chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 12.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Dizziness, Immediate post-injection reaction, Nausea, Syncope
Clinical narrative: Pt received three vaccines during his office visit. Immediately after the third vaccine administration, the pt fainted. Pt awoke post arousal. He complained of nausea and dizziness which resolved in the office. Upon leaving the office, pt reported no adverse symptoms.
Age: 18.0
Sex: F
Vaccine: HPV9
Symptoms: Maternal exposure before pregnancy, Ultrasound antenatal screen
Clinical narrative: This spontaneous prospective pregnancy report was received from a Registered Nurse (RN) referring to an 18 year old female patient with no concurrent conditions. The patient's medical history included leukaemia. On 05-JUL-2017 and 05-SEP-2017, the patient was vaccinated with the first and second doses, respectively, of GARDASIL 9 lot number M035486 (expiration date of 05-JUN-2019) for prophylaxis (strength, dose, and route of administration were not provided). There was no information on concomitant medications. On an unspecified day in 2017, the patient became pregnant (confirmed by a positive ultrasound test performed on 21-SEP-2017). The patient's last menstrual period (LMP) was reported as on 25-SEP-2017. The patient's estimated delivery date (EDD) was on 04-JUL-2018. Neither the pregnancy outcome nor the fetal outcome were known at the time of the report. The therapy was taken before the patient became pregnant.
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Laceration, Product container issue
Clinical narrative: Initial unsolicited report received from a Nurse on 16-Jan-2018. This case involves a female patient (age not reported) who was removing cap from DTaP component (batch number: C5230AA) vial of PENTACEL (batch number: C5420AA and expiry date was not reported) and the top of the vial broke off at the neck. The patient's medical history and concomitant medications were not reported. On an unknown date, during vaccination, the patient was sustained a small laceration to her right thumb when top of vial broke off. It was also a case of product container issue. Relevant lab investigation was not reported. Laceration was covered with Band-Aid as corrective treatment. The patient was recovered from the event (lasted for couple days). List of documents held by sender: none.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Abdominal X-ray, Haematochezia, Incarcerated inguinal hernia, Intussusception
Clinical narrative: Child received the rotavirus vaccine and the next day was admitted to hospital with intususeption. Intususeption resolved spontaneously. Surgeon felt the obstruction was the result of incarcerated right inguinal hernia in a premature infant. I was concerned about the association of the intususeption and the administration of the rotavirus vaccine
Age: 62.0
Sex: F
Vaccine: FLU4
Symptoms: Rash
Clinical narrative: Rash all over back and sides.
Age: 0.5
Sex: M
Vaccine: HIBV
Symptoms: Asthenia, Crying, Decreased appetite, Dyspnoea, Immediate post-injection reaction
Clinical narrative: Rush, trouble breathing, body week as if air has been sucked out of his body. At night crying for all night, fever, lost of appetite.
Age: 0.5
Sex: M
Vaccine: HIBV
Symptoms: Pyrexia, Rash, Slow response to stimuli
Clinical narrative: Rush, trouble breathing, body week as if air has been sucked out of his body. At night crying for all night, fever, lost of appetite.
Age: 46.0
Sex: F
Vaccine: FLUC4, FLUC4
Symptoms: Arthralgia, Heart rate increased
Clinical narrative: Fast heartbeat - same day. Aching joints - next day.
Age: 46.0
Sex: F
Vaccine: FLUC4, FLUC4
Symptoms: Arthralgia, Heart rate increased, Neck pain
Clinical narrative: Fast heartbeat - same day. Aching joints - next day.
Age: 12.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site pain, Injection site reaction, Rash erythematous
Clinical narrative: Pt developed red rash and tenderness to injection site. Relieved by benadryl. Advised to call back with new/worsening symptoms.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Rash, Rash papular
Clinical narrative: Pt developed popular rash to anterior chest, posterior neck and behind ears bilaterally about 4 hours after the injection. She had no other symptoms.
Age: 10.0
Sex: F
Vaccine: FLUC4
Symptoms: Dizziness, Fall, Loss of consciousness
Clinical narrative: Patient passed out after vaccination. She fell and hit her head on a padded chair, so there was no evident injury. No symptoms other than the "dizziness" she described immediately to falling down. She was alert immediately afterward.
Age: 21.0
Sex: F
Vaccine: HEP
Symptoms: Injection site erythema, Injection site pain, Rash
Clinical narrative: EMPLOYEE STATED THAT THE NEXT DAY, 21DEC2017, THE SITE WAS TENDER, SORE AND HAD REDNESS. THEN 2-3 DAYS AFTER THE INJECTION SHE DEVELOPED A RASH ON HER UPPER BODY THAT TOOK ABOUT A WEEK TO RESOLVE.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Alopecia, Anaemia, Full blood count normal, Menorrhagia, Thyroid function test normal
Clinical narrative: The student was vaccinated 7 months ago. The reaction is just being reported to staff now because she is due for her second dose. Mother works where clinic was held last June. Mother reports that 3-4 days post vaccination with first dose of HPV9 (Gardasil), patient started with diffuse hair loss that began  as "not clumps, just diffuse spots". Patient complained to mom but was not worried about it because she has thick hair. Mother then noticed hair brush full of hair which lasted a few weeks. Took her to pediatrician a few weeks later and doctor did not associate hair loss with HPV vaccination, just cyclical shedding/coincidence. Doctor ordered some blood work, which came back normal. Hair loss has stopped but has subsequently been experiencing prolonged menses which were normal prior to this. This has caused anemia for which she is being treated for since November 2017.
