chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 23.0
Sex: M
Vaccine: ANTH, ANTH
Symptoms: Arthropathy, Asthenia, Dyspepsia, Fatigue, Feeling abnormal
Clinical narrative: Information received on 15MAR2016 from a consumer. On 15MAR2016 information was received from a 37 year old male who received BioThrax while in the military at age 23.  He reported constant "muscle pain, digestion problems, constant sweating", feelings of "being eaten alive", not able to "run anymore", and inability "to function like a normal person from the ages of 27 to 37". On 16MAR2016 a follow up call to the consumer was made to obtain additional information. The consumer reported that he had been to an agency related to the complaints and was told he was "getting older"; and did not receive an explanation for his pain. He stated that he has aches, pains, and stiffness. He declined to complete a data collection form from the vaccine manufacturer, and said that he had previously reported the information to Vaccine Adverse Event Reporting System (VAERS) . He reported that currently, at age 37 he "can only do little house cleaning jobs", has no strength, has aches, pains, and stiffness. He stated that he "cannot gain strength or muscle" and that exercise leaves him with pain. He noted that he has had "13 years of pain" and at 37 years old wakes up every day with stiffness and aches. He reported that he "must have some type of auto-immune disease".  At the time of report, the symptoms had not resolved. Consumer stated the information had been reported to VAERS: Temporary VAERS E-Report #: 102199. Treatments not reported. Concurrent medical conditions not reported. Medical history not reported. Concomitant medications not reported. Relevant laboratory/diagnostics not reported. Additional information expected. Sender's Comments: This report was received from a consumer who received BioThrax vaccine approximately 14 years ago. The sponsor considers the event of Impaired work ability to be Medically Significant, therefore the report is considered Serious.  The report describes a complex medical scenario and is without records of medical evaluation or testing.  In the absence of adequate medical assessment of the reported events, a causality association is deemed not assessable.
Age: 23.0
Sex: M
Vaccine: ANTH, ANTH
Symptoms: Muscle atrophy
Clinical narrative: Information received on 15MAR2016 from a consumer. On 15MAR2016 information was received from a 37 year old male who received BioThrax while in the military at age 23.  He reported constant "muscle pain, digestion problems, constant sweating", feelings of "being eaten alive", not able to "run anymore", and inability "to function like a normal person from the ages of 27 to 37". On 16MAR2016 a follow up call to the consumer was made to obtain additional information. The consumer reported that he had been to an agency related to the complaints and was told he was "getting older"; and did not receive an explanation for his pain. He stated that he has aches, pains, and stiffness. He declined to complete a data collection form from the vaccine manufacturer, and said that he had previously reported the information to Vaccine Adverse Event Reporting System (VAERS) . He reported that currently, at age 37 he "can only do little house cleaning jobs", has no strength, has aches, pains, and stiffness. He stated that he "cannot gain strength or muscle" and that exercise leaves him with pain. He noted that he has had "13 years of pain" and at 37 years old wakes up every day with stiffness and aches. He reported that he "must have some type of auto-immune disease".  At the time of report, the symptoms had not resolved. Consumer stated the information had been reported to VAERS: Temporary VAERS E-Report #: 102199. Treatments not reported. Concurrent medical conditions not reported. Medical history not reported. Concomitant medications not reported. Relevant laboratory/diagnostics not reported. Additional information expected. Sender's Comments: This report was received from a consumer who received BioThrax vaccine approximately 14 years ago. The sponsor considers the event of Impaired work ability to be Medically Significant, therefore the report is considered Serious.  The report describes a complex medical scenario and is without records of medical evaluation or testing.  In the absence of adequate medical assessment of the reported events, a causality association is deemed not assessable.
Age: 23.0
Sex: M
Vaccine: ANTH, ANTH
Symptoms: Activities of daily living impaired, Asthenia, Dyspepsia, Feeling abnormal, Hyperhidrosis
Clinical narrative: Information received on 15MAR2016 from a consumer. On 15MAR2016 information was received from a 37 year old male who received BioThrax while in the military at age 23.  He reported constant "muscle pain, digestion problems, constant sweating", feelings of "being eaten alive", not able to "run anymore", and inability "to function like a normal person from the ages of 27 to 37". On 16MAR2016 a follow up call to the consumer was made to obtain additional information. The consumer reported that he had been to an agency related to the complaints and was told he was "getting older"; and did not receive an explanation for his pain. He stated that he has aches, pains, and stiffness. He declined to complete a data collection form from the vaccine manufacturer, and said that he had previously reported the information to Vaccine Adverse Event Reporting System (VAERS) . He reported that currently, at age 37 he "can only do little house cleaning jobs", has no strength, has aches, pains, and stiffness. He stated that he "cannot gain strength or muscle" and that exercise leaves him with pain. He noted that he has had "13 years of pain" and at 37 years old wakes up every day with stiffness and aches. He reported that he "must have some type of auto-immune disease".  At the time of report, the symptoms had not resolved. Consumer stated the information had been reported to VAERS: Temporary VAERS E-Report #: 102199. Treatments not reported. Concurrent medical conditions not reported. Medical history not reported. Concomitant medications not reported. Relevant laboratory/diagnostics not reported. Additional information expected. Sender's Comments: This report was received from a consumer who received BioThrax vaccine approximately 14 years ago. The sponsor considers the event of Impaired work ability to be Medically Significant, therefore the report is considered Serious.  The report describes a complex medical scenario and is without records of medical evaluation or testing.  In the absence of adequate medical assessment of the reported events, a causality association is deemed not assessable.
