Barre Syndrome (most likely). About that time, lumbar puncture of patient was to be pursued, symptoms spontaneously resolved. It was reported that, the symptoms lasted about 05 months. On 25 Nov 2014, laboratory data included Borrelia burgdorferi Ab negative, serum copper as 50 (units and normal range unspecified), serum zinc as 113 (units and normal range unspecified), serum folate as 16.7 (units and normal range unspecified), vitamin B12 400 (units and normal range unspecified), complete blood count (reported as within normal limits), Epstein Barr virus (EBV) nuclear antibodies as 7.59 (units and normal range unspecified), EBV capsid Ab IgG 5.829 (units and normal range unspecified), EBV capsid Ab IgM as 0059 (units and normal range unspecified), Cytomegalovirus (CMV) Ab IgG negative and CMV Ab IgM negative, hemoglobin A1C as 5.2 percent (normal range unspecified), erythrocyte sedimentation rate as 3 (units and normal range unspecified) and C reactive protein as 6.3 (units and normal range unspecified). The patient visited the emergency room. The outcome of the events Guillain Barre Syndrome, hypoaesthesia, asthenia, paraesthesia and pyrexia was reported as complete recovery on an unknown date. The seriousness of the events Guillain Barre Syndrome, hypoaesthesia, asthenia, paraesthesia and pyrexia was reported as non serious. The causality of the events was not reported. Seriousness assessment of the event Guillain Barre syndrome was upgraded to serious (medically significant) based on the NVS IME list. Seriousness assessment of the events hypoaesthesia, asthenia and paraesthesia was upgraded to serious (medically significant) based on the information available in the source document. Following an internal review done for the data received on 06 Jul 2016, following significant correction was done: The event mononucleosis syndrome was deleted from the case, the event Lyme disease was deleted from case narrative and other comments were updated. Follow up report received from quality assurance department on 25 Aug 2016: Updated suspect drug batch number information (deleted invalid batch number from product tab and narrative).
Age: 27.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: C-reactive protein, Cytomegalovirus test negative, Epstein-Barr virus antibody positive, Full blood count normal, Glycosylated haemoglobin normal
Clinical narrative: Case number PHHY2016US093642, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 633901) website on 06 Jul 2016. This report refers to a 27 years old male patient. Past medical history included gastroesophageal reflux disease (GERD). Concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: not reported (earlier reported as invalid batch number: 42N4L) intramuscularly in left arm on 16 Oct 2014. On 29 Oct 2014, the patient experienced fever, weakness, numbness and tingling in both feet and lower extremities. The patient was worked up for mononucleosis, Lyme disease and Guillain Barre Syndrome (most likely). About that time, lumbar puncture of patient was to be pursued, symptoms spontaneously resolved. It was reported that, the symptoms lasted about 05 months. On 25 Nov 2014, laboratory data included Borrelia burgdorferi Ab negative, serum copper as 50 (units and normal range unspecified), serum zinc as 113 (units and normal range unspecified), serum folate as 16.7 (units and normal range unspecified), vitamin B12 400 (units and normal range unspecified), complete blood count (reported as within normal limits), Epstein Barr virus (EBV) nuclear antibodies as 7.59 (units and normal range unspecified), EBV capsid Ab IgG 5.829 (units and normal range unspecified), EBV capsid Ab IgM as 0059 (units and normal range unspecified), Cytomegalovirus (CMV) Ab IgG negative and CMV Ab IgM negative, hemoglobin A1C as 5.2 percent (normal range unspecified), erythrocyte sedimentation rate as 3 (units and normal range unspecified) and C reactive protein as 6.3 (units and normal range unspecified). The patient visited the emergency room. The outcome of the events Guillain Barre Syndrome, hypoaesthesia, asthenia, paraesthesia and pyrexia was reported as complete recovery on an unknown date. The seriousness of the events Guillain Barre Syndrome, hypoaesthesia, asthenia, paraesthesia and pyrexia was reported as non serious. The causality of the events was not reported. Seriousness assessment of the event Guillain Barre syndrome was upgraded to serious (medically significant) based on the NVS IME list. Seriousness assessment of the events hypoaesthesia, asthenia and paraesthesia was upgraded to serious (medically significant) based on the information available in the source document. Following an internal review done for the data received on 06 Jul 2016, following significant correction was done: The event mononucleosis syndrome was deleted from the case, the event Lyme disease was deleted from case narrative and other comments were updated. Follow up report received from quality assurance department on 25 Aug 2016: Updated suspect drug batch number information (deleted invalid batch number from product tab and narrative).
