chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 64.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Pyrexia
Clinical narrative: Initial unsolicited report received from a healthcare professional via other company (Pfizer) on 01 February 2016. Manufacturer report number: 2016049631. This case involves a 64-years-old male patient who was vaccinated with a dose Flu Vaccine (batch number, expiration date, dose, dose in series, route and site of administration were not reported) on an unspecified date. Medical history was not reported. Concomitant medication included Lisinopril (20 mg Tablet, 1 tablet Orally Once a day), Amlodipine Besylate (10 mg Tablet. 1 tablet Orally Once a day), Cilostazol (100 mg Tablet, 1 tablet 30 minutes before or 2 hours after breakfast and dinner orally twice a day), Trazodone HCI (50 MG Tablet, 1 tablet at bedtime as needed Orally Once a day Start Date: 03 September 2015), Saline Wound Wash Solution (Wash with saline Externally Up to three times a day), Skintegrity Wound Liquid (A spray to wound externally after patient comes home from gym), Atorvastatin Calcium (40 mg tablet, 1 tablet Orally Once a day), Fluocinonide 0.05 percentage Cream (as directed Externally twice a day Start Date: 08 July 2014), Tizanldine HCI (4 mg tablet, 1 tablet as needed Orally every 8 hours), Oxygen Liters per Minute Gas, lpm Nasal Continuous at night, Probiotic (Daily Capsule, Orally,) Centrum Silver Tablet, Orally, DiphenhydrAMINE HCI (25 mg Capsule, 1 capsule as needed Orally every 6 hours), Lactulose (10 gm/15ml Solution, 15 ml as needed Orally Once a day Start Date: 09 October 2014), Hydrocodone-Acetaminophen (10-325 mg tablet, 1 tablet as needed for severe pain Orally Twice a day Start Date: 14 October 2014), Zolpidem Tartrate (10 mg tablet, 1 tablet at bedtime as needed Orally Once a day Start Date: 09 September 2015), Alprazolam (0.25 mg tablet, 1 tablet Orally Twice a day as needed), Lyrica (100 mg Capsule, 1 capsule Orally once a day at bedtime), Metoprolol Succinate ER (50 mg tablet Extended Release 24 Hour, 1 tablet Orally Once a day Start Date: 07 January 2016), Clopidogrel Bisulfate (75 mg tablet, 1 tablet Orally Once a day),Aspirin (81 mg tablet, 1 tablet Orally Once a day). On an unspecified date, following the vaccination, the patient experienced fever. Lab data and corrective treatments were not reported. Outcome of event was not reported. List of documents held by sender: none.
Sex: U
Vaccine: PNC13, PPV, TDAP
Symptoms: Allergy to vaccine, Swelling
Clinical narrative: Initial unsolicited report received from a nurse via partner company (Pfizer) (under manufacturer report number- 2016032624) on 02 February 2016. This case involves a patient (age and gender not reported) who was vaccinated with a dose of DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE (Tdap), PNEUMOCOCCAL (POLYSACCHARIDE) (23 SEROTYPES) VACCINE (Pneumovax 23) and PNEUMOCOCCAL POLYSACCHARIDE VACCINE (Prevnar) (batch number, route and site of administration not reported) on an unspecified date. The patient's medical history and concomitant medications were not reported. On an unspecified date, following the vaccination, the patient had experienced allergy to Tdap vaccine and significant swelling. Laboratory data and corrective treatment were not reported. The outcome of event was not reported. List of documents held by sender: none.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Eyelid ptosis, Herpes zoster, Ophthalmic herpes zoster, Rash, VIIth nerve paralysis
Clinical narrative: This spontaneous report was received from a physician via company representative and refers to a 72 year old male patient. There was no information about patient's pertinent medical history, concomitant medications, drug reactions or allergies reported. In approximately 2007 (reported as 9 years ago), the patient was vaccinated with ZOSTAVAX (lot#, expiration date, anatomical location and route of administration were not reported) 0.65 ml. On an unknown date in December 2015 (reported as approximately 2 months ago), while the patient was traveling he developed a shingles rash, even though he had received ZOSTAVAX in the past. The patient saw an unspecified doctor, who gave him antiviral medication (unspecified). The patient experienced zoster of the eye and mild Bell's palsy resulting in a droopy eyelid. The adverse events had affected his eyesight, which the patient considered a significant disability/incapacity. The patient sought medical attention and visited a doctor. The outcome of the events was unknown. Upon internal review the events of a droopy eyelid was considered to be medically significant. The relatedness between the events and ZOSTAVAX was not reported. Additional information is not expected, as there was no consent for follow up.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Visual acuity reduced
Clinical narrative: This spontaneous report was received from a physician via company representative and refers to a 72 year old male patient. There was no information about patient's pertinent medical history, concomitant medications, drug reactions or allergies reported. In approximately 2007 (reported as 9 years ago), the patient was vaccinated with ZOSTAVAX (lot#, expiration date, anatomical location and route of administration were not reported) 0.65 ml. On an unknown date in December 2015 (reported as approximately 2 months ago), while the patient was traveling he developed a shingles rash, even though he had received ZOSTAVAX in the past. The patient saw an unspecified doctor, who gave him antiviral medication (unspecified). The patient experienced zoster of the eye and mild Bell's palsy resulting in a droopy eyelid. The adverse events had affected his eyesight, which the patient considered a significant disability/incapacity. The patient sought medical attention and visited a doctor. The outcome of the events was unknown. Upon internal review the events of a droopy eyelid was considered to be medically significant. The relatedness between the events and ZOSTAVAX was not reported. Additional information is not expected, as there was no consent for follow up.
