chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 50.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Anaphylactic reaction, Blood immunoglobulin E, Chest discomfort, Dyspnoea, Echocardiogram
Clinical narrative: This spontaneous report as received from a 50 year old female patient reporting on herself with asthma, drug allergy to ADVAIR and seasonal allergy. On 25-MAY-2016 the patient was vaccinated with a dose of ZOSTAVAX, 1 shot, subdermal. Dose, lot number and expiration date were not provided. Concomitant therapies included ALLEGRA, SINGULAIR AND VENTOLIN. On 25-MAY-2016, within 10 minutes after therapy with ZOSTAVAX the patient began to manifest symptoms. It was thought to be anaphylaxis as she had rapid pulse, swollen throat, shortness of breath and tightness in chest. The patient was rushed to an unspecified hospital and was hospitalized for unspecified length of time. She was discharged as they were unable to diagnose her; then, she visited a cardiologist who did an EKG and echocardiogram, which results were not provided. The patient was sent to unspecified hospital two other unspecified times for unstated lengths of time as her symptoms had persisted and had not improved at all. The patient stated that she had visited several specialists who had been unable to identify the condition, however, she had been on anxiety medication, acid reflux medication and several other unspecified medicines to rule out all possibilities. Additionally, the patient stated that she was receiving allergy shots around the time of the vaccination with ZOSTAVAX and she did not know if that contributed to the seemingly immune system related issues. Also, the patient reported an IgE blood test but she did not reported the result for this laboratory test. The outcome of the events was reported as not recovered. The causality between therapy with ZOSTAVAX and the events was unknown. Additional information has been requested.
Age: 50.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Electrocardiogram, Heart rate increased, Pharyngeal oedema
Clinical narrative: This spontaneous report as received from a 50 year old female patient reporting on herself with asthma, drug allergy to ADVAIR and seasonal allergy. On 25-MAY-2016 the patient was vaccinated with a dose of ZOSTAVAX, 1 shot, subdermal. Dose, lot number and expiration date were not provided. Concomitant therapies included ALLEGRA, SINGULAIR AND VENTOLIN. On 25-MAY-2016, within 10 minutes after therapy with ZOSTAVAX the patient began to manifest symptoms. It was thought to be anaphylaxis as she had rapid pulse, swollen throat, shortness of breath and tightness in chest. The patient was rushed to an unspecified hospital and was hospitalized for unspecified length of time. She was discharged as they were unable to diagnose her; then, she visited a cardiologist who did an EKG and echocardiogram, which results were not provided. The patient was sent to unspecified hospital two other unspecified times for unstated lengths of time as her symptoms had persisted and had not improved at all. The patient stated that she had visited several specialists who had been unable to identify the condition, however, she had been on anxiety medication, acid reflux medication and several other unspecified medicines to rule out all possibilities. Additionally, the patient stated that she was receiving allergy shots around the time of the vaccination with ZOSTAVAX and she did not know if that contributed to the seemingly immune system related issues. Also, the patient reported an IgE blood test but she did not reported the result for this laboratory test. The outcome of the events was reported as not recovered. The causality between therapy with ZOSTAVAX and the events was unknown. Additional information has been requested.
Age: 50.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Anxiety, Blood immunoglobulin E, Chest discomfort, Dyspnoea, Echocardiogram
Clinical narrative: This spontaneous report as received from a 50 year old female patient reporting on herself with asthma, drug allergy to ADVAIR and seasonal allergy. On 25-MAY-2016 the patient was vaccinated with a dose of ZOSTAVAX, 1 shot, subdermal. Dose, lot number and expiration date were not provided. Concomitant therapies included ALLEGRA, SINGULAIR AND VENTOLIN. On 25-MAY-2016, within 10 minutes after therapy with ZOSTAVAX the patient began to manifest symptoms. It was thought to be anaphylaxis as she had rapid pulse, swollen throat, shortness of breath and tightness in chest. The patient was rushed to an unspecified hospital and was hospitalized for unspecified length of time. She was discharged as they were unable to diagnose her; then, she visited a cardiologist who did an EKG and echocardiogram, which results were not provided. The patient was sent to unspecified hospital two other unspecified times for unstated lengths of time as her symptoms had persisted and had not improved at all. The patient stated that she had visited several specialists who had been unable to identify the condition, however, she had been on anxiety medication, acid reflux medication and several other unspecified medicines to rule out all possibilities. Additionally, the patient stated that she was receiving allergy shots around the time of the vaccination with ZOSTAVAX and she did not know if that contributed to the seemingly immune system related issues. Also, the patient reported an IgE blood test but she did not reported the result for this laboratory test. The outcome of the events was reported as not recovered. The causality between therapy with ZOSTAVAX and the events was unknown. Additional information has been requested.