Age: 6.0
Sex: F
Vaccine: TDAP
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Patient was administered Tdap instead of Dtap and is 6 years old. Patient did not have any adverse reaction.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Borrelia test positive, Cardiac disorder, Endometriosis, Irritable bowel syndrome, Laboratory test abnormal
Clinical narrative: I first developed heart problems and seizures, then horrible digestion problems, chronic neurological Lyme disease, PCOS, and Endometriosis all after receiving this vaccine. I had no previous food allergies or medical conditions.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Lyme disease, Polycystic ovaries, Seizure
Clinical narrative: I first developed heart problems and seizures, then horrible digestion problems, chronic neurological Lyme disease, PCOS, and Endometriosis all after receiving this vaccine. I had no previous food allergies or medical conditions.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site mass, Injection site pain, Injection site swelling
Clinical narrative: Pain and swelling at site. Swelling was unusally large. Patient described it over phone to the Pharmacy that she had a lump the size of small ball.
Age: 37.0
Sex: M
Vaccine: HEPA
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Patient was given his first Hepatitis A dose on 10/05/17. He was administered his second dose on 1/22/17. No known adverse event.
Age: 60.0
Sex: F
Vaccine: HEP
Symptoms: Back pain, Balance disorder, Dizziness, Headache, Hypoaesthesia
Clinical narrative: Patient Received Hep B dose #2 on 10/26/17. She had dose #1 on 9/20/17 with no adverse reaction.  she sent agency an email on 11/3/17 stating she was having side effects that were "most notable 10/30-11/2" and is now starting to feel better. Her symptoms included dizziness, light headed when getting up from lying or seated position suddenly, headache, itching of hands and feet, runny nose, back pain and stiffness in neck and shoulder. She described it as "off balance, feeling hung over".  She also had numbness on bottoms of feet and described having to hold onto the bedside table for fear of falling. Staff responded to her email that these were normal side effects. Followed up with patient on 1/12/18 and she states she is still experiencing slight dizziness, lightheaded when getting out of bed/off balance. All other symptoms are gone except back stiffness and stated she has been seeing a chiropractor for that since before vaccination. She has not sought medical treatment for these ongoing symptoms yet, but has an appointment scheduled for 3/1/18 with her PCP.
Age: 60.0
Sex: F
Vaccine: HEP
Symptoms: Musculoskeletal stiffness, Pruritus, Rhinorrhoea
Clinical narrative: Patient Received Hep B dose #2 on 10/26/17. She had dose #1 on 9/20/17 with no adverse reaction.  she sent agency an email on 11/3/17 stating she was having side effects that were "most notable 10/30-11/2" and is now starting to feel better. Her symptoms included dizziness, light headed when getting up from lying or seated position suddenly, headache, itching of hands and feet, runny nose, back pain and stiffness in neck and shoulder. She described it as "off balance, feeling hung over".  She also had numbness on bottoms of feet and described having to hold onto the bedside table for fear of falling. Staff responded to her email that these were normal side effects. Followed up with patient on 1/12/18 and she states she is still experiencing slight dizziness, lightheaded when getting out of bed/off balance. All other symptoms are gone except back stiffness and stated she has been seeing a chiropractor for that since before vaccination. She has not sought medical treatment for these ongoing symptoms yet, but has an appointment scheduled for 3/1/18 with her PCP.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain in extremity
Clinical narrative: PATIENT EXPERIENCE PAIN IN ARM-STILL CAUSING PAIN 3 WEEKS LATER. AT 2 WEEKS SHE DEVELOPED SHINGLES IN THE PUBIC AREA. SHE HAS HAD SHINGLES BEFORE.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU4, MMRV
Symptoms: Erythema, Peripheral swelling, Pruritus
Clinical narrative: Mom called us to report that child had both feet swollen and red from the toes to above the ankles. Child also complained of his feet itching. This was on 01-11-2018. This nurse suggested BENADRYL and TYLENOL. The morning of 01-12-2018, the swelling was down and the redness was decreased. The itching went away with one dose of BENADRYL.
Age: 1.42
Sex: M
Vaccine: DTAP, HEP, MMR, RV1
Symptoms: Abnormal behaviour, Aphasia, Decreased eye contact, Diarrhoea, Emotional poverty
Clinical narrative: A few hours after we got home, patient spiked a fever. It went up to 104 at one point. Once the fever broke he lost all eye contact, stopped talking, started banging his head on things, started screeching so loud it would make your ears ring, had terrible diarrhea daily, lined up toys instead of playing with them, and just lost all emotion. We have had him in speech therapy, occupational therapy, a special teacher all once a week. He goes to the chiropractor twice a week. Weve tried many many other remedies as well. Vitamins, b12 shots, etc. He is coming around a little bit. But not as much as we had hoped.
