chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 6.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Erythema, Hyperaesthesia, Pain in extremity, Pruritus, Screaming
Clinical narrative: Case number PHHY2016US065165, is an initial spontaneous report received Vaccine Adverse Event Reporting System (VAERS reference number: 628139) website on 11 May 2016. This report refers to a 06 years old female patient. Past medical history was not reported. Current conditions included as streptococcus exposure but no signs was reported (given amoxicillin prescription but did not administer) and diarrhea (hospital advised antibiotics not needed (seen in emergency room (ER) at approximately 20:00 PM for reaction). Concomitant medications was not reported. The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) into left arm on 18 Mar 2016 at 13:30 PM. On the same day, at 20:00 PM, the patient experienced severe itching and burning skin, large hives, welts all over body beginning on back, stomach and face. It quickly spread to all other body parts. The patient went to the emergency room (ER). The patient received BENADRYL 2 tablespoons every 06 hours all night. On 18 Mar 2016 at 22:00 PM, the patient suffered with severe itching and painful feet, given a 2 tablespoons BENADRYL. The patient's feet were completely red on soles and warm to touch. It was reported that, the patient tried to soak feet but water burnt her (warm or cold water had same reaction) and child screamed in pain. It was stated that, the patient's feet was dried, laid her comfortably with feet propped up for approximately 45 minutes and applied Dermicil lotion. Redness faded except for toes, heel and pad under big toe after 02 hours and still painful to touch. It was reported that, the patient would go to clinic on 21 Mar 2016 morning, if nothing else occurred before that required emergency visit to hospital again. The outcome of the events was reported as condition unchanged. The seriousness of the events was reported as non serious. The causality of the events was not reported. Seriousness assessment of urticaria, pruritus and erythema was upgraded to medically significant based on the information available in the source document.
Age: 6.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Skin burning sensation, Skin warm, Urticaria
Clinical narrative: Case number PHHY2016US065165, is an initial spontaneous report received Vaccine Adverse Event Reporting System (VAERS reference number: 628139) website on 11 May 2016. This report refers to a 06 years old female patient. Past medical history was not reported. Current conditions included as streptococcus exposure but no signs was reported (given amoxicillin prescription but did not administer) and diarrhea (hospital advised antibiotics not needed (seen in emergency room (ER) at approximately 20:00 PM for reaction). Concomitant medications was not reported. The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) into left arm on 18 Mar 2016 at 13:30 PM. On the same day, at 20:00 PM, the patient experienced severe itching and burning skin, large hives, welts all over body beginning on back, stomach and face. It quickly spread to all other body parts. The patient went to the emergency room (ER). The patient received BENADRYL 2 tablespoons every 06 hours all night. On 18 Mar 2016 at 22:00 PM, the patient suffered with severe itching and painful feet, given a 2 tablespoons BENADRYL. The patient's feet were completely red on soles and warm to touch. It was reported that, the patient tried to soak feet but water burnt her (warm or cold water had same reaction) and child screamed in pain. It was stated that, the patient's feet was dried, laid her comfortably with feet propped up for approximately 45 minutes and applied Dermicil lotion. Redness faded except for toes, heel and pad under big toe after 02 hours and still painful to touch. It was reported that, the patient would go to clinic on 21 Mar 2016 morning, if nothing else occurred before that required emergency visit to hospital again. The outcome of the events was reported as condition unchanged. The seriousness of the events was reported as non serious. The causality of the events was not reported. Seriousness assessment of urticaria, pruritus and erythema was upgraded to medically significant based on the information available in the source document.
Age: 6.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Erythema, Pain in extremity, Pruritus, Screaming, Skin burning sensation
Clinical narrative: Case number PHHY2016US065165, is an initial spontaneous report received Vaccine Adverse Event Reporting System (VAERS reference number: 628139) website on 11 May 2016. This report refers to a 06 years old female patient. Past medical history was not reported. Current conditions included as streptococcus exposure but no signs was reported (given amoxicillin prescription but did not administer) and diarrhea (hospital advised antibiotics not needed (seen in emergency room (ER) at approximately 20:00 PM for reaction). Concomitant medications was not reported. The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) into left arm on 18 Mar 2016 at 13:30 PM. On the same day, at 20:00 PM, the patient experienced severe itching and burning skin, large hives, welts all over body beginning on back, stomach and face. It quickly spread to all other body parts. The patient went to the emergency room (ER). The patient received BENADRYL 2 tablespoons every 06 hours all night. On 18 Mar 2016 at 22:00 PM, the patient suffered with severe itching and painful feet, given a 2 tablespoons BENADRYL. The patient's feet were completely red on soles and warm to touch. It was reported that, the patient tried to soak feet but water burnt her (warm or cold water had same reaction) and child screamed in pain. It was stated that, the patient's feet was dried, laid her comfortably with feet propped up for approximately 45 minutes and applied Dermicil lotion. Redness faded except for toes, heel and pad under big toe after 02 hours and still painful to touch. It was reported that, the patient would go to clinic on 21 Mar 2016 morning, if nothing else occurred before that required emergency visit to hospital again. The outcome of the events was reported as condition unchanged. The seriousness of the events was reported as non serious. The causality of the events was not reported. Seriousness assessment of urticaria, pruritus and erythema was upgraded to medically significant based on the information available in the source document.