Age: 50.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Electrocardiogram, Gastrooesophageal reflux disease, Heart rate increased, Pharyngeal oedema
Clinical narrative: This spontaneous report as received from a 50 year old female patient reporting on herself with asthma, drug allergy to ADVAIR and seasonal allergy. On 25-MAY-2016 the patient was vaccinated with a dose of ZOSTAVAX, 1 shot, subdermal. Dose, lot number and expiration date were not provided. Concomitant therapies included ALLEGRA, SINGULAIR AND VENTOLIN. On 25-MAY-2016, within 10 minutes after therapy with ZOSTAVAX the patient began to manifest symptoms. It was thought to be anaphylaxis as she had rapid pulse, swollen throat, shortness of breath and tightness in chest. The patient was rushed to an unspecified hospital and was hospitalized for unspecified length of time. She was discharged as they were unable to diagnose her; then, she visited a cardiologist who did an EKG and echocardiogram, which results were not provided. The patient was sent to unspecified hospital two other unspecified times for unstated lengths of time as her symptoms had persisted and had not improved at all. The patient stated that she had visited several specialists who had been unable to identify the condition, however, she had been on anxiety medication, acid reflux medication and several other unspecified medicines to rule out all possibilities. Additionally, the patient stated that she was receiving allergy shots around the time of the vaccination with ZOSTAVAX and she did not know if that contributed to the seemingly immune system related issues. Also, the patient reported an IgE blood test but she did not reported the result for this laboratory test. The outcome of the events was reported as not recovered. The causality between therapy with ZOSTAVAX and the events was unknown. Additional information has been requested.
Age: 50.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Chest discomfort, Diarrhoea, Dizziness, Dyspnoea
Clinical narrative: This spontaneous report as received from a 50 year old female patient reporting on herself with asthma, drug allergy to fluticasone  and ADVAIR and seasonal allergy. On 25-MAY-2016 the patient was vaccinated with a dose of ZOSTAVAX, 1 shot, subdermal. Dose, lot number and expiration date were not provided. Concomitant therapies included ALLEGRA, SINGULAIR  and VENTOLIN. On 25-MAY-2016, within 10 minutes after therapy with ZOSTAVAX the patient began to manifest symptoms. It was thought to be anaphylaxis as she had rapid pulse, swollen throat, shortness of breath and tightness in chest. The patient was rushed to an unspecified hospital and was hospitalized for unspecified length of time. She was discharged as they were unable to diagnose her; then ,  she visited a cardiologist who did an EKG and echocardiogram, which results were not provided. The patient was sent to unspecified hospital two other unspecified times for unstated lengths of time as her symptoms had persisted and had not improved at all. the patient stated that she had visited several specialists who had been unable to identify the condition, however, she had been on anxiety medication, acid reflux medication and several other unspecified medicines to rule out all possibilities. Additionally, the patient stated that she was receiving allergy shots around the time of the vaccination with ZOSTAVAX and she did not know if that contributed to the seemingly immune system related issues. Also, the patient reported an IgE blood test but she did not reported the results for this laboratory test. The outcome of the events was reported as not recovered. The causality between therapy with ZOSTAVAX and the events were  unknown. Additional information has been requested.
Age: 50.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Anaphylactic reaction, Blood immunoglobulin E, Chest discomfort, Dyspnoea, Echocardiogram
Clinical narrative: This spontaneous report as received from a 50 year old female patient reporting on herself with asthma, drug allergy to fluticasone  and ADVAIR and seasonal allergy. On 25-MAY-2016 the patient was vaccinated with a dose of ZOSTAVAX, 1 shot, subdermal. Dose, lot number and expiration date were not provided. Concomitant therapies included ALLEGRA, SINGULAIR  and VENTOLIN. On 25-MAY-2016, within 10 minutes after therapy with ZOSTAVAX the patient began to manifest symptoms. It was thought to be anaphylaxis as she had rapid pulse, swollen throat, shortness of breath and tightness in chest. The patient was rushed to an unspecified hospital and was hospitalized for unspecified length of time. She was discharged as they were unable to diagnose her; then ,  she visited a cardiologist who did an EKG and echocardiogram, which results were not provided. The patient was sent to unspecified hospital two other unspecified times for unstated lengths of time as her symptoms had persisted and had not improved at all. the patient stated that she had visited several specialists who had been unable to identify the condition, however, she had been on anxiety medication, acid reflux medication and several other unspecified medicines to rule out all possibilities. Additionally, the patient stated that she was receiving allergy shots around the time of the vaccination with ZOSTAVAX and she did not know if that contributed to the seemingly immune system related issues. Also, the patient reported an IgE blood test but she did not reported the results for this laboratory test. The outcome of the events was reported as not recovered. The causality between therapy with ZOSTAVAX and the events were  unknown. Additional information has been requested.