Age: 1.42
Sex: M
Vaccine: DTAP, HEP, MMR, RV1
Symptoms: Head banging, Pyrexia
Clinical narrative: A few hours after we got home, patient spiked a fever. It went up to 104 at one point. Once the fever broke he lost all eye contact, stopped talking, started banging his head on things, started screeching so loud it would make your ears ring, had terrible diarrhea daily, lined up toys instead of playing with them, and just lost all emotion. We have had him in speech therapy, occupational therapy, a special teacher all once a week. He goes to the chiropractor twice a week. Weve tried many many other remedies as well. Vitamins, b12 shots, etc. He is coming around a little bit. But not as much as we had hoped.
Age: 84.0
Sex: M
Vaccine: PPV
Symptoms: Fall, Injected limb mobility decreased, Injection site pain, Loss of consciousness, Syncope
Clinical narrative: 84 Y/O male received one vaccine IM injection into Left deltoid muscle at 1 PM on 1/27/18 and the following signs and symptoms occurred: Initial soreness at injection site associated with reduced range of motion in raising Left arm from 180 degrees or full elevation to less than 30 degrees over 4 hour period. This was followed by a syncopal episode at 5 PM where upon patient collapsed to floor of bathroom. There was no head trauma. Immediately prior to episode no chest pain, SOB. Period of unresponsiveness approx 4 minutes. Shortly thereafter had second unwitnessed LOC and tumble into bathtub. Again denies no head trauma. Report had recent PMD exam. No health problem IE elevated BP, EKG problems, CNS trouble. Visited private provider and scheduled for vein surgery next month. Patient's concern was reduced ROM and Syncopal episodes and possible relationship to vaccine.
Age: 84.0
Sex: M
Vaccine: PPV
Symptoms: Unresponsive to stimuli
Clinical narrative: 84 Y/O male received one vaccine IM injection into Left deltoid muscle at 1 PM on 1/27/18 and the following signs and symptoms occurred: Initial soreness at injection site associated with reduced range of motion in raising Left arm from 180 degrees or full elevation to less than 30 degrees over 4 hour period. This was followed by a syncopal episode at 5 PM where upon patient collapsed to floor of bathroom. There was no head trauma. Immediately prior to episode no chest pain, SOB. Period of unresponsiveness approx 4 minutes. Shortly thereafter had second unwitnessed LOC and tumble into bathtub. Again denies no head trauma. Report had recent PMD exam. No health problem IE elevated BP, EKG problems, CNS trouble. Visited private provider and scheduled for vein surgery next month. Patient's concern was reduced ROM and Syncopal episodes and possible relationship to vaccine.
Age: 62.0
Sex: M
Vaccine: PPV, VARZOS
Symptoms: Erythema, Pruritus, Skin warm, Tremor, Urticaria
Clinical narrative: SHINGRIX admin 1030AM; patient experienced hives, red and itchy skin, warmth and redness all over, shaking. S/S developed approximately 2PM.
Age: 4.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Rash, Rash pruritic, Urticaria
Clinical narrative: Rash - hive-like to bilateral arms and legs. Described as pink streaks, rash itches.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Diarrhoea, Vomiting
Clinical narrative: Vomiting 1 day after Rotavirus , diarrhea 2 days after Rotavirus.
Age: 58.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Extensive swelling of vaccinated limb, Heart rate increased, Injection site erythema, Injection site warmth, Local reaction
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 58-year-old female patient who received SHINGRIX (batch number 9XC39, expiry date 30th January 2020). Concomitant products included FLUZONE QUADRIVALENT. On 16th January 2018, the patient received the 1st dose of SHINGRIX. In January 2018, less than a week after receiving SHINGRIX, the patient experienced extensive swelling of vaccinated limb (serious criteria hospitalization), injection site erythema (serious criteria hospitalization), injection site warmth (serious criteria hospitalization) and heart rate increased (serious criteria hospitalization). In January 2018, the outcome of the extensive swelling of vaccinated limb, injection site erythema, injection site warmth and heart rate increased were recovered/resolved. It was unknown if the reporter considered the extensive swelling of vaccinated limb, injection site erythema, injection site warmth and heart rate increased to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on left arm and FLUZONE on right arm. The healthcare professional (HCP) reported that, the patient developed a localized reaction of a red, swollen area about 4 by 5 inches in diameter, which was hot or warm to the touch, after receiving SHINGRIX. The patient also developed increased heart rate which resulted in hospitalization for one day and the patient received treatment to lower the heart rate. No further information was reported regarding the event.
Age: 59.0
Sex: F
Vaccine: FLUC4
Symptoms: Discomfort, Injection site pain
Clinical narrative: Patient describes pain at injection and after. Prolonged discomfort has continued for approximately 6 days now.
Age: 72.0
Sex: U
Vaccine: PPV
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Whole upper arm is red. Some part of the arm blew up like a big bubble and it moves down below elbow.
Age: 13.0
Sex: M
Vaccine: FLU3
Symptoms: Dizziness, Pallor, Syncope
Clinical narrative: Patient fainted shortly after leaving immunization room. Told his mom he felt dizzy. I brought him back into immunization room, gave him some water to drink and a couple pieces of chocolate to eat. Was very pale but regained his color and wasn't dizzy after resting for about 10-15 minutes.
