chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 4.0
Sex: M
Vaccine: DTPIPV, MMRV, MMRV
Symptoms: Rash generalised, Subcutaneous abscess
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 4 year old male patient. The patient's pertinent medical history, drug reactions/allergies and concomitant medications were unspecified. On 16-JUN-2016, the patient was vaccinated with PROQUAD (Merck) injection (strength, lot# and dose# unspecified) 0.5 ml, subcutaneously, in physician's office. The reporter stated that, on 16-JUN-2016, immediately after receiving the injection, the patient had a reaction and began getting itchy over his entire body. The patient also developed a rash over his body, and had a hard time swallowing. The patient sought medical attention, he was treated with epinephrine 0.15 ml, and BENADRYL 5 ml. The patient was then still in the office being monitored and appeared to be recovering. Product quality complaint (PQC) was not involved. The reporter did not provide the causality assessment between the events and the suspect therapy PROQUAD (Merck). No further information was provided. Upon internal review, the events 'immediate post-injection reaction, pruritus generalised and rash generalised' was determined to be medically significant. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: DTPIPV, MMRV, MMRV
Symptoms: Dysphagia, Immediate post-injection reaction, Pruritus generalised, Rash generalised
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 4 year old male patient. The patient's pertinent medical history, drug reactions/allergies and concomitant medications were unspecified. On 16-JUN-2016, the patient was vaccinated with PROQUAD (Merck) injection (strength, lot# and dose# unspecified) 0.5 ml, subcutaneously, in physician's office. The reporter stated that, on 16-JUN-2016, immediately after receiving the injection, the patient had a reaction and began getting itchy over his entire body. The patient also developed a rash over his body, and had a hard time swallowing. The patient sought medical attention, he was treated with epinephrine 0.15 ml, and BENADRYL 5 ml. The patient was then still in the office being monitored and appeared to be recovering. Product quality complaint (PQC) was not involved. The reporter did not provide the causality assessment between the events and the suspect therapy PROQUAD (Merck). No further information was provided. Upon internal review, the events 'immediate post-injection reaction, pruritus generalised and rash generalised' was determined to be medically significant. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: PNC13
Symptoms: Discomfort, Erythema, Swelling
Clinical narrative: Redness of skin, minor discomfort, swelling.
Age: 63.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site discomfort, Injection site erythema, Nausea
Clinical narrative: Localized erythema around the injection site 5cm by 7 cm. Felt nauseated and discomfort in left shoulder.
Age: 25.0
Sex: M
Vaccine: FLU3, MMR
Symptoms: Cold sweat, Depressed level of consciousness, Dizziness, Hyperhidrosis, Pallor
Clinical narrative: Pt had a vasovagal reaction. Pt felt lightheaded, had an episode of semi-consciousness. Pt skin was pale, clammy, and diaphoretic. Pt was laid back in chair. Episode lasted around 15-20 seconds then pt came to. Pt did not fall or sustain any injuries. Pt was given an ice pack behind his neck and put a fan on him. Pt was given water and told to take small sips. Got 4 sets of vitals signs every 5 minutes as follows: 79/36 HR-43, 87/36 HR-45, 123/59 HR-53, 122/62 HR-53.
Age: 25.0
Sex: M
Vaccine: FLU3, MMR
Symptoms: Presyncope
Clinical narrative: Pt had a vasovagal reaction. Pt felt lightheaded, had an episode of semi-consciousness. Pt skin was pale, clammy, and diaphoretic. Pt was laid back in chair. Episode lasted around 15-20 seconds then pt came to. Pt did not fall or sustain any injuries. Pt was given an ice pack behind his neck and put a fan on him. Pt was given water and told to take small sips. Got 4 sets of vitals signs every 5 minutes as follows: 79/36 HR-43, 87/36 HR-45, 123/59 HR-53, 122/62 HR-53.
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Dyskinesia, Eye movement disorder, Fear, Malaise, Musculoskeletal stiffness
Clinical narrative: After injection was given patient became pale. She had a blank stare and her eyes rolled back. Patients body then started to stiffen up and her arms started to jerk. Patient did come through quickly. She began to yell and say that she was scared and did not feel well. She immediately knew who she was and where she was. She was also aware of time and date. We did get a full set of vital signs on patient during the event, and after the event. Patient was examined by a physician.