Age: 23.0
Sex: M
Vaccine: ANTH, ANTH
Symptoms: Mobility decreased, Musculoskeletal stiffness, Myalgia, Pain
Clinical narrative: Information received on 15MAR2016 from a consumer. On 15MAR2016 information was received from a 37 year old male who received BioThrax while in the military at age 23.  He reported constant "muscle pain, digestion problems, constant sweating", feelings of "being eaten alive", not able to "run anymore", and inability "to function like a normal person from the ages of 27 to 37". On 16MAR2016 a follow up call to the consumer was made to obtain additional information. The consumer reported that he had been to an agency related to the complaints and was told he was "getting older"; and did not receive an explanation for his pain. He stated that he has aches, pains, and stiffness. He declined to complete a data collection form from the vaccine manufacturer, and said that he had previously reported the information to Vaccine Adverse Event Reporting System (VAERS) . He reported that currently, at age 37 he "can only do little house cleaning jobs", has no strength, has aches, pains, and stiffness. He stated that he "cannot gain strength or muscle" and that exercise leaves him with pain. He noted that he has had "13 years of pain" and at 37 years old wakes up every day with stiffness and aches. He reported that he "must have some type of auto-immune disease".  At the time of report, the symptoms had not resolved. Consumer stated the information had been reported to VAERS: Temporary VAERS E-Report #: 102199. Treatments not reported. Concurrent medical conditions not reported. Medical history not reported. Concomitant medications not reported. Relevant laboratory/diagnostics not reported. Additional information expected. Sender's Comments: This report was received from a consumer who received BioThrax vaccine approximately 14 years ago. The sponsor considers the event of Impaired work ability to be Medically Significant, therefore the report is considered Serious.  The report describes a complex medical scenario and is without records of medical evaluation or testing.  In the absence of adequate medical assessment of the reported events, a causality association is deemed not assessable.
Sex: M
Vaccine: PPV, PPV
Symptoms: Adverse reaction
Clinical narrative: Information has been received from a physician via a Healthcare worker concerning a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 (lot # L019835 and expiration date 23-MAR-2017) 0.5 ml, (dose number and route were not provided). Concomitant medications were not reported. On an unknown date, the patient experienced "severe reactions". Therefore, the patient visited an unspecified emergency room. The outcome of the adverse reaction was unknown. The primary reporter did not provide the causality between PNEUMOVAX 23 and the adverse reaction. Follow up information has been received on 09-MAR-2016 from the reporting physician, via company and was assigned manufacturer report number 00006494300. The physician stated that this case concerns a middle aged (60's) male patient who had developed hard lump around the injection site, almost like an abscess looking. The reporter sent the patient to see a dermatologist who stated that it was a hypersensitivity reaction to the vaccine. The physician reported that the patient was doing much better and that the symptoms went away in the next two weeks. A phone call was placed to the physician on 28-MAR-2016. All telephone attempts to obtain follow-up information have been unsuccessful. This is one of two reports from the same reporter. This case has been downgraded. The patient was never hospitalized. Additional information has been requested. Narrative has been updated.
Sex: M
Vaccine: PPV, PPV
Symptoms: Hypersensitivity, Injection site induration, Injection site mass
Clinical narrative: Information has been received from a physician via a Healthcare worker concerning a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 (lot # L019835 and expiration date 23-MAR-2017) 0.5 ml, (dose number and route were not provided). Concomitant medications were not reported. On an unknown date, the patient experienced "severe reactions". Therefore, the patient visited an unspecified emergency room. The outcome of the adverse reaction was unknown. The primary reporter did not provide the causality between PNEUMOVAX 23 and the adverse reaction. Follow up information has been received on 09-MAR-2016 from the reporting physician, via company and was assigned manufacturer report number 00006494300. The physician stated that this case concerns a middle aged (60's) male patient who had developed hard lump around the injection site, almost like an abscess looking. The reporter sent the patient to see a dermatologist who stated that it was a hypersensitivity reaction to the vaccine. The physician reported that the patient was doing much better and that the symptoms went away in the next two weeks. A phone call was placed to the physician on 28-MAR-2016. All telephone attempts to obtain follow-up information have been unsuccessful. This is one of two reports from the same reporter. This case has been downgraded. The patient was never hospitalized. Additional information has been requested. Narrative has been updated.
Age: 69.0
Sex: M
Vaccine: PPV, PPV, PPV, PPV
Symptoms: Anger, Asthenia, Confusional state, Constipation, Dizziness
Clinical narrative: PPSV/PPV23 vaccine injection. Adverse reaction: pain at injection site, extreme vertigo, weakness, slight nausea, constipation, general ill feeling, confusion, for a week after getting shot. After 12 days, still some occasional dizziness, no energy.