Age: 27.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Guillain-Barre syndrome, Haemoglobin decreased, Hypoaesthesia, Paraesthesia, Pyrexia
Clinical narrative: Case number PHHY2016US093642, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 633901) website on 06 Jul 2016. This report refers to a 27 years old male patient. Past medical history included gastroesophageal reflux disease (GERD). Concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: not reported (earlier reported as invalid batch number: 42N4L) intramuscularly in left arm on 16 Oct 2014. On 29 Oct 2014, the patient experienced fever, weakness, numbness and tingling in both feet and lower extremities. The patient was worked up for mononucleosis, Lyme disease and Guillain Barre Syndrome (most likely). About that time, lumbar puncture of patient was to be pursued, symptoms spontaneously resolved. It was reported that, the symptoms lasted about 05 months. On 25 Nov 2014, laboratory data included Borrelia burgdorferi Ab negative, serum copper as 50 (units and normal range unspecified), serum zinc as 113 (units and normal range unspecified), serum folate as 16.7 (units and normal range unspecified), vitamin B12 400 (units and normal range unspecified), complete blood count (reported as within normal limits), Epstein Barr virus (EBV) nuclear antibodies as 7.59 (units and normal range unspecified), EBV capsid Ab IgG 5.829 (units and normal range unspecified), EBV capsid Ab IgM as 0059 (units and normal range unspecified), Cytomegalovirus (CMV) Ab IgG negative and CMV Ab IgM negative, hemoglobin A1C as 5.2 percent (normal range unspecified), erythrocyte sedimentation rate as 3 (units and normal range unspecified) and C reactive protein as 6.3 (units and normal range unspecified). The patient visited the emergency room. The outcome of the events Guillain Barre Syndrome, hypoaesthesia, asthenia, paraesthesia and pyrexia was reported as complete recovery on an unknown date. The seriousness of the events Guillain Barre Syndrome, hypoaesthesia, asthenia, paraesthesia and pyrexia was reported as non serious. The causality of the events was not reported. Seriousness assessment of the event Guillain Barre syndrome was upgraded to serious (medically significant) based on the NVS IME list. Seriousness assessment of the events hypoaesthesia, asthenia and paraesthesia was upgraded to serious (medically significant) based on the information available in the source document. Following an internal review done for the data received on 06 Jul 2016, following significant correction was done: The event mononucleosis syndrome was deleted from the case, the event Lyme disease was deleted from case narrative and other comments were updated. Follow up report received from quality assurance department on 25 Aug 2016: Updated suspect drug batch number information (deleted invalid batch number from product tab and narrative).
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, DTAPHEPBIP, PNC13
Symptoms: Crying
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of crying in a 2-month-old female patient who received PEDIARIX (Batch number 529PP, expiry date 27th May 2018). Concomitant products included ACTHIB and PREVENAR 13. On 8th June 2016, the patient received PEDIARIX .5 ml. On 8th June 2016, immediately after receiving PEDIARIX, the patient experienced crying. On 10th June 2016, the outcome of the crying was recovered/resolved. It was unknown if the reporter considered the crying to be related to PEDIARIX. Additional details were provided as follows: This case was reported by a certified medical assistant (CMA). Concomitant medication included ACTHIB vaccine (batch number UI301AA, expiry date 8th November 2016) which was received in the patient's left thigh. the patient received PEDIARIX in her right thigh. On the same day, the patient concomitantly received 1st dose of PREVENAR 13 (batch number M60993, expiry date 31st July 2017) in her left thigh. At the day of reporting, 2 months after vaccination, the patient's mother reported to the other healthcare professional that the patient had cried inconsolably for 2 days after vaccination with PEDIARIX.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, DTAPHEPBIP, PNC13
Symptoms: Crying, Immediate post-injection reaction
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of crying in a 2-month-old female patient who received PEDIARIX (Batch number 529PP, expiry date 27th May 2018). Concomitant products included ACTHIB and PREVENAR 13. On 8th June 2016, the patient received PEDIARIX .5 ml. On 8th June 2016, immediately after receiving PEDIARIX, the patient experienced crying. On 10th June 2016, the outcome of the crying was recovered/resolved. It was unknown if the reporter considered the crying to be related to PEDIARIX. Additional details were provided as follows: This case was reported by a certified medical assistant (CMA). Concomitant medication included ACTHIB vaccine (batch number UI301AA, expiry date 8th November 2016) which was received in the patient's left thigh. the patient received PEDIARIX in her right thigh. On the same day, the patient concomitantly received 1st dose of PREVENAR 13 (batch number M60993, expiry date 31st July 2017) in her left thigh. At the day of reporting, 2 months after vaccination, the patient's mother reported to the other healthcare professional that the patient had cried inconsolably for 2 days after vaccination with PEDIARIX.