Age: 6.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Skin warm, Tenderness, Urticaria
Clinical narrative: Case number PHHY2016US065165, is an initial spontaneous report received Vaccine Adverse Event Reporting System (VAERS reference number: 628139) website on 11 May 2016. This report refers to a 06 years old female patient. Past medical history was not reported. Current conditions included as streptococcus exposure but no signs was reported (given amoxicillin prescription but did not administer) and diarrhea (hospital advised antibiotics not needed (seen in emergency room (ER) at approximately 20:00 PM for reaction). Concomitant medications was not reported. The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) into left arm on 18 Mar 2016 at 13:30 PM. On the same day, at 20:00 PM, the patient experienced severe itching and burning skin, large hives, welts all over body beginning on back, stomach and face. It quickly spread to all other body parts. The patient went to the emergency room (ER). The patient received BENADRYL 2 tablespoons every 06 hours all night. On 18 Mar 2016 at 22:00 PM, the patient suffered with severe itching and painful feet, given a 2 tablespoons BENADRYL. The patient's feet were completely red on soles and warm to touch. It was reported that, the patient tried to soak feet but water burnt her (warm or cold water had same reaction) and child screamed in pain. It was stated that, the patient's feet was dried, laid her comfortably with feet propped up for approximately 45 minutes and applied Dermicil lotion. Redness faded except for toes, heel and pad under big toe after 02 hours and still painful to touch. It was reported that, the patient would go to clinic on 21 Mar 2016 morning, if nothing else occurred before that required emergency visit to hospital again. The outcome of the events was reported as condition unchanged. The seriousness of the events was reported as non serious. The causality of the events was not reported. Seriousness assessment of urticaria, pruritus and erythema was upgraded to medically significant based on the information available in the source document.
Age: 41.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Amino acid level, Antiphospholipid antibodies, Biopsy, Blood copper, Blood folate
Clinical narrative: Case number PHHY2016US064963, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 628150) website on 11 May 2016. This report refers to 41 years old male patient. Past historical conditions was not reported. Current condition included anemia. Concomitant medication included baclofen (manufacturer unknown). The patient was vaccinated with seasonal influenza vaccine (manufacturer unknown and batch number: not reported), intramuscularly on right arm on 13 Oct 2015. On 23 Oct 2015, he developed severe tingling/electrical feeling in left leg. Several days later the same feeling began in right leg and then by 31 Oct 2015 in arms and legs. On an unknown date, he developed pain across all extremities. On an unknown date, he was diagnosed with peripheral neuropathy. He underwent brain magnetic resonance imaging (MRI), thoracic MRI, lumbosacral MRI, small fiber biopsy, cerebrospinal fluid test via lumbar puncture, multiple blood tests such as lupus, copper, B12 deficiency, folate, methylmalonic acid, ceruloplasmin and multiple other blood tests and an electromyography (EMG)/ nerve conduction test (results not provided). The symptoms were present till date (given as 19 Mar 2016). The final outcome of the events was condition unchanged. The seriousness of the events was reported as serious (disability) and causality was not reported.
Age: 41.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Blood test, CSF test, Ceruloplasmin, Electromyogram, Nerve conduction studies
Clinical narrative: Case number PHHY2016US064963, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 628150) website on 11 May 2016. This report refers to 41 years old male patient. Past historical conditions was not reported. Current condition included anemia. Concomitant medication included baclofen (manufacturer unknown). The patient was vaccinated with seasonal influenza vaccine (manufacturer unknown and batch number: not reported), intramuscularly on right arm on 13 Oct 2015. On 23 Oct 2015, he developed severe tingling/electrical feeling in left leg. Several days later the same feeling began in right leg and then by 31 Oct 2015 in arms and legs. On an unknown date, he developed pain across all extremities. On an unknown date, he was diagnosed with peripheral neuropathy. He underwent brain magnetic resonance imaging (MRI), thoracic MRI, lumbosacral MRI, small fiber biopsy, cerebrospinal fluid test via lumbar puncture, multiple blood tests such as lupus, copper, B12 deficiency, folate, methylmalonic acid, ceruloplasmin and multiple other blood tests and an electromyography (EMG)/ nerve conduction test (results not provided). The symptoms were present till date (given as 19 Mar 2016). The final outcome of the events was condition unchanged. The seriousness of the events was reported as serious (disability) and causality was not reported.