Age: 69.0
Sex: M
Vaccine: PPV, PPV, PPV, PPV
Symptoms: Dizziness postural, Feeling abnormal, Malaise, Vertigo
Clinical narrative: PPSV/PPV23 vaccine injection. Adverse reaction: pain at injection site, extreme vertigo, weakness, slight nausea, constipation, general ill feeling, confusion, for a week after getting shot. After 12 days, still some occasional dizziness, no energy.
Age: 69.0
Sex: M
Vaccine: PPV, PPV, PPV, PPV
Symptoms: Asthenia, Balance disorder, Dizziness, Nausea
Clinical narrative: PPSV/PPV23 vaccine injection. Adverse reaction: pain at injection site, extreme vertigo, weakness, slight nausea, constipation, general ill feeling, confusion, for a week after getting shot. After 12 days, still some occasional dizziness, no energy.
Age: 69.0
Sex: M
Vaccine: PPV, PPV, PPV, PPV
Symptoms: Asthenia, Confusional state, Constipation, Dizziness, Injection site pain
Clinical narrative: PPSV/PPV23 vaccine injection. Adverse reaction: pain at injection site, extreme vertigo, weakness, slight nausea, constipation, general ill feeling, confusion, for a week after getting shot. After 12 days, still some occasional dizziness, no energy.
Age: 69.0
Sex: M
Vaccine: PPV, PPV, PPV, PPV
Symptoms: Malaise, Nausea, Vertigo
Clinical narrative: PPSV/PPV23 vaccine injection. Adverse reaction: pain at injection site, extreme vertigo, weakness, slight nausea, constipation, general ill feeling, confusion, for a week after getting shot. After 12 days, still some occasional dizziness, no energy.
Age: 69.0
Sex: M
Vaccine: PPV, PPV, PPV, PPV
Symptoms: Asthenia, Balance disorder, Blood chloride increased, Blood creatinine normal, Blood glucose normal
Clinical narrative: PPSV/PPV23 vaccine injection. Adverse reaction: pain at injection site, extreme vertigo, weakness, slight nausea, constipation, general ill feeling, confusion, for a week after getting shot. After 12 days, still some occasional dizziness, no energy.
Age: 69.0
Sex: M
Vaccine: PPV, PPV, PPV, PPV
Symptoms: Blood potassium normal, Blood sodium normal, Blood urea normal, Carbon dioxide decreased, Dizziness
Clinical narrative: PPSV/PPV23 vaccine injection. Adverse reaction: pain at injection site, extreme vertigo, weakness, slight nausea, constipation, general ill feeling, confusion, for a week after getting shot. After 12 days, still some occasional dizziness, no energy.
Age: 69.0
Sex: M
Vaccine: PPV, PPV, PPV, PPV
Symptoms: Haematocrit normal, Haemoglobin normal, Lymphadenopathy, Nausea, Neurological examination abnormal
Clinical narrative: PPSV/PPV23 vaccine injection. Adverse reaction: pain at injection site, extreme vertigo, weakness, slight nausea, constipation, general ill feeling, confusion, for a week after getting shot. After 12 days, still some occasional dizziness, no energy.
Age: 69.0
Sex: M
Vaccine: PPV, PPV, PPV, PPV
Symptoms: Nystagmus, Vertigo
Clinical narrative: PPSV/PPV23 vaccine injection. Adverse reaction: pain at injection site, extreme vertigo, weakness, slight nausea, constipation, general ill feeling, confusion, for a week after getting shot. After 12 days, still some occasional dizziness, no energy.
Age: 0.19
Sex: M
Vaccine: DTAP, HIBV, IPV, RVX
Symptoms: Body temperature increased, Crying, Screaming
Clinical narrative: Inconsolable high-pitched screaming, rising body temperature lasting up to 7 hours after the vaccines were administered. Treated with Tylenol, but it didn't help.
Age: 51.0
Sex: F
Vaccine: HEP
Symptoms: Back pain, Burning sensation, Chills, Electrocardiogram normal, Hyperhidrosis
Clinical narrative: This was my second booster for hepatitis B I got on March 16, 2016. I got the first shot on February 17 and was told to get this one one month later. Soreness in hip and leg joints started after the first shot, particularly on the lower right side. Strange pain in middle of my back started about 3 days after the booster. Then, starting March 22, I started to feel sharp pains down my back, and a general feeling of unwellness. On March 26, burning sensations across my back started, felt sharp pain in my lower spine and my legs and arms started to tremble so I went to the emergency room. I got an EKG, they checked my O2 levels and both were fine. I explained that I was having some sort of nerve reaction to the hep B vaccine. The doctor did a reflex test to test for Guillain Barre and said I was okay. Said to take ibuprofen for any inflammation. March 28 I still feel burning sensation, now in my legs. Also I have periodic chills and sweats.