Age: 25.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Adverse event, Bone disorder, Computerised tomogram, Gait disturbance, Hemiplegia
Clinical narrative: This spontaneous report as received from a patient's mother refers to an approximately 26 year old non-pregnant female patient. There were no concomitant medications, concurrent conditions and medical history reported. In February 2008, September 2008 and January 2009, the patient was vaccinated with first, second and third dose respectively of GARDASIL (route and site of administration, lot number, expiration date and indication were not reported). It was reported that the patient was hospitalized at the beginning of 2009 (reported as 20 days after receiving the third and final dose of GARDASIL). At the time of hospitalization, the doctors stated that the patient's "immune system was attacking her". It was also reported that the right side of the patient's body "had essentially been crippled". She no longer had the ability to move her right hand backwards and muscle growth along the right side of her body had ceased. There was no flexibility in the patient's right foot. In order to walk the patient had to "drag her leg" and driving was very difficult for her. The reporter also stated that the patient's symptoms have gotten worse since the original symptoms have developed. The patient's mother also reported that the patient's right ankle bone was much bigger than her left ankle, during the call she compared the right ankle to "that of 60 year old woman", she also mentioned that the patient experienced unspecified symptoms related to her condition occurring in her ribcage area. Lab diagnostic studies included bone tests on wrists and ankles, x-rays, and computerised tomography (CT) (results not provided). The patient sought medical attention via several doctors visits. The outcome of the events was reported as not recovered/not resolved at the time of the report. The reporter did not provide the relatedness, however the doctors at the hospital did not associate the patient's symptoms with the GARDASIL. The reporter considered the events as significant disability. Upon internal review the event of hemiplegia was considered as medically significant. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Immune system disorder, Impaired driving ability, Laboratory test, Mobility decreased, Muscle disorder
Clinical narrative: This spontaneous report as received from a patient's mother refers to an approximately 26 year old non-pregnant female patient. There were no concomitant medications, concurrent conditions and medical history reported. In February 2008, September 2008 and January 2009, the patient was vaccinated with first, second and third dose respectively of GARDASIL (route and site of administration, lot number, expiration date and indication were not reported). It was reported that the patient was hospitalized at the beginning of 2009 (reported as 20 days after receiving the third and final dose of GARDASIL). At the time of hospitalization, the doctors stated that the patient's "immune system was attacking her". It was also reported that the right side of the patient's body "had essentially been crippled". She no longer had the ability to move her right hand backwards and muscle growth along the right side of her body had ceased. There was no flexibility in the patient's right foot. In order to walk the patient had to "drag her leg" and driving was very difficult for her. The reporter also stated that the patient's symptoms have gotten worse since the original symptoms have developed. The patient's mother also reported that the patient's right ankle bone was much bigger than her left ankle, during the call she compared the right ankle to "that of 60 year old woman", she also mentioned that the patient experienced unspecified symptoms related to her condition occurring in her ribcage area. Lab diagnostic studies included bone tests on wrists and ankles, x-rays, and computerised tomography (CT) (results not provided). The patient sought medical attention via several doctors visits. The outcome of the events was reported as not recovered/not resolved at the time of the report. The reporter did not provide the relatedness, however the doctors at the hospital did not associate the patient's symptoms with the GARDASIL. The reporter considered the events as significant disability. Upon internal review the event of hemiplegia was considered as medically significant. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: X-ray
Clinical narrative: This spontaneous report as received from a patient's mother refers to an approximately 26 year old non-pregnant female patient. There were no concomitant medications, concurrent conditions and medical history reported. In February 2008, September 2008 and January 2009, the patient was vaccinated with first, second and third dose respectively of GARDASIL (route and site of administration, lot number, expiration date and indication were not reported). It was reported that the patient was hospitalized at the beginning of 2009 (reported as 20 days after receiving the third and final dose of GARDASIL). At the time of hospitalization, the doctors stated that the patient's "immune system was attacking her". It was also reported that the right side of the patient's body "had essentially been crippled". She no longer had the ability to move her right hand backwards and muscle growth along the right side of her body had ceased. There was no flexibility in the patient's right foot. In order to walk the patient had to "drag her leg" and driving was very difficult for her. The reporter also stated that the patient's symptoms have gotten worse since the original symptoms have developed. The patient's mother also reported that the patient's right ankle bone was much bigger than her left ankle, during the call she compared the right ankle to "that of 60 year old woman", she also mentioned that the patient experienced unspecified symptoms related to her condition occurring in her ribcage area. Lab diagnostic studies included bone tests on wrists and ankles, x-rays, and computerised tomography (CT) (results not provided). The patient sought medical attention via several doctors visits. The outcome of the events was reported as not recovered/not resolved at the time of the report. The reporter did not provide the relatedness, however the doctors at the hospital did not associate the patient's symptoms with the GARDASIL. The reporter considered the events as significant disability. Upon internal review the event of hemiplegia was considered as medically significant. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Acne, Arthralgia, Atrophy, Blood test, Computerised tomogram
