chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 53.0
Sex: F
Vaccine: TDAP
Symptoms: Mobility decreased, Musculoskeletal stiffness, Nausea, Pain in extremity
Clinical narrative: Extreme pain and swelling, hot to touch at injection site. Swelling subsided after 2 weeks. Contacted Dr. and was seen over 30 days later for same symptoms. June 3, 2015 still have inability to lift or use arm normally. Terrible pain, sore, stiff arm muscle, causing nausea and inability to sleep. Unable to do daily chores, my daughter helps me dress, she is only 8 years old.
Age: 41.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site rash, Injection site reaction, Injection site swelling, Local swelling, Oropharyngeal pain
Clinical narrative: The site of the DTAP injection began to swell and and the injection site turned scaley. Small 1mm black spots on the skin formed within a 1cm radius from the injection site and red dots formed on the shoulder within 10 cm. The swelling progressed within the next 24 hours to the neck, jaw and head before going down. A sore throat was experienced within the 24 hour period.
Age: 41.0
Sex: M
Vaccine: DTAP
Symptoms: Rash erythematous, Skin exfoliation, Swelling face
Clinical narrative: The site of the DTAP injection began to swell and and the injection site turned scaley. Small 1mm black spots on the skin formed within a 1cm radius from the injection site and red dots formed on the shoulder within 10 cm. The swelling progressed within the next 24 hours to the neck, jaw and head before going down. A sore throat was experienced within the 24 hour period.
Age: 1.32
Sex: M
Vaccine: MMR, PNC13
Symptoms: Rash generalised
Clinical narrative: Per pt's mother pt started to run 102-103 fever on 5/28/15. 5/30/15 rash on whole body. Rash worsen 5/31/15. 6/01/15 rash improved, 6/02/15 rash faded almost completely, no treatment recommend but advised if rash persist or worsen. Pt needs to be seen for further evaluation.
Age: 15.0
Sex: F
Vaccine: HEPA, TYP, YF
Symptoms: Abdominal discomfort, Abdominal pain upper, Dizziness, Loss of consciousness, Nausea
Clinical narrative: Pt. began typoid oral medication on 5/26/15- slight upset stomach that increased with each pill. 6/1/15 became dizzy sharp stomach pains, nausea and then passed out. Someone called-pt passed out again taken to ER. Was given fluids and released. Felt better after fluids.
Age: 16.0
Sex: F
Vaccine: RAB
Symptoms: Asthenia, Dizziness, Headache, Nausea, Pain
Clinical narrative: At 8-9 pm pt c/o of headache, nausea, tingling in both arms and legs "felt weak and sore" and "dizzy". Woke up this AM and vomited. Denies any rash, throat tightness.
Age: 16.0
Sex: F
Vaccine: RAB
Symptoms: Paraesthesia, Vomiting
Clinical narrative: At 8-9 pm pt c/o of headache, nausea, tingling in both arms and legs "felt weak and sore" and "dizzy". Woke up this AM and vomited. Denies any rash, throat tightness.
Sex: F
Vaccine: MMR
Symptoms: Measles antibody negative, Splenectomy
Clinical narrative: Information has been received from a physician assistant via a company representative referring to a female patient of unknown age. No concurrent or historical conditions were reported. The physician assistant stated that on an unknown date the patient might been vaccinated with a dose of MMR (manufacturer unknown) (dose, frequency, route, lot# and expiration date were not reported) when she was a child. Concomitant therapies were not reported. On an unspecified date the patient had titers drawn and the result showed that the patient had no titers for measles. It was also reported that the patient had her spleen removed on an unspecified date. The patient was seen by the physician assistant on an unspecified date and no treatment was given for the events. The outcome of the events and the causality were not provided. Upon internal review, the event "spleen removed" was considered to be medically significant. Additional information has been requested.
Age: 77.0
Sex: M
Vaccine: PPV
Symptoms: Dyspnoea, Extra dose administered
Clinical narrative: This spontaneous report was received from a consumer (patient's daughter) refers to an approximately 77 year old male patient. No medical history was reported. On 12-MAY-2015, the patient was vaccinated with PNEUMOVAX 23 (dose 1, dose not provided). No concomitant therapy was reported. On an unknown date in May 2015, the patient experienced shortness of breath. On an unknown date in May 2015, the patient sought medical attention and saw the physician. On an unknown date in May 2015, the patient was hospitalized. The patient was inadvertently administered a second dose of PNEUMOVAX 23 on 29-MAY-2015. The outcome of the event was reported as not recovered. The causality assessment was not provided. Additional information has been requested.
Age: 69.0
Sex: M
Vaccine: PPV
Symptoms: Hypoaesthesia, Injection site bruising, Injection site hypoaesthesia, Injection site pain, Nuclear magnetic resonance imaging
Clinical narrative: 3-13-15 vaccine given, soreness at injection site; extensive bruising in upper left arm; numbness in entire left arm; severe pain day and night; no relief w/prednisone. 5/4/15 surgery-left shoulder.