Age: 11.0
Sex: M
Vaccine: MNQ, MNQ
Symptoms: Peripheral swelling, Pruritus, Rash
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of generalized pruritus in a 11-year-old male patient who received MENVEO (batch number M15149, expiry date 31st July 2017). On an unknown date, the patient received MENVEO. On 17th August 2016, an unknown time after receiving MENVEO, the patient experienced generalized pruritus, rash and hand swelling. On an unknown date, the outcome of the generalized pruritus, rash and hand swelling were unknown. It was unknown if the reporter considered the generalized pruritus, rash and hand swelling to be related to MENVEO. Additional details were provided as follows: The reporter would like to be contacted regarding report. The patient was 11 years and two months old. The reporter stated that, the patient experienced generalized itching, a rash on the back and knees and swollen hands after vaccination with MENVEO. The patient's date of birth was unknown.
Age: 11.0
Sex: M
Vaccine: MNQ, MNQ
Symptoms: Peripheral swelling, Pruritus generalised, Rash
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of generalized pruritus in a 11-year-old male patient who received MENVEO (batch number M15149, expiry date 31st July 2017). On an unknown date, the patient received MENVEO. On 17th August 2016, an unknown time after receiving MENVEO, the patient experienced generalized pruritus, rash and hand swelling. On an unknown date, the outcome of the generalized pruritus, rash and hand swelling were unknown. It was unknown if the reporter considered the generalized pruritus, rash and hand swelling to be related to MENVEO. Additional details were provided as follows: The reporter would like to be contacted regarding report. The patient was 11 years and two months old. The reporter stated that, the patient experienced generalized itching, a rash on the back and knees and swollen hands after vaccination with MENVEO. The patient's date of birth was unknown.
Sex: F
Vaccine: DTAPHEPBIP, PNC, RV5, DTAPHEPBIP, PNC13, RV5
Symptoms: Full blood count normal, Injection site erythema, Irritability
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of injection site swelling in a 6-month-old female patient who received PEDIARIX (batch number 33E9E, expiry date November 2018). Concomitant products included PREVENAR and ROTATEQ. On an unknown date, the patient received PEDIARIX .5 ml. On an unknown date, less than a year after receiving PEDIARIX, the patient experienced injection site swelling (serious criteria other: serious as per reporter). On an unknown date, the outcome of the injection site swelling was unknown. The reporter considered the injection site swelling to be possibly related to PEDIARIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received a dose of PEDIARIX in her left thigh. On the same day, the patient concomitantly received PREVENAR and ROTATEQ vaccines. In 2016, the patient experienced local swelling at injection site of PREVENAR. The reporter was informed that a follow up would be conducted. This case has been linked with cases US2016125176 and US2016GSK128180, reported by the same reporter.
Sex: F
Vaccine: DTAPHEPBIP, PNC, RV5, DTAPHEPBIP, PNC13, RV5
Symptoms: Injection site swelling
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of injection site swelling in a 6-month-old female patient who received PEDIARIX (batch number 33E9E, expiry date November 2018). Concomitant products included PREVENAR and ROTATEQ. On an unknown date, the patient received PEDIARIX .5 ml. On an unknown date, less than a year after receiving PEDIARIX, the patient experienced injection site swelling (serious criteria other: serious as per reporter). On an unknown date, the outcome of the injection site swelling was unknown. The reporter considered the injection site swelling to be possibly related to PEDIARIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received a dose of PEDIARIX in her left thigh. On the same day, the patient concomitantly received PREVENAR and ROTATEQ vaccines. In 2016, the patient experienced local swelling at injection site of PREVENAR. The reporter was informed that a follow up would be conducted. This case has been linked with cases US2016125176 and US2016GSK128180, reported by the same reporter.