Age: 41.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Neuropathy peripheral, Nuclear magnetic resonance imaging brain, Nuclear magnetic resonance imaging spinal, Nuclear magnetic resonance imaging thoracic, Pain in extremity
Clinical narrative: Case number PHHY2016US064963, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 628150) website on 11 May 2016. This report refers to 41 years old male patient. Past historical conditions was not reported. Current condition included anemia. Concomitant medication included baclofen (manufacturer unknown). The patient was vaccinated with seasonal influenza vaccine (manufacturer unknown and batch number: not reported), intramuscularly on right arm on 13 Oct 2015. On 23 Oct 2015, he developed severe tingling/electrical feeling in left leg. Several days later the same feeling began in right leg and then by 31 Oct 2015 in arms and legs. On an unknown date, he developed pain across all extremities. On an unknown date, he was diagnosed with peripheral neuropathy. He underwent brain magnetic resonance imaging (MRI), thoracic MRI, lumbosacral MRI, small fiber biopsy, cerebrospinal fluid test via lumbar puncture, multiple blood tests such as lupus, copper, B12 deficiency, folate, methylmalonic acid, ceruloplasmin and multiple other blood tests and an electromyography (EMG)/ nerve conduction test (results not provided). The symptoms were present till date (given as 19 Mar 2016). The final outcome of the events was condition unchanged. The seriousness of the events was reported as serious (disability) and causality was not reported.
Age: 41.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Paraesthesia, Vitamin B12
Clinical narrative: Case number PHHY2016US064963, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 628150) website on 11 May 2016. This report refers to 41 years old male patient. Past historical conditions was not reported. Current condition included anemia. Concomitant medication included baclofen (manufacturer unknown). The patient was vaccinated with seasonal influenza vaccine (manufacturer unknown and batch number: not reported), intramuscularly on right arm on 13 Oct 2015. On 23 Oct 2015, he developed severe tingling/electrical feeling in left leg. Several days later the same feeling began in right leg and then by 31 Oct 2015 in arms and legs. On an unknown date, he developed pain across all extremities. On an unknown date, he was diagnosed with peripheral neuropathy. He underwent brain magnetic resonance imaging (MRI), thoracic MRI, lumbosacral MRI, small fiber biopsy, cerebrospinal fluid test via lumbar puncture, multiple blood tests such as lupus, copper, B12 deficiency, folate, methylmalonic acid, ceruloplasmin and multiple other blood tests and an electromyography (EMG)/ nerve conduction test (results not provided). The symptoms were present till date (given as 19 Mar 2016). The final outcome of the events was condition unchanged. The seriousness of the events was reported as serious (disability) and causality was not reported.
Age: 41.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Antiphospholipid antibodies, Biopsy, Blood copper, Blood folate, Blood test
Clinical narrative: Case number PHHY2016US064963, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 628150) website on 11 May 2016. This report refers to 41 years old male patient. Past historical conditions was not reported. Current condition included anemia. Concomitant medication included baclofen (manufacturer unknown). The patient was vaccinated with seasonal influenza vaccine (manufacturer unknown and batch number: not reported), intramuscularly on right arm on 13 Oct 2015. On 23 Oct 2015, he developed severe tingling/electrical feeling in left leg. Several days later the same feeling began in right leg and then by 31 Oct 2015 in arms and legs. On an unknown date, he developed pain across all extremities. On an unknown date, he was diagnosed with peripheral neuropathy. He underwent brain magnetic resonance imaging (MRI), thoracic MRI, lumbosacral MRI, small fiber biopsy, cerebrospinal fluid test via lumbar puncture, multiple blood tests such as lupus, copper, B12 deficiency, folate, methylmalonic acid, ceruloplasmin and multiple other blood tests and an electromyography (EMG)/ nerve conduction test (results not provided). The symptoms were present till date (given as 19 Mar 2016). The final outcome of the events was condition unchanged. The seriousness of the events was reported as serious (disability) and causality was not reported.
Age: 41.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: CSF test, Ceruloplasmin, Electromyogram, Laboratory test, Nerve conduction studies
Clinical narrative: Case number PHHY2016US064963, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 628150) website on 11 May 2016. This report refers to 41 years old male patient. Past historical conditions was not reported. Current condition included anemia. Concomitant medication included baclofen (manufacturer unknown). The patient was vaccinated with seasonal influenza vaccine (manufacturer unknown and batch number: not reported), intramuscularly on right arm on 13 Oct 2015. On 23 Oct 2015, he developed severe tingling/electrical feeling in left leg. Several days later the same feeling began in right leg and then by 31 Oct 2015 in arms and legs. On an unknown date, he developed pain across all extremities. On an unknown date, he was diagnosed with peripheral neuropathy. He underwent brain magnetic resonance imaging (MRI), thoracic MRI, lumbosacral MRI, small fiber biopsy, cerebrospinal fluid test via lumbar puncture, multiple blood tests such as lupus, copper, B12 deficiency, folate, methylmalonic acid, ceruloplasmin and multiple other blood tests and an electromyography (EMG)/ nerve conduction test (results not provided). The symptoms were present till date (given as 19 Mar 2016). The final outcome of the events was condition unchanged. The seriousness of the events was reported as serious (disability) and causality was not reported.