Age: 69.0
Sex: M
Vaccine: PPV
Symptoms: Shoulder operation, X-ray limb
Clinical narrative: 3-13-15 vaccine given, soreness at injection site; extensive bruising in upper left arm; numbness in entire left arm; severe pain day and night; no relief w/prednisone. 5/4/15 surgery-left shoulder.
Age: 17.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Cataplexy, Condition aggravated, Electroencephalogram normal, Hypotonia, Nuclear magnetic resonance imaging brain normal
Clinical narrative: This medically confirmed literature report (initial receipt 19-May-2015) concerns a 17 year old female patient with a medical history of anxiety and fibromyalgia and was referred to a sleep centre after being diagnosed with narcolepsy and cataplexy. The narcolepsy symptoms began approximately four years prior to presenting to the clinic with excessive daytime sleepiness, sleep-related hallucinations and cataplexy but no sleep paralysis. A subsequent overnight polysomnogram revealed an AHI (Apnea-Hypopnea Index) <1, PLMI (Periodic Limb Movement Index) 14/hr, sleep latency of four minutes and sleep efficiency of 92%. The next morning MSLT (Multiple Sleep Latency Test) demonstrated a mean sleep latency of 2.6 minutes and 2 out of 5 sleep onset REM (Rapid Eye Movement) periods. She scored 20/24 on her Epworth Sleepiness scale. The patient was positive for DQBI*06:02 allele and CSF (Cerebrospinal Fluid) hypocretin levels were not obtained. Baseline EEG (Electroencephalography) did not demonstrate straight epileptiform activity and brain MRI (Magnetic Resonance Imaging) was normal. In the fall of 2013, approximately four years after her first cataplexy symptoms, the patient received the Influenza virus vaccine (manufacturer and batch number not provided). Within twenty minutes of influenza vaccination administration, she began experiencing cataplexy symptoms that lasted for approximately twenty-four hours. Her status cataplecticus manifested as episodic and instantaneous loss of tone in her lower extremities without loss of consciousness. The episodes were captured on home video. Her daytime sleepiness and cataplexy were much improved on sodium oxybate, armodafinil and sertraline. Outcome was not reported. Reporter comments: The reporter stated that the influenza vaccine may have served as a trigger of status cataplecticus in this patient with known narcolepsy.
Age: 17.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Sleep study abnormal, Somnolence
Clinical narrative: This medically confirmed literature report (initial receipt 19-May-2015) concerns a 17 year old female patient with a medical history of anxiety and fibromyalgia and was referred to a sleep centre after being diagnosed with narcolepsy and cataplexy. The narcolepsy symptoms began approximately four years prior to presenting to the clinic with excessive daytime sleepiness, sleep-related hallucinations and cataplexy but no sleep paralysis. A subsequent overnight polysomnogram revealed an AHI (Apnea-Hypopnea Index) <1, PLMI (Periodic Limb Movement Index) 14/hr, sleep latency of four minutes and sleep efficiency of 92%. The next morning MSLT (Multiple Sleep Latency Test) demonstrated a mean sleep latency of 2.6 minutes and 2 out of 5 sleep onset REM (Rapid Eye Movement) periods. She scored 20/24 on her Epworth Sleepiness scale. The patient was positive for DQBI*06:02 allele and CSF (Cerebrospinal Fluid) hypocretin levels were not obtained. Baseline EEG (Electroencephalography) did not demonstrate straight epileptiform activity and brain MRI (Magnetic Resonance Imaging) was normal. In the fall of 2013, approximately four years after her first cataplexy symptoms, the patient received the Influenza virus vaccine (manufacturer and batch number not provided). Within twenty minutes of influenza vaccination administration, she began experiencing cataplexy symptoms that lasted for approximately twenty-four hours. Her status cataplecticus manifested as episodic and instantaneous loss of tone in her lower extremities without loss of consciousness. The episodes were captured on home video. Her daytime sleepiness and cataplexy were much improved on sodium oxybate, armodafinil and sertraline. Outcome was not reported. Reporter comments: The reporter stated that the influenza vaccine may have served as a trigger of status cataplecticus in this patient with known narcolepsy.