Age: 4.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Cheilitis, Injection site reaction, Irritability, Rash, Rash erythematous
Clinical narrative: At 7:38 AM my husband saw numerous pink raised rash located on patient's bilateral anterior and posterior legs, bilateral soles of the feet, and bilateral anterior and posterior arms, . On 9/7/16 noted 4 tiny raised rash around patient's right side of his lips. Prior to this eruption patient was fussy and his skin felt hot on 9/2/16 and 9/3/16. 5 ml of liquid Tylenol was given on 9/2/16 and 9/3/16. My husband contacted my son's doctor and was told that a rash is normal and will go away in a week. We applied hydrocortisone cream twice a day since the rash erupted.
Age: 4.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Skin warm
Clinical narrative: At 7:38 AM my husband saw numerous pink raised rash located on patient's bilateral anterior and posterior legs, bilateral soles of the feet, and bilateral anterior and posterior arms, . On 9/7/16 noted 4 tiny raised rash around patient's right side of his lips. Prior to this eruption patient was fussy and his skin felt hot on 9/2/16 and 9/3/16. 5 ml of liquid Tylenol was given on 9/2/16 and 9/3/16. My husband contacted my son's doctor and was told that a rash is normal and will go away in a week. We applied hydrocortisone cream twice a day since the rash erupted.
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Pyrexia, Rash, Rash pruritic
Clinical narrative: Fever of 101.4 began at 11pm on Saturday 9/3/16. Fever continued until Monday (Labor Day) 9/5/16. I gave him a dose of acetaminophen for fever at 2pm for a fever of 101.2 This was the last dose needed fever subsided after and he did not require any more fever reducers. On Wednesday 9/7/16 about 2pm I noticed a rash on his back that he said was itchy. Rash continues....
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Burning sensation, Headache, Hypoaesthesia, Muscle fatigue, Musculoskeletal stiffness
Clinical narrative: The day following the vaccine I developed a headache. Two days after the vaccine I developed tingling in extremities which was followed by numbness and burning sensations and fatigued muscles. I also developed a stiff neck that comes in waves.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Paraesthesia
Clinical narrative: The day following the vaccine I developed a headache. Two days after the vaccine I developed tingling in extremities which was followed by numbness and burning sensations and fatigued muscles. I also developed a stiff neck that comes in waves.
Age: 68.0
Sex: F
Vaccine: YF
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Initial unsolicited report received from a Pharmacist on 29 August 2016. This case involves a 68-year-old female patient who was vaccinated with a dose of YF-Vax vaccine (batch number: UI292AC, expiry date: 22 April 2018, dose not reported) subcutaneously on left arm on 17 August 2016. Patient had no known allergies. Illness at the time of vaccination was reported as none. Patient's other medical history and concomitant medications were not reported. On 18 August 2016, one day following the vaccination, the patient experienced redness and itching at the injection site on left arm and since that time, patient had intermittent redness and itching at site continued till 29 August 2016. Lab data and corrective treatment was not reported. The patient was not recovered from events (the outcome of event was also reported as unknown). List of documents held by sender: none.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Dizziness, Injected limb mobility decreased, Nausea, Pain in extremity, Peripheral swelling
Clinical narrative: Swollen right arm, could not raise arm, severe pain in arm, dizzy, nauseas, rash on arm. Took a percaset to try to relieve pain - it did not work. Applied ice packs throughout the night.  Pain only subsided somewhat next day but still hurt.  Was able to lift my arm slightly the next day.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Rash
Clinical narrative: Swollen right arm, could not raise arm, severe pain in arm, dizzy, nauseas, rash on arm. Took a percaset to try to relieve pain - it did not work. Applied ice packs throughout the night.  Pain only subsided somewhat next day but still hurt.  Was able to lift my arm slightly the next day.