Clinical narrative: This spontaneous report as received from a patient's mother refers to an approximately 26 year old non-pregnant female patient. There were no concomitant medications, concurrent conditions and medical history reported. In February 2008, September 2008 and January 2009, the patient was vaccinated with first, second and third dose respectively of GARDASIL (route and site of administration, lot number, expiration date and indication were not reported). It was reported that the patient was hospitalized at the beginning of 2009 (reported as 20 days after receiving the third and final dose of GARDASIL). At the time of hospitalization, the doctors stated that the patient's "immune system was attacking her". It was also reported that the right side of the patient's body "had essentially been crippled". She no longer had the ability to move her right hand backwards and muscle growth along the right side of her body had ceased. There was no flexibility in the patient's right foot. In order to walk the patient had to "drag her leg" and driving was very difficult for her. The reporter also stated that the patient's symptoms have gotten worse since the original symptoms have developed. The patient's mother also reported that the patient's right ankle bone was much bigger than her left ankle, during the call she compared the right ankle to "that of 60 year old woman", she also mentioned that the patient experienced unspecified symptoms related to her condition occurring in her ribcage area. Lab diagnostic studies included bone tests on wrists and ankles, x-rays, and computerised tomography (CT) (results not provided). The patient sought medical attention via several doctors visits. The outcome of the events was reported as not recovered/not resolved at the time of the report. The reporter did not provide the relatedness, however the doctors at the hospital did not associate the patient's symptoms with the GARDASIL. The reporter considered the events as significant disability. Upon internal review the event of hemiplegia was considered as medically significant. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Gait disturbance, Immune system disorder, Influenza like illness, Laboratory test, Mobility decreased
Clinical narrative: This spontaneous report as received from a patient's mother refers to an approximately 26 year old non-pregnant female patient. There were no concomitant medications, concurrent conditions and medical history reported. In February 2008, September 2008 and January 2009, the patient was vaccinated with first, second and third dose respectively of GARDASIL (route and site of administration, lot number, expiration date and indication were not reported). It was reported that the patient was hospitalized at the beginning of 2009 (reported as 20 days after receiving the third and final dose of GARDASIL). At the time of hospitalization, the doctors stated that the patient's "immune system was attacking her". It was also reported that the right side of the patient's body "had essentially been crippled". She no longer had the ability to move her right hand backwards and muscle growth along the right side of her body had ceased. There was no flexibility in the patient's right foot. In order to walk the patient had to "drag her leg" and driving was very difficult for her. The reporter also stated that the patient's symptoms have gotten worse since the original symptoms have developed. The patient's mother also reported that the patient's right ankle bone was much bigger than her left ankle, during the call she compared the right ankle to "that of 60 year old woman", she also mentioned that the patient experienced unspecified symptoms related to her condition occurring in her ribcage area. Lab diagnostic studies included bone tests on wrists and ankles, x-rays, and computerised tomography (CT) (results not provided). The patient sought medical attention via several doctors visits. The outcome of the events was reported as not recovered/not resolved at the time of the report. The reporter did not provide the relatedness, however the doctors at the hospital did not associate the patient's symptoms with the GARDASIL. The reporter considered the events as significant disability. Upon internal review the event of hemiplegia was considered as medically significant. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Pain, Quality of life decreased, Rheumatoid arthritis, Swelling, Thyroid disorder
Clinical narrative: This spontaneous report as received from a patient's mother refers to an approximately 26 year old non-pregnant female patient. There were no concomitant medications, concurrent conditions and medical history reported. In February 2008, September 2008 and January 2009, the patient was vaccinated with first, second and third dose respectively of GARDASIL (route and site of administration, lot number, expiration date and indication were not reported). It was reported that the patient was hospitalized at the beginning of 2009 (reported as 20 days after receiving the third and final dose of GARDASIL). At the time of hospitalization, the doctors stated that the patient's "immune system was attacking her". It was also reported that the right side of the patient's body "had essentially been crippled". She no longer had the ability to move her right hand backwards and muscle growth along the right side of her body had ceased. There was no flexibility in the patient's right foot. In order to walk the patient had to "drag her leg" and driving was very difficult for her. The reporter also stated that the patient's symptoms have gotten worse since the original symptoms have developed. The patient's mother also reported that the patient's right ankle bone was much bigger than her left ankle, during the call she compared the right ankle to "that of 60 year old woman", she also mentioned that the patient experienced unspecified symptoms related to her condition occurring in her ribcage area. Lab diagnostic studies included bone tests on wrists and ankles, x-rays, and computerised tomography (CT) (results not provided). The patient sought medical attention via several doctors visits. The outcome of the events was reported as not recovered/not resolved at the time of the report. The reporter did not provide the relatedness, however the doctors at the hospital did not associate the patient's symptoms with the GARDASIL. The reporter considered the events as significant disability. Upon internal review the event of hemiplegia was considered as medically significant. Additional information has been requested.