Age: 17.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Apnoea test, Cataplexy, Condition aggravated, Electroencephalogram abnormal, Hypotonia
Clinical narrative: This medically confirmed literature report (initial receipt 19-May-2015) concerns a 17 year old female patient with a medical history of anxiety and fibromyalgia and was referred to a sleep centre after being diagnosed with narcolepsy and cataplexy. The narcolepsy symptoms began approximately four years prior to presenting to the clinic with excessive daytime sleepiness, sleep-related hallucinations and cataplexy but no sleep paralysis. A subsequent overnight polysomnogram revealed an AHI (Apnea-Hypopnea Index) <1, PLMI (Periodic Limb Movement Index) 14/hr, sleep latency of four minutes and sleep efficiency of 92%. The next morning MSLT (Multiple Sleep Latency Test) demonstrated a mean sleep latency of 2.6 minutes and 2 out of 5 sleep onset REM (Rapid Eye Movement) periods. She scored 20/24 on her Epworth Sleepiness scale. The patient was positive for DQBI*06:02 allele and CSF (Cerebrospinal Fluid) hypocretin levels were not obtained. Baseline EEG (Electroencephalography) did not demonstrate straight epileptiform activity and brain MRI (Magnetic Resonance Imaging) was normal. In the fall of 2013, approximately four years after her first cataplexy symptoms, the patient received the Influenza virus vaccine (manufacturer and batch number not provided). Within twenty minutes of influenza vaccination administration, she began experiencing cataplexy symptoms that lasted for approximately twenty-four hours. Her status cataplecticus manifested as episodic and instantaneous loss of tone in her lower extremities without loss of consciousness. The episodes were captured on home video. Her daytime sleepiness and cataplexy were much improved on sodium oxybate, armodafinil and sertraline. Outcome was not reported. Reporter comments: The reporter stated that the influenza vaccine may have served as a trigger of status cataplecticus in this patient with known narcolepsy.
Age: 17.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Nuclear magnetic resonance imaging brain normal, Somnolence
Clinical narrative: This medically confirmed literature report (initial receipt 19-May-2015) concerns a 17 year old female patient with a medical history of anxiety and fibromyalgia and was referred to a sleep centre after being diagnosed with narcolepsy and cataplexy. The narcolepsy symptoms began approximately four years prior to presenting to the clinic with excessive daytime sleepiness, sleep-related hallucinations and cataplexy but no sleep paralysis. A subsequent overnight polysomnogram revealed an AHI (Apnea-Hypopnea Index) <1, PLMI (Periodic Limb Movement Index) 14/hr, sleep latency of four minutes and sleep efficiency of 92%. The next morning MSLT (Multiple Sleep Latency Test) demonstrated a mean sleep latency of 2.6 minutes and 2 out of 5 sleep onset REM (Rapid Eye Movement) periods. She scored 20/24 on her Epworth Sleepiness scale. The patient was positive for DQBI*06:02 allele and CSF (Cerebrospinal Fluid) hypocretin levels were not obtained. Baseline EEG (Electroencephalography) did not demonstrate straight epileptiform activity and brain MRI (Magnetic Resonance Imaging) was normal. In the fall of 2013, approximately four years after her first cataplexy symptoms, the patient received the Influenza virus vaccine (manufacturer and batch number not provided). Within twenty minutes of influenza vaccination administration, she began experiencing cataplexy symptoms that lasted for approximately twenty-four hours. Her status cataplecticus manifested as episodic and instantaneous loss of tone in her lower extremities without loss of consciousness. The episodes were captured on home video. Her daytime sleepiness and cataplexy were much improved on sodium oxybate, armodafinil and sertraline. Outcome was not reported. Reporter comments: The reporter stated that the influenza vaccine may have served as a trigger of status cataplecticus in this patient with known narcolepsy.
Age: 0.38
Sex: F
Vaccine: DTAP, HIBV, IPV, RV5
Symptoms: Irritability, Pyrexia, Rash
Clinical narrative: Mother of the baby reported that during the night after receiving the vaccines the baby started to complain and developed a fever. Next morning the baby had a skin rash in the head. Her pediatrician recommended to check the vaccine lot.
Age: 3.0
Sex: M
Vaccine: FLU4
Symptoms: Expired product administered
Clinical narrative: NONE. IIV4 GIVEN. Later found the vaccine expiry date was 5.20.15 GSK FLUARIX lot # SJ9E9 .5 IM.
Age: 11.0
Sex: F
Vaccine: FLU3, HPV4, MNQ, TDAP
Symptoms: Dizziness, Immediate post-injection reaction, Syncope
Clinical narrative: RIGHT AFTER THE VACCINE ADMISNITRATION THE CHILD FELT DIZZY AND FAINTED.
Age: 75.0
Sex: F
Vaccine: PNC13
Symptoms: Headache, Muscle spasms, Musculoskeletal discomfort, Pyrexia
Clinical narrative: PATIENT WOKE UP WITH LEG CRAMPS, SOME MUSCLE DISCOMFORT, A HEADACHE, AND A SLIGHT FEVER AND IT WOKE HER UP AT ABOUT 2:30 AM THE DAY AFTER RECEIVING THE INJECTION.
Age: 54.0
Sex: M
Vaccine: TDAP
Symptoms: Dizziness, Faecal incontinence, Feeling abnormal, Feeling hot, Loss of consciousness
Clinical narrative: Less than one minute after the injection, I had a prickly sensation all over my scalp which worsened.  I got very hot then passed out.  I lost control of my bowels while unconscious.  I came to about one minute later and remained at the clinic for another hour and one half for observation.  Since that time, I have had an unclear feeling in my head similar to the effect of nighttime cold medicine.  The second ongoing symptom since the time of this vaccination is dizziness.  This has not improved any since the time of vaccination.