Age: 50.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Electrocardiogram, Heart rate increased, Pharyngeal oedema
Clinical narrative: This spontaneous report as received from a 50 year old female patient reporting on herself with asthma, drug allergy to fluticasone  and ADVAIR and seasonal allergy. On 25-MAY-2016 the patient was vaccinated with a dose of ZOSTAVAX, 1 shot, subdermal. Dose, lot number and expiration date were not provided. Concomitant therapies included ALLEGRA, SINGULAIR  and VENTOLIN. On 25-MAY-2016, within 10 minutes after therapy with ZOSTAVAX the patient began to manifest symptoms. It was thought to be anaphylaxis as she had rapid pulse, swollen throat, shortness of breath and tightness in chest. The patient was rushed to an unspecified hospital and was hospitalized for unspecified length of time. She was discharged as they were unable to diagnose her; then ,  she visited a cardiologist who did an EKG and echocardiogram, which results were not provided. The patient was sent to unspecified hospital two other unspecified times for unstated lengths of time as her symptoms had persisted and had not improved at all. the patient stated that she had visited several specialists who had been unable to identify the condition, however, she had been on anxiety medication, acid reflux medication and several other unspecified medicines to rule out all possibilities. Additionally, the patient stated that she was receiving allergy shots around the time of the vaccination with ZOSTAVAX and she did not know if that contributed to the seemingly immune system related issues. Also, the patient reported an IgE blood test but she did not reported the results for this laboratory test. The outcome of the events was reported as not recovered. The causality between therapy with ZOSTAVAX and the events were  unknown. Additional information has been requested.
Age: 50.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Anxiety, Blood immunoglobulin E, Chest discomfort, Dyspnoea, Echocardiogram
Clinical narrative: This spontaneous report as received from a 50 year old female patient reporting on herself with asthma, drug allergy to fluticasone  and ADVAIR and seasonal allergy. On 25-MAY-2016 the patient was vaccinated with a dose of ZOSTAVAX, 1 shot, subdermal. Dose, lot number and expiration date were not provided. Concomitant therapies included ALLEGRA, SINGULAIR  and VENTOLIN. On 25-MAY-2016, within 10 minutes after therapy with ZOSTAVAX the patient began to manifest symptoms. It was thought to be anaphylaxis as she had rapid pulse, swollen throat, shortness of breath and tightness in chest. The patient was rushed to an unspecified hospital and was hospitalized for unspecified length of time. She was discharged as they were unable to diagnose her; then ,  she visited a cardiologist who did an EKG and echocardiogram, which results were not provided. The patient was sent to unspecified hospital two other unspecified times for unstated lengths of time as her symptoms had persisted and had not improved at all. the patient stated that she had visited several specialists who had been unable to identify the condition, however, she had been on anxiety medication, acid reflux medication and several other unspecified medicines to rule out all possibilities. Additionally, the patient stated that she was receiving allergy shots around the time of the vaccination with ZOSTAVAX and she did not know if that contributed to the seemingly immune system related issues. Also, the patient reported an IgE blood test but she did not reported the results for this laboratory test. The outcome of the events was reported as not recovered. The causality between therapy with ZOSTAVAX and the events were  unknown. Additional information has been requested.