Age: 17.0
Sex: M
Vaccine: FLU4, HPV9, MENB, MNQ
Symptoms: Body temperature increased, Malaise, Nausea
Clinical narrative: Patient c/o nausea after breakfast.  Attempted to follow normal routine for school.  11AM he c/o increased nausea and not feeling well.  T=102.8.  Placed on Medical Isolation to rest in room.  Placed on clear liquid diet and.  Admin Tylenol 650mg Placed on Vital Signs and Tylenol 650mg Q 4 hours and encourage PO fluid intake.  Monitored.  2/13/16 7AM, he was afebrile and no c/o voiced.  VSS.  Returned to normal routine.
Age: 43.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Axillary mass, Dizziness, Injection site pain, Mass, Mobility decreased
Clinical narrative: Pain and tense at injection site. Now a days lump at shoulder and armpit and I am feeling very severe dizzy. I can't lift my hand because of pain and very severe tense at injection site.
Age: 43.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Pain in extremity
Clinical narrative: Pain and tense at injection site. Now a days lump at shoulder and armpit and I am feeling very severe dizzy. I can't lift my hand because of pain and very severe tense at injection site.
Age: 61.0
Sex: M
Vaccine: HEP
Symptoms: Arthralgia, Fatigue, Rash
Clinical narrative: Reports fatigue, joint pain and a blister type rash by his nose and mouth.
Age: 96.0
Sex: F
Vaccine: PNC13
Symptoms: Asthenia, Decreased appetite, Dehydration, Feeling abnormal, Hypotension
Clinical narrative: NIECE REPORTS ROUTINE VISIT TO CARDIOLOGIST 01/13/16 WITHOUT S/S.  LATER 01/13/16 BEGAN FEELING WEAK, BAD, NO APPETITE.  BY MONDAY NEXT WEEK DEVELOPED ULCERS IN MOUTH, LOW BP, DEHYDRATED.  ADMITTED TO HOSPITAL STAYED 5 DAYS. REQUIRED NURSING HOME PLACEMENT.
Age: 96.0
Sex: F
Vaccine: PNC13
Symptoms: Mouth ulceration
Clinical narrative: NIECE REPORTS ROUTINE VISIT TO CARDIOLOGIST 01/13/16 WITHOUT S/S.  LATER 01/13/16 BEGAN FEELING WEAK, BAD, NO APPETITE.  BY MONDAY NEXT WEEK DEVELOPED ULCERS IN MOUTH, LOW BP, DEHYDRATED.  ADMITTED TO HOSPITAL STAYED 5 DAYS. REQUIRED NURSING HOME PLACEMENT.
Age: 3.0
Sex: M
Vaccine: FLUX
Symptoms: Abdominal distension, Eye swelling, Nephrotic syndrome, Peripheral swelling, Swelling face
Clinical narrative: Swelling under eyes, face, feet, belly.
Age: 15.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: Arm swelled significantly and was very warm to touch and red from shoulder to elbow.
Age: 14.0
Sex: F
Vaccine: HPV9, FLU3, HEPA, HPV9
Symptoms: Dizziness, Loss of consciousness, Tremor
Clinical narrative: Light headiness, dizziness, passed out, shaking, quivering.
Age: 14.0
Sex: F
Vaccine: HPV9, FLU3, HEPA, HPV9
Symptoms: Syncope, Tonic clonic movements
Clinical narrative: Light headiness, dizziness, passed out, shaking, quivering.
Age: 53.0
Sex: F
Vaccine: TTOX
Symptoms: Allergy to vaccine
Clinical narrative: Initial unsolicited report received from a healthcare professional via other company (Pfizer) on 02 February 2016. Manufacturer Report Number: 201604309. This case involves 53-year-old female patient who was vaccinated with a dose of Tetanus toxoid (batch number, expiry date, dose, dose in series, route and site of administration were not reported) on an unknown date. The patient's medical history and concomitant medications were not reported. On an unknown date, following the vaccination, the patient had developed allergy to vaccine. The patient's laboratory data and corrective treatment were not reported. The outcome of event was not reported. List of documents held by sender: none.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Egg sized redness surrounding the injection sit, which is hot and hard and rough. 5 days after vaccination it is no better. This is the first time combined vaccine given. He usually gets separated shots (polio and DTaP as separate shots instead of Kinrix combined shot).
Age: 67.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Electrocardiogram normal, Injection site discomfort, Nuclear magnetic resonance imaging normal, Pain, Pain in extremity
Clinical narrative: Persistent discomfort in left arm at site of immunization, now almost three months after the injection.  No redness, swelling or induration.  Pain increases when the arm is used or elevated above head.