Age: 54.0
Sex: M
Vaccine: TDAP
Symptoms: Paraesthesia
Clinical narrative: Less than one minute after the injection, I had a prickly sensation all over my scalp which worsened.  I got very hot then passed out.  I lost control of my bowels while unconscious.  I came to about one minute later and remained at the clinic for another hour and one half for observation.  Since that time, I have had an unclear feeling in my head similar to the effect of nighttime cold medicine.  The second ongoing symptom since the time of this vaccination is dizziness.  This has not improved any since the time of vaccination.
Age: 30.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site inflammation
Clinical narrative: INFLAMMATION AND REDNESS ON THE LEFT ARM (DELTOID AREA AND RIGHT UNDERARM).
Age: 16.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Tremor
Clinical narrative: Noticeable tremors in left arm. (Vaccine was administered in left deltoid.) Lasted about 20 minutes.
Age: 6.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Injection site pain, Pain in extremity, Pyrexia
Clinical narrative: Fever at 100.1. Enter arm was sore and aching not just at the spot of the shot but the entire arm.
Age: 2.0
Sex: F
Vaccine: HEPA
Symptoms: Injection site reaction, Urticaria
Clinical narrative: Guardian reports onset of whelps that began on face then spread to arms and legs. She gave child Benadryl orally x 3 days and whelps resolved.
Age: 39.0
Sex: M
Vaccine: ANTH, TYP
Symptoms: Abdominal pain, Chills, Headache, Injection site erythema, Injection site pain
Clinical narrative: Pt had pain, swelling and redness to the right shoulder/arm with streaks going down his arm after receiving anthrax vaccine (#16).  He experienced fever/chills, headaches, and abdominal pains/nausea over the last 2-3 days.  Pt was seen by physician and immunization clinic staff and treated with steroids MEDROL dose pack), antihistamines (Zantac and Zyrtec), and Motrin.
Age: 39.0
Sex: M
Vaccine: ANTH, TYP
Symptoms: Injection site streaking, Injection site swelling, Nausea, Pyrexia
Clinical narrative: Pt had pain, swelling and redness to the right shoulder/arm with streaks going down his arm after receiving anthrax vaccine (#16).  He experienced fever/chills, headaches, and abdominal pains/nausea over the last 2-3 days.  Pt was seen by physician and immunization clinic staff and treated with steroids MEDROL dose pack), antihistamines (Zantac and Zyrtec), and Motrin.
Age: 48.0
Sex: M
Vaccine: PPV
Symptoms: Asthenia, Cough, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Weakness, coughing, high fever arm swell where the shot was given and turned red and was hot to the touch.
Age: 48.0
Sex: M
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: Weakness, coughing, high fever arm swell where the shot was given and turned red and was hot to the touch.
Sex: M
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a male patient of unknown age who is also a pharmacist. The concurrent condition and medical history was not reported. On 13-AUG-2010, the patient was vaccinated with RECOMBIVAX HB dose 1, 1 ml, intramuscular. The concomitant medications were not reported. On 10-SEP-2010, the patient was vaccinated with dose 2 of RECOMBIVAX HB and on an unknown date in August 2011 with dose 3 of RECOMBIVAX HB (inappropriate schedule of drug administration). No adverse experience reported. 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 registered nurse refers to 3 patients of unknown age and gender. On an unknown dates, the patients were vaccinated with doses of VARIVAX (dose, frequency, route of administration were not provided; lot # K021487, expiration date 03-NOV-2016) that had been improperly stored. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Facial pain, Headache, Injection site erythema, Injection site pain
Clinical narrative: This spontaneous report as received form a 65 year old female consumer reporting on herself with back pain and there was no allergies or drug reaction reported. On 12-MAY-2015, the patient was vaccinated with a dose of ZOSTAVAX injection (dose, route, lot number and expiry date were not reported). It was the patient was on therapy with an unspecified pain medication for existing back pian which had not helped the headache. On the same date, 2 hours after vaccination, the patient developed redness (injection site erythema, soreness (injection site pain) and swelling at the injection site (injection site swelling) along with headache, facial pain and dizziness. The patient did not seek medical attention, there was no treatment received or laboratory diagnostics studies performed. The outcome of facial pain, headache, injection site swelling, injection site pain, injection site erythema and dizziness was reported as not recovered since there was no adverse event improvement. The relatedness between the events and ZOSTAVAX was not provided. Additional information is not expected because no reporter details were provided.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling
Clinical narrative: This spontaneous report as received form a 65 year old female consumer reporting on herself with back pain and there was no allergies or drug reaction reported. On 12-MAY-2015, the patient was vaccinated with a dose of ZOSTAVAX injection (dose, route, lot number and expiry date were not reported). It was the patient was on therapy with an unspecified pain medication for existing back pian which had not helped the headache. On the same date, 2 hours after vaccination, the patient developed redness (injection site erythema, soreness (injection site pain) and swelling at the injection site (injection site swelling) along with headache, facial pain and dizziness. The patient did not seek medical attention, there was no treatment received or laboratory diagnostics studies performed. The outcome of facial pain, headache, injection site swelling, injection site pain, injection site erythema and dizziness was reported as not recovered since there was no adverse event improvement. The relatedness between the events and ZOSTAVAX was not provided. Additional information is not expected because no reporter details were provided.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date, the patients were vaccinated with improperly stored doses of GARDASIL (dose and route were not reported), lot # K006117, expiration date 14-JAN-2017; K009482, expiration dat e 06-MAR-2017; K011492, expiration date 22-JUN-2016; L001442, expiration date 04-NOV-2016 and lot # reported as K006396, expiration date 04-MAY-2016. Total number of doses administered was 39. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's historical drug included VARIVAX (Merck) (vaccinated on 07-APR-2014). On 19-MAY-2015, the patient was accidentally vaccinated with a dose of PROQUAD (Merck) (dose, route, lot # and expiration date were not reported) instead of a dose of M-M-R II. There was no adverse effect reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date, the patients were vaccinated with improperly stored doses of M-M-R II (dose and route were not reported), lot # Joo6995, expiration date 14-JUN-23015; lot # J013315, expiration date 18-OCT-2015; lot # K002527, expiration date 18-FEB-2016; lot # K006396, expiration date 04-MAY-2016 and lot # reported as K002919, expiration date 26-FEB-2016. Total number of doses administered was 17. No adverse effects were reported. This is one of several reports received from he 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 nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date, the patients were vaccinated with improperly stored doses of VARIVAX (Merck) (dose and route were not reported), lot # J013904, expiration date 30-OCT-2015; lot # K002919, expiration date 26-FEB-2016; lot # reported as K005183, expiration DATE 10-APR-2016; lot # reported as K008880, expiration date 09-SEP-2015 and lot # reported as K023624, expiration date 19-FEB-2016. Total number of doses administered was 37. No adverse effects were reported. 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 License Practical Nurse refers to unknown number of patients of unknown age and gender. On unknown dates, the patients were inadvertently administered VARIVAX, that had been improperly stored (dosage, lot # and route of administration not provided). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected as there was no consent to contact physician.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date, the patients were vaccinated with improperly stored doses of VAQTA (dose and route were not reported), lot # H019104, expiration date 19-JUL-2015 and lot # reported as J001162, expiration date 20-SEP-2015. Total number of doses administered was 5. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to unknown number of patients of unknown age and gender. On unknown dates, the patients were inadvertently administered PROQUAD (Merck), that had been improperly stored (dosage, lot # and route of administration not provided). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected as there was no consent to contact physician.
Age: 18.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 18 year old patient of unknown gender. Medical history and concurrent conditions were not reported. On 08-MAY-2015, the patient was vaccinated with an improperly stored GARDASIL dose 2, lot # K005881, expiration date 14-JAN-2017 (dose and route were not reported). No adverse event reported. No co-suspect and concomitant therapies were reported. This is one of several reports from the same source. Additional information is not expected. All follow up requested to complete the case were received.
Age: 13.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 13 year old patient of unknown gender. Medical history and concurrent conditions were not reported. On 04-MAY-2015, the patient was vaccinated with an improperly stored GARDASIL dose 3, lot # K005881, expiration date 14-JAN-2007 (dose and route were not reported). No adverse event reported. No co-suspect and concomitant therapies were reported. This is one of several reports from the same source. Additional information is not expected. All follow up requested to complete the case were received.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. On an unknown date, the patient was vaccinated with a dose of PROQUAD (Merck) (dose, frequency, route of administration were not provided; lot # K025760, expiration date 08-JUN-2016) that had been improperly stored. No adverse effects reported. This is one of several reports from the same reporter. Additional information has been requested.
Age: 46.0
Sex: F
Vaccine: HEP, VARCEL, VARCEL
Symptoms: Dizziness, Injection site erythema, Injection site pain
Clinical narrative: (R) arm injection site redness and sore. No temperature/fever. Patient states was fine day of, felt sore following morning then noticed redness came in to pharmacy on 6/3/15 at 9:30 AM. Patient had 2nd dose Hep B on 6/1/15 (L) arm which was stated on 6/1/15. On 6/3/15 patient said she felt lightheaded during Hep B shot which was not mentioned on 6/1/15 during VARIVAX apt.