Sex: F
Vaccine: HPV4
Symptoms: Autoantibody positive
Clinical narrative: Positive for the G-protein coupled autoantibodies (ß2 adrenergic and M2 muscarinic); This spontaneous report was received from the physician refers to female patients of unknown age. Patient's concurrent conditions, medical history and historical conditions were not reported.   On an unknown date, patients were vaccinated with quadrivalent human papillomavirus (types 6, 11, 16, 18) recomb. Vaccine (GARDASIL) (dose, units and frequency not reported) (lot # and expiry date not reported). It was reported that, all female patients were presented with similar symptoms and preliminarily tested positive for the G-protein coupled autoantibodies (ß2 adrenergic and M2 muscarinic) after  quadrivalent human papillomavirus (types 6, 11, 16, 18) recomb. Vaccine (GARDASIL) vaccination. The outcome of the event was not reported. The causal assessment for the event positive for the G-protein coupled autoantibodies (ß2 adrenergic and M2 muscarinic) was not provided.  This is one of three reports from the same reporter. ; Sender's Comments:  US-009507513-1712USA008588: US-009507513-1801USA013305:
Sex: M
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: Case number PHHY2017US022326, is an initial spontaneous report received from a consumer (patient) via social media via Vaccine Adverse Events Reporting System (VAERS reference number: 660249) on 23 Jan 2017. This report refers to a male patient of an unknown age. Medical history was not reported. In the vaccination history it was reported that, every time the patient took the influenza virus vaccine (unknown whether pandemic or seasonal (manufacturer unknown), batch number: not reported) he got sick (see case PHHY2017US022380). Concomitant medication was not reported. The patient was vaccinated with seasonal influenza vaccine (manufacturer unknown, batch number: not reported) on an unknown date. On an unknown date after vaccination, the patient got sick. Patient's lab data and corrective treatment was not reported. The outcome of the event was not reported. The seriousness of the event was reported as non serious and causality was not reported.
Sex: M
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: Case number PHHY2017US022661, is an initial spontaneous report received from a consumer via social media via Vaccine Adverse Event Reporting System (VAERS reference number: 660563) website on 23 Jan 2017. This report refers to a male patient of an unknown age. Medical history was not reported. Concomitant medication was not reported. He was vaccinated with seasonal influenza vaccine (manufacturer unknown, batch number not reported) on an unknown date. On an unspecified date, following the vaccination, the patient got sick. Laboratory data and corrective treatment was not reported. The outcome of event was complete recovery on an unknown date. The seriousness and causality of the event were not reported.
Sex: F
Vaccine: FLUX, HPV9
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Case number PHHY2017US017993, is an initial spontaneous report received from registered nurse via Vaccine Adverse Events Reporting System (VAERS reference number: 667047) on 23 Jan 2017. This report refers to 29 years old pregnant female patient. The patient did not have any pertinent disease history. Historical medication included PRENATE PIXIE therapy which was started on 07 May 2016. Current condition included allergy to CECLOR. Concomitant medication was not reported. The patient was pregnant with last menstrual period (LMP) 11 Apr 2016 and estimated date of delivery (EDD) was 16 Jan 2017. The patient at gestation age of 27 weeks and 01 day was vaccinated with seasonal influenza vaccine (manufacturer unknown, batch number: not reported) and GARDASIL 9 (other manufacturer (batch number: M021407, expiry date: 30 Apr 2018) on 19 Oct 2016. Pregnancy outcome was reported as pending and the fetal outcome was reported as unknown. No adverse reaction reported following this vaccine exposure during pregnancy. The seriousness of vaccine exposure during pregnancy was reported as non serious. The case was lost to follow up at the time of case processing.
Sex: F
Vaccine: PPV, PPV
Symptoms: Emotional distress, Infection, Injection site pain, Joint fluid drainage, Musculoskeletal pain
Clinical narrative: This initial spontaneous report was received from a female patient of unknown age referring to herself.  Concurrent conditions included rheumatoid arthritis and sensitivity to aluminum in deodorants (was treated with steroids on an unspecified date). Concomitant medications were not provided. On an unspecified date, the patient was vaccinated with PNEUMOVAX 23 (lot number and expiration unknown). One hour afterwards, her entire arm and the front of her shoulder became very painful and progressed from there. She stated "I couldn't touch it, couldn't leave it dangling, couldn't raise it or move it." On an unspecified date, she went to the hospital in the middle of the night, and was referred from the Emergency Room to an Orthopedist. On an unspecified date, the Orthopedist "drained fluid from my arm." On an unspecified date, another physician "drained fluid from my arm completely." The patient reported that on an unspecified date, "the physicians looked to see if there was an infection."  She added that the pain left her unable to sleep. The patient stated that "my Rheumatologist told me it might be Asia Syndrome." On unspecified dates, she was doing "occupational therapy for 2 months" she was "still hurting." The outcome of the events were not recovered. Causality assessment was not specified. The patient requested "compensation for pain and suffering." Upon internal review, arm pain, shoulder pain and movement disorder requiring joint fluid drainage and autoimmune disorder were considered medically significant. The patient did not provide consent to follow-up with her healthcare provider.
