chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.75
Sex: M
Vaccine: IPV
Symptoms: Induration, Injection site swelling, Irritability, Nodule, Somnolence
Clinical narrative: Swelling at injection, hard knot, sleepiness, irritability 2/11/2015.
Age: 16.0
Sex: M
Vaccine: HPV4
Symptoms: Injection site erythema, Rash generalised
Clinical narrative: Redness around insertion site and rash on upper body.
Age: 71.0
Sex: M
Vaccine: PNC13
Symptoms: Cardiac arrest, Death
Clinical narrative: Patient passed away 02/10/2015 due to Cardiac arrest.
Age: 30.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL
Symptoms: Cellulitis, Erythema, Peripheral swelling, Skin warm, Tenderness
Clinical narrative: On January 29 patient notice his upper right arm developed redness, swelling, warmness and tenderness to touch. He went to Hospital and the Physician diagnosed him as having a cellulitis. He was admitted immediately and treated with I.V. antibiotics. He stay at Hosp 4 days.
Age: 76.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Injection site reaction, Local reaction, Pruritus
Clinical narrative: Localized injection site reaction.  Redness and pruritis.  Patient self-treated with Benadryl cream.  On 02/10/2015 patient reported back to vaccinator for advice.  Patient was advised to take oral Benadryl and discontinue Benadryl cream.  Monitor for fever or other severe symptoms.  On 02/12/2015 patient was consulted by phone and stated her reaction had cleared.
Age: 1.02
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Peripheral swelling, Rash erythematous, Rash generalised, Rash macular, Skin reaction
Clinical narrative: Massive skin reaction which increased in severity until vanishing on day five. The child's hands, arms, feet, legs, and face were covered in a splotchy red rash. Swelling was present on hands, feet, and face.
Age: 1.02
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Swelling face
Clinical narrative: Massive skin reaction which increased in severity until vanishing on day five. The child's hands, arms, feet, legs, and face were covered in a splotchy red rash. Swelling was present on hands, feet, and face.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Injection site erythema, Injection site rash, Injection site swelling, Rash generalised
Clinical narrative: Erythema of leg from thigh to calf, swelling of right knee.  Resolved by next day.  3 days later onset of rash starting on thighs and spread to whole body, concerning for serum sickness like reaction, hives, or erythema multiforme.
Age: 15.0
Sex: F
Vaccine: FLUN4
Symptoms: Abdominal pain, Culture urine negative, Death, Mental status changes, Pyrexia
Clinical narrative: Seen at PMD for adb pain (pt had menses at this time) on 1/30/15. Dx with UTI, started Bactrim and patient was stopped from meds after a few days due to neg urine cx and the patient also was feeling better. On Wed 2/4/15 the abd pain returned and the patient then developed a fever of 102.6 and an all over body rash (non-pruritic). Seen at PMD on that day and was dx with suspect viral illness. Abd ultrasound was also done at the PMD and negative. On Thurs 2/5 the patient came in to the hospital due to dramatic altered mental status and vomiting stomach contents. The mental status worsened throught out hospitalization. Patient passed away.
Age: 15.0
Sex: F
Vaccine: FLUN4
Symptoms: Rash generalised, Ultrasound abdomen normal, Urinary tract infection, Viral infection, Vomiting
Clinical narrative: Seen at PMD for adb pain (pt had menses at this time) on 1/30/15. Dx with UTI, started Bactrim and patient was stopped from meds after a few days due to neg urine cx and the patient also was feeling better. On Wed 2/4/15 the abd pain returned and the patient then developed a fever of 102.6 and an all over body rash (non-pruritic). Seen at PMD on that day and was dx with suspect viral illness. Abd ultrasound was also done at the PMD and negative. On Thurs 2/5 the patient came in to the hospital due to dramatic altered mental status and vomiting stomach contents. The mental status worsened throught out hospitalization. Patient passed away.
Age: 78.0
Sex: F
Vaccine: PNC13
Symptoms: Abscess, Drug administered at inappropriate site, Inflammation, Scab, Skin exfoliation
Clinical narrative: This is a spontaneous report from a non-clinical study program from a contactable retired physician reporting for herself. A 78-year-old female patient received PREVNAR 13, via an unspecified route of administration in arm, on 08Dec2014, at single dose. Relevant medical history included asthma and osteoarthritis. Concomitant medications included ADVAIR 2x/day, SINGULAIR at 10mg 1x/day and meloxicam at 60 mg. Past drug history included PREVNAR 13 in 1997 or 1998, with no adverse reaction. On 08Dec2014 PREVNAR 13 was given too much in the arm and the patient experienced abnormal reactions to PREVNAR 13. Two days after vaccination the patient experienced inflammation in the deltoid area of her upper arm. She said that on 14Dec2014 it burst in abscesses, her skin was sloughed off and it drained out. The reporter said that when it slowed down she left it open during the day time but at night she had to cover it as it was still draining. She had to change clothes two times a day. Drainage recovered on 28Dec2014. The physician also said her last big scab filled out on 13Jan2015. On 15Dec2014 her doctor put her on KEFLEX 500 mg four times a day for 10 days. The physician said that KEFLEX helped her a lot. Outcome of the other reported events was unknown at the time of this report. The physician assessed all the events as directly connected with the administration of PREVNAR 13 as it was given too much in the arm.