Age: 1.0
Sex: F
Vaccine: DTAP, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Electroencephalogram, Metabolic function test, Microscopy, Polymerase chain reaction, Pyrexia
Clinical narrative: Vomiting, Seizures, Rash, Fever.
Age: 1.0
Sex: F
Vaccine: DTAP, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Rash, Respiratory viral panel, Seizure, Urine analysis, Viral test negative
Clinical narrative: Vomiting, Seizures, Rash, Fever.
Age: 1.0
Sex: F
Vaccine: DTAP, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Vomiting
Clinical narrative: Vomiting, Seizures, Rash, Fever.
Age: 66.0
Sex: F
Vaccine: FLU4, FLU3
Symptoms: Mobility decreased, Periarthritis, Rotator cuff syndrome
Clinical narrative: Terrible pain in my left rotator cuff. Extremely painful and can hardly even move that arm.  Like a frozen shoulder. Have an appointment 9/8/16 with my primary care doctor  to see what needs to be done. Possible physical therapy required.
Age: 66.0
Sex: F
Vaccine: FLU4, FLU3
Symptoms: Musculoskeletal pain, Pain in extremity
Clinical narrative: Terrible pain in my left rotator cuff. Extremely painful and can hardly even move that arm.  Like a frozen shoulder. Have an appointment 9/8/16 with my primary care doctor  to see what needs to be done. Possible physical therapy required.
Age: 25.0
Sex: M
Vaccine: SMALL
Symptoms: Fatigue, Headache, Musculoskeletal stiffness, Nodule
Clinical narrative: Swollen nodule L axillary, fatigue, frontal lobe headache x 3 days, neck stiffness.
Age: 62.0
Sex: M
Vaccine: FLU4
Symptoms: Chills, Diarrhoea, Pyrexia, Tremor, Vomiting
Clinical narrative: Vomiting. Loose stool. High fever. Muscle shakes and chills. No treatment. Fever broke by midnight.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Intussusception, Surgery, Ultrasound scan, X-ray
Clinical narrative: Intussusception 6 d after rotavirus, Hep B, IPV, DTaP, Hib, PCV13. Surgical intervention required.
Age: 58.0
Sex: F
Vaccine: FLU4, PNC13
Symptoms: Cold sweat, Discomfort, Nausea
Clinical narrative: Nausea, cold sweat, all over feeling uncomfortable not in pain. Did not seek healthcare professional. I relaxed in a chair for about an hour and the symptoms were relieved.
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Muscular weakness
Clinical narrative: Patient received vaccine on 3/10/14 and she had muscle weakness head to toe for 2 weeks after injection.
Age: 60.0
Sex: M
Vaccine: PPV
Symptoms: Blood culture positive, Injection site erythema, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: Site of administration very swollen, red, hot to touch, pt now running fever (may or may not be related).
Age: 60.0
Sex: M
Vaccine: PPV
Symptoms: White blood cell count increased
Clinical narrative: Site of administration very swollen, red, hot to touch, pt now running fever (may or may not be related).
Age: 45.0
Sex: M
Vaccine: PPV
Symptoms: Back pain, Blood culture, Cellulitis, Chills, Fatigue
Clinical narrative: At first, low-grade fever, muscle aches (lower back), fatigue, and chills. Over the next 48 hrs fever increased to 103.2, extreme chills with physical shaking, severe back pain, and injection site became large, red, and swollen. Went to ER and was admitted and held for 4 days while treated with numerous antibiotics. Determination was what appeared to be a localized infection causing cellulitis. Still being treated oral antibiotics at home, so situation is not definitively resolved.
Age: 45.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Laboratory test, Localised infection, Myalgia
Clinical narrative: At first, low-grade fever, muscle aches (lower back), fatigue, and chills. Over the next 48 hrs fever increased to 103.2, extreme chills with physical shaking, severe back pain, and injection site became large, red, and swollen. Went to ER and was admitted and held for 4 days while treated with numerous antibiotics. Determination was what appeared to be a localized infection causing cellulitis. Still being treated oral antibiotics at home, so situation is not definitively resolved.