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Pallor, Staring
Clinical narrative: After injection was given patient became pale. She had a blank stare and her eyes rolled back. Patients body then started to stiffen up and her arms started to jerk. Patient did come through quickly. She began to yell and say that she was scared and did not feel well. She immediately knew who she was and where she was. She was also aware of time and date. We did get a full set of vital signs on patient during the event, and after the event. Patient was examined by a physician.
Age: 1.27
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Body temperature increased, Febrile convulsion
Clinical narrative: Febrile seizure, TMAX 101.7. Pt seen and discharged from ED.
Age: 22.0
Sex: F
Vaccine: MMR
Symptoms: Abdominal pain, Arthralgia, Asthenia, Diarrhoea, Dizziness
Clinical narrative: Visual disturbance, shortness of breath, abdominal pain, diarrhea, dizziness/nausea, joint pain, weakness, fever.
Age: 22.0
Sex: F
Vaccine: MMR
Symptoms: Dyspnoea, Nausea, Pyrexia, Visual impairment
Clinical narrative: Visual disturbance, shortness of breath, abdominal pain, diarrhea, dizziness/nausea, joint pain, weakness, fever.
Age: 16.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Dehydration, Seizure, Syncope
Clinical narrative: After receiving vaccines, patient had a syncopal episode.  He was brought back to an exam room to be assessed and he had two seizure type episodes that lasted lest than 5 seconds each.  He is transported to the hospital by ambulance.  Diagnosed with vasovagal syncope, post syncope convulsions, and dehydration.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Influenza like illness, Injected limb mobility decreased, Nausea, Sleep disorder
Clinical narrative: Pt received PNEUMOVAX on 6/13/2016. On 6/14/2016 she called physician to report that she awakened at 3am due to nausea and severe joint pain. She can barely move her left arm where she received the injection. She feels like she has the flu, and has pain in all of her joints of the left arm and the right arm. Has funny noises in her head, like a washing machine.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Tinnitus
Clinical narrative: Pt received PNEUMOVAX on 6/13/2016. On 6/14/2016 she called physician to report that she awakened at 3am due to nausea and severe joint pain. She can barely move her left arm where she received the injection. She feels like she has the flu, and has pain in all of her joints of the left arm and the right arm. Has funny noises in her head, like a washing machine.
Age: 54.0
Sex: M
Vaccine: TDAP
Symptoms: Chills, Erythema, Fatigue, Headache, Pain
Clinical narrative: Fever, chills, fatigue, redness, swelling, headache, body aches.
Age: 54.0
Sex: M
Vaccine: TDAP
Symptoms: Pyrexia, Swelling
Clinical narrative: Fever, chills, fatigue, redness, swelling, headache, body aches.
Age: 17.0
Sex: M
Vaccine: HPV9, MENB
Symptoms: Abdominal pain upper, Crying, Malaise, Middle insomnia, Nausea
Clinical narrative: Woke up during then night crying with stomach pain, nausea, couldn't touch area where she had vaccine.  Felt ill for 3-4 days.
Age: 17.0
Sex: M
Vaccine: HPV9, MENB
Symptoms: Vaccination site pain
Clinical narrative: Woke up during then night crying with stomach pain, nausea, couldn't touch area where she had vaccine.  Felt ill for 3-4 days.
Age: 30.0
Sex: F
Vaccine: MMR
Symptoms: Unevaluable event
Clinical narrative: Unknown.
Age: 65.0
Sex: M
Vaccine: PNC13
Symptoms: Blister, Erythema, Skin warm, Swelling, Wound
Clinical narrative: Redness, swelling, warmth, swelling, blistering, open area to skin.
Age: 24.0
Sex: F
Vaccine: TYP, YF, TYP, YF
Symptoms: Erythema multiforme, Rash, Rash erythematous, Rash pruritic
Clinical narrative: Sudden onset itchy red raised rash legs and arms.  Slight relief with topical steroids.  Oral prednisone taper with gradual resolution.
Age: 24.0
Sex: F
Vaccine: TYP, YF, TYP, YF
Symptoms: Erythema multiforme, Pruritus, Rash, Rash erythematous, Rash pruritic
Clinical narrative: Sudden onset itchy red raised rash legs and arms.  Slight relief with topical steroids.  Oral prednisone taper with gradual resolution.