Age: 50.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Electrocardiogram, Gastrooesophageal reflux disease, Heart rate increased, Pharyngeal oedema
Clinical narrative: This spontaneous report as received from a 50 year old female patient reporting on herself with asthma, drug allergy to fluticasone  and ADVAIR and seasonal allergy. On 25-MAY-2016 the patient was vaccinated with a dose of ZOSTAVAX, 1 shot, subdermal. Dose, lot number and expiration date were not provided. Concomitant therapies included ALLEGRA, SINGULAIR  and VENTOLIN. On 25-MAY-2016, within 10 minutes after therapy with ZOSTAVAX the patient began to manifest symptoms. It was thought to be anaphylaxis as she had rapid pulse, swollen throat, shortness of breath and tightness in chest. The patient was rushed to an unspecified hospital and was hospitalized for unspecified length of time. She was discharged as they were unable to diagnose her; then ,  she visited a cardiologist who did an EKG and echocardiogram, which results were not provided. The patient was sent to unspecified hospital two other unspecified times for unstated lengths of time as her symptoms had persisted and had not improved at all. the patient stated that she had visited several specialists who had been unable to identify the condition, however, she had been on anxiety medication, acid reflux medication and several other unspecified medicines to rule out all possibilities. Additionally, the patient stated that she was receiving allergy shots around the time of the vaccination with ZOSTAVAX and she did not know if that contributed to the seemingly immune system related issues. Also, the patient reported an IgE blood test but she did not reported the results for this laboratory test. The outcome of the events was reported as not recovered. The causality between therapy with ZOSTAVAX and the events were  unknown. Additional information has been requested.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13
Symptoms: Injection site discolouration
Clinical narrative: Initial unsolicited report received from other healthcare professional on 05 July 2016. This case involves a six-month-old female patient who was vaccinated with third dose of ACTHIB (batch number: UI379AAA, expiry date 27 February 2017 and route of administration not reported), in the left thigh, a dose of PREVENAR 13 (manufacturer: Pfizer) (batch number, expiry date and route of administration not reported), in the left thigh and a dose of PEDIARIX (manufacturer: GSK) (batch number, expiry date and route of administration not reported), in the right thigh on 04 February 2016. The patient's pre-existing physician diagnosed allergies, birth defects, medical conditions was reported as NKA (no known allergy), none. Illness at time of vaccination was reported as none. Any other vaccinations within 4 weeks of vaccinations was reported as none. On 18 February 2016, two weeks following the vaccination, the patient developed quarter size brown area (brown mark) on left thigh. The patient required ER/doctor visit. Laboratory data was reported as none at this time. The patient's corrective treatment was not reported. The patient had not recovered from the event. It was reported that, they looked at the site in May at the 9 month check up and told mom to wait to see if it improves. They spoke with mom about 2 weeks ago and she says it's still present. List of documents held by sender: none.
Age: 0.51
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5
Symptoms: Abnormal behaviour, Hyporesponsive to stimuli, Pyrexia
Clinical narrative: Vaccines were administered Monday 5/16/2016 at 2:45pm after a normal well visits. On Wednesday morning, 5/18/16 mother contacted provider stating temp 99.6, and seems less responsive to sounds. Night of vaccine woke every 5 hours crying, Wednesday 5/18/16 afternoon and still seems to be acting weird and mom believes she cannot hear. Mom called back later that day to say she believed patient to be "coming back around" and that she had sang to her in the car and she did seem hear her. Thursday 5/19/16 in the morning mom texted saying patient is still not talking much or responding when spoken to. Patient remains afebrile no other complaints. An appointment was made for patient to see covering physician for the next morning. Mother stated by later that evening patient was acting more normal and was "Chatty Kathy" that night at dinner. Friday 5/20/2016, patient was seen by covering physician and had negative exam, was sent to ENT for hearing test which was unable to be performed due to patient's age. Parents declined further testing, since at that time patient was acting fine and has remained fine with no further concerns.
Age: 0.51
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5
Symptoms: Abnormal behaviour, Body temperature increased, Crying, Hypoacusis, Hyporesponsive to stimuli
Clinical narrative: Vaccines were administered Monday 5/16/2016 at 2:45pm after a normal well visits. On Wednesday morning, 5/18/16 mother contacted provider stating temp 99.6, and seems less responsive to sounds. Night of vaccine woke every 5 hours crying, Wednesday 5/18/16 afternoon and still seems to be acting weird and mom believes she cannot hear. Mom called back later that day to say she believed patient to be "coming back around" and that she had sang to her in the car and she did seem hear her. Thursday 5/19/16 in the morning mom texted saying patient is still not talking much or responding when spoken to. Patient remains afebrile no other complaints. An appointment was made for patient to see covering physician for the next morning. Mother stated by later that evening patient was acting more normal and was "Chatty Kathy" that night at dinner. Friday 5/20/2016, patient was seen by covering physician and had negative exam, was sent to ENT for hearing test which was unable to be performed due to patient's age. Parents declined further testing, since at that time patient was acting fine and has remained fine with no further concerns.