Age: 45.0
Sex: M
Vaccine: PPV
Symptoms: Pyrexia, Tremor
Clinical narrative: At first, low-grade fever, muscle aches (lower back), fatigue, and chills. Over the next 48 hrs fever increased to 103.2, extreme chills with physical shaking, severe back pain, and injection site became large, red, and swollen. Went to ER and was admitted and held for 4 days while treated with numerous antibiotics. Determination was what appeared to be a localized infection causing cellulitis. Still being treated oral antibiotics at home, so situation is not definitively resolved.
Age: 1.5
Sex: M
Vaccine: DTAP, HIBV, PPV
Symptoms: Cellulitis, Erythema, Swelling
Clinical narrative: B/l thigh redness and swelling, treated with cephalexin as cellulitis.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal distension, Amenorrhoea, Autoimmune hepatitis, Biopsy liver, Blood test abnormal
Clinical narrative: Patient stopped getting her menstrual cycle for months, lost weight, constant feeling bloated/full. Liver levels in blood laboratory showed 7x higher than normal.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Ultrasound abdomen, Weight decreased
Clinical narrative: Patient stopped getting her menstrual cycle for months, lost weight, constant feeling bloated/full. Liver levels in blood laboratory showed 7x higher than normal.
Age: 0.18
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Croup infectious, Culture, Diarrhoea, Gastrointestinal tube insertion, Vomiting
Clinical narrative: Croup 1 day after vaccines. 2d later developed bilious emesis. Upper GI (-). Intussusception eval (-). Then developed severe diarrhea. Hospitalized x 9 day, IVF, NJ placement.
Age: 0.18
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: X-ray with contrast upper gastrointestinal tract
Clinical narrative: Croup 1 day after vaccines. 2d later developed bilious emesis. Upper GI (-). Intussusception eval (-). Then developed severe diarrhea. Hospitalized x 9 day, IVF, NJ placement.
Age: 84.0
Sex: M
Vaccine: FLU3
Symptoms: Contusion, International normalised ratio increased
Clinical narrative: Arm bruised down to the elbow.
Age: 17.0
Sex: M
Vaccine: HPV9
Symptoms: Headache, Nausea, Pyrexia
Clinical narrative: Headache, nausea, and fever of 100.8 starting 1 hr after vaccine administration. Taking ibuprofen with relief. Symptoms still present on evaluation 9/8/2016.
Age: 67.0
Sex: F
Vaccine: FLU4
Symptoms: Asthma, Chills, Dyspnoea, Sleep disorder
Clinical narrative: Awoke with breathing difficulty (Asthma Attack) which lasted about 20 minutes I was able to take my inhaler and a cup of hot herbal tea to calm the symptoms. Afterwards, tried to sleep again, but awoke with chills.
Age: 4.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Local swelling
Clinical narrative: Localized swelling and redness 2 inches in diameter.
Age: 30.0
Sex: M
Vaccine: FLU3
Symptoms: Pyrexia
Clinical narrative: Two days after Flu shot patient had a fever ranging from 99-102 for 2 days.
Age: 23.0
Sex: M
Vaccine: FLU4
Symptoms: Rash generalised, Throat irritation, Urticaria
Clinical narrative: Widespread rash (hives) slight throat irritation.