Age: 51.0
Sex: F
Vaccine: HEP
Symptoms: Malaise, Reflex test normal, Spinal pain, Tremor, Vaccination complication
Clinical narrative: This was my second booster for hepatitis B I got on March 16, 2016. I got the first shot on February 17 and was told to get this one one month later. Soreness in hip and leg joints started after the first shot, particularly on the lower right side. Strange pain in middle of my back started about 3 days after the booster. Then, starting March 22, I started to feel sharp pains down my back, and a general feeling of unwellness. On March 26, burning sensations across my back started, felt sharp pain in my lower spine and my legs and arms started to tremble so I went to the emergency room. I got an EKG, they checked my O2 levels and both were fine. I explained that I was having some sort of nerve reaction to the hep B vaccine. The doctor did a reflex test to test for Guillain Barre and said I was okay. Said to take ibuprofen for any inflammation. March 28 I still feel burning sensation, now in my legs. Also I have periodic chills and sweats.
Age: 80.0
Sex: M
Vaccine: VARZOS
Symptoms: Diplegia, Guillain-Barre syndrome
Clinical narrative: Information has been received from a physician assistant via company representative referring to an 80 year old male patient. Information about medical history and concurrent condition was unspecified. On an  unknown date the patient was vaccinated with a dose of ZOSTAVAX (lot number, expiration date, dose and route were unknown). Concomitant medication was unspecified. On an unknown date, one week after the administration of ZOSTAVAX, the patient developed paralysis in the lower extremities and went to the emergency room, then he was diagnosed with Guillain-Barre Syndrome. The outcome of Guillain-Barre Syndrome and the causality were unknown. Upon internal review, the event Guillain-Barre Syndrome was considered to be medically significant. Additional information has been requested.
Age: 36.0
Sex: F
Vaccine: RAB
Symptoms: Paraesthesia
Clinical narrative: Initial unsolicited report received from a Consumer on 02 September 2015. This case involves a 36-year-old female patient, who had received first dose of Imovax (batch number, route and site of administration were not reported) and a dose of IMMUNOGLOBULIN HUMAN ANTIRABIES (RIG) (batch number, route and site of administration were not reported) on 19 August 2015. It was reported that patient also received second dose (day 3) dose of Imovax polio on 22 August 2015 and third dose (day 7) on 26 August 2015. Illness at time of vaccination was reported that patient had exposure to bat in her house (non bite). Pre-existing physician diagnosed allergies, birth defects, medical conditions were provided as that patient was scheduled for In vitro fertilization or fertilization (IVF) in next week. Other medical history and concomitant medications were not reported. On 21 August 2015, 2 days after vaccination patient experienced tingling in her fingers and toes. Laboratory investigations and corrective treatments were not reported. Patient continues experience tingling in fingers and toes after the vaccination. Hence patient was not recovered from the event. Documents held by sender: none.
Age: 43.0
Sex: U
Vaccine: RAB
Symptoms: Unevaluable event
Clinical narrative: Initial unsolicited report received from a physician on 18 September 2015. This case involves a 43 year old (gender unknown) patient who was vaccinated with a [dose not reported] [route and dose series not reported] dose of RABIES VACCINE (batch number, expiry date site of administration were not reported) on 29 June 2015, received a dose of rabies vaccine (batch number, expiry date site of administration were not reported) on 22 June 2015 and received a dose of rabies vaccine (batch number, expiry date site of administration were not reported) on 15 June 2015. Medical history and concomitant medications were not reported. On an unspecified date, following the vaccination patient had dog bite. Patient laboratory investigation and corrective treatment was not reported. The outcome of event was unknown. Follow-up information received from a nurse on 02 November 2015. It was reported that the patient denies any adverse event after the rabies vaccine and the vaccine was not administred at office but done at urgent care unit. On an unknown date, the patient was recovered. List of documents held by sender: none.
Age: 17.0
Sex: M
Vaccine: HEPA
Symptoms: Seizure
Clinical narrative: This spontaneous report as received from a physician refers to a 17 year old male patient. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided. On an unknown date, the patient was vaccinated with the dose of VAQTA injection (dose, route of administration, lot# and expiration date were not reported). On an unknown date (reported as after the dose of VAQTA was administered), the patient experienced seizure. The outcome of seizure and the causality between seizure and VAQTA were not provided. Upon internal review, the event of seizure was considered to be medically significant. Additional information has been requested.
Age: 77.0
Sex: F
Vaccine: PNC13
Symptoms: Activities of daily living impaired, Blood creatine phosphokinase normal, Erythema, Metabolic function test normal, Mobility decreased
Clinical narrative: The day after the shot her arm was quite red and became very sore. Over a week the redness went away but she continued to have soreness all through the upper arm. She also developed significant weakness in the arm. She couldn't open a sliding glass door with her R hand. She is right-handed. She couldn't lift her arm above horizontal either forward or to the side. She especially has pain and weakness with internal rotation behind her back.
Age: 77.0
Sex: F
Vaccine: PNC13
Symptoms: Muscular weakness, Pain, Pain in extremity
Clinical narrative: The day after the shot her arm was quite red and became very sore. Over a week the redness went away but she continued to have soreness all through the upper arm. She also developed significant weakness in the arm. She couldn't open a sliding glass door with her R hand. She is right-handed. She couldn't lift her arm above horizontal either forward or to the side. She especially has pain and weakness with internal rotation behind her back.