Sex: F
Vaccine: PPV, PPV
Symptoms: Insomnia, Joint fluid drainage, Mobility decreased, Musculoskeletal pain, Pain in extremity
Clinical narrative: This initial spontaneous report was received from a female patient of unknown age referring to herself.  Concurrent conditions included rheumatoid arthritis and sensitivity to aluminum in deodorants (was treated with steroids on an unspecified date). Concomitant medications were not provided. On an unspecified date, the patient was vaccinated with PNEUMOVAX 23 (lot number and expiration unknown). One hour afterwards, her entire arm and the front of her shoulder became very painful and progressed from there. She stated "I couldn't touch it, couldn't leave it dangling, couldn't raise it or move it." On an unspecified date, she went to the hospital in the middle of the night, and was referred from the Emergency Room to an Orthopedist. On an unspecified date, the Orthopedist "drained fluid from my arm." On an unspecified date, another physician "drained fluid from my arm completely." The patient reported that on an unspecified date, "the physicians looked to see if there was an infection."  She added that the pain left her unable to sleep. The patient stated that "my Rheumatologist told me it might be Asia Syndrome." On unspecified dates, she was doing "occupational therapy for 2 months" she was "still hurting." The outcome of the events were not recovered. Causality assessment was not specified. The patient requested "compensation for pain and suffering." Upon internal review, arm pain, shoulder pain and movement disorder requiring joint fluid drainage and autoimmune disorder were considered medically significant. The patient did not provide consent to follow-up with her healthcare provider.
Sex: F
Vaccine: PPV, PPV
Symptoms: Tenderness
Clinical narrative: This initial spontaneous report was received from a female patient of unknown age referring to herself.  Concurrent conditions included rheumatoid arthritis and sensitivity to aluminum in deodorants (was treated with steroids on an unspecified date). Concomitant medications were not provided. On an unspecified date, the patient was vaccinated with PNEUMOVAX 23 (lot number and expiration unknown). One hour afterwards, her entire arm and the front of her shoulder became very painful and progressed from there. She stated "I couldn't touch it, couldn't leave it dangling, couldn't raise it or move it." On an unspecified date, she went to the hospital in the middle of the night, and was referred from the Emergency Room to an Orthopedist. On an unspecified date, the Orthopedist "drained fluid from my arm." On an unspecified date, another physician "drained fluid from my arm completely." The patient reported that on an unspecified date, "the physicians looked to see if there was an infection."  She added that the pain left her unable to sleep. The patient stated that "my Rheumatologist told me it might be Asia Syndrome." On unspecified dates, she was doing "occupational therapy for 2 months" she was "still hurting." The outcome of the events were not recovered. Causality assessment was not specified. The patient requested "compensation for pain and suffering." Upon internal review, arm pain, shoulder pain and movement disorder requiring joint fluid drainage and autoimmune disorder were considered medically significant. The patient did not provide consent to follow-up with her healthcare provider.
Age: 14.0
Sex: M
Vaccine: HPV9, HPV9
Symptoms: Biopsy kidney, Blood test, Renal function test, Tubulointerstitial nephritis and uveitis syndrome
Clinical narrative: This spontaneous report was received from the mother of a 14 year old male patient. The patient did not have any medical history, concurrent conditions, drug reactions or allergies to report. The patient's concomitant medications included PROAIR. It was informed that on 30-NOV-2016, the patient was vaccinated with GARDASIL 9 injection, 0.5ml once, for prevention of Human Papiloma Virus (HPV), lot #LO30554 (strength, route of administration and expiration date were not reported). Approximately on 03-APR-2017 (reported as April 3rd or 4th), the patient developed an autoimmune diseased called Tubulointerstitial Nephritis and Uveitis Syndrome (TINU). The patient also had 2 months of bad vision. The patient's mother informed that the patient was not really admitted, that the patient was in the hospital overnight for a kidney biopsy. It was also reported that the patient had an unspecified bloodwork and an ultrasound of his kidneys (no results provided). The patient received unspecified treatment and visited several doctors. At the time of reporting, the outcome of Tubulointerstitial Nephritis and Uveitis Syndrome (TINU) was reported as not recovered. The causal relationship between the vaccination with GARDASIL 9 and the event was not provided by the reporter. Upon internal review, Tubulointerstitial Nephritis and Uveitis Syndrome (TINU) was determined to be a medically significant event. Lot number LO30554 not valid for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast).
Age: 14.0
Sex: M
Vaccine: HPV9, HPV9
Symptoms: Biopsy kidney, Blood test, Tubulointerstitial nephritis and uveitis syndrome, Ultrasound kidney, Visual impairment
Clinical narrative: This spontaneous report was received from the mother of a 14 year old male patient. The patient did not have any medical history, concurrent conditions, drug reactions or allergies to report. The patient's concomitant medications included PROAIR. It was informed that on 30-NOV-2016, the patient was vaccinated with GARDASIL 9 injection, 0.5ml once, for prevention of Human Papiloma Virus (HPV), lot #LO30554 (strength, route of administration and expiration date were not reported). Approximately on 03-APR-2017 (reported as April 3rd or 4th), the patient developed an autoimmune diseased called Tubulointerstitial Nephritis and Uveitis Syndrome (TINU). The patient also had 2 months of bad vision. The patient's mother informed that the patient was not really admitted, that the patient was in the hospital overnight for a kidney biopsy. It was also reported that the patient had an unspecified bloodwork and an ultrasound of his kidneys (no results provided). The patient received unspecified treatment and visited several doctors. At the time of reporting, the outcome of Tubulointerstitial Nephritis and Uveitis Syndrome (TINU) was reported as not recovered. The causal relationship between the vaccination with GARDASIL 9 and the event was not provided by the reporter. Upon internal review, Tubulointerstitial Nephritis and Uveitis Syndrome (TINU) was determined to be a medically significant event. Lot number LO30554 not valid for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast).