Age: 33.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Chest X-ray, Chills, Cough, Impaired work ability, Influenza A virus test positive
Clinical narrative: Case number PHHY2016US066186, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 628681) on 11 May 2016. This report refers to a 33 years old female patient. Past medical history was not reported. Concomitant medication included SYNTHROID 25 mcg. The patient was vaccinated with seasonal influenza vaccine (manufacturer unknown, batch number: not reported) intramuscularly on 20 Oct 2015. On 18 Mar 2016, the patient experienced fever with body temperature 104, chills, congestion, cough, vomiting. The patient tested positive for influenza A and had tuberculosis antigen skin test. The patient visited the emergency care on an unknown date. The patient would perform chest X-ray. The patient had missed 04 days of work. It was reported that patient's 15 month infant also tested positive for influenza A even though she required the flu shot. The final outcome of the events was reported as complete recovery. The seriousness of the events was reported as non serious and causality not reported. Seriousness assessment of the events influenza, pyrexia, respiratory tract congestion, cough, vomiting, chills and vaccination failure and pyrexia was upgraded based on information available in the source document.
Age: 33.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Pyrexia, Respiratory tract congestion, Vomiting
Clinical narrative: Case number PHHY2016US066186, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 628681) on 11 May 2016. This report refers to a 33 years old female patient. Past medical history was not reported. Concomitant medication included SYNTHROID 25 mcg. The patient was vaccinated with seasonal influenza vaccine (manufacturer unknown, batch number: not reported) intramuscularly on 20 Oct 2015. On 18 Mar 2016, the patient experienced fever with body temperature 104, chills, congestion, cough, vomiting. The patient tested positive for influenza A and had tuberculosis antigen skin test. The patient visited the emergency care on an unknown date. The patient would perform chest X-ray. The patient had missed 04 days of work. It was reported that patient's 15 month infant also tested positive for influenza A even though she required the flu shot. The final outcome of the events was reported as complete recovery. The seriousness of the events was reported as non serious and causality not reported. Seriousness assessment of the events influenza, pyrexia, respiratory tract congestion, cough, vomiting, chills and vaccination failure and pyrexia was upgraded based on information available in the source document.
Age: 33.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Chills, Cough, Influenza, Influenza A virus test positive, Pyrexia
Clinical narrative: Case number PHHY2016US066186, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 628681) on 11 May 2016. This report refers to a 33 years old female patient. Past medical history was not reported. Concomitant medication included SYNTHROID 25 mcg. The patient was vaccinated with seasonal influenza vaccine (manufacturer unknown, batch number: not reported) intramuscularly on 20 Oct 2015. On 18 Mar 2016, the patient experienced fever with body temperature 104, chills, congestion, cough, vomiting. The patient tested positive for influenza A and had tuberculosis antigen skin test. The patient visited the emergency care on an unknown date. The patient would perform chest X-ray. The patient had missed 04 days of work. It was reported that patient's 15 month infant also tested positive for influenza A even though she required the flu shot. The final outcome of the events was reported as complete recovery. The seriousness of the events was reported as non serious and causality not reported. Seriousness assessment of the events influenza, pyrexia, respiratory tract congestion, cough, vomiting, chills and vaccination failure and pyrexia was upgraded based on information available in the source document.
Age: 33.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Respiratory tract congestion, Vaccination failure, Vomiting
Clinical narrative: Case number PHHY2016US066186, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 628681) on 11 May 2016. This report refers to a 33 years old female patient. Past medical history was not reported. Concomitant medication included SYNTHROID 25 mcg. The patient was vaccinated with seasonal influenza vaccine (manufacturer unknown, batch number: not reported) intramuscularly on 20 Oct 2015. On 18 Mar 2016, the patient experienced fever with body temperature 104, chills, congestion, cough, vomiting. The patient tested positive for influenza A and had tuberculosis antigen skin test. The patient visited the emergency care on an unknown date. The patient would perform chest X-ray. The patient had missed 04 days of work. It was reported that patient's 15 month infant also tested positive for influenza A even though she required the flu shot. The final outcome of the events was reported as complete recovery. The seriousness of the events was reported as non serious and causality not reported. Seriousness assessment of the events influenza, pyrexia, respiratory tract congestion, cough, vomiting, chills and vaccination failure and pyrexia was upgraded based on information available in the source document.
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB, FLUX, PPV, DTAPIPVHIB, FLUX, PPV
Symptoms: Rash generalised
Clinical narrative: Case number PHHY2016US066288 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 629443) on 11 May 2016. This report refers to a female neonate (age: 0.5). The patient had no medical history and concurrent conditions. The patient had no concomitant medications. The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) intramuscularly into leg on 07 Oct 2014. On the same day the patient was also vaccinated with DTAP IPV HIB (batch number: not reported, other manufacturer) intramuscularly into leg and PPV (batch number: not reported, other manufacturer) intramuscularly into unspecified site. On 10 Oct 2014 the patient developed a small rash on the back and then spread all over the body. The patient was taken to emergency room due to this event. No tests were performed now but they would have allergy tests later. It took one month of antihistamines to counteract it. Final outcome of the event rash generalized was recovered. Seriousness and causality of the event was not reported. Seriousness assessment of "rash generalized" was upgraded based on information in the source document.