Age: 6.0
Sex: F
Vaccine: HIBV
Symptoms: Crying, Dermatitis contact, Expired product administered, Eyelid oedema, Fatigue
Clinical narrative: Initial unsolicited misuse report received from a consumer on 21 January 2016. This case involves a 06-year-old female patient who was vaccinated with a dose of ACTHIB (batch number, expiry date, route and site of administration were not reported) on 21 October 2015. The diluent's batch number was UA016AA and expiry date was 03 February 2001. The patient's illness at time of vaccination was denied and pre-existing physician diagnosed allergies, birth defects, medical conditions were reported as PMH bronchitis. Concomitant medications were not reported. On 23 October 2015, two days following the vaccination, the patient had developed red bumpy rash at the injection site. It was reported that after evaluation by nurse that the rash was most likely due to the adhesive on the bandaid. It was an expired vaccine used. It was reported that the lot number provided was for ActHIB diluent that expired in 2001. Laboratory data and corrective treatment was not reported. The outcome of the event was reported as unknown. Follow up information received from consumer on 01 March 2016. The patient was vaccinated with 0.5 ml dose of Flu shot (batch number- UA0166AA, site of administration not reported) intramuscularly on 20 October 2015. The patient also received ActHIB vaccine with expired 0.4% saline diluent. The patient's previous vaccination history was provided. It was reported that the vaccination history records looked suspicious. The paperwork which was used to transcribe the informaton was shredded but the lot number (UA016AA) was not carried by clinic. On an unspecified date, following the vaccination, the patient had experienced red scab mark (with aid adhesive) and rash surrounding the area of left arm and redness and swelling at the vaccination site. The patient's face was blotchy and the patient cried, tired and had puffy eyes. It was reported that the rash was probably from the bandaid adhesive. The patient had received Benadryl as corrective treatment. The patient's mother ran warm soapy water over the area. The alcohol was used to remove remainder adhesive. The outcome of the event of rash was not recovered (it was reported that the rash did not go the "next day". The outcome of event scab, tired, blotchy and puffy eyes was not reported. List of documents held by sender: none.
Age: 6.0
Sex: F
Vaccine: HIBV
Symptoms: Injection site erythema, Injection site reaction, Injection site scab, Rash erythematous, Rash macular
Clinical narrative: Initial unsolicited misuse report received from a consumer on 21 January 2016. This case involves a 06-year-old female patient who was vaccinated with a dose of ACTHIB (batch number, expiry date, route and site of administration were not reported) on 21 October 2015. The diluent's batch number was UA016AA and expiry date was 03 February 2001. The patient's illness at time of vaccination was denied and pre-existing physician diagnosed allergies, birth defects, medical conditions were reported as PMH bronchitis. Concomitant medications were not reported. On 23 October 2015, two days following the vaccination, the patient had developed red bumpy rash at the injection site. It was reported that after evaluation by nurse that the rash was most likely due to the adhesive on the bandaid. It was an expired vaccine used. It was reported that the lot number provided was for ActHIB diluent that expired in 2001. Laboratory data and corrective treatment was not reported. The outcome of the event was reported as unknown. Follow up information received from consumer on 01 March 2016. The patient was vaccinated with 0.5 ml dose of Flu shot (batch number- UA0166AA, site of administration not reported) intramuscularly on 20 October 2015. The patient also received ActHIB vaccine with expired 0.4% saline diluent. The patient's previous vaccination history was provided. It was reported that the vaccination history records looked suspicious. The paperwork which was used to transcribe the informaton was shredded but the lot number (UA016AA) was not carried by clinic. On an unspecified date, following the vaccination, the patient had experienced red scab mark (with aid adhesive) and rash surrounding the area of left arm and redness and swelling at the vaccination site. The patient's face was blotchy and the patient cried, tired and had puffy eyes. It was reported that the rash was probably from the bandaid adhesive. The patient had received Benadryl as corrective treatment. The patient's mother ran warm soapy water over the area. The alcohol was used to remove remainder adhesive. The outcome of the event of rash was not recovered (it was reported that the rash did not go the "next day". The outcome of event scab, tired, blotchy and puffy eyes was not reported. List of documents held by sender: none.
Age: 6.0
Sex: F
Vaccine: HIBV
Symptoms: Vaccination site swelling
Clinical narrative: Initial unsolicited misuse report received from a consumer on 21 January 2016. This case involves a 06-year-old female patient who was vaccinated with a dose of ACTHIB (batch number, expiry date, route and site of administration were not reported) on 21 October 2015. The diluent's batch number was UA016AA and expiry date was 03 February 2001. The patient's illness at time of vaccination was denied and pre-existing physician diagnosed allergies, birth defects, medical conditions were reported as PMH bronchitis. Concomitant medications were not reported. On 23 October 2015, two days following the vaccination, the patient had developed red bumpy rash at the injection site. It was reported that after evaluation by nurse that the rash was most likely due to the adhesive on the bandaid. It was an expired vaccine used. It was reported that the lot number provided was for ActHIB diluent that expired in 2001. Laboratory data and corrective treatment was not reported. The outcome of the event was reported as unknown. Follow up information received from consumer on 01 March 2016. The patient was vaccinated with 0.5 ml dose of Flu shot (batch number- UA0166AA, site of administration not reported) intramuscularly on 20 October 2015. The patient also received ActHIB vaccine with expired 0.4% saline diluent. The patient's previous vaccination history was provided. It was reported that the vaccination history records looked suspicious. The paperwork which was used to transcribe the informaton was shredded but the lot number (UA016AA) was not carried by clinic. On an unspecified date, following the vaccination, the patient had experienced red scab mark (with aid adhesive) and rash surrounding the area of left arm and redness and swelling at the vaccination site. The patient's face was blotchy and the patient cried, tired and had puffy eyes. It was reported that the rash was probably from the bandaid adhesive. The patient had received Benadryl as corrective treatment. The patient's mother ran warm soapy water over the area. The alcohol was used to remove remainder adhesive. The outcome of the event of rash was not recovered (it was reported that the rash did not go the "next day". The outcome of event scab, tired, blotchy and puffy eyes was not reported. List of documents held by sender: none.