Age: 46.0
Sex: F
Vaccine: HEP, VARCEL, VARCEL
Symptoms: Injection site rash, Injection site swelling, Pain in extremity
Clinical narrative: (R) arm injection site redness and sore. No temperature/fever. Patient states was fine day of, felt sore following morning then noticed redness came in to pharmacy on 6/3/15 at 9:30 AM. Patient had 2nd dose Hep B on 6/1/15 (L) arm which was stated on 6/1/15. On 6/3/15 patient said she felt lightheaded during Hep B shot which was not mentioned on 6/1/15 during VARIVAX apt.
Age: 79.0
Sex: M
Vaccine: PNC13
Symptoms: Alpha haemolytic streptococcal infection, Chest X-ray, Chills, Computerised tomogram abdomen, Computerised tomogram head
Clinical narrative: PREVNAR 13 administered in AM. Patient developed fever/rigors that evening. Four days later admitted to hospital with sepsis. Bacterial culture with Strep. Viridans successfully treated with IV Abx.
Age: 79.0
Sex: M
Vaccine: PNC13
Symptoms: Computerised tomogram pelvis, Echocardiogram, Electrocardiogram, Pyrexia, Sepsis
Clinical narrative: PREVNAR 13 administered in AM. Patient developed fever/rigors that evening. Four days later admitted to hospital with sepsis. Bacterial culture with Strep. Viridans successfully treated with IV Abx.
Age: 79.0
Sex: M
Vaccine: PNC13
Symptoms: Streptococcus test positive
Clinical narrative: PREVNAR 13 administered in AM. Patient developed fever/rigors that evening. Four days later admitted to hospital with sepsis. Bacterial culture with Strep. Viridans successfully treated with IV Abx.
Age: 0.36
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Febrile convulsion
Clinical narrative: Febrile seizure x 2.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Lymph node pain, Pyrexia, Rash pustular, Tenderness
Clinical narrative: Very red, tender to the area and down to elbow. All glands were sore to touch, low grade fever and a small bump that looked like a chicken-pox pustule on leg, at knee.
Age: 13.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 13 year old patient of unknown gender. Medical history and concurrent conditions were not reported. On 29-MAR-2015, the patient was vaccinated with an improperly stored GARDASIL dose 3, lot # K005881, expiration date 14-JAN-2017 (dose and route were not reported). No adverse event reported. No co-suspect and concomitant therapies were reported. This is one of several reports from the same source. Additional information is not expected. All follow up requested to complete the case were received.
Age: 13.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 13 year old patient of unknown gender. Medical history and concurrent conditions were not reported. On 20-APR-2015, the patient was vaccinated with an improperly stored GARDASIL dose 3, K005881, expiration date 14-JAN-2017 (dose and route were not reported). No adverse event reported. No co-suspect and concomitant therapies were reported. This is one of several reports from the same source. Additional information is not expected. All follow up requested to complete the case were received.
Age: 14.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 14 year old patient of unknown gender. Medical history and concurrent conditions were not reported. On 09-MAR-2015, the patient was vaccinated with an improperly stored GARDASIL dose 3, lot # K005881, expiration date 14-JAN-2017 (dose and route were not reported). No adverse event reported. No co-suspect and concomitant therapies were reported. This is one of several reports from the same source. Additional information is not expected. All follow up requested to complete the case were received.
Age: 0.19
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Brain injury, Cardiac arrest, Cardio-respiratory arrest, Computerised tomogram head abnormal, Crying
Clinical narrative: This information is regarding the description of adverse events and treatment. Most of the information is basically being obtained from the pediatric intensivist information when the child was in the pediatric intensive care unit. At the time of vaccination, which was on May 28, 2015 Mom stated that her daughter had some cold symptoms that had actually gotten better. She was otherwise doing well. She did well the day of the vaccines and her visit for the well check with no issues nor significant exam findings. She apparently on May 29, 2015, the following day, decreased her oral intake and slept a lot during the day. At 1830 in the evening she had normal feed and went to sleep after 2 loose stools. At 2100 she refused to feed and was not crying and was limp. Once Mom put her in the car seat she was alert and looking around, crying, and kicking and at 2200 she went to sleep. On May 30, 2015 the mother woke her up at 8 o'clock in the morning and she began "gasping" and was limp after 1 ounce of formula feeding. The mother assessed or believed the child to be in cardiopulmonary arrest and started CPR. The EMS was called and intubated her and gave her epinephrine and continued CPR. She was taken to the local emergency room and then taken to the referral center with the pediatric intensive care unit.