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB, FLUX, PPV, DTAPIPVHIB, FLUX, PPV
Symptoms: Drug administered to patient of inappropriate age, Rash generalised
Clinical narrative: Case number PHHY2016US066288 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 629443) on 11 May 2016. This report refers to a female neonate (age: 0.5). The patient had no medical history and concurrent conditions. The patient had no concomitant medications. The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) intramuscularly into leg on 07 Oct 2014. On the same day the patient was also vaccinated with DTAP IPV HIB (batch number: not reported, other manufacturer) intramuscularly into leg and PPV (batch number: not reported, other manufacturer) intramuscularly into unspecified site. On 10 Oct 2014 the patient developed a small rash on the back and then spread all over the body. The patient was taken to emergency room due to this event. No tests were performed now but they would have allergy tests later. It took one month of antihistamines to counteract it. Final outcome of the event rash generalized was recovered. Seriousness and causality of the event was not reported. Seriousness assessment of "rash generalized" was upgraded based on information in the source document.
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Influenza, Vaccination failure
Clinical narrative: Case number PHHY2016US064937, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System VAERS reference number: 630258) on 11 May 2016. This report refers to a male patient of an unknown age. Past medical history and concomitant medication were not reported. He was vaccinated with seasonal influenza vaccine (unknown manufacturer, batch number: not reported) on an unknown date. Following vaccination, on an unspecified date, he experienced flu. It was also the case for vaccination failure. Lab data and corrective treatments were not reported. The outcome of flu was not reported. It was unknown at the time of vaccination whether the patient developed any adverse event or not. The seriousness and causality of the events were not reported. Seriousness of the events influenza and vaccination failure was upgraded (medically significant) based on the information available in the source document.
Age: 22.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Abnormal behaviour, Diarrhoea, Influenza like illness, Learning disorder, Maternal exposure before pregnancy
Clinical narrative: Case number PHHY2016US064877, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 630507) on 11 May 2016. This report refers to a 22 years old pregnant female patient. Past medical history and concomitant medication were not reported. She was vaccinated with seasonal influenza vaccine (unknown manufacturer, batch number: not reported) into the arm on 01 Dec 2011. It was reported that she was pregnant during this time. After vaccination, on 11 Dec 2011, she experienced severe flu like symptoms, vomiting, fever, nausea and diarrhea. The outcome of the events flu like symptoms, vomiting, nausea, diarrhea, fever was reported as condition unchanged. The outcome of pregnancy was reported as full-term live birth (live neonate), please see baby case (PHHY2016US065600). The events flu like symptoms, vomiting, nausea, diarrhea, fever were reported as serious (disability). The causality of the events was not reported.
Age: 22.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Nausea, Pyrexia, Vomiting
Clinical narrative: Case number PHHY2016US064877, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 630507) on 11 May 2016. This report refers to a 22 years old pregnant female patient. Past medical history and concomitant medication were not reported. She was vaccinated with seasonal influenza vaccine (unknown manufacturer, batch number: not reported) into the arm on 01 Dec 2011. It was reported that she was pregnant during this time. After vaccination, on 11 Dec 2011, she experienced severe flu like symptoms, vomiting, fever, nausea and diarrhea. The outcome of the events flu like symptoms, vomiting, nausea, diarrhea, fever was reported as condition unchanged. The outcome of pregnancy was reported as full-term live birth (live neonate), please see baby case (PHHY2016US065600). The events flu like symptoms, vomiting, nausea, diarrhea, fever were reported as serious (disability). The causality of the events was not reported.
Age: 22.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Diarrhoea, Exposure during pregnancy, Influenza like illness, Nausea, Pyrexia
Clinical narrative: Case number PHHY2016US064877, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 630507) on 11 May 2016. This report refers to a 22 years old pregnant female patient. Past medical history and concomitant medication were not reported. She was vaccinated with seasonal influenza vaccine (unknown manufacturer, batch number: not reported) into the arm on 01 Dec 2011. It was reported that she was pregnant during this time. After vaccination, on 11 Dec 2011, she experienced severe flu like symptoms, vomiting, fever, nausea and diarrhea. The outcome of the events flu like symptoms, vomiting, nausea, diarrhea, fever was reported as condition unchanged. The outcome of pregnancy was reported as full-term live birth (live neonate), please see baby case (PHHY2016US065600). The events flu like symptoms, vomiting, nausea, diarrhea, fever were reported as serious (disability). The causality of the events was not reported.
Age: 22.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Vomiting
Clinical narrative: Case number PHHY2016US064877, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 630507) on 11 May 2016. This report refers to a 22 years old pregnant female patient. Past medical history and concomitant medication were not reported. She was vaccinated with seasonal influenza vaccine (unknown manufacturer, batch number: not reported) into the arm on 01 Dec 2011. It was reported that she was pregnant during this time. After vaccination, on 11 Dec 2011, she experienced severe flu like symptoms, vomiting, fever, nausea and diarrhea. The outcome of the events flu like symptoms, vomiting, nausea, diarrhea, fever was reported as condition unchanged. The outcome of pregnancy was reported as full-term live birth (live neonate), please see baby case (PHHY2016US065600). The events flu like symptoms, vomiting, nausea, diarrhea, fever were reported as serious (disability). The causality of the events was not reported.