Age: 78.0
Sex: F
Vaccine: PNC13
Symptoms: Subcutaneous abscess
Clinical narrative: This is a spontaneous report from a non-clinical study program from a contactable retired physician reporting for herself. A 78-year-old female patient received PREVNAR 13, via an unspecified route of administration in arm, on 08Dec2014, at single dose. Relevant medical history included asthma and osteoarthritis. Concomitant medications included ADVAIR 2x/day, SINGULAIR at 10mg 1x/day and meloxicam at 60 mg. Past drug history included PREVNAR 13 in 1997 or 1998, with no adverse reaction. On 08Dec2014 PREVNAR 13 was given too much in the arm and the patient experienced abnormal reactions to PREVNAR 13. Two days after vaccination the patient experienced inflammation in the deltoid area of her upper arm. She said that on 14Dec2014 it burst in abscesses, her skin was sloughed off and it drained out. The reporter said that when it slowed down she left it open during the day time but at night she had to cover it as it was still draining. She had to change clothes two times a day. Drainage recovered on 28Dec2014. The physician also said her last big scab filled out on 13Jan2015. On 15Dec2014 her doctor put her on KEFLEX 500 mg four times a day for 10 days. The physician said that KEFLEX helped her a lot. Outcome of the other reported events was unknown at the time of this report. The physician assessed all the events as directly connected with the administration of PREVNAR 13 as it was given too much in the arm.
Age: 30.0
Sex: U
Vaccine: DTAP
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Initial misuse report received from a healthcare professional on 23 July 2013. A 30-year-old patient (no other information was provided regarding the patient) had received DAPTACEL vaccine instead of ADACEL. No adverse event was reported. Documents held by sender: None.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Dermatitis bullous, Eye swelling
Clinical narrative: Based on additional information received on 06 February 2015, this case initially considered as non-serious was upgraded to serious because the patient was hospitalized. Initial unsolicited report received from a physician on 19 December 2014. Additional information received on 06 February 2015 clarified that the patient had been hospitalized, and so the case was upgraded to serious. An elderly female patient whose age and concomitant medications were not reported, had received a dose of FLUZONE HD (batch number U5063BA, expiry date 06 June 2015 through intramuscular route in unknown site) on 12 Feb 2014. The patient had received FLUZONE HD vaccine previously without any adverse events. On an unspecified date few days after vaccination the patient experienced bilateral eye swelling. Laboratory investigations were not reported and corrective treatments includes treatment with BENADRYL and steroids. The patient required ER or doctor visit. The patient outcome was unknown. Follow-up information was received from the physician on 06 February 2015, which upgraded the case to serious. Age was noted to be 72 years at the time of the event. The patient began to experience bilateral eye swelling on approximately 11 December 2014 i.e 9 days after vaccination, in addition to a bullous skin rash. She was seen by her physician on 06 January 2015, at which time she was noted to have taken only steroids, not BENADRYL as prescribed. She was admitted to the hospital on 06 January 2015 where she was undergoing evaluation. The patient was vaccinated at a private doctor's office/hospital. At the time of the report on 06 February 2015 the patient remained hospitalized. Documents held by sender: none.
Age: 54.0
Sex: F
Vaccine: MMR
Symptoms: Pruritus, Rash generalised, Rash morbilliform
Clinical narrative: Morbilliform rash on all extremities, trunk, neck and few on face.  Palms and soles spared. No fever. Mild itching.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Cellulitis, Discomfort, Fatigue, Rash
Clinical narrative: Large rash on vaccinated arm, discomfort, fatigue.
Sex: U
Vaccine: TYP
Symptoms: Anaphylactic reaction
Clinical narrative: Initial unsolicited case received from a nurse via Merck on 05 February 2015. A patient had received a TYPHOID VACCINE (manufacturer, lot number, route and site of administration not reported) on an unspecified date "many years ago" and subsequently experienced an anaphylaxis reaction. Treatment was unspecified, and the event recovered. The reporter in this case did not wish to be contacted for further information. Documents held by sender: None.
Age: 0.33
Sex: F
Vaccine: DTAP
Symptoms: Abnormal behaviour, Encephalopathy, Irritability, Poor feeding infant, Speech disorder
Clinical narrative: Initial unsolicited report received from a healthcare professional on 05 February 2015. A 3-month old female patient, with no reported medical history, received an injection of DAPTACEL (lot number not reported) on 06 March 2008. The patient's mother reported symptoms began on the day of vaccination; within 3 days of vaccination, the patient's mother reported irritability, poor feeding, decreased babbling, and that the infant was not responsive. The patient's mother reported to the healthcare professional that the patient had been evaluated by a neurologist and diagnosed with encephalopathy, however the patient was not hospitalized for treatment. Per the reporter, the patient seemed developmentally appropriate for her age at the time of the report, but the patient's mother had some behavioral concerns. Outcome was not reported. The reporter noted that the event had been reported to VAERS, however this information was unavailable to the reporter. Documents held by sender: None.