Age: 27.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Induration, Pain, Paraesthesia, Swelling
Clinical narrative: Swelling, red spot, hard spot, painful, pins and needles in both feet and hands.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Pyrexia
Clinical narrative: Fever 101.2, chills, dull headache.
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a Registered Nurse referring to an 18 year old female patient. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported. On 10-OCT-2017, the patient was vaccinated with her first dose of GARDASIL 9, then she received her second and third dose on 11-DEC-2017 and 09-JAN-2018 respectively, Intramuscular route with lot # N02157 and expiration date 01-MAY-2020 (dose and anatomical location were unknown) for prophylaxis. This doses were administered outside of prescribing information. No adverse effect were reported.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age.    On an unknown date the patient was vaccinated with a dose of improperly stored VAQTA lot # N020689 expiry date 22-OCT-2018 (product storage error) for prophylaxis. The medical assistant reports that the details of the excursion are unknown as they are due to a shipping issue. No adverse effects reported. No additional information provided. Temperature and time frame was unknown by reporter. No previous temperature excursion was involved. The digital data logger was not involved. This is one of the two reports linked via same reporter link.; Sender's Comments:  US-009507513-1801USA014574:
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Foreign body sensation in eyes, Herpes zoster
Clinical narrative: This spontaneous report was received from a 78 year old male patient with unspecified heart condition, type 2 diabetes mellitus and high blood pressure, reporting on himself. The patient was taking unspecified concomitant medications for the aforementioned current conditions, and did not have drug reactions/allergies to be reported. On 08-MAR-2014, the patient was vaccinated with ZOSTAVAX, vaccine dose to prevent shingles (route of administration, lot# and expiration date were not reported). On an unknown date in August 2017, the patient was diagnosed with shingles (herpes zoster) and also reported that his right eye "felt like it had sand in it" (foreign body sensation in eyes).The patient sought medical attention and received an unknown treatment. No laboratory works were performed. At the time of the report, the outcome of foreign body sensation in eyes and herpes zoster was reported as not recovered and the causality assessment between the ZOSTAVAX and the aforementioned events was not reported.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from an administrator of vaccine, referring to a patient of an unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not provided. On an unknown date, the patient was vaccinated with one dose of improperly stored ROTATEQ (lot# M045546 with expiration date 12-JUN-2018; route, dose unknown) for prophylaxis. No adverse effects were reported. The vaccines were exposed to temperature excursion of 32 up to 35 (33.8) degrees Fahrenheit for 34 minutes, 32 up to 35 (35) degrees Fahrenheit for 5 minutes, 47 up to 77 (47.6) degrees Fahrenheit for 3 hours and 27 minutes, 32 up to 35 (35) degrees Fahrenheit for 5 minutes, 47 up to 77 (49.1) degrees Fahrenheit for 23 hours and 50 minutes, 47 up to 77 (48.7) degrees Fahrenheit for 24 hours, 47 up to 77 (49.4) degrees Fahrenheit for 9 hours and 47 minutes. There were no previous temperature excursions.  Data logger was involved. No product quality complaint (PQC) was involved in this case. This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-1801USA014621:
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age. On an unknown date the patient was vaccinated with a dose of improperly stored VAQTA lot # N020689 expiry date 22-OCT-2018 for prophylaxis. The medical assistant reports that the details of the excursion are unknown as they are due to a shipping issue. No adverse effects reported. No additional information provided. Temperature and time frame was unknown by reporter. This is one of the two reports linked via same reporter link. Sender's Comments: US-009507513-1801USA008116.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from an administrator of vaccine, referring to a patient of an unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not provided. On an unknown date, the patient was vaccinated with one dose of improperly stored ROTATEQ (lot# M032643 with expiration date 04-MAR-2018; route, dose unknown) for prophylaxis. The vaccines were exposed to temperature excursion of 32 up to 35 (33.8) degrees Fahrenheit for 34 minutes, 32 up to 35 (35) degrees Fahrenheit for 5 minutes, 47 up to 77 (47.6) degrees Fahrenheit for 3 hours and 27 minutes, 32 up to 35 (35) degrees Fahrenheit for 5 minutes, 47 up to 77 (49.1) degrees Fahrenheit for 23 hours and 50 minutes, 47 up to 77 (48.7) degrees Fahrenheit for 24 hours, 47 up to 77 (49.4) degrees Fahrenheit for 9 hours and 47 minutes. No adverse effects were reported. There were no previous temperature excursions. Data logger was involved. No product quality complaint (PQC) was involved in this case. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1801USA009598.