Age: 2.0
Sex: M
Vaccine: FLU3, FLUX
Symptoms: Pyrexia, Seizure
Clinical narrative: Case number PHHY2016US064908, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 630662) website on 11 May 2016. This report refers to a 2 year old male patient. Medical history and concomitant medication were not reported. The patient had no current illness. The patient was vaccinated with a seasonal influenza vaccine (manufacturer and batch number: not reported) intramuscularly in arm on 09 Nov 2015. On the same day after vaccination, the patient experienced fever and seizure (febrile convulsion). Final outcome of the event was reported as complete recovery. Seriousness and causality of the event were not reported. Seriousness assessment of the event fever and seizure (febrile convulsion) was upgraded (medically significant) based on the information available in the source document.
Age: 2.0
Sex: M
Vaccine: FLU3, FLUX
Symptoms: Febrile convulsion
Clinical narrative: Case number PHHY2016US064908, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 630662) website on 11 May 2016. This report refers to a 2 year old male patient. Medical history and concomitant medication were not reported. The patient had no current illness. The patient was vaccinated with a seasonal influenza vaccine (manufacturer and batch number: not reported) intramuscularly in arm on 09 Nov 2015. On the same day after vaccination, the patient experienced fever and seizure (febrile convulsion). Final outcome of the event was reported as complete recovery. Seriousness and causality of the event were not reported. Seriousness assessment of the event fever and seizure (febrile convulsion) was upgraded (medically significant) based on the information available in the source document.
Age: 63.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Middle insomnia, Mobility decreased, Musculoskeletal pain, Pain
Clinical narrative: Case number PHHY2016US066283 is an initial spontaneous report received from a consumer via Vaccine Adverse Events Reporting System (VAERS reference number: 630846) on 11 May 2016. This report refers to a 63 year old male patient. His medical history included chronic pain. He had no current conditions. His concomitant medications were tramadol, bupropion and baclofen. He was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) in the left arm on 25 Nov 2015. On 28 Nov 2015, he had pain in left shoulder which progressed to inability to move his shoulder and arm without severe pain. He could not lift his arm to put on a jacket. His pain was progressively worse and it did not start to regress for about a month. He still had pain in left shoulder to where it woke him up at night if he rolled to that side. He stated that the shot was administered to the bursa and rotator cuff in his left shoulder. He went to lab and was given an appointment to evaluate the damage and a series of exercises to relieve the pain. The events outcome was reported as condition unchanged. The seriousness of the events was not reported, but the events left shoulder pain, inability to move his shoulder and arm without severe pain and could not lift his arm were upgraded as medically significant based on the information available in the source documents. The causality of the events was not reported.
Age: 63.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Injection site joint movement impairment, Injection site pain, Pain, Poor quality sleep
Clinical narrative: Case number PHHY2016US066283 is an initial spontaneous report received from a consumer via Vaccine Adverse Events Reporting System (VAERS reference number: 630846) on 11 May 2016. This report refers to a 63 year old male patient. His medical history included chronic pain. He had no current conditions. His concomitant medications were tramadol, bupropion and baclofen. He was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) in the left arm on 25 Nov 2015. On 28 Nov 2015, he had pain in left shoulder which progressed to inability to move his shoulder and arm without severe pain. He could not lift his arm to put on a jacket. His pain was progressively worse and it did not start to regress for about a month. He still had pain in left shoulder to where it woke him up at night if he rolled to that side. He stated that the shot was administered to the bursa and rotator cuff in his left shoulder. He went to lab and was given an appointment to evaluate the damage and a series of exercises to relieve the pain. The events outcome was reported as condition unchanged. The seriousness of the events was not reported, but the events left shoulder pain, inability to move his shoulder and arm without severe pain and could not lift his arm were upgraded as medically significant based on the information available in the source documents. The causality of the events was not reported.
Age: 0.4
Sex: U
Vaccine: HEPA, HIBV, PNC13, HEPA
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a nurse referring to a "5 months old" patient. No medical history or allergy was reported. On an unknown date the patient was inadvertently administered VAQTA 25/0.5 (units unknown) intramuscularly (dose unknown). No adverse effect was reported. No further information was provided. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Dizziness, Headache, Injection site erythema, Injection site induration, Injection site pruritus
Clinical narrative: Extreme hardness, redness, hot, itching and swelling at injection area.  As of today this has now spread to an area larger than my hand can cover and is still spreading.  Mild headaches and dizziness.  I am thinking about seeking emergency room care today.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: Extreme hardness, redness, hot, itching and swelling at injection area.  As of today this has now spread to an area larger than my hand can cover and is still spreading.  Mild headaches and dizziness.  I am thinking about seeking emergency room care today.