Age: 0.19
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Death, Diarrhoea, Diet refusal, Dyspnoea, Endotracheal intubation
Clinical narrative: This information is regarding the description of adverse events and treatment. Most of the information is basically being obtained from the pediatric intensivist information when the child was in the pediatric intensive care unit. At the time of vaccination, which was on May 28, 2015 Mom stated that her daughter had some cold symptoms that had actually gotten better. She was otherwise doing well. She did well the day of the vaccines and her visit for the well check with no issues nor significant exam findings. She apparently on May 29, 2015, the following day, decreased her oral intake and slept a lot during the day. At 1830 in the evening she had normal feed and went to sleep after 2 loose stools. At 2100 she refused to feed and was not crying and was limp. Once Mom put her in the car seat she was alert and looking around, crying, and kicking and at 2200 she went to sleep. On May 30, 2015 the mother woke her up at 8 o'clock in the morning and she began "gasping" and was limp after 1 ounce of formula feeding. The mother assessed or believed the child to be in cardiopulmonary arrest and started CPR. The EMS was called and intubated her and gave her epinephrine and continued CPR. She was taken to the local emergency room and then taken to the referral center with the pediatric intensive care unit.
Age: 0.19
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Hypophagia, Hypotonia, Intensive care, Resuscitation, Somnolence
Clinical narrative: This information is regarding the description of adverse events and treatment. Most of the information is basically being obtained from the pediatric intensivist information when the child was in the pediatric intensive care unit. At the time of vaccination, which was on May 28, 2015 Mom stated that her daughter had some cold symptoms that had actually gotten better. She was otherwise doing well. She did well the day of the vaccines and her visit for the well check with no issues nor significant exam findings. She apparently on May 29, 2015, the following day, decreased her oral intake and slept a lot during the day. At 1830 in the evening she had normal feed and went to sleep after 2 loose stools. At 2100 she refused to feed and was not crying and was limp. Once Mom put her in the car seat she was alert and looking around, crying, and kicking and at 2200 she went to sleep. On May 30, 2015 the mother woke her up at 8 o'clock in the morning and she began "gasping" and was limp after 1 ounce of formula feeding. The mother assessed or believed the child to be in cardiopulmonary arrest and started CPR. The EMS was called and intubated her and gave her epinephrine and continued CPR. She was taken to the local emergency room and then taken to the referral center with the pediatric intensive care unit.
Sex: F
Vaccine: VARZOS
Symptoms: Adverse event, Neuropathy peripheral
Clinical narrative: This spontaneous report was received from a pharmacist via company representative refers to a female patient of unknown age. No pertinent medical history was reported. On an unknown date, the patient was vaccinated with ZOSTAVAX (dose, route, lot # were not reported). On an unknown date, the patient experienced neuropathy peripheral and a breakout. The pharmacist did not clarify the type of neuropathy or the type of breakout the patient experienced. Patient sought medical attention. Action taken was not applicable. The outcome of neuropathy peripheral and a breakout was unknown. The reporter did not provide the causality between the event and the suspect therapy. Additional information has been requested.
Age: 15.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 15 year old patient of unknown gender. Medical history and concurrent conditions were not reported. On 05-MAR-2015, the patient was vaccinated with an improperly stored GARDASIL dose 3, lot # K005881, expiration date 14-JAN-2017 (dose and route were not reported). No adverse event reported. No co-suspect and concomitant therapies were reported. This is one of several reports from the same source. Additional information is not expected. All follow up requested to complete the case were received.
Age: 30.0
Sex: F
Vaccine: TDAP
Symptoms: Chest pain, Injection site reaction, Myalgia, Pain in extremity
Clinical narrative: Patient reported severe muscle pain at injection site that spread to her left arm/down to finger, and across chest beginning approx. 2 hours after receiving vaccine. Patient has been applying cold compresses and taking ibuprofen. Client states she has improved a lot today. Now rates pain 2/10.  Patient states she saw a physician yesterday afternoon and was prescribed Keflex, which she has just picked up and plans to start taking.
Age: 1.53
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Decreased appetite, Diarrhoea, Lethargy, Measles post vaccine, Pyrexia
Clinical narrative: Contracted mild case of measles from vaccine- Dr. confirmed. High fever, loss of appetite, lethargy, loose stools, and rash; lasted 4-5 days.
Age: 1.53
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Rash
Clinical narrative: Contracted mild case of measles from vaccine- Dr. confirmed. High fever, loss of appetite, lethargy, loose stools, and rash; lasted 4-5 days.
Age: 14.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 14 year old patient of unknown gender. Medical history and concurrent conditions were not reported. On 09-MAR-2015, the patient was vaccinated with an improperly stored GARDASIL dose 3, lot # K005881, expiration date 14-JAN-2017 (dose and route were not reported). No adverse event reported. No co-suspect and concomitant therapies were  reported. This is one of several reports from the same source. Additional information is not expected. All follow up requested to complete the case were received.