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Body temperature increased, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: Left arm sore and stiff, temperature 101 degrees.  Seen by Private Physician. Treated with Antibiotic for seven days.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Pain
Clinical narrative: Upper"L" arm soreness especially when moving or lifting arm.  No swelling or redness at injection site.
Age: 68.0
Sex: F
Vaccine: HEP, PNC13
Symptoms: Injection site bruising, Injection site induration, Injection site mass
Clinical narrative: Pt had a bruise and "hard lump" to injection site on RIGHT ARM (Pneumovax side). I assessed in clinic when she mentioned it to me on 2/1/16. On that day (13 days later) had 2cm indurated area with healing bruise of same size.
Age: 40.0
Sex: M
Vaccine: VARCEL
Symptoms: Chills, Dizziness, Injection site warmth, Pruritus, Systemic lupus erythematosus
Clinical narrative: Employee complains of dizziness, chills and itchy neck.  Assessment only reveals warmth at site of injection, temp of 98.2 and no redness at injection site.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Right thigh where the patient received Proquad and Kinrix the day before. The area appeared red, swollen, and was pruritic. Treatment with diphenhydramine as needed. Follow up closely.
Age: 79.0
Sex: F
Vaccine: PNC13
Symptoms: Induration, Nodule
Clinical narrative: A hard knot formed on her upper arm 11 days after administration of the Prevnar 13 vaccine.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash macular, Vaccination site reaction, Vaccination site warmth
Clinical narrative: The next day after receiving the shingles vaccine, she developed a red blotch on the area of the vaccine about the size of a 50-cent coin that was warm to the touch. She also developed a rash on top of her hand. She wasn't sure if that was related to the vaccine or if it was coincidental. Both resolved in about 3 days.
Age: 1.02
Sex: F
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Injection site mass, Vaccination site granuloma
Clinical narrative: Lump on leg. Suspected vaccination granuloma. Appeared approx 2 weeks post vaccination. Still present today 2/15/2016. Lump non painful, size of a quarter.
Age: 61.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Influenza like illness, Pruritus, Rash
Clinical narrative: Felt I had the flu which I thought was normal given I had the vaccine, however when I began to have small bumps on my eyebrow, chin, cheek and mouth area my first response was aged acne until I began to itch and rubbed my left side and felt a circular rash.
Age: 74.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site pain, Vaccination site swelling
Clinical narrative: Red and swollen on the upper arm where vaccination was given. The following morning the redness was as large as my fist and continued to increase in size.  The lump was very hard and extremely painful. On Sunday, 2/14/2016 I proceeded to the Urgent Care facility. I was seen be Dr. and her gave me a prescription for Bactrim DS. As of today, 2/15/16 I see very little improvement and if still not much improvement I should proceed to the ER tomorrow.
Age: 60.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site pain, Myalgia, Pyrexia
Clinical narrative: Fevers to 101 degrees F, myalgia, and local pain at the site of injection.
Sex: U
Vaccine: ANTH
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information received from a consumer on 23JAN2015. The consumer stated that on 21JAN2015 a fellow employee was administered a dose of BIOTHRAX (dose, lot, route not reported) which had expired on 20JAN2015.  No adverse events were reported. Further information not available. Sender's Comments: No adverse event reported; therefore the case is considered not assessable.
Sex: U
Vaccine: ANTH
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information received on 08MAY2015 from a health care provider. An individual of unspecified gender and age received a fourth dose of BIOTHRAX (Lot unknown) two months early.  No further information was provided. Additional information requested. Sender's Comments: Inappropriate schedule reported; no adverse event; not assessable.
Sex: F
Vaccine: ANTH
Symptoms: Condition aggravated, Eye pruritus, Fatigue, Influenza like illness, Migraine
Clinical narrative: Spontaneous report received on 21MAY2015 from a physician. An approximately 30 year old female with a history of seasonal / environmental allergies and migraines received her 3rd dose of BioThrax (Lot FAV374) in approximately JAN2015. Of note, after dose 1 and 2, she experienced a migraine which the reporter attributed to her previous "sensitivity to migraines". After the third dose of BioThrax, she again experienced a migraine, and over the course of two days, she developed flu like symptoms, muscle aches, fatigue, nasal stuffiness and itchy eyes. The symptoms subsequently resolved.
Sex: F
Vaccine: ANTH
Symptoms: Myalgia, Nasal congestion
Clinical narrative: Spontaneous report received on 21MAY2015 from a physician. An approximately 30 year old female with a history of seasonal / environmental allergies and migraines received her 3rd dose of BioThrax (Lot FAV374) in approximately JAN2015. Of note, after dose 1 and 2, she experienced a migraine which the reporter attributed to her previous "sensitivity to migraines". After the third dose of BioThrax, she again experienced a migraine, and over the course of two days, she developed flu like symptoms, muscle aches, fatigue, nasal stuffiness and itchy eyes. The symptoms subsequently resolved.
Age: 1.74
Sex: F
Vaccine: DTAPIPV, FLU4
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: No adverse event.