Age: 69.0
Sex: F
Vaccine: PPV, RAB, TD, VARZOS
Symptoms: Erythema, Injection site erythema, Loss of personal independence in daily activities, Pain in extremity, Pruritus
Clinical narrative: Right arm is red, painful, and mildly itchy. Redness starts at site of injection(s) and spreads about 2 inches towards elbow. Client states arm is painful at rest and tender to the touch. Pain interfered with exercise.
Age: 69.0
Sex: F
Vaccine: PPV, RAB, TD, VARZOS
Symptoms: Tenderness
Clinical narrative: Right arm is red, painful, and mildly itchy. Redness starts at site of injection(s) and spreads about 2 inches towards elbow. Client states arm is painful at rest and tender to the touch. Pain interfered with exercise.
Age: 26.0
Sex: F
Vaccine: HPV9
Symptoms: Abdominal pain upper, Anal haemorrhage, Anorectal swelling, Chills, Cold sweat
Clinical narrative: By 10:30 I was extremely nauseous. Nausea continued, getting worse every time I stood or walked, until around 4PM. I felt motion sickness from riding in an elevator or on an escalator. Diarrhea: I had a loose stool around 11AM, and that continued until 11PM (not responding to an OTC anti-diarrheal). By the evening my anus was swollen, painful, and bloody from the number of times I'd had to use the bathroom. Stomach pain: possibly related to the diarrhea/gassiness, my stomach ached very badly until around midnight. It was physically painful to swallow water, soup, etc. (but I kept drinking in order to avoid dehydration). Fever: Around 9PM I took my temperature and it was 100.4F. By 11PM it was 101.1F. Fortunately, the fever broke overnight. Muscle cramps: possibly related to the fever, my back and stomach muscles cramped up to the point where it was difficult to move. I took a warm bath, which helped, but then I started shivering because of my wet skin & fever. By 1AM I was feeling gassy, but the diarrhea had stopped.
Age: 26.0
Sex: F
Vaccine: HPV9
Symptoms: Diarrhoea, Flatulence, Mobility decreased, Motion sickness, Muscle spasms
Clinical narrative: By 10:30 I was extremely nauseous. Nausea continued, getting worse every time I stood or walked, until around 4PM. I felt motion sickness from riding in an elevator or on an escalator. Diarrhea: I had a loose stool around 11AM, and that continued until 11PM (not responding to an OTC anti-diarrheal). By the evening my anus was swollen, painful, and bloody from the number of times I'd had to use the bathroom. Stomach pain: possibly related to the diarrhea/gassiness, my stomach ached very badly until around midnight. It was physically painful to swallow water, soup, etc. (but I kept drinking in order to avoid dehydration). Fever: Around 9PM I took my temperature and it was 100.4F. By 11PM it was 101.1F. Fortunately, the fever broke overnight. Muscle cramps: possibly related to the fever, my back and stomach muscles cramped up to the point where it was difficult to move. I took a warm bath, which helped, but then I started shivering because of my wet skin & fever. By 1AM I was feeling gassy, but the diarrhea had stopped.
Age: 26.0
Sex: F
Vaccine: HPV9
Symptoms: Nausea, Odynophagia, Proctalgia, Pyrexia
Clinical narrative: By 10:30 I was extremely nauseous. Nausea continued, getting worse every time I stood or walked, until around 4PM. I felt motion sickness from riding in an elevator or on an escalator. Diarrhea: I had a loose stool around 11AM, and that continued until 11PM (not responding to an OTC anti-diarrheal). By the evening my anus was swollen, painful, and bloody from the number of times I'd had to use the bathroom. Stomach pain: possibly related to the diarrhea/gassiness, my stomach ached very badly until around midnight. It was physically painful to swallow water, soup, etc. (but I kept drinking in order to avoid dehydration). Fever: Around 9PM I took my temperature and it was 100.4F. By 11PM it was 101.1F. Fortunately, the fever broke overnight. Muscle cramps: possibly related to the fever, my back and stomach muscles cramped up to the point where it was difficult to move. I took a warm bath, which helped, but then I started shivering because of my wet skin & fever. By 1AM I was feeling gassy, but the diarrhea had stopped.
Age: 5.0
Sex: M
Vaccine: FLU4
Symptoms: Erythema, Induration, Pyrexia
Clinical narrative: Local erythema, Induration, Fever of 101 F.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: Redness, swelling, and pain in upper right arm. Prednisone taper and ZYRTEC given at appointment 1/30/18. Has a follow up appointment on Friday 2/2/18. Symptoms started 1/29/18 after receiving vaccine at pharmacy.
Age: 71.0
Sex: F
Vaccine: FLUA3, PPV, FLUA3, PPV
Symptoms: Chills, Fatigue, Muscular weakness, Pain in extremity, Peripheral swelling
Clinical narrative: Painful arm, swollen with a rash from a hand's width above the elbow up and over the shoulder. She was exhausted, chills, body muscle weakness for a total of 5 days.
Age: 71.0
Sex: F
Vaccine: FLUA3, PPV, FLUA3, PPV
Symptoms: Rash
Clinical narrative: Painful arm, swollen with a rash from a hand's width above the elbow up and over the shoulder. She was exhausted, chills, body muscle weakness for a total of 5 days.