Age: 0.51
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5
Symptoms: Middle insomnia, Speech disorder
Clinical narrative: Vaccines were administered Monday 5/16/2016 at 2:45pm after a normal well visits. On Wednesday morning, 5/18/16 mother contacted provider stating temp 99.6, and seems less responsive to sounds. Night of vaccine woke every 5 hours crying, Wednesday 5/18/16 afternoon and still seems to be acting weird and mom believes she cannot hear. Mom called back later that day to say she believed patient to be "coming back around" and that she had sang to her in the car and she did seem hear her. Thursday 5/19/16 in the morning mom texted saying patient is still not talking much or responding when spoken to. Patient remains afebrile no other complaints. An appointment was made for patient to see covering physician for the next morning. Mother stated by later that evening patient was acting more normal and was "Chatty Kathy" that night at dinner. Friday 5/20/2016, patient was seen by covering physician and had negative exam, was sent to ENT for hearing test which was unable to be performed due to patient's age. Parents declined further testing, since at that time patient was acting fine and has remained fine with no further concerns.
Age: 0.51
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5
Symptoms: Abnormal behaviour, Asocial behaviour, Crying, Hypoacusis, Hyporesponsive to stimuli
Clinical narrative: Vaccines were administered Monday 5/16/2016 at 2:45pm after a normal well visits. On Wednesday morning, 5/18/16 mother contacted provider stating temp 99.6, and seems less responsive to sounds. Night of vaccine woke every 5 hours crying, Wednesday 5/18/16 afternoon and still seems to be acting weird and mom believes she cannot hear. Mom called back later that day to say she believed patient to be "coming back around" and that she had sang to her in the car and she did seem hear her. Thursday 5/19/16 in the morning mom texted saying patient is still not talking much or responding when spoken to. Patient remains afebrile no other complaints. An appointment was made for patient to see covering physician for the next morning. Mother stated by later that evening patient was acting more normal and was "Chatty Kathy" that night at dinner. Friday 5/20/2016, patient was seen by covering physician and had negative exam, was sent to ENT for hearing test which was unable to be performed due to patient's age. Parents declined further testing, since at that time patient was acting fine and has remained fine with no further concerns.
Age: 0.51
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5
Symptoms: Middle insomnia, Pyrexia, Speech disorder
Clinical narrative: Vaccines were administered Monday 5/16/2016 at 2:45pm after a normal well visits. On Wednesday morning, 5/18/16 mother contacted provider stating temp 99.6, and seems less responsive to sounds. Night of vaccine woke every 5 hours crying, Wednesday 5/18/16 afternoon and still seems to be acting weird and mom believes she cannot hear. Mom called back later that day to say she believed patient to be "coming back around" and that she had sang to her in the car and she did seem hear her. Thursday 5/19/16 in the morning mom texted saying patient is still not talking much or responding when spoken to. Patient remains afebrile no other complaints. An appointment was made for patient to see covering physician for the next morning. Mother stated by later that evening patient was acting more normal and was "Chatty Kathy" that night at dinner. Friday 5/20/2016, patient was seen by covering physician and had negative exam, was sent to ENT for hearing test which was unable to be performed due to patient's age. Parents declined further testing, since at that time patient was acting fine and has remained fine with no further concerns.
Age: 47.0
Sex: F
Vaccine: HEP
Symptoms: Blood test, Disturbance in attention, Dizziness, Eye movement disorder, Feeling abnormal
Clinical narrative: Vertigo with involuntary eye movement when trying to get up and any time I moved my head even lying down.  Next day on 7/14/2016 8AM, lessening of severity of vertigo, but general dizziness and the mind feeling "foggy" and unable to concentrate.  No sign of fever or any other symptom.
Age: 47.0
Sex: F
Vaccine: HEP
Symptoms: Injection site pain, Vertigo
Clinical narrative: Vertigo with involuntary eye movement when trying to get up and any time I moved my head even lying down.  Next day on 7/14/2016 8AM, lessening of severity of vertigo, but general dizziness and the mind feeling "foggy" and unable to concentrate.  No sign of fever or any other symptom.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Fatigue, Peripheral swelling, Pyrexia
Clinical narrative: Fever as high as 102.5 by 2:20 PM, swollen arm, fatigue.
Age: 53.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Cellulitis, Erythema, Peripheral swelling
Clinical narrative: Cellulitis, swelling, erythema covering nearly entire arm.