Age: 19.0
Sex: F
Vaccine: HEP
Symptoms: Diarrhoea, Nausea, Vomiting
Clinical narrative: Employee reports nausea, vomiting and loose stools.
Age: 82.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site discolouration, Pain
Clinical narrative: Presents with purplish discoloration on the injection site with approx. 1.25 inches by 1.25 inches, complain of soreness specially of extension of the left arm. No medications.
Age: 39.0
Sex: F
Vaccine: MMR
Symptoms: Exposure during pregnancy, Ultrasound antenatal screen
Clinical narrative: It was unknown to pt and staff, but at the time of the vaccination, pt was 11 wks pregnant.
Age: 0.61
Sex: M
Vaccine: DTAPIPVHIB, FLU3, PNC13, RV5
Symptoms: Decreased appetite, Pyrexia, Screaming, White blood cell count increased
Clinical narrative: 2-3 days of high fever, not eating/drinking and screaming if not sleeping. Took him back to doctor and they did blood work which came back with an exceedingly high white blood cell count and was advised to take him to the ER immediately.
Age: 74.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Injection site erythema, Pruritus, Pyrexia, Skin warm
Clinical narrative: Fever of 101 redness at the injection site.  She came in today and her arm is red, itching, and hot to the touch.
Sex: U
Vaccine: PPV
Symptoms: Peripheral swelling
Clinical narrative: This spontaneous report was received from a physician via company representative refers to a patient of unknown age. The medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with PNEUMOVAX 23. On an unknown date, the patient reported that the arm "really swelled up". The physician sent the patient to an allergist after the swelling that was experienced. Treatment information was not reported. The outcome of the event was unknown. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: TYP
Symptoms: Abdominal pain, Diarrhoea, Faecal incontinence, Nausea, Vomiting
Clinical narrative: EXPERIENCE ABDOMINAL PAIN, NAUSEA, VOMITING.  VOMITED AT LEAST ONCE EVERY HOUR UP UNTIL 3:00 AM, DIARRHEA STARTED ALONG WITH VOMITING. VOMITED CEASED AT 4:30 AM. DIARRHEA WAS EXPLOSIVE AND INCONTINENT.  SPOKE WITH PT AT 11:00 AM.  FEELING BETTER, BUT STILL HAVING SOME DIARRHEA.
Age: 1.02
Sex: F
Vaccine: HEPA, MMRV
Symptoms: Decreased appetite, Irritability, Pyrexia, Rash
Clinical narrative: Child began running a fever of 103.5 3/24/16 at 6:00pm. Fever continued until 3/25/16 at 5:00pm. Child woke up with rash on chest on 3/26/16 and was very cranky and had a loss of appetite. Rash spread to back, face, neck, and arms on 3/27/16 and patient was still cranky and would no eat. Rash was less predominant on 3/28/16 and was gone by 3/29/16.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema
Clinical narrative: Big redness around injection site came on 2/10/16 about 2 PM.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse referring to a patient of unknown age and gender. Patient's medical history and concurrent conditions were not reported. On 14-MAR-2016 or 15-MAR-2016 (reported as Monday or Tuesday of this week), the patient was vaccinated with improperly stored GARDASIL 9 lot # L043213 and expiry date on 28-AUG-2017, (route, strength, dose and frequency were not reported). Concomitant medications were not reported. No adverse effects were reported and no product quality complaint was involved. Additional information is not expected as the reporter did not want to be contacted regarding the report.
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Abdominal pain upper, Diarrhoea, Nausea, Nervousness
Clinical narrative: This spontaneous report was received from a registered nurse refers to a 14 year old female patient. The patient was not pregnant. The patient's pertinent medical history, drug reactions/allergies and concomitant medications were reported as none. On 06-JAN-2016, the patient was vaccinated with the first dose in the series of GARDASIL 9, lot # L016428, expiry date 30-JUL-2017, 0.5 ml, intramuscularly. On 06-JAN-2016 (also reported as same "evening"), the patient experienced a "sudden shaky feeling, nausea, stomach pain, and diarrhea". The nurse reported that the patient sought medical attention by calling another unspecified provider the next day on 07-JAN-2016. The nurse reported that the unspecified provider prescribed a treatment of "fluids and rest" on 07-JAN-2016. Lab diagnostics studies performed were reported as none. The outcome of the events was recovering (by the next day the patient felt better). The causality assessment was not provided. No product quality complaint (PQC) was involved. Additional information has been requested.