Age: 0.33
Sex: F
Vaccine: DTAP
Symptoms: Unresponsive to stimuli
Clinical narrative: Initial unsolicited report received from a healthcare professional on 05 February 2015. A 3-month old female patient, with no reported medical history, received an injection of DAPTACEL (lot number not reported) on 06 March 2008. The patient's mother reported symptoms began on the day of vaccination; within 3 days of vaccination, the patient's mother reported irritability, poor feeding, decreased babbling, and that the infant was not responsive. The patient's mother reported to the healthcare professional that the patient had been evaluated by a neurologist and diagnosed with encephalopathy, however the patient was not hospitalized for treatment. Per the reporter, the patient seemed developmentally appropriate for her age at the time of the report, but the patient's mother had some behavioral concerns. Outcome was not reported. The reporter noted that the event had been reported to VAERS, however this information was unavailable to the reporter. Documents held by sender: None.
Age: 70.0
Sex: F
Vaccine: PNC13
Symptoms: Asthenia, Blood glucose normal, Dehydration, Electrocardiogram abnormal, Hypotension
Clinical narrative: This is a spontaneous report from a contactable medical assistant from a doctor office. A 70 year-old female patient received the first dose of PREVNAR 13 (Lot J80525, expiration date Apr2016) intramuscular on 29Jan2015 at 11:45 am at 0.5 ml single in the left upper arm. Medical history included hypertension and diabetes mellitus, from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient did not receive any other vaccine on the same day or in the 4 weeks before to the suspect vaccine administration. The patient had previously taken for immunization PNEUMOVAX in 2011. On 30Jan2015 she experienced cellulitis of left bicep at injection site, she was hypotensive, she had muscle ache, weakness, tachycardia, large amount of erythema at left bicep at the injection site, dehydration. Due to the reported events the patient was transported to the hospital by ambulance but she was not hospitalized. The patient underwent laboratory tests and procedures on 30Jan2015 which included blood glucose: 194, an electrocardiogram which showed tachycardia, negative flu swabs. The outcome of the reported events was unknown.                    Adjudication Data Entry       Select the radio button next to any fields that need editing and enter data.   Box 7 Describe Adverse Event  (and treatment if any)
Age: 70.0
Sex: F
Vaccine: PNC13
Symptoms: Influenza virus test negative, Injection site cellulitis, Injection site erythema, Myalgia, Tachycardia
Clinical narrative: This is a spontaneous report from a contactable medical assistant from a doctor office. A 70 year-old female patient received the first dose of PREVNAR 13 (Lot J80525, expiration date Apr2016) intramuscular on 29Jan2015 at 11:45 am at 0.5 ml single in the left upper arm. Medical history included hypertension and diabetes mellitus, from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient did not receive any other vaccine on the same day or in the 4 weeks before to the suspect vaccine administration. The patient had previously taken for immunization PNEUMOVAX in 2011. On 30Jan2015 she experienced cellulitis of left bicep at injection site, she was hypotensive, she had muscle ache, weakness, tachycardia, large amount of erythema at left bicep at the injection site, dehydration. Due to the reported events the patient was transported to the hospital by ambulance but she was not hospitalized. The patient underwent laboratory tests and procedures on 30Jan2015 which included blood glucose: 194, an electrocardiogram which showed tachycardia, negative flu swabs. The outcome of the reported events was unknown.                    Adjudication Data Entry       Select the radio button next to any fields that need editing and enter data.   Box 7 Describe Adverse Event  (and treatment if any)
Age: 40.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Asthenia, Blood culture negative, Body temperature increased, Cellulitis, Erythema
Clinical narrative: Pt complained of weakness/tiredness; arm pain. Arm was red, swollen and very hot to the touch. Temp 39.1 - pt transferred to Med/Surg unit for IV abx with diagnosis of cellultis.
Age: 40.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Fatigue, Pain in extremity, Peripheral swelling, Skin warm, White blood cell count increased
Clinical narrative: Pt complained of weakness/tiredness; arm pain. Arm was red, swollen and very hot to the touch. Temp 39.1 - pt transferred to Med/Surg unit for IV abx with diagnosis of cellultis.
Age: 44.0
Sex: M
Vaccine: FLUC3
Symptoms: Blood test, Discomfort, Guillain-Barre syndrome, Hypoaesthesia, Lumbar puncture
Clinical narrative: I came home from work and as I got out of my car to go in the house both my hands and both my feet simultaneously went numb and started tingling. After 3 days of the symptoms not going away I went to the emergency room and clinic. After a spinal tap at a series of blood test it was suspected that I had GBS. I was sent home only for the symptoms to get worse and I went back to emergency and stayed for 5 days only to leave worth the same painful uncomfortable symptoms.