Age: 19.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Syncope
Clinical narrative: Syncopal episode within 5 minutes of immunizations. Patient's father was with her and eased her to chair, then to floor.  Patient did not fall.  BP 120/70.  Applied cool compress to head.  Rested for 10 minutes, then left (ambulatory) with father.
Age: 68.0
Sex: M
Vaccine: PPV
Symptoms: Hypoaesthesia oral, Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a pharmacist referring to a 68 year old male patient with diabetes. The patient had no known drug reactions/allergies. On an unknown date in October 2014, the patient was vaccinated with a dose of PNEUMOVAX23 (lot#, expiration date, dose and route unspecified). On 26-JUN-2015, the patient also vaccinated with a dose of PREVNAR 13 (lot#, expiration date, dose and route unspecified) (Inappropriate schedule of vaccine administered). On 12-JUL-2016, the patient was vaccinated again with a dose of PNEUMOVAX23 (lot#, expiration date, dose and route unspecified) (Inappropriate schedule of vaccine administered). The reporter called the patient a few hours after vaccination on 12-JUL-2016 and patient stated that he had a slight sensation of numbness around his lips. The patient did not seek medical attention. No treatment was given for the event numbness around his lips. No lab diagnostics studies performed. The outcome of the event numbness around his lips was unknown. Additional information has been requested.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Information was received from a certified medical assistant via a company representative referring to a teenage patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not reported. On 07-JUL-2016, at the same office visit, the teenage patient was inadvertently administered one dose of (Oka-Merck) PROQUAD (lot#, expiry and route unknown) injection and one dose of (Oka/Merck) VARIVAX (lot#, expiry and route unknown) (accidental overdose). No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect dose administered, No adverse event, Wrong technique in product usage process
Clinical narrative: This spontaneous report was received from a nurse practitioner regarding an unspecified number of patients of unknown demographics. The patients' concurrent conditions, medical history and concomitant medication were not reported. The reporter stated that, some of the nurses at her facility were properly reconstituting M-M-R II by using entire volume of sterile water diluent supplied which was about 0.7 ml. However, they are improperly withdrawing and administering only 0.5 ml of the total reconstituted dose subcutaneously which resulted in patients' receiving partial doses of M-M-R II. No adverse events were reported. No product quality complaint was involved. Additional information is not expected as consent to contact was not provided.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from registered nurse refers to a patient of unknown age and gender. Patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with improperly stored (temperature 7C, time frame of 25 minutes, because of data logger) VARIVAX, injection, lot # M000756, expiry date 06-JAN-2018 or lot # M000995, expiry date 06-JAN-2018, subcutaneous in the left arm, (dose and frequency not reported). Vaccine was back in temperature. No adverse effects were reported. Previous excursion were 13.6 F for 21 minutes and 9.2 F 43 minutes. The outcome of the events was unknown. No product quality complaint (PQC) was involved. No further information provided. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to an unspecified patients of unspecified demographics. There was no information about the patients' medical history, concomitant therapies and concurrent conditions. On unknown multiple dates, the patients were vaccinated with improperly stored VARIVAX lot # K021935, expiration date 10-NOV-2016; lot # L027287, expiration date 21-JUL-2017 (strength, dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccine experienced the temperature excursion of -12 degree Celsius till an unknown duration. No data logger was involved. No product quality complaint was reported. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.