Age: 81.0
Sex: F
Vaccine: PNC13
Symptoms: Chills, Nausea
Clinical narrative: On 06/21/16, 81 yo F with h/o HTN presented to clinic for blood pressure check. During this visit, the pt was ordered to receive Pneumococcal conjugate vaccine 13-valent IM (PREVNAR 13). At 0940, pt received the injection of 0.5 mL in the left deltoid (NDC: 0005-1971-01; Lot #m79319; exp: 8/30/2017). Pt tolerated injection without incident and was discharged home. On 06/22, pt called the clinic and reported new onset nausea and chills. Pt did not own a thermometer, so presence of fever was not verified. Pt was queried about the injection site and reported no swelling, redness, or warmth at the site. Pt was advised to take acetaminophen for symptom management and notify office if symptoms persist beyond 2 days. No current outcome known.
Age: 57.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Diarrhoea, Fatigue, Nausea, Pain
Clinical narrative: Employee complains of chills, fatigue, nausea, diarrhea, body aches, possible low grade temp, has not taken temperature. Has taken two ALEVE.
Age: 22.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Exposure during pregnancy, Foetal hypokinesia
Clinical narrative: Patient is 33 weeks pregnant and received BOOSTRIX on 06/21/16. Today she reports that baby has not been moving as much as he was prior to vaccination. Patient was advised to contact her Physician immediately. She was instructed by Physician to come in immediately to be seen.
Age: 22.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Exposure during pregnancy, Foetal disorder
Clinical narrative: Patient is 33 weeks pregnant and received BOOSTRIX on 06/21/16. Today she reports that baby has not been moving as much as he was prior to vaccination. Patient was advised to contact her Physician immediately. She was instructed by Physician to come in immediately to be seen.
Age: 20.0
Sex: F
Vaccine: TDAP
Symptoms: Decreased appetite, Erythema, Headache, Mobility decreased, Pain in extremity
Clinical narrative: Initial unsolicited report received from a consumer on 08 June 2016. This case involves a 20-year-old female patient who was vaccinated with a dose of Adacel (batch number, route and site of administration not reported) on 07 June 2016. The patient's Pre-existing physician diagnosed allergies, birth defects, medical conditions included allergy to mortin. Illness at time of vaccination and concomitant medications were not reported. On 07 June 2016, same day following the vaccination, the patient had very sore arm, difficult to move arm, red streaks running down arm, severe headache, no appetite, and feeling of throat closing. The symptoms were continuing as of 08 June 2016. Laboratory data and corrective treatment were not reported. The patient had not recovered from events. List of documents held by sender: none.
Age: 20.0
Sex: F
Vaccine: TDAP
Symptoms: Throat tightness
Clinical narrative: Initial unsolicited report received from a consumer on 08 June 2016. This case involves a 20-year-old female patient who was vaccinated with a dose of Adacel (batch number, route and site of administration not reported) on 07 June 2016. The patient's Pre-existing physician diagnosed allergies, birth defects, medical conditions included allergy to mortin. Illness at time of vaccination and concomitant medications were not reported. On 07 June 2016, same day following the vaccination, the patient had very sore arm, difficult to move arm, red streaks running down arm, severe headache, no appetite, and feeling of throat closing. The symptoms were continuing as of 08 June 2016. Laboratory data and corrective treatment were not reported. The patient had not recovered from events. List of documents held by sender: none.
Age: 19.0
Sex: F
Vaccine: HEP, HEPA, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Nodule
Clinical narrative: Bilateral red swollen upper arm. painful and hot to touch, she has no fever. Large knot in left arm.
Age: 37.0
Sex: F
Vaccine: MNQ
Symptoms: Erythema, Localised oedema, Tenderness
Clinical narrative: Large local edema, Tenderness, Erythema down left arm.
Age: 0.34
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Immediate post-injection reaction, Injection site urticaria
Clinical narrative: IMMEDIATELY FOLLOWING SHOTS, PATIENT DEVELOPED URTICARIAL LESION LON BILATERAL LOWER EXTREMITIES, THEY RESOLVED WITHIN 15 MINUTES, THERE WAS NO BREATHING DISCOMFORT.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Rash vesicular
Clinical narrative: Vesicular rash on leg.
Age: 2.0
Sex: M
Vaccine: HEP
Symptoms: Lymphadenopathy
Clinical narrative: Swollen lymph nodes.
Age: 3.0
Sex: M
Vaccine: HEPA
Symptoms: Allergy test, Injection site nodule
Clinical narrative: Subcutaneous skin nodules on legs by injection site.
Age: 31.0
Sex: M
Vaccine: TDAP
Symptoms: Pain in extremity
Clinical narrative: Initial unsolicited report received from a pharmacist on 31-May-2016. This case involves a 31-year-old male patient who was vaccinated with ADACEL (batch number: U5406AA expiry date: 05-Jun-2018, route of administration was not reported) in left deltoid on 14-May-2016. Patient had no illness at the time of vaccination. Patient had a history of low back pain since 2000 and concomitant medications were not reported. On an unspecified date, some time after vaccination patient developed shooting pan down his legs into his feet. It was reported that the patient required ER/doctor visit. No laboratory investigations were performed. Corrective treatment was not reported. Patient was suggested to seek further medical treatment as needed. The outcome was reported as not recovered. Documents held by sender: none.