Age: 10.0
Sex: F
Vaccine: FLU3
Symptoms: Cellulitis, Injection site cellulitis
Clinical narrative: Immunization given left deltoid on 10/23/15. The patient recently finished a 6 week course of griseofulvin for a kerion that found to have MSSA. Patient also on rituximab for previous history of valve replacement. Cellulitis of Left upper arm (area on vaccine injection site) and scalp on 10/31/15.
Age: 1.26
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Body temperature, Irritability, Rash
Clinical narrative: RASH, CRANKY TEMP.
Age: 66.0
Sex: M
Vaccine: PNC13
Symptoms: Loss of consciousness, Swelling face, Urinary incontinence
Clinical narrative: PT ALSO TOOK A AMOXICILLIN TAB. AND DEVELOPED A PASSING OUT EPISODE WITH URINARY INCONTINENCE, LATER STARTING FACIAL SWELLING. WAS ADMINISTERED ADRENALIN 0.5MG AND THEN REPEATED AFTER 20 MIN.
Age: 81.0
Sex: F
Vaccine: PNC13
Symptoms: Death, Fall, Head injury, Pulmonary embolism, Resuscitation
Clinical narrative: Patient dropped to the floor and hit her head shortly after being immunized with Prevnar.  CPR administered on site.  Patient later died at hospital.  Dr./coroner believes it was not related to the shot but rather a pulmonary embolism.
Age: 72.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Abdominal pain lower, Asthenia, Cellulitis, Chest X-ray, Chills
Clinical narrative: Chills, lower quadrant abdominal pain, fever - 102.4 degrees, weakness, disoriented, aching, soreness in Rt arm. Dx: cellulitis on RUE down to elbow.
Age: 72.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Disorientation, Electrocardiogram, Full blood count, Pain, Pain in extremity
Clinical narrative: Chills, lower quadrant abdominal pain, fever - 102.4 degrees, weakness, disoriented, aching, soreness in Rt arm. Dx: cellulitis on RUE down to elbow.
Age: 72.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Pyrexia, Urine analysis
Clinical narrative: Chills, lower quadrant abdominal pain, fever - 102.4 degrees, weakness, disoriented, aching, soreness in Rt arm. Dx: cellulitis on RUE down to elbow.
Age: 81.0
Sex: F
Vaccine: PNC13
Symptoms: Peripheral swelling, Pyrexia, Rash
Clinical narrative: Patient received PCV-13 vaccine on 06/02/16. State that she started with fever the same day and continued for 48 hrs. Also developed rash on both arms (5x7 right arm) and swollen hands.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Dermatomal rash on RT flank/back.
Age: 7.0
Sex: F
Vaccine: FLU3, HIBV, PPV
Symptoms: Injection site pain, Injection site warmth, Pyrexia
Clinical narrative: Warmth and pain in both arms where the shots were given. Left worse than right. Child had fever up to 103F. Alternating the Motrin and Tylenol every 4 hours and to keep ice on the are - on for 20 minutes and off for 20 minute. Went to ED then admitted for 24 hrs for observation. Gave antibiotic and Zyrtec.
Age: 12.0
Sex: F
Vaccine: VARCEL
Symptoms: Anxiety, Blood test normal, Depression, Dizziness, Dysarthria
Clinical narrative: This was the last dose of HPV, since the first one she began having fatigue, muscle stiffness and headaches. After the last dose, she began having fainting spells, dizziness, irregular menstrual periods, episodes where she loses control of her hand muscles and it progresses to drooping of one side of her face and slurred speech, palpitations, depression, anxiety and muscle spasms.
Age: 12.0
Sex: F
Vaccine: VARCEL
Symptoms: Dyskinesia, Facial paralysis, Fatigue, Headache, Menstruation irregular
Clinical narrative: This was the last dose of HPV, since the first one she began having fatigue, muscle stiffness and headaches. After the last dose, she began having fainting spells, dizziness, irregular menstrual periods, episodes where she loses control of her hand muscles and it progresses to drooping of one side of her face and slurred speech, palpitations, depression, anxiety and muscle spasms.
Age: 12.0
Sex: F
Vaccine: VARCEL
Symptoms: Muscle spasms, Musculoskeletal stiffness, Palpitations, Syncope
Clinical narrative: This was the last dose of HPV, since the first one she began having fatigue, muscle stiffness and headaches. After the last dose, she began having fainting spells, dizziness, irregular menstrual periods, episodes where she loses control of her hand muscles and it progresses to drooping of one side of her face and slurred speech, palpitations, depression, anxiety and muscle spasms.