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Rash erythematous, Rash pruritic
Clinical narrative: PHARMACY INFORMED BY PATIENT ON 9/8 OF POTENTIAL REACTION.  PATIENT DESCRIBES HAVING ITCHY RED BUMPS ON HER ABDOMEN AND LEGS. SHE STATES SHE DID NOT CHANGE HER DETERGENTS, SOAPS, OR DAILY HABITS.  SHE DOES NOT STATE THAT IT IS SPREADING FROM THOSE AREAS OR ANY OTHER COMPLICATIONS (BREATHING ISSUES/SWELLING/EDEMA). PATIENT INSTRUCTED TO APPLY CORTISONE TOPICALLY AS NEEDED FOR ITCHING AND TO TAKE BENADRYL 25 MG AT BEDTIME.  PATIENT INSTRUCTED TO FOLLOW UP WITH PHARMACY IF THE AREAS DO NOT CLEAR.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Injection site pain, Injection site swelling, Injection site warmth, Local reaction
Clinical narrative: Patient was seen for a physical exam on 9/6/16 and was given MENVEO, left deltoid, mother state that patient was c/o swelling and pain to left deltoid that same evening, on 9/7/16 left deltoid was worse, warm to touch and pain. On exam on 9/8/16 seen for follow up PNP notice 16x16cm localize reaction and prescribe KEFLEX 250mg/5ml, BENADRYL prn. Pt to follow up on 9/12/16.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Abasia, Activities of daily living impaired, Dyspepsia, Dyspnoea, Dysstasia
Clinical narrative: NERVE TINGLING, TWITCHING, WEAKNESS. STARTED IN LEGS AND MOVED UP THOUGH UPPER LIMBS. PROGRESSED TO SYSTEMIC PAIN AND MUSCLE CRAMPS, PAIN, SEIZING, SWELLING, AND PARTIAL PARALYZATION OF ANKLE, KNEES, WRIST. HAD SPEECH PROBLEMS, VISION PROBLEMS DIGESTION PROBLEMS, BREATHING PROBLEMS. COULD NOT WALK, STAND, DRIVE OR BATHE. PROBLEMS ARE STILL PERSISTENT.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Impaired driving ability, Laboratory test, Muscle spasms, Muscle twitching, Muscular weakness
Clinical narrative: NERVE TINGLING, TWITCHING, WEAKNESS. STARTED IN LEGS AND MOVED UP THOUGH UPPER LIMBS. PROGRESSED TO SYSTEMIC PAIN AND MUSCLE CRAMPS, PAIN, SEIZING, SWELLING, AND PARTIAL PARALYZATION OF ANKLE, KNEES, WRIST. HAD SPEECH PROBLEMS, VISION PROBLEMS DIGESTION PROBLEMS, BREATHING PROBLEMS. COULD NOT WALK, STAND, DRIVE OR BATHE. PROBLEMS ARE STILL PERSISTENT.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Paraesthesia, Paralysis, Seizure, Speech disorder
Clinical narrative: NERVE TINGLING, TWITCHING, WEAKNESS. STARTED IN LEGS AND MOVED UP THOUGH UPPER LIMBS. PROGRESSED TO SYSTEMIC PAIN AND MUSCLE CRAMPS, PAIN, SEIZING, SWELLING, AND PARTIAL PARALYZATION OF ANKLE, KNEES, WRIST. HAD SPEECH PROBLEMS, VISION PROBLEMS DIGESTION PROBLEMS, BREATHING PROBLEMS. COULD NOT WALK, STAND, DRIVE OR BATHE. PROBLEMS ARE STILL PERSISTENT.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Swelling, Visual impairment
Clinical narrative: NERVE TINGLING, TWITCHING, WEAKNESS. STARTED IN LEGS AND MOVED UP THOUGH UPPER LIMBS. PROGRESSED TO SYSTEMIC PAIN AND MUSCLE CRAMPS, PAIN, SEIZING, SWELLING, AND PARTIAL PARALYZATION OF ANKLE, KNEES, WRIST. HAD SPEECH PROBLEMS, VISION PROBLEMS DIGESTION PROBLEMS, BREATHING PROBLEMS. COULD NOT WALK, STAND, DRIVE OR BATHE. PROBLEMS ARE STILL PERSISTENT.
Age: 24.0
Sex: M
Vaccine: FLU3, HEPAB, PPV
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: Patient described pain in left arm and swelling in area.
Age: 30.0
Sex: F
Vaccine: FLU4, PNC13
Symptoms: Urticaria
Clinical narrative: Hives began around bed time and patient took one Benadryl. The hives persisted and she took another Benadryl (total for both doses was 50mg). Hives dissipated after second dose of Benadryl.
Age: 42.0
Sex: F
Vaccine: HEP
Symptoms: Body temperature increased, Diarrhoea, Injection site erythema, Injection site pain, Malaise
Clinical narrative: EMPLOYEE REPORTS DAY AFER RECEIVING IMMUNIZATION THAT SHE WASN'T FEELING WELL, DEVELOPED DIARRHEA, GENERAL MALAISE, ARM SORE AT SIGHT, WITH REDNESS,TEMP WAS 101.0.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Rash erythematous
Clinical narrative: Red, raised rash on stomach and back. Lasted 3 hours. Not itchy, could have occurred overnight while sleeping.