Age: 0.17
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to an unspecified number of patients of unknown age and gender. On unknown dates the patients were vaccinated with unspecified doses of improperly stored RECOMBIVAX HB (lot # L048849, expiration date 04-FEB-2018, route not reported). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to unspecified patients of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies and concomitant medication were not reported. On unknown dates, the patients were vaccinated with 20 doses of improperly stored GARDASIL 9 (lot # was reported as K010215 (invalid) with expiration date 05-MAY-2017; dose and route were not reported). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to an unspecified number of patients of unknown age and gender. On unknown dates the patients were vaccinated with unspecified doses of improperly stored VAQTA (lot # K004856, expiration date 07-DEC-2016, route not reported). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to an unspecified number of patients of unknown age and gender. On unknown date the patients were vaccinated with unspecified doses of improperly stored ROTATEQ (lot # M004508, expiration date 29-JUN-2017, route not reported). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to an unspecified patients of unspecified demographics. There was no information about the patients' medical history, concomitant therapies and concurrent conditions. On unknown multiple dates, the patients were vaccinated with improperly stored PNEUMOVAX 23 lot # M000592, expiration date 08-OCT-2017; lot # M000592, expiration date 12-OCT-2017 (strength, dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccine experienced the temperature excursion of -2.37 degree Celsius till an unknown duration. Data logger was involved. No product quality complaint was reported. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On 18-MAY-2016, the patient was vaccinated with an improperly stored dose of M-M-R II 0.5 ml injection, lot# L026553, expiration date: 16-JUL-2017, (route and site of administration were not reported). Concomitant therapies were not provided. According to the reporter, the vaccine was stored at a temperature of 11.1 Celsius degree for 1 hour and 36 minutes and also at a temperature of -12.3 Celsius degree for 1 hour and 33 minutes (excursion dates were not reported). No adverse symptoms were reported. No product quality complain (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On 01-APR-2016, the patient was vaccinated with an improperly stored dose of rotavirus vaccine (manufacturer unknown) reported lot# L026553, expiration date: 16-JUL-2017 (route and site of administration were not reported). Concomitant therapies were not provided. According to the reporter, the vaccine was stored at temperature of 11.1 Celsius degree for 1 hour and 36 minutes and also at a temperature of -12.3 Celsius degree for 1 hour and 33 minutes (excursion dates were not reported). No adverse symptoms were reported. No product quality complain (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Systemic lupus erythematosus
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a female patient of unknown age. The patient's medical history, drug reactions, allergies and concomitant medications were not reported. On 21-NOV-2012, the patient was vaccinated with a first dose of GARDASIL lot# 1696AA (dose, route of administration and expiration date were not reported). Then on 08-APR-2013, the patient was vaccinated with a second dose of GARDASIL lot # 0636AE (dose, route of administration and expiration date were not provided). In July 2013, the patient was diagnosed with lupus (systemic lupus erythematosus). At the reporting time, the outcome of the event was unknown. The relatedness between the event and GARDASIL was not reported. Upon internal review, the event of systemic lupus erythematosus was considered to be medically significant. 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 registered nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On 16-JUN-2016, the patient was vaccinated with improperly stored dose of M-M-R II 0.5 ml injection, lot # L026553, expiration date: 16-JUL-2017 (route and site of administration were not reported). Concomitant therapies were not provided. According to the reporter, the vaccine was stored at a temperature of 11.1 Celsius degree for 1 hour and 36 minutes and also at a temperature of -12.3 Celsius degree for 1 hour and 33 minutes (excursion dates were not reported). No adverse symptoms were reported. No product quality complain (PQC) was involved. This is one of several reports 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 registered nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On 17-JUN-2016, the patient was vaccinated with an improperly stored dose of M-M-R II 0.5 ml injection, lot# L026553, expiration date: 16-JUL-2017, (route and site of administration were not reported). Concomitant therapies were not provided. According to the reporter, the vaccine was stored at a temperature of 11.1 Celsius degree for 1 hour and 36 minutes and also at a temperature of -12.3 Celsius degree for 1 hour and 33 minutes (excursion dates were not reported). No adverse symptoms were reported. No product quality complain (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker, refers to multiple unspecified patients of unknown demographics. No pertinent medical history, drug reactions/allergies or concurrent conditions were reported. On an unknown date, the patients were vaccinated with improperly stored doses of PROQUAD which had a lot # L045678 and expiration date of 09-MAY-2017 (dose, dosage number and route of administration were not provided). Nonetheless, no adverse effects were reported. The vaccines experienced the following temperature excursion on an unspecified date: 5.4 F for 16 hours. Reportedly, there had been previous temperature excursion and the aforementioned one was identified due to a data logger. Furthermore, no product quality complaint was involved. This is one of the several reports 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 registered nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On 09-MAY-2016, the patient