Age: 44.0
Sex: M
Vaccine: FLUC3
Symptoms: Pain, Paraesthesia
Clinical narrative: I came home from work and as I got out of my car to go in the house both my hands and both my feet simultaneously went numb and started tingling. After 3 days of the symptoms not going away I went to the emergency room and clinic. After a spinal tap at a series of blood test it was suspected that I had GBS. I was sent home only for the symptoms to get worse and I went back to emergency and stayed for 5 days only to leave worth the same painful uncomfortable symptoms.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report has been received from a healthcare worker refers to a patient of unknown age and gender. On an unknown date, the patient was vaccinated with ROTATEQ (lot#, dose unknown) orally The ROTATEQ was exposed to 33F for 20 days. The outcome and causality were not reported. This is one of several reports from the same source. Additional information has been requested.
Age: 80.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Nodule, Pain, Rash, Skin warm
Clinical narrative: Localized Rash, Redness, sore, knot, warm to touch.
Age: 6.0
Sex: M
Vaccine: VARZOS
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: There have been no reportable adverse events at this time.
Age: 46.0
Sex: M
Vaccine: HEP
Symptoms: Dysgeusia
Clinical narrative: Patient reports that 1-2 hours after the vaccination, he experienced a metallic taste in his mouth. This disappeared 2-3 hours after onset.
Age: 10.0
Sex: F
Vaccine: DTAP, TDAP
Symptoms: Induration, Injection site rash, Peripheral swelling, Urticaria
Clinical narrative: Hard, swollen arm with baseball sized rash over the site; that went away after a week, then hives developed and ongoing for about a week now.
Age: 10.0
Sex: F
Vaccine: DTAP, TDAP
Symptoms: Erythema, Local reaction, Swelling, Urticaria
Clinical narrative: Hard, swollen arm with baseball sized rash over the site; that went away after a week, then hives developed and ongoing for about a week now.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Injected limb mobility decreased, Injection site reaction
Clinical narrative: She has not been able to lift her arm up at all since she got the vaccine.  She has been to the doctor and is now scheduled to see an orthopedic surgery regarding this.  She says that she has had flu shots here in the past and been fine and it has always been very gentle.  She says that when the pharmacist was giving the vaccine, he just "jabbed" it in and when he did they both heard something crunch.  She doesn't know if she had an allergic reaction or if it was the way it was administered.  She is going to let us know what the doctor says.
Age: 40.0
Sex: F
Vaccine: DTAP
Symptoms: Blood glucose normal, Body temperature increased, Dizziness, Dysstasia, Electrocardiogram normal
Clinical narrative: Feels faint, dizzy, unable to stand about 1.5 hrs after vaccination. Vital signs taken, bed rest with foot of bed elevated. EMS called and transported to local ER after 1.5 hrs monitoring and continued faintness.
Age: 40.0
Sex: F
Vaccine: DTAP
Symptoms: Neurological examination normal
Clinical narrative: Feels faint, dizzy, unable to stand about 1.5 hrs after vaccination. Vital signs taken, bed rest with foot of bed elevated. EMS called and transported to local ER after 1.5 hrs monitoring and continued faintness.
Age: 45.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain, Pain
Clinical narrative: CHRONIC DIFFUSE PAIN OF ENTIRE LEFT DELTOID WITH RADIATING QUALITIES. PAIN IS DAILY AND HAS NOT IMPROVED SINCE INJECTION DATE. PAIN IS WORSE WITH ACTIVITIES THAT CONTRACT THE DELTOID MUSCLE.
Age: 2.0
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Dysphemia
Clinical narrative: Patients mother called the office on 2/9/15 reporting pt started stuttering significantly 2 days ago.
Age: 52.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Guillain-Barre syndrome, Pain, Paraesthesia
Clinical narrative: Guillain Barre Syndrome; global parasthesias, weakness and pain. Will be getting IVIG 2/12-2/16.
Age: 2.0
Sex: F
Vaccine: HIBV, PNC, HIBV, PNC13
Symptoms: Allergy test negative, Injection site rash, Rash, Urticaria
Clinical narrative: Hives and rash on right leg and buttock.  Attempted to treat with diaper rash cream.
Age: 2.0
Sex: F
Vaccine: HIBV, PNC, HIBV, PNC13
Symptoms: Allergy test negative, Blood test normal, Cough, Erythema, Hypersensitivity
Clinical narrative: Hives and rash on right leg and buttock.  Attempted to treat with diaper rash cream.
Age: 2.0
Sex: F
Vaccine: HIBV, PNC, HIBV, PNC13
Symptoms: Injection site erythema, Injection site urticaria, Peripheral swelling, Skin test negative, Urticaria
Clinical narrative: Hives and rash on right leg and buttock.  Attempted to treat with diaper rash cream.