Age: 31.0
Sex: F
Vaccine: FLU4
Symptoms: Drug administered at inappropriate site, Mobility decreased, Musculoskeletal pain, Myalgia
Clinical narrative: I received a flu vaccine on November 17 at Employee Health and noticed that the injection site was high on my left shoulder near my joint. That evening I could hardly move my arm and since then have had shoulder pain and muscle soreness.
Age: 63.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Asthenia, Chills, Erythema, Nausea
Clinical narrative: Extreme soreness at vaccination sight, weakness, nausea, chills, eventually high fever (103) with body and joint aches.  By the 3rd day the site of the vaccination have multiple red patches and there was continued nausea and soreness in the arm.
Age: 63.0
Sex: F
Vaccine: PPV
Symptoms: Pain, Pain in extremity, Pyrexia, Vaccination site pain
Clinical narrative: Extreme soreness at vaccination sight, weakness, nausea, chills, eventually high fever (103) with body and joint aches.  By the 3rd day the site of the vaccination have multiple red patches and there was continued nausea and soreness in the arm.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site nodule
Clinical narrative: I had a knot in my arm at the injection site about the size of an egg.  Finally in December I had my primary doctor give me a cortisone shot, but it didn't help.  A follow-up appointment with a another doctor in February gave me another injection that helped much more.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Chest pain, Nausea, Vomiting
Clinical narrative: Patient complained of constant sharp pains in chest as well as nausea and vomiting.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Dysphonia, Eye pruritus, Ocular hyperaemia, Swelling face
Clinical narrative: Red itchy eyes, face swollen, throat hoarse.
Age: 23.0
Sex: M
Vaccine: FLU3
Symptoms: Arthralgia, Dizziness, Oropharyngeal pain, Pyrexia, Rash
Clinical narrative: 4 days after receiving an injection patient began to experience a sore throat which progressed into a sinus infection by the next day and lasted for 5 days. On day 6 the patient began to experience dizziness, tinnitus, fever and aching joints. The night of day 7 the fever worsened at night and then broke and disappeared over the course of the next day, along with the joint aches and dizziness. On the eighth day the patient noticed an unidentified rash on the outer pinna of both ears that has continued without abate until the present (day 11).
Age: 23.0
Sex: M
Vaccine: FLU3
Symptoms: Sinusitis, Tinnitus
Clinical narrative: 4 days after receiving an injection patient began to experience a sore throat which progressed into a sinus infection by the next day and lasted for 5 days. On day 6 the patient began to experience dizziness, tinnitus, fever and aching joints. The night of day 7 the fever worsened at night and then broke and disappeared over the course of the next day, along with the joint aches and dizziness. On the eighth day the patient noticed an unidentified rash on the outer pinna of both ears that has continued without abate until the present (day 11).
Age: 28.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Back pain, Guillain-Barre syndrome, Hypoaesthesia, Nausea
Clinical narrative: Numbness to feet that traveled to arms nausea weakness back pain  hospitalization with diagnosis of Guillain Barre syndrome.
Age: 12.0
Sex: M
Vaccine: FLUX, HPVX, PPV, FLUX, HPVX, PPV
Symptoms: Injection site pruritus, Injection site urticaria
Clinical narrative: Hives and itching at injection site and elsewhere on body. Diphenhydramine oral administered for 1 week since. Symptoms persist, mildly, 1 week later.
Age: 12.0
Sex: M
Vaccine: FLUX, HPVX, PPV, FLUX, HPVX, PPV
Symptoms: Injection site pruritus, Injection site urticaria, Pruritus, Urticaria
Clinical narrative: Hives and itching at injection site and elsewhere on body. Diphenhydramine oral administered for 1 week since. Symptoms persist, mildly, 1 week later.
Age: 0.26
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Urticaria
Clinical narrative: Per mom hives on chest, itching. No coughing, wheezing or swelling of her face. Resolved after 2.5 ml of BENADRYL. "Hives were gone in 2 minutes after BENADRYL."
Age: 17.0
Sex: F
Vaccine: FLU3, HEPA, HPV9, MNQ, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Left arm was swollen, red, and painful at the site varicella vaccine was administered. Patient was instructed to take ibuprofen for pain and use an ice pack at the site for swelling and irritation.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLUN4, MMRV
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Erythema and induration at site of PROQUAD injection. Measured approx 3 cms in dia.