Age: 67.0
Sex: F
Vaccine: PNC
Symptoms: Chills, Injection site erythema, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Redness, swelling and pain at injection site. Also c/o fever and chills, Temp today 101.3.
Age: 5.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site oedema, Injection site pruritus
Clinical narrative: Localized erythema and edema at site of injection, deltoid, extending over entire area of upper arm with pruritis. Oral Benadryl subsided pruritis. Other symptoms lasted 7 days.
Age: 1.25
Sex: F
Vaccine: IPV
Symptoms: Angioedema, Erythema
Clinical narrative: There is a discrepancy from the chart notes from the visit on 6/21/11. Per MOC when I asked her last week, patient began to have redness of chest, possible urticarial rash, and facial angioedema within hours of IPV administration. Per chart notes, this began the following morning after the vaccine was administered. There is no mention of redness to chest or urticaria in the chart notes, just mild-moderate angioedema of upper eyelids.
Age: 46.0
Sex: F
Vaccine: PNC13
Symptoms: Blood glucose increased, Condition aggravated, Feeling abnormal, Type 1 diabetes mellitus
Clinical narrative: My blood sugar, which is normally good (A1C of 7.3), was elevated last night. It was 380 this morning and 530 just now. I, of course, feel horrible. I have been treating with extra insulin but can hardly keep up with the constant increase. I get it down just to have it rise even higher in the next few hours. Diabetics (I am Type I) need to be warned this can happen. It is awful. I'm afraid that for the first time in 42 years I will have to go to the hospital for high blood sugar.
Age: 31.0
Sex: F
Vaccine: HEPAB, TDAP
Symptoms: Decreased appetite, Dizziness, Headache, Hyperhidrosis, Hypoaesthesia
Clinical narrative: About 10 minutes after receiving the shots my left arm went numb and I was unable to move it without concentrating on the action for about 15 minutes. 5:00 PM began feeling nauseous within an hour I had developed a low grade fever. By 9 PM I had a fever of 100, I took 2 Ibuprofen 200mg and went to bed. I woke up sweating and shaking at 10:59 PM. The next morning I didn't have an appetite, but ate oatmeal for breakfast. By 10:30 AM I was feeling dizzy with a headache and extreme nausea when standing. The low fever returned around 2 PM. By 6PM my temperature had returned to 100 this time with body aches I took 2 more Ibuprofen. The next day I still didn't have an appetite, but the fever and nausea were gone.
Age: 31.0
Sex: F
Vaccine: HEPAB, TDAP
Symptoms: Injected limb mobility decreased, Nausea, Pain, Pyrexia, Tremor
Clinical narrative: About 10 minutes after receiving the shots my left arm went numb and I was unable to move it without concentrating on the action for about 15 minutes. 5:00 PM began feeling nauseous within an hour I had developed a low grade fever. By 9 PM I had a fever of 100, I took 2 Ibuprofen 200mg and went to bed. I woke up sweating and shaking at 10:59 PM. The next morning I didn't have an appetite, but ate oatmeal for breakfast. By 10:30 AM I was feeling dizzy with a headache and extreme nausea when standing. The low fever returned around 2 PM. By 6PM my temperature had returned to 100 this time with body aches I took 2 more Ibuprofen. The next day I still didn't have an appetite, but the fever and nausea were gone.