Age: 19.0
Sex: M
Vaccine: HPV4
Symptoms: Erythema, Lymphadenopathy
Clinical narrative: SWOLLEN, RED AND ENLARGED LYMPH NODES UNDER ARMPITS ABOUT THE SIZE OF A SMALL MARBLE. HPV VACCINE #2 GIVEN ON 5/19/2015.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Decreased appetite, Headache, Pyrexia, Vomiting
Clinical narrative: This spontaneous report as received from a nurse refers to a 26 year old female patient. No information on patient's medical history or concurrent conditions was provided. On 23-APR-2015, the patient was vaccinated with the first dose of GARDASIL 0.5 ml, intramuscularly, lot # reported as K010547 (which was invalid), expiration date 08-APR-2017. Concomitant medications included: LORYNA 3 mg (reported as MORYNA. On an unspecified day in 2015, after receiving the first dose of the vaccine, the patient called the physician's office to report headache, fever, vomiting, and loss of appetite. No treatment was provided to the patient. On unspecified date in 2015, the patient fully recovered. On 30-APR-2015, the patient received the second dose of GARDASIL, and then called the physician's office on 10-MAY-2015, to report headache, fever, vomiting, and loss of appetite again. No treatment was provided to the patient. At the time of this report the patient was recovering. No lab diagnostics studies were performed. The patient sought medical attention via calling the physician. It was not specified by reporter if the therapy was discontinued. The causality between reported episodes of headache, fever, vomiting, and loss of appetite and GARDASIL was not provided. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from the nurse refers to unspecified number of patients. No medical history and concurrent conditions were reported. On an unknown date, the unspecified number of patients were inadvertently vaccinated with improperly stored M-M-R II (lot number, dose, frequency and route of administration was not reported) and did not experience any adverse event. The outcome of the reported events were unknown. The reporter considered incorrect product storage to be not related to M-M-R II. No product quality complaint (PQC) was filed. No further information was provided. This is one of the 4 reports of the same reporter. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from the nurse refers to unspecified number of patients. No medical history and concurrent conditions were reported. On an unknown date, the unspecified number of patients were inadvertently vaccinated with improperly stored LIQUID PEDVAXHIB (lot number, dose, frequency and route of administration was not reported) and did not experience any adverse event. The outcome of the reported events were unknown. The reporter considered incorrect product storage to be not related to LIQUID PEDVAXHIB. No product quality complaint (PQC) was filed. No further information was provided. This is one of the 4 reports of the same reporter. Additional information has been requested.
Sex: F
Vaccine: MMR
Symptoms: Aphasia, Autism, Decreased eye contact, Head banging, Pyrexia
Clinical narrative: This spontaneous report as received from a consumer refers to currently 21 month old female patient (his daughter). On an unknown date the patient was vaccinated with M-M-R II (dose, route or administration, anatomical localization were not reported). The reporter stated that evening after receiving the vaccine, his daughter experienced a fever, then a couple of days later she stopped talking and began head banging. He also stated that at the time of report she did not talk and she would not look him in th eye. The outcome of the events was reported as not recovered/not resolved. The reporter considered autism to be related to M-M-R II. The relatedness between fever and M-M-R II was not reported. Additional information has been requested.
Age: 83.0
Sex: M
Vaccine: VARZOS
Symptoms: Conjunctivitis, Decreased appetite, Dizziness, Eye pain, Eye swelling
Clinical narrative: Information has been received from a retired pediatric nurse practitioner concerning her 83 year old husband who on 08-MAY-2008 was vaccinated with a dose of ZOSTAVAX (lot#656861/0329U). The patient was seen in the emergency room on 21-JUL-2009 (date reported by reporter) for pain in right eye and over the eye. He was diagnosed with conjunctivitis and probable early shingles. He was given an prescription for the conjunctivitis and another for acyclovir to be filled the next day if it was shingles. The next day it was obvious he had shingles and the prescription was filled and started on 22-JUN-2008 (date reported by reporter). The swelling continued into his right eye and he was seen on 24-JUN-2008 (date reported by reporter) by an ophthalmologist. She did an exam and changed his eye drops and saw him again on 30-JUN-2008 (date reported by reporter). He had another appointment in September. On 15-JUN-2008(date reported by reporter) the patient was seen by the family doctor, because he felt ill. He had blood work on that day which was mostly within normal limits. He had another appointment with him on 05-AUG-2008 (date reported by reporter). The doctor gave him an prescription for LYRICA for nerve pain. It relieved the nerve pain but caused drowsiness and dizziness. At that time, because he was not eating well, the reporter started him on minerals (unspecified) (+) protein (unspecified) (+) vitamins (unspecified) (High Protein Ensure) and he had improved greatly. At the time of the report, the patient's status was unknown. Follow-up information has been received on 28-MAY-2015, from the reporting nurse, who was also the patient's wife. The patient's concurrent conditions included allergy to DAYPRO. It was reported that the patient received a dose of ZOSTAVAX in 2009. His concomitant medication was reported as "dalacyclovir". At the time of the report, the patient was experiencing a second episode of shingles (onset date unknown). He sought unspecified medical attention and was treated with DALTREX, per oral. The outcome of the adverse event was unknown. The relatedness between use of ZOSTAVAX and reported adverse events was not provided. Additional information has been requested.