Age: 2.0
Sex: M
Vaccine: MMR
Symptoms: Pyrexia
Clinical narrative: 103.1 Fever, gave 5ML infant Tylenol.
Age: 1.09
Sex: F
Vaccine: FLU3, HEPA, MMR, VARCEL
Symptoms: Injection site rash, Injection site urticaria, Rash, Rash erythematous
Clinical narrative: Developed red patchy rash to both legs.  Described as "hives" but really red and patchy.  Given Benadryl.  Rash resolved on own.  Parents did not call our office and did not report this to us until today.
Age: 52.0
Sex: M
Vaccine: DTAP
Symptoms: Headache, Pyrexia, Vomiting
Clinical narrative: I HAD VOMITING, FEVER, AND HEADACHE.
Age: 25.0
Sex: M
Vaccine: DTIPV
Symptoms: Rash
Clinical narrative: Rash.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Contusion, Haemorrhage subcutaneous, Hypersensitivity, Rash, Rash erythematous
Clinical narrative: PATIENT STATES THAT SHE HAD RED DOTS ON HER LEGS. HER DOCTOR SAID ITS BLEEDING UNDER THE SKIN/BRUISING, AN ALLERGIC REACTION TO THE VACCINE.
Age: 20.0
Sex: F
Vaccine: TDAP
Symptoms: Expired product administered
Clinical narrative: This case was reported by a pharmacist and described the occurrence of expired vaccine used in a 20-year-old female patient who received BOOSTRIX (batch number AC52B094AA, expiry date 8th November 2014). On 3rd December 2041, the patient received BOOSTRIX .5 ml. On an unknown date, an unknown time after receiving BOOSTRIX, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.
Age: 2.0
Sex: M
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: This case was reported by a other health professional and described the occurrence of accidental overdose in a 2-year-old male patient who received FLUARIX QUADRIVALENT (batch number F45C5, expiry date 30th June 2015). On 8th December 2014, the patient received the 1st dose of FLUARIX QUADRIVALENT .5 ml. On an unknown date, an unknown time after receiving FLUARIX QUADRIVALENT, the patient experienced accidental overdose and inappropriate age at vaccine administration. On an unknown date, the outcome of the accidental overdose and inappropriate age at vaccine administration were unknown. Additional information received: Inadvertently gave 2 years old male 0.5 mL dose of FLUARIX QUADRIVALENT today 12/8/14. Adult vaccine given to child.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: This case was reported by a pharmacist and described the occurrence of injection site pain in a 58-year-old female patient who received FLUARIX (batch number 5J9F9, expiry date 20th May 2015). Previously administered products included flu vaccine. On 7th October 2014, the patient received the 1st dose of FLUARIX. On an unknown date, an unknown time after receiving FLUARIX, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was not recovered/not resolved. It was unknown if the reporter considered the injection site pain to be related to FLUARIX.
Sex: F
Vaccine: FLUX
Symptoms: Injection site erythema, Injection site swelling, Malaise
Clinical narrative: This case was reported by a nurse via other manufacturer and described the occurrence of injection site swelling in a adult female patient who received Influenza vaccine. On an unknown date, the patient received Influenza vaccine at an unknown dose. On an unknown date, an unknown time after receiving Influenza vaccine, the patient experienced injection site swelling, injection site erythema and feeling unwell. On an unknown date, the outcome of the injection site swelling, injection site erythema and feeling unwell were unknown. It was unknown if the reporter considered the injection site swelling, injection site erythema and feeling unwell to be related to Influenza vaccine. Additional information received: Nurse who states that she received an unspecified FLU vaccine, date unspecified, which resulted in swelling and approximately 3" of redness surrounding the vaccine site. She also felt sick, so specific qualifiers provided for the term sick, for at least two weeks post vaccination. No other information provided.
Sex: M
Vaccine: FLUX
Symptoms: Encephalitis
Clinical narrative: Initial unsolicited case was received on 05 February 2015 from a consumer who is also the patient's daughter. A male patient (date of birth not reported) with an unknown past medical history had received on an unspecified date "four months ago" an Influenza vaccine (manufacturer, lot number, route and site of administration not reported) and an unspecified amount of time later, developed encephalitis. The event was considered life-threatening and required an ER/doctor visit. No further information was provided at the time of the report. Outcome was unknown. Documents held by sender: none.
Sex: F
Vaccine: TDAP
Symptoms: Incorrect product storage
Clinical narrative: This case was reported by a other health professional and described the occurrence of incorrect storage of drug in a adult female patient who received BOOSTRIX (batch number 3P9CL, expiry date 15th April 2016). On an unknown date, the patient received BOOSTRIX. On an unknown date, an unknown time after receiving BOOSTRIX, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown. Additional information received: 3 patients vaccinated with vaccine that was stored at -2.56C.