Age: 0.5
Sex: M
Vaccine: TDAP
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Patient received the TDAP instead of the DTAP.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Mobility decreased, Pain, Pain in extremity
Clinical narrative: The vaccine was administered just below the shoulder joint when I was at my Ob/Gyn office (which has now closed). The next day, there was severe pain and limitation of mobility. It hurt to rotate my wrist to look at my watch, get dressed, and do other activities of daily living. This lasted for days and was very different than normal soreness in a muscle where you get a shot. This was very sharp pains with movement. It slowly improved with time but took weeks to return to normal. I saw my PCP about it in December because it was still bothering me. It feels fine for day to day activities now, but it will still hurt if I sleep on my side or if I do strengthening activities with weights (even 3lbs, 5lbs).
Sex: F
Vaccine: MMRV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a other health professional refers to a 50 year old female patient. The patient's vaccination history included measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (manufacturer unknown). On an unknown date the patient was vaccinated with PROQUAD from lot N021725 expiry date 06-FEB-2019 for prophylaxis.  Concomitant therapies included sterile diluent. No adverse effects reported. No further details provided.
Sex: M
Vaccine: PPV
Symptoms: Genital rash, Pruritus generalised, Rash, Rash pruritic
Clinical narrative: This spontaneous report was received from the patient's wife referring to her husband, a 74 year old male patient. The patient's medical history included heart bypass; and the patient's concomitant therapies included unspecified therapies for high blood pressure (HBP), cholesterol and prostate which had been taken for years. The patient had no allergies. On an unknown date in January 2017, the patient was vaccinated with a dose of PNEUMOVAX 23 one shot once in the arm (strength, route, lot # and expiration date were not reported) for prophylaxis. On an unknown date in January 2017, the patient started to experience a combination of itching and a spreading rash (rash pruritic) that occurred  within hours of getting of getting vaccinated with PNEUMOVAX 23. The patient had been to the physician five times since this started; and the physician gave to the patient an unspecified shot which the patient was told that it should fix it; however, the shot did not work and the itching and rash became worse. On an unknown date in 2017, the itching was on his full body (the worst itching where the rash was), including legs, arms, back and chest (pruritus generalised); and the worst part was that the rash that occurred within the last few weeks, spread between legs and privates (rash and genital rash). no laboratory diagnostics/studies were performed. The outcome of genital rash, rash, pruritus generalised and rash pruritic was reported as not recovered. The reporter did not assess a causal relationship between the aforementioned events and PNEUMOVAX 23.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a other health professional refers to 4 year old patient unknown gender. On an unknown date, the patient was vaccinated with an improperly stored dose of GARDASIL 9 lot # L019297, expiration date: 18-AUG-2017, via intramuscular route for prophylaxis. The vaccine underwent temperature excursion of 0.8 degree Celsius (also reported as 0.8 F) for 24 hours 30 minutes. There was previous temperature excursion. Call was because of a data logger. It was reported that the patient's age did not match the age indicated for GARDASIL 9. No adverse effects were reported. No product quality complaint involved. No other information was available.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Mobility decreased, Pain, Swelling
Clinical narrative: This is a spontaneous report from a contactable physician communicated to a Pfizer sales representative. A 17-year-old female patient of an unspecified ethnicity received TRUMENBA, via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient experienced had swelling, pain and unable to move her arm following vaccination with meningococcal group b rlp2086. The patient was not given any other vaccine. Outcome of the events was unknown. The information regarding the batch/lot number had been requested.
Sex: U
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site warmth, Product deposit
Clinical narrative: This is a spontaneous report from a contactable nurse or medical assistant communicated to a Pfizer sales representative. The  other hcp reported similar events for two patients, this is the 1st of two cases. A patient of unspecified age ethnicity and gender received PREVNAR 13 (Lot Number: T36368, Expiry: Jul2019), via an unspecified route of administration in Jan2018 at single dose for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced in Jan2018, 7-10 days post vaccination, a warm, red, induration or lump where the injections went with outcome of unknown. It was like a latent reaction. The administered product contained excessive sediment. The reporter explained that the office reported that it took 2 hours to get close to dissolving the sediment in the product and it was unlike it normally was. It was mentioned that normally they can get rid of it quickly. The reporter did not know if the 2 hour time frame was specific or meant to explain how difficult it was to get rid of the sediment. The product was properly stored and was sealed and intact with no damage when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2018037240 same drug  same event, different patient.
Sex: U
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site warmth, Product deposit
Clinical narrative: This is a spontaneous report from a contactable nurse or medical assistant communicated to a Pfizer sales representative. The other hcp reported similar events for two patients, this is the second of two cases. A patient of unspecified age ethnicity and gender received PREVNAR 13 (Lot Number: S35326, Expiry: Aug2018), via an unspecified route of administration in Jan2018 at single dose for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced in Jan2018, 7-10 days post vaccination, a warm, red, induration or lump where the injections went with outcome of unknown. It was like a latent reaction. The administered product contained excessive sediment. The reporter explained that the office reported that it took 2 hours to get close to dissolving the sediment in the product and it was unlike it normally was. It was mentioned that normally they can get rid of it quickly. The reporter did not know if the 2 hour time frame was specific or meant to explain how difficult it was to get rid of the sediment. The product was properly stored and was sealed and intact with no damage when received. Sender's Comments: Linked Report(s) : US-PFIZER INC-2018037099 same drug  same event, different patient.