Age: 16.0
Sex: M
Vaccine: FLU3
Symptoms: Anxiety, Blood iron decreased, Computerised tomogram abnormal, Electroencephalogram abnormal, Hypoaesthesia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of iron decreased in a 16-year-old male patient who received FLUARIX. Previously experienced adverse reactions included tremor, nausea, anxiety, numbness and tingling (after receiving FLUARIX vaccine in Oct 2014, refers case US2016018245). Previously administered products included Flu vaccine (non-GSK vaccine received prior to 2014 without experiencing any adverse events). Concurrent medical conditions included esophageal acid reflux and pineal gland cyst (since birth). Concomitant products included MENINGITIS VACCINE, omeprazole and vitamin D nos. In October 2015, the patient received FLUARIX (intramuscular). In November 2015, 30 days after receiving FLUARIX, the patient experienced nausea, anxiety, numbness of extremities, tingling feet/hands and panic attack. On an unknown date, the patient experienced iron decreased. The patient was treated with iron. In December 2015, the outcome of the nausea, anxiety, numbness of extremities, tingling feet/hands and panic attack were recovered/resolved. On an unknown date, the outcome of the iron decreased was not recovered/not resolved. It was unknown if the reporter considered the iron decreased, nausea, anxiety, numbness of extremities, tingling feet/hands and panic attack were recovered/resolved. On an unknown date, the outcome of the iron decreased was not recovered/not resolved. It was unknown if the reporter considered the iron decreased, nausea, anxiety, numbness of extremities, tingling feet/hands and panic attack to be related to FLUARIX. Additional details were provided as follows: This case was previously reported to a doctor. This case was reported by the patient's grandmother. In 2015, the patient also had  meningitis vaccine along with flu vaccine, but the reporter thought the patient only had flu vaccine in 2014. The reporter did not know which GLAXOSMITHKLINE flu vaccine the patient received. In November 2015, approximately 1 month after receiving the vaccine, the patient experienced nausea, anxiety, numbness and tingling in hands and feet, and panic attack (same symptoms occurred after vaccinated in October 2014 except the tremors). The patient had a total of 2 panic attacks that required a visit to the emergency room (ER) between November 2015 and December 2015. The patient sometimes had more minor symptoms that subsided without medical attention. This year the symptoms were more concentrated on the patient's right side. In 2015, the patient underwent laboratory test such as Magnetic Resonance Imaging (MRI), Electroencephalogram (EEG) and Computerized tomogram (CT), but all that was found was a cyst on the patient's pineal gland that was thought to be benign and something he was born with. Since December 2015, the patient did not experience any event. At the time of reporting, the patient had started having low iron levels.
Age: 16.0
Sex: M
Vaccine: FLU3
Symptoms: Nausea, Nuclear magnetic resonance imaging abnormal, Panic attack, Paraesthesia, Pineal gland cyst
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of iron decreased in a 16-year-old male patient who received FLUARIX. Previously experienced adverse reactions included tremor, nausea, anxiety, numbness and tingling (after receiving FLUARIX vaccine in Oct 2014, refers case US2016018245). Previously administered products included Flu vaccine (non-GSK vaccine received prior to 2014 without experiencing any adverse events). Concurrent medical conditions included esophageal acid reflux and pineal gland cyst (since birth). Concomitant products included MENINGITIS VACCINE, omeprazole and vitamin D nos. In October 2015, the patient received FLUARIX (intramuscular). In November 2015, 30 days after receiving FLUARIX, the patient experienced nausea, anxiety, numbness of extremities, tingling feet/hands and panic attack. On an unknown date, the patient experienced iron decreased. The patient was treated with iron. In December 2015, the outcome of the nausea, anxiety, numbness of extremities, tingling feet/hands and panic attack were recovered/resolved. On an unknown date, the outcome of the iron decreased was not recovered/not resolved. It was unknown if the reporter considered the iron decreased, nausea, anxiety, numbness of extremities, tingling feet/hands and panic attack were recovered/resolved. On an unknown date, the outcome of the iron decreased was not recovered/not resolved. It was unknown if the reporter considered the iron decreased, nausea, anxiety, numbness of extremities, tingling feet/hands and panic attack to be related to FLUARIX. Additional details were provided as follows: This case was previously reported to a doctor. This case was reported by the patient's grandmother. In 2015, the patient also had  meningitis vaccine along with flu vaccine, but the reporter thought the patient only had flu vaccine in 2014. The reporter did not know which GLAXOSMITHKLINE flu vaccine the patient received. In November 2015, approximately 1 month after receiving the vaccine, the patient experienced nausea, anxiety, numbness and tingling in hands and feet, and panic attack (same symptoms occurred after vaccinated in October 2014 except the tremors). The patient had a total of 2 panic attacks that required a visit to the emergency room (ER) between November 2015 and December 2015. The patient sometimes had more minor symptoms that subsided without medical attention. This year the symptoms were more concentrated on the patient's right side. In 2015, the patient underwent laboratory test such as Magnetic Resonance Imaging (MRI), Electroencephalogram (EEG) and Computerized tomogram (CT), but all that was found was a cyst on the patient's pineal gland that was thought to be benign and something he was born with. Since December 2015, the patient did not experience any event. At the time of reporting, the patient had started having low iron levels.