Sex: U
Vaccine: RV5
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. The nurse reported that on an unknown dates an unspecified number of patients received doses of ROTATEQ (orally, dose, frequency and lot # not reported) that were improperly stored. No adverse experiences reported. No further information provided. This is one of several reports from the same source. Additional information has been requested.
Age: 46.0
Sex: F
Vaccine: HEP, PPV, TDAP
Symptoms: Cellulitis, Erythema, Induration, Peripheral swelling, Skin warm
Clinical narrative: (L) arm cellulitis pt stated that after she received the PNEUMOVAX on (L) deltoid her arm got red and swollen, hardened hot area has been getting bigger. No fever, chills, wheezing or respiratory distress. (R) arm fine pt was given clindamycin 300mg 1 po TID x 7 days. CIPRO 500mg 1 BID x 7 days.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Erythema, Induration
Clinical narrative: Left arm with mild erythema and mild induration.
Age: 24.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Oedema, Skin warm, Tenderness
Clinical narrative: Local erythema, edema, tenderness and some warm.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant, concerning a patient of an unknown age and gender. Medical history and current conditions were not reported. On 28-JAN-2015, the patient was vaccinated with a dose of (Oka/Merck) VARIVAX (dose number, lot number and expiration date were not reported), 0.5 ml dose, subcutaneous route, that underwent a supported temperature excursion. No adverse experience reported. Co-suspect and concomitant therapies were not reported. Additional information has been requested. This is one (1) of four (4) reports from the same source.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant, concerning an unknown number of patients of an unknown age and gender. Medical history and current conditions were not reported. On 29-JAN-2015, the patients were vaccinated with a dose of (Oka/Merck) VARIVAX (dose number, lot number and expiration date were not reported), 0.5 ml dose, subcutaneous,that was exposed to supported temperature excursions. No adverse effects reported. Co-suspect and concomitant therapies were not reported. Additional information has been requested. This is one (1) of four (4) reports from the same source.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant, concerning three (3) patients of an unknown age and gender. Medical history and current conditions were not reported. On 04-FEB-2015, the patients were vaccinated with a dose of (Oka/Merck) VARIVAX (dose number, lot number and expiration date were not reported), 0.5 ml dose, subcutaneous route, that was exposed to supported temperature excursions. No adverse effects reported. Co-suspect and concomitant therapies were not reported. Additional information has been requested. This is one (1) of four (4) reports from the same source.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. On 14-AUG-2012, the patient was intramuscularly vaccinated with the first dose of GARDASIL 0.5 ml (anatomical location, lot # and expiration date were not reported). On 17-NOV-2014, the patient was intramuscularly vaccinated with the second dose of GARDASIL 0.5 ml (anatomical location, lot # and expiration date were not reported). On 10-FEB-2015, the patient was intramuscularly vaccinated with the third dose of GARDASIL 0.5 ml (anatomical location, lot # and expiration date were not reported). The medical assistant reported that the patient was administered GARDASIL outside the prescribing information. No adverse effects were reported. Additional information has been requested.
Age: 0.5
Sex: M
Vaccine: DTAPIPV
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: This case was reported by a other health professional and described the occurrence of inappropriate age at vaccine administration in a 6-month-old patient who received KINRIX (batch number 99A7M, expiry date 3rd September 2016). On an unknown date, the patient received KINRIX .5 ml. On an unknown date, an unknown time after receiving KINRIX, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.
Sex: F
Vaccine: HEP
Symptoms: Incorrect route of drug administration
Clinical narrative: This case was reported by a other health professional and described the occurrence of inappropriate route of vaccination in a female patient who received ENGERIX B adult (batch number 15MN2, expiry date 2nd September 2016). On an unknown date, the patient received ENGERIX B adult (intravenous). On an unknown date, an unknown time after receiving ENGERIX B adult, the patient experienced inappropriate route of vaccination. On an unknown date, the outcome of the inappropriate route of vaccination was unknown. Additional information received: ENGERIX B 40mcg dose was administered via IV route to a patient on dialysis. No AE reported.
Age: 17.0
Sex: M
Vaccine: HPV4
Symptoms: Fatigue, Injection site hypoaesthesia
Clinical narrative: This spontaneous report was received from a medical assistant refers to a 17 year old male patient. Concurrent conditions, medical history and allergies were not reported. On an unknown date in 2014, the patient was vaccinated with the first dose of GARDASIL, (strength, dose, lot number and expiration date were not reported), route reported as "injection". It was reported that immediately following each of the two first doses of GARDASIL on an unknown dates in 2014, the patient experienced fatigue and injection site hypoaesthesia for 24 hours. The patient sought medical attention through contacted the clinic and no treatment was given for the adverse events. On an unspecified date, the patient decided to discontinue the GARDASIL series after the second dose and decided not to receive the third dose. The outcome of fatigue and injection site hypoaesthesia after each of the first two doses of GARDASIL series was reported as recovered/resolved on an unknown dates in 2014 after 24 hours. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Expired product administered
Clinical narrative: This case was reported by a nurse and described the occurrence of expired vaccine used in a 4-year-old male patient who received KINRIX (batch number AC20B225BA, expiry date 23rd November 2014).  On 4th December 2014, the patient received KINRIX. On an unknown date, an unknown time after receiving KINRIX, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.