Age: 24.0
Sex: U
Vaccine: VARZOS
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Information has been received from a nurse practitioner concerning a 24 year old patient of unknown gender, who on 23-MAR-2016 was inadvertently administered a dose of ZOSTAVAX (lot#, expiration date, dose and route unspecified) (inappropriate schedule of drug administration). No adverse effects were reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Extra dose administered, Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a license practical nurse refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant therapy were not reported. On 02-JUN-2014, the patient was vaccinated with the first dose of GARDASIL (lot number J013324 and expiration date 12-FEB-2016, dose and route of administration were not reported). On 14-AUG-2014, the patient received the second dose of GARDASIL (lot number J013324 and expiration date 04-AUG-2015, dose and route of administration were not reported( and on 02-OCT-2014 the third dose (lot number K000146 and expiration date 11-AUG-2016, dose and route of administration were not reported). The nurse stated that on an unknown date in 2016, the patient was administered a fourth dose of GARDASIL (dose, route of administration, lot number and expiration date were not reported) at a different office. No adverse effects were reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Age: 0.6
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a health care professional refers to a 7 month old patient of unknown gender. On 16-MAR-2016 the patient was inadvertently administered with the third dose of ROTATEQ which was expired with a lot # K004773; expiry: 22-FEB-2016 (dosing regimen unspecified). On an unknown date, previously patient was vaccinated with 2 doses of ROTATEQ. This was supported as per stability memo. No adverse effects reported. There was no product quality complaint involved. No further information provided.
Sex: U
Vaccine: VARCEL, VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a multiple unspecified patients of unknown age and gender. The patients' concurrent conditions and medical histories were not reported. On unknown dates, the patients were vaccinated with doses of improperly stored (Merck) VARIVAX lot # L019126, expiration date: 27-MAY-2017; lot # K005429, expiration date: 15-APR-2016; lot # K026387, expiration date: 15-DEC-2016; L019126, expiration date: 27-MAY-2017 or ZOSTAVAX lot # L012039, expiration date: 07-JUL-2016; lot # L000448, expiration date: 08-MAR-2016 (exact doses, routes of administration and anatomical locations were not reported). There were no concomitant medications provided. There were no adverse effects reported. Administered doses of vaccines experienced the temperature excursion of 25 degrees Fahrenheit for 15 hours and 20 minutes. There was no previous temperature excursion. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a Registered Nurse and refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions and concomitant medications was reported. On an unknown date, the patient was administered with the second dose in the series of GARDASIL 9 (dose, route of administration, injection site, lot# and expiration date were not reported) at a less than recommended internal. No adverse effects were reported. Product quality complaint (PQC) was not involved. Additional information has been requested.
Age: 22.0
Sex: M
Vaccine: PPV
Symptoms: Lymphadenopathy, Pain in extremity, Tenderness
Clinical narrative: This spontaneous report was received from a pharmacist concerning a 22 year old male patient with drug hypersensitivity to quinolones, cephalosporins, penicillin, vancomycin and tetracycline, asthma and tobacco user. The medical history was not reported. On 14-MAR-2016, the patient was vaccinated on an unspecified arm with an unspecified dose of PNEUMOVAX 23 lot # L024129, expiration date 21-JAN-2017, 0.5 ml, intramuscular. Concomitant therapies were not specified by the reporter. On 16-MAR-2016, the patient called the pharmacist to report that "his whole arm felt sore and tender and underneath his arm pit felt swollen, like a gland was swollen", this was the same unspecified arm where PNEUMOVAX 23 was administered. The patient did not receive any treatment and not laboratory tests were performed. The patient sought medical attention since he spoke to the pharmacist. The outcome of pain in extremity and lymphadenopathy was reported as not recovered. The causal relationship between PNEUMOVAX 23 and adverse events were not reported. Additional information is not expected as the reporter did not want to be contacted.
Age: 4.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 4 year old patient of unknown gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 22-MAR-2016, the patient was vaccinated with a third dose of M-M-R II, lot # L026553, expiry date 16-JUL-2017 (route and site of administration were not reported) and a third dose of VARIVAX (Merck), lot # L043619, expiry date 02-NOV-2017. The patient received them in error because provider believed that the patient did not receive the second doses. The error was due to an oversight of the date on which the second doses of vaccine were previously administered. The patient received the vaccines previously on 21-JUL-2014 and 21-SEP-2015. No adverse experience has been reported. Additional information has been requested.
Age: 1.1
Sex: F
Vaccine: UNK
Symptoms: Rash, Rash erythematous
Clinical narrative: Rash (red bumps) on cheeks and nose.  Got worse as week went on.  Still there as of today....3/29/2016 and not getting better yet.
Age: 0.33
Sex: F
Vaccine: DTAPIPV
Symptoms: Drug administered to patient of inappropriate age, Pyrexia, Wrong drug administered
Clinical narrative: Child was ordered DTaP and Polio - I gave KINRIX - combination of DTaP and Polio - KINRIX not recommended for children less than 4.