Age: 15.0
Sex: M
Vaccine: FLU3
Symptoms: Anxiety, Hypoaesthesia, Nausea, Panic attack, Paraesthesia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of tremor in a 15-year-old male patient who received FLUARIX. Concurrent medical conditions included esophageal acid reflux. Concomitant products included omeprazole and Vitamin D. In October 2014, the patient received FLUARIX (intramuscular). In November 2014, 30 days after receiving FLUARIX, the patient experienced tremor (serious criteria hospitalization), nausea (serious criteria hospitalization), anxiety (serious criteria hospitalization), numbness of extremities (serious criteria hospitalization), tingling feet/hands (serious criteria hospitalization) and panic attack (serious criteria hospitalization). In January 2015, the outcome of the tremor, nausea, anxiety, numbness of extremities, tingling feet/hands and panic attack were recovered/resolved. It was unknown if the reporter considered the tremor, nausea, anxiety, numbness of extremities, tingling feet/hands and panic attack to be related to FLUARIX. Additional details were provided as follows: This case was previously reported to a doctor. This case was reported by the patient's grandmother. The reporter did not know which GSK flu vaccine the patient received. Three times between November 2014 and December 2014, the patient had a sudden onset of tremors, numbness and tingling in hands and feet, and severe nausea. He visited emergency room (ER) each time and at least once was kept under observation for 2 days. It was believed that the patient experienced panic attacks, but the reporter thought he was only anxious because he did not understand what had happened to him. The symptoms subsided between panic attacks before suddenly coming back out of the blue. The patient was fine between January 2015 to October 2015. For tolerance to vaccination received in October 2015, refer case US2016GSK020967.
Age: 15.0
Sex: M
Vaccine: FLU3
Symptoms: Tremor
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of tremor in a 15-year-old male patient who received FLUARIX. Concurrent medical conditions included esophageal acid reflux. Concomitant products included omeprazole and Vitamin D. In October 2014, the patient received FLUARIX (intramuscular). In November 2014, 30 days after receiving FLUARIX, the patient experienced tremor (serious criteria hospitalization), nausea (serious criteria hospitalization), anxiety (serious criteria hospitalization), numbness of extremities (serious criteria hospitalization), tingling feet/hands (serious criteria hospitalization) and panic attack (serious criteria hospitalization). In January 2015, the outcome of the tremor, nausea, anxiety, numbness of extremities, tingling feet/hands and panic attack were recovered/resolved. It was unknown if the reporter considered the tremor, nausea, anxiety, numbness of extremities, tingling feet/hands and panic attack to be related to FLUARIX. Additional details were provided as follows: This case was previously reported to a doctor. This case was reported by the patient's grandmother. The reporter did not know which GSK flu vaccine the patient received. Three times between November 2014 and December 2014, the patient had a sudden onset of tremors, numbness and tingling in hands and feet, and severe nausea. He visited emergency room (ER) each time and at least once was kept under observation for 2 days. It was believed that the patient experienced panic attacks, but the reporter thought he was only anxious because he did not understand what had happened to him. The symptoms subsided between panic attacks before suddenly coming back out of the blue. The patient was fine between January 2015 to October 2015. For tolerance to vaccination received in October 2015, refer case US2016GSK020967.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash generalised
Clinical narrative: Rash over all her body/BENADRYL.
Age: 6.0
Sex: F
Vaccine: DTAP, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Mild swelling, redness, left deltoid.
Age: 71.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site cellulitis, Injection site erythema, Injection site swelling
Clinical narrative: Pt developed red raised area on arm where vaccinated. Pt went to urgent care and received cephalexin Rx for cellulitis.
Age: 76.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Itchy redness surrounding injection site and spreading down arm. Pt states no treatment. Pt states sx started 24 hr after injection.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to unspecified patients of unknown age and gender. On unknown dates the patients were vaccinated with doses of improperly stored VAQTA (lot # L03600 with expiration date of 04-NOV-2016, lot# reported as L045713 with expiration date of 14-JAN-2017, dose, strength and route unknown). The VAQTA were stored at 9.9 Celsius degree for 1 hours and 23 minutes. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Certified Medical Assistant referring to unspecified number of unspecified patients. Patients' medical history and concurrent conditions were not reported. On an unknown date, the patients were vaccinated with improperly stored ROTATEQ lot # L013193 and expiry date 20-JAN-2017, oral (strength, dose and frequency were not reported). Concomitant medications were not provided. No adverse effects were reported and no product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from two Licensed Vocational Nurses (L.V.N.) referring to an unspecified number of patients of unknown age and gender. Pertinent medical history and drug reactions/allergies were not reported. Since 27-JAN-2016 the patients were vaccinated with improperly stored M-M-R II (lot # L020189, expiration date: 03-JUN-2017; lot # L024265, expiration date 01-JUL-2017; lot # L028274, expiration date 28-JUL-2017; lot # L027591, expiration date 23-JUL-2017; route and dose were not reported). The vaccines were exposed to 47.8 for 1 hours and 5 minutes with previous temperature excursion of 27.5 for 1 hour 20 minutes. No adverse event had been reported. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from two Licensed Vocational Nurses (L.V.N.) referring to an unspecified number of patients of unknown age and gender. Pertinent medical history and drug reactions/allergies were not reported. Since 27-JAN-2016 the patients were vaccinated with improperly stored PNEUMOVAX 23 (lot # L019836, expiration date: 24-MAR-2017; lot # L029306, expiration date 26-MAR-2017; lot # L019836, expiration date 24-MAR-2017, route and dose were not reported). The vaccine were exposed to 47.8 F for 1 hour and 5 minutes with previous temperature excursion of 27. 5 F for 1 hour 20 minutes. No adverse event had been reported. This is one of the several reports from the same reporter. Additional information has been requested.