Age: 17.0
Sex: F
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: This case reported by a pharmacist and described the occurrence of inappropriate age at vaccine administration in a 17-year-old female patient who received HAVRIX ADULT (batch number GX2LA, expiry date 7th June 2015). On an unknown date, the patient received HAVRIX ADULT. On an unknown date, an unknown time after receiving HAVRIX ADULT, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown. Additional information received: An adult dose of HAVRIX was written by an MD and administered to a 17 YO patient. This error was identified when the patient returned for their booster dose of HAVRIX.
Age: 0.39
Sex: F
Vaccine: DTAPIPV
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: This case was reported by a nurse and described the occurrence of inappropriate age of vaccine administration in a 4-month-old female patient who received KINRIX (batch number KJ924, expiry date 22nd October 2015). On 18th September 2014, the patient received KINRIX. On an unknown date, an unknown time after receiving KINRIX, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to unspecified number of patients of unknown age and unknown gender. Patients concurrent conditions and relevant medical history was not reported. On an unknown date, unspecified number of patients were vaccinated with improperly stored doses of VAQTA (lot number, dose, frequency and route unspecified) (incorrect product storage). Concomitant medications were not reported. No adverse effects (no adverse event) were reported. The outcome of the events was unknown. The causality of the events with VAQTA was not reported. Product quality issue was not involved. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to unspecified number of patients of unknown age and unknown gender. Patients concurrent conditions and relevant medical history was not reported. On an unknown date, unspecified number of patients were vaccinated with improperly stored doses of GARDASIL (lot number, dose, frequency and route unspecified) (incorrect product storage). Concomitant medications were not reported. No adverse effects (no adverse event) were reported. The outcome of the events was unknown. The causality of the events with GARDASIL was not reported. Product quality issue was not involved. This is one of the several reports from 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 a pharmacist refers to unspecified number of patients of unknown age and unknown gender. Patients concurrent conditions and relevant medical history was not reported. On an unknown date, unspecified number of patients were vaccinated with improperly stored doses of LIQUID PEDVAXHIB (lot number, dose, frequency and route unspecified). Concomitant medications were not reported. No adverse effects were reported. The outcome of the events was unknown. The causality of the events with LIQUID PEDVAXHIB was not reported. Product quality issue was not involved. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Autonomic nervous system imbalance
Clinical narrative: This spontaneous report as received from a physician refers to a non-pregnant female patient of unknown age. On an unknown date, the patient was vaccinated with GARDASIL (dose, route, anatomical location, lot # and expiration date were not reported) (3 dose series vaccine). On an unknown date, after receiving GARDASIL (dose number was unspecified), the patient experienced dysautonomia syndrome. The patient was not given a treatment for the adverse event. The patient sought unspecified medical attention. The outcome of dysautonomia syndrome was unknown. The relatedness between the event and the vaccination with GARDASIL was not provided. Additional information has been requested.
Age: 20.0
Sex: M
Vaccine: MMR
Symptoms: Autism
Clinical narrative: Information has been received from a consumer refers to his current 20 year old male grandson. No relevant history was reported. In 1995, the patient was vaccinated with M-M-R II (dose, route and lot number not provided) for vaccine. On an unknown date the patient experienced autism. The outcome of autism was unknown. This is one of several reports received from the same source. The other report is 1502USA002550. Additional information is not expected as no contact information.
Sex: F
Vaccine: HIBV
Symptoms: Abdominal pain, Upper respiratory tract infection
Clinical narrative: Information has been received from an occupational therapist referring to her daughter, a female patient of unknown age with allergic to soy and beef. The patient had no pertinent medical history. On unspecified dates the patient received three doses of LIQUID PEDVAXHIB (lot#, dose, frequency not reported, for vaccination). The therapist added that the patient also received PREVNAR concomitant with LIQUID PEDVAXHIB (also reported that there was no concomitant medication), but she was not sure how many doses of PREVNAR were administered. The therapist reported that the patient experienced severe abdominal pain and upper respiratory infection (dates unspecified) after each of three doses of LIQUID PEDVAXHIB. The abdominal pain and upper respiratory infections resolved on unknown dates without requiring medical treatment. No lab diagnostics studies were performed. The patient had sought medical attention via office visit with unspecified physician. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report has been received from a healthcare worker refers to a patient of unknown age and gender. On an unknown date, the patient was vaccinated with LIQUID PEDVAXHIB (lot# dose and route unknown). The LIQUID PEDVAXHIB was exposed to 33F for 20 days. The outcome and causality were not provided. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a healthcare worker refers to a patient of unknown age and gender. On 05-FEB-2015 the patient was vaccinated with PROQUAD (Merck) (lot # K009894, exp date 11-JAN-2016), 0.5 ml, subcutaneous. The PROQUAD was exposed to a maximum of 23 degree centigrade for 15 days. No adverse effects were reported. The outcome and causality were not provided. No PQC (Production Quality Control) was involved. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a pharmacist on 10-FEB-2015, referring to a patient of unknown age. No concurrent or historical conditions were reported. On that day the patient was inadvertently administered a dose of 0.5 ml PNEUMOVAX23 (lot # J013344, expiration date 22-JAN-2015), intramuscular (expired vaccine used). No adverse effects reported. Additional information is not expected because the reporter refused additional contact.