Age: 1.1
Sex: F
Vaccine: VARCEL
Symptoms: Rash
Clinical narrative: Rash on face, 3 days.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Contusion, Injected limb mobility decreased, Injection site pain, Injection site swelling, Pain in extremity
Clinical narrative: Reported arm and shoulder pain, swelling around the site, difficulty moving arm due to pain on same day as injection. Next day pain, swelling continued also with bruising and red spots. Pt took Advil and Benadryl. Also used cold compresses. Still with minimal swelling and bruising 5 days after.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Rash erythematous
Clinical narrative: Reported arm and shoulder pain, swelling around the site, difficulty moving arm due to pain on same day as injection. Next day pain, swelling continued also with bruising and red spots. Pt took Advil and Benadryl. Also used cold compresses. Still with minimal swelling and bruising 5 days after.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Amenorrhoea, Anti-Muellerian hormone level, Autonomic nervous system imbalance, Contusion, Dizziness
Clinical narrative: Increased bruising noted.  8/2013 greatly decreased menstrual bleeding noted after 3 years of regular periods.  Also noticed episodic dizziness and feeling faint, fatigue, generalized achiness, dilated pupils, HAs.  9/2013 Severe muscle spasm and episodic dizziness, HAs, dilated pupils continue.  Menstrual period very very light, again.  10/23/2013 HPV #2 given.  11/2013 amenorrhea.  Began to notice periods of facial and extremity duskiness and pallor along with above symptoms.  Numbness and tingling also noted.  12/2013 AMH (antimullerian hormone which indicates ovarian reserve) is found to be similar to perimenopausal woman.  Amenorrhea continues along with other symptoms.  6 through 8/2014 diagnosed with POTS/Dysautonomia.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Fatigue, Headache, Hypoaesthesia, Menstrual disorder, Muscle spasms
Clinical narrative: Increased bruising noted.  8/2013 greatly decreased menstrual bleeding noted after 3 years of regular periods.  Also noticed episodic dizziness and feeling faint, fatigue, generalized achiness, dilated pupils, HAs.  9/2013 Severe muscle spasm and episodic dizziness, HAs, dilated pupils continue.  Menstrual period very very light, again.  10/23/2013 HPV #2 given.  11/2013 amenorrhea.  Began to notice periods of facial and extremity duskiness and pallor along with above symptoms.  Numbness and tingling also noted.  12/2013 AMH (antimullerian hormone which indicates ovarian reserve) is found to be similar to perimenopausal woman.  Amenorrhea continues along with other symptoms.  6 through 8/2014 diagnosed with POTS/Dysautonomia.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Mydriasis, Pain, Pallor, Paraesthesia, Postural orthostatic tachycardia syndrome
Clinical narrative: Increased bruising noted.  8/2013 greatly decreased menstrual bleeding noted after 3 years of regular periods.  Also noticed episodic dizziness and feeling faint, fatigue, generalized achiness, dilated pupils, HAs.  9/2013 Severe muscle spasm and episodic dizziness, HAs, dilated pupils continue.  Menstrual period very very light, again.  10/23/2013 HPV #2 given.  11/2013 amenorrhea.  Began to notice periods of facial and extremity duskiness and pallor along with above symptoms.  Numbness and tingling also noted.  12/2013 AMH (antimullerian hormone which indicates ovarian reserve) is found to be similar to perimenopausal woman.  Amenorrhea continues along with other symptoms.  6 through 8/2014 diagnosed with POTS/Dysautonomia.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Tilt table test
Clinical narrative: Increased bruising noted.  8/2013 greatly decreased menstrual bleeding noted after 3 years of regular periods.  Also noticed episodic dizziness and feeling faint, fatigue, generalized achiness, dilated pupils, HAs.  9/2013 Severe muscle spasm and episodic dizziness, HAs, dilated pupils continue.  Menstrual period very very light, again.  10/23/2013 HPV #2 given.  11/2013 amenorrhea.  Began to notice periods of facial and extremity duskiness and pallor along with above symptoms.  Numbness and tingling also noted.  12/2013 AMH (antimullerian hormone which indicates ovarian reserve) is found to be similar to perimenopausal woman.  Amenorrhea continues along with other symptoms.  6 through 8/2014 diagnosed with POTS/Dysautonomia.
Age: 83.0
Sex: M
Vaccine: FLUX, PNC13, FLUX, PNC13
Symptoms: Burning sensation, Oropharyngeal pain, Pain, Pain in extremity
Clinical narrative: From PCP note: per pt sick, hurted all over, legs aches, burning sensation, sore throat, ha for 10 day.
Age: 83.0
Sex: M
Vaccine: FLUX, PNC13, FLUX, PNC13
Symptoms: Burning sensation, Headache, Oropharyngeal pain, Pain, Pain in extremity
Clinical narrative: From PCP note: per pt sick, hurted all over, legs aches, burning sensation, sore throat, ha for 10 day.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to unspecified patients of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 23-MAR-2016 (also reported as 23-MAR-2017), the patients were vaccinated with improperly stored (Oka/Merck) VARIVAX lot # L041204, expiry date 20-OCT-2017 (dose, route and site of administration were not reported). No adverse events were reported. Temperature excursion was reported as -13.7 Celsius for 20 minutes, it was not out of range before. Additional information has been requested.