Sex: M
Vaccine: TTOX
Symptoms: Adverse reaction
Clinical narrative: Initial unsolicited report received from a non-healthcare professional (medical assistant) on 07 June 2016. This case involves male patient (unknown age) who was vaccinated with dose of Tetanus vaccine (batch number was reported as unknown, expiration date, route and site of administration was not reported) on an unspecified date. Illness at time of vaccination was reported as unknown and pre-existing physician diagnosed allergies, birth defects, medical conditions was not reported. Concomitant medications were reported as unknown. On an unspecified date, following vaccination, patient experienced bad reaction. Lab data and corrective treatment were not reported. Outcome of event was reported as unknown. List of documents held by sender: none.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness, Swelling, large red ring around injection site that was spreading up and down the arm.
Age: 0.17
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC13, RV5
Symptoms: Haematochezia
Clinical narrative: Mom noticed blood in stool 3 times in the evening of the day the pt received the ROTATEQ vaccine.
Age: 31.0
Sex: F
Vaccine: UNK
Symptoms: Limb discomfort, Muscular weakness, Pain in extremity
Clinical narrative: Pain, discomfort and weakness in my left arm. When I informed the nurse about the symptoms she recommended that I apply a cold pack of ice to the left arm. She instructed me to apply the ice pack 10 minutes near the injection then take the ice pack off for 10 minutes. I followed the directions exactly as given by the nurse.
Age: 39.0
Sex: M
Vaccine: TDAP
Symptoms: Administration site pain, Arthralgia, Fatigue, Injected limb mobility decreased, Injection site swelling
Clinical narrative: Intense soreness/pain at administration site (left deltoid shoulder). Pain so severe I can't raise my left arm above chest. Some mild swelling at injection area, but no redness. Some joint and muscle pain throughout body and feeling tired. Pain in deltoid is worse on 06/23/2016. Pain in shoulder area is 8 out of 10 when trying to lift arm above chest level.
Age: 39.0
Sex: M
Vaccine: TDAP
Symptoms: Myalgia
Clinical narrative: Intense soreness/pain at administration site (left deltoid shoulder). Pain so severe I can't raise my left arm above chest. Some mild swelling at injection area, but no redness. Some joint and muscle pain throughout body and feeling tired. Pain in deltoid is worse on 06/23/2016. Pain in shoulder area is 8 out of 10 when trying to lift arm above chest level.
Age: 28.0
Sex: M
Vaccine: PPV
Symptoms: Hypoaesthesia, Injection site erythema, Injection site pain, Injection site warmth, Joint range of motion decreased
Clinical narrative: Left arm localized pain in left shoulder woke out of sleep. Decreased range of motion reported. Left shoulder redness and warmth at injection site. site dry and intact. Reporting 6/22/16 left arm numbness/tingling down to middle/ring finger intermittently. 6/23/16 denies any left arm numbness/tingling.
Age: 28.0
Sex: M
Vaccine: PPV
Symptoms: Paraesthesia
Clinical narrative: Left arm localized pain in left shoulder woke out of sleep. Decreased range of motion reported. Left shoulder redness and warmth at injection site. site dry and intact. Reporting 6/22/16 left arm numbness/tingling down to middle/ring finger intermittently. 6/23/16 denies any left arm numbness/tingling.
Age: 13.0
Sex: M
Vaccine: HEPA
Symptoms: Discomfort, Fatigue, Headache, Injection site erythema, Injection site swelling
Clinical narrative: Patient had HA, fatigue, sense of heaviness, fever, and local arm swelling and redness at injection site after HPV #3 vaccine and Hep A vaccine.  Persistent erythema at injection site 2wk after immunizations. Clinical course most c/w HPV vaccine reaction.
Age: 13.0
Sex: M
Vaccine: HEPA
Symptoms: Pyrexia
Clinical narrative: Patient had HA, fatigue, sense of heaviness, fever, and local arm swelling and redness at injection site after HPV #3 vaccine and Hep A vaccine.  Persistent erythema at injection site 2wk after immunizations. Clinical course most c/w HPV vaccine reaction.
Age: 17.0
Sex: F
Vaccine: FLU3, HPV4
Symptoms: Cognitive disorder, Dizziness, Dry mouth, Fatigue, Headache
Clinical narrative: Patient had 1st adverse symptoms when she collapsed to the floor and was unable to move her lower extremities. These symptoms resolved within 7 days and she gradually regained the strength in her legs. In Dec '15 she developed pain in legs and shoulders. In the next months she developed fatigue, intermittent muscle spasm, tingling in the legs, leg weakness, cognitive dysfunction, dry mouth , night sweats, headaches, and episodes of dizziness. While hospitalized in May '16 she tested positive for POTS- postural orthostatic tachycardia syndrome.