was vaccinated with an improperly stored dose of M-M-R II 0.5 ml injection, lot# L026553, expiration date: 16-JUL-2017, (route and site of administration were not reported). Concomitant therapies were not provided. According to the reporter, the vaccine was stored at a temperature of 11.1 Celsius degree for 1 hour and 36 minutes and also at a temperature of -12.3 Celsius degree for 1 hour and 33 minutes (excursion dates were not reported). No adverse symptoms were reported. No product quality complain (PQC) was involved. This is one of several reports 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 registered nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On 14-JUN-2016, the patient was vaccinated with an improperly stored dose of M-M-R II 0.5 ml injection, lot# L026553 expiration date: 16-JUL-2017, (route and site of administration were not reported). Concomitant therapies were not provided. According to the reporter, the vaccine was stored at a temperature of 11.1 Celsius degree for 1 hour and 36 minutes and also at a temperature of -12.3 Celsius degree for 1 hour and 33 minutes (excursion dates were not reported). No adverse symptoms were reported. No product quality complain (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a physician referring to an unspecified patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies and concomitant medication were not reported. On an unknown date in June 2015, the patient was administered the first dose of GARDASIL 9 (lot #, expiration date, dose and route were not provided) in the series of three. The second and the third doses (lot #, expiration date, dose and route were not provided) were administered on an unknown date in June 2016 and 13-JUL-2016, respectively (inappropriate schedule of drug administration). No adverse effects were reported. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Skin warm
Clinical narrative: One day after MENVEO vaccine, mother noticed, red, raised firm area at right deltoid. 2 days after area larger, still firm, hard, warm to touch, area 8 cm. Given Prednisolone 15mg/5ml. Take 10ml x2days.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On 31-MAY-2016, the patient was vaccinated with an improperly stored dose of MMR II 0.5 ml injection (lot# L026553, expiration date was not reported) (route and site of administration were not reported). Concomitant therapies were not provided. According to the reporter, the vaccine was stored at a temperature of 11.1 Celsius degree for 1 hour and 36 minutes and also at a temperature of -12.3 Celsius degree for 1 hour and 33 minutes (excursion dates were not reported). No adverse symptoms were reported. No product quality complaint (PQC) was involved. This is one of several reports 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 registered nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On 10-JUN-2016, the patient was vaccinated with an improperly stored dose of M-M-R II 0.5 ml injection, lot# L026553, expiration date: 16-JUL-2017 (route and site of administration were not reported). Concomitant therapies were not provided. According to the reporter, the vaccine was stored at a temperature of 11.1 Celsius degree for 1 hour and 36 minutes and also at a temperature of -12.3 Celsius degree for 1 hour and 33 minutes (excursion dates were not reported). No adverse symptoms were reported. No product quality complain (PQC) was involved. This is one of several reports 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 registered nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On 13-JUN-2016, the patient was vaccinated with an improperly stored dose of M-M-R II 0.5ml injection, lot# L026553, expiration date: 16-JUL-2017 (route and site of administration were not reported). Concomitant therapies were not provided. According to the reporter, the vaccine was stored at a temperature of 11.1 Celsius degree for 1 hour and 36 minutes and also at a temperature of -12.3 Celsius degree for 1 hour and 33 minutes (excursion dates were not reported). No adverse symptoms were reported. No product quality complain (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 46.0
Sex: F
Vaccine: ANTH
Symptoms: Abdominal pain, Alanine aminotransferase increased, Aspartate aminotransferase increased, Asthenia, Blood alkaline phosphatase increased
Clinical narrative: A non-serious spontaneous report was received on 27JUN2016 from a consumer. On 22JUN2016, the consumer received her 12th dose of BioThrax (anthrax vaccine adsorbed). On 25JUN2016 she experienced flu-like symptoms.  On 27JUN2016, she reported experiencing fever of 102.6 F (also reported as 104 F), abdominal pain, dizziness, nausea, weakness, fatigue, and sweating. Patient went to Urgent Care and was referred to emergency room where she had blood test drawn (test names and results unknown). No other treatment given in ER, no diagnosis given. The patient left emergency room due to the long wait of 5 to 8 hours to see a doctor. The subject self-treated symptoms at home with rest, fluids, and ibuprofen. On 28JUN2016, she reported that her fever began to break and that she had vomited. She also reported that she would not be going to work for the day. On 29JUN2016 she reported that her adverse events were resolving. Additional follow-up information was received on 04JUL2016 from a consumer's roommate that contained serious criteria that upgraded case to expedited. On 03JUL2016, per report by consumer's roommate, the consumer made two trips to a local emergency room both for a migraine. It was reported that the second visit resulted in an overnight stay at the hospital for more testing. The consumer's roommate reported that the consumer's liver was not functioning as it should. The consumer was reported to have slept for about a week except for the times that she was able to make it to work. Treatments reported include Ibuprofen, fluids and rest. No medical history reported. No concomitant medication reported. Relevant laboratory tests: Alanine aminotransferase - 260; Aspartate aminotransferase - 132; Blood alkaline phosphatase - 286; Glucose - 117; Neutrophil count - 8.03; White blood cell count - 11.33; Hepatitis panel drawn - waiting results. Additional information requested.