Sex: U
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Headache, Pain
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and unknown gender. Patient's concurrent conditions and relevant medical history was not reported. On 06-FEB-2015 the patient was vaccinated with ZOSTAVAX (lot number, dose, frequency and route of administration unspecified). Concomitant medications were not reported. On an unknown date in February 2015 the patient experienced body aches (pain) and headache which made patient to feel sick to the stomach (abdominal discomfort). The outcome of the events was reported as not recovered/not resolved. The causality of the events with ZOSTAVAX was not reported. Product quality issue was not involved. Additional information has been requested.
Age: 27.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Adverse event, Blood test, Exposure during pregnancy
Clinical narrative: This spontaneous prospective pregnancy report was received from a 27 year old female patient regarding herself. Patient's concurrent conditions and relevant medical history was not reported. Approximately on an unknown date in December 2014, the patient was vaccinated with first dose M-M-R II (dose, frequency and route unspecified) and first dose of (Oka/Merck) VARIVAX (dose, frequency and route unspecified). Concomitant medications were not reported. On 07-FEB-2015, the patient was vaccinated with second dose of (Oka/Merck) VARIVAX (dose, frequency and route unspecified). The patient reported that now she was four weeks pregnant (exposure during pregnancy). No treatment was received by the patient for the adverse event. On an unknown date, blood work was done but results were not reported. The patient sought medical attention by contacting office. The outcome of the event was unknown. The causality of the event with M-M-R II and VARIVAX was not reported. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Balance disorder, Blood iron, Disturbance in attention, Dizziness, Feeling abnormal
Clinical narrative: Headache within 30 minutes persisting for 2-3 days. Dizziness, described as "wobbly" feeling 'foggy' thinking, inability to concentrate. Reported shorter duration headache with previous doses.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Full blood count, Haematocrit decreased, Haemoglobin normal, Headache, Iron binding capacity total
Clinical narrative: Headache within 30 minutes persisting for 2-3 days. Dizziness, described as "wobbly" feeling 'foggy' thinking, inability to concentrate. Reported shorter duration headache with previous doses.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Serum ferritin
Clinical narrative: Headache within 30 minutes persisting for 2-3 days. Dizziness, described as "wobbly" feeling 'foggy' thinking, inability to concentrate. Reported shorter duration headache with previous doses.
Sex: U
Vaccine: MMRV
Symptoms: Pyrexia
Clinical narrative: Initial information has been received from a student nurse who was the patient's mother concerning a patient of unknown age and gender. On an unknown date the patient was vaccinated with a dose of PROQUAD (Merck) (injection, lot#, dose and route were unspecified). Concomitant medication was not provided. After receiving of the vaccine, the patient experienced a fever of 101 degrees (date unspecified). It was not specified which dose in the series the patient received, and due to the lack of specifics, it was not clear if the patient was eligible for subsequent doses or if subsequent doses would be discontinued. It was unspecified if patient had sought medical attention or not. The outcome of event and causality between event and therapy were unknown. Additional information is not expected as no demographics were provided for the student nurse or patient or physician.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to an unknown number of patients of unknown age and gender. Patients' concurrent conditions, concomitant medication and medical history were not provided. On unknown dates, four improperly stored doses of (Oka/Merck) VARIVAX (injection, lot#, dose, route and dose number were not provided) were administered to patients after the temperature excursion which occurred on 05-DEC-2014. No adverse events were reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to unspecified number of patients of unknown age and unknown gender. Patients concurrent conditions and relevant medical history was not reported. On an unknown date, unspecified number of patients were vaccinated with improperly stored doses of PNEUMOVAX 23 (lot number, dose, frequency and route unspecified). Concomitant medications were not reported. No adverse effects were reported. The outcome of the events was unknown. The causality of the events with PNEUMOVAX 23 was not reported. Product quality issue was not involved. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to unspecified number of patients  of unknown age and unknown gender. Patients concurrent conditions and relevant medical history was not reported. On an unknown date, unspecified number of patients were vaccinated with improperly stored doses RECOMBIVAX HB (lot number, dose, frequency and route unspecified). Concomitant medications were not reported. No adverse effects were reported. The outcome of the events was unknown. The causality of the events with RECOMBIVAX HB was not reported. Product quality issue was not involved. This is one of the several reports from the same reporter. Additional information has been requested.