Age: 17.0
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Concussion, Fall, Laceration, Syncope
Clinical narrative: Patient with syncope episode after receiving HPV and MENACTRA vaccines. Laceration to scalp and concussion due to fall. EMS transported patient to ED where patient was admitted overnight.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal distension, Abdominal pain upper, Back pain, Chest pain, Chills
Clinical narrative: Information was received from a lawyer regarding a case in litigation regarding an 11 year old female with history of a twisted and necrotic ovary with surgery (January 2011). It was reported that the patient followed her physician's advice and on 30-MAR-2011 was vaccinated with her first dose of GARDASIL, (Lot number 667866/1437Z, expiration 25-FEB-2013). On 08-AUG-2011, the patient was vaccinated with her second dose of GARDASIL, (Lot number 667194/1271Z expiration 11-DEC-2012). On 12-DEC-2011, the patient was vaccinated with her third dose of GARDASIL, (Lot number 670049/1261AA, expiration 11-NOV-2013). It was reported that on 30-MAR-2011, almost immediately after the first injection, the patient began to experience stomach pain, bloating, feeling full, nauseated and bladder infection-like symptoms. After the completion of the three vaccinations, the symptoms worsened, and she began to suffer additional symptoms of insomnia, night sweats, day sweats, and chills. On an unknown date, she developed headaches, fatigue, fever, light sensitivity, blurred vision, personality changes, back pain itchiness, dizziness, chest pains and racing heart, spasms in her limbs, tingling and numbness in the hand and feet, confusion, and other mental abnormalities, all of which were reported to be caused by GARDASIL. The patient was told for over three years by her physician that her symptoms she experienced were post-operative symptoms. The patient's symptoms worsened and medical advice from another physician on 20-NOV-2014, reported that the patient "is vaccine injured". The patient's mother found medical literature regarding a finding of contamination of GARDASIL in nine different countries, and unfortunately, one of the listed GARDASIL contaminated lots was GARDASIL Lot # 1437Z, which is the lot number of the patient's first injection of GARDASIL on 30-MAR-2011. The patient's conditions were reported directly and proximately caused by the GARDASIL and are permanent. The conditions the patient has experienced has continued for over five years and are presumed to be permanent. Stomach pain, bloating/feeling full, nauseated and bladder infection-like symptoms, insomnia, night sweats, day sweats, chills, headaches, fatigue, fever, light sensitivity, blurred vision, personality changes, back pain itchiness, dizziness, chest pain and racing heart, spasms in her limbs, tingling and numbness in the hand and feet, confusion, and other mental abnormalities are considered disabling. Upon internal review, mental abnormalities was determined to be important medical event. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Confusional state, Cystitis, Dizziness, Fatigue, Headache
Clinical narrative: Information was received from a lawyer regarding a case in litigation regarding an 11 year old female with history of a twisted and necrotic ovary with surgery (January 2011). It was reported that the patient followed her physician's advice and on 30-MAR-2011 was vaccinated with her first dose of GARDASIL, (Lot number 667866/1437Z, expiration 25-FEB-2013). On 08-AUG-2011, the patient was vaccinated with her second dose of GARDASIL, (Lot number 667194/1271Z expiration 11-DEC-2012). On 12-DEC-2011, the patient was vaccinated with her third dose of GARDASIL, (Lot number 670049/1261AA, expiration 11-NOV-2013). It was reported that on 30-MAR-2011, almost immediately after the first injection, the patient began to experience stomach pain, bloating, feeling full, nauseated and bladder infection-like symptoms. After the completion of the three vaccinations, the symptoms worsened, and she began to suffer additional symptoms of insomnia, night sweats, day sweats, and chills. On an unknown date, she developed headaches, fatigue, fever, light sensitivity, blurred vision, personality changes, back pain itchiness, dizziness, chest pains and racing heart, spasms in her limbs, tingling and numbness in the hand and feet, confusion, and other mental abnormalities, all of which were reported to be caused by GARDASIL. The patient was told for over three years by her physician that her symptoms she experienced were post-operative symptoms. The patient's symptoms worsened and medical advice from another physician on 20-NOV-2014, reported that the patient "is vaccine injured". The patient's mother found medical literature regarding a finding of contamination of GARDASIL in nine different countries, and unfortunately, one of the listed GARDASIL contaminated lots was GARDASIL Lot # 1437Z, which is the lot number of the patient's first injection of GARDASIL on 30-MAR-2011. The patient's conditions were reported directly and proximately caused by the GARDASIL and are permanent. The conditions the patient has experienced has continued for over five years and are presumed to be permanent. Stomach pain, bloating/feeling full, nauseated and bladder infection-like symptoms, insomnia, night sweats, day sweats, chills, headaches, fatigue, fever, light sensitivity, blurred vision, personality changes, back pain itchiness, dizziness, chest pain and racing heart, spasms in her limbs, tingling and numbness in the hand and feet, confusion, and other mental abnormalities are considered disabling. Upon internal review, mental abnormalities was determined to be important medical event. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Hyperhidrosis, Hypoaesthesia, Insomnia, Mental disorder, Muscle spasms
Clinical narrative: Information was received from a lawyer regarding a case in litigation regarding an 11 year old female with history of a twisted and necrotic ovary with surgery (January 2011). It was reported that the patient followed her physician's advice and on 30-MAR-2011 was vaccinated with her first dose of GARDASIL, (Lot number 667866/1437Z, expiration 25-FEB-2013). On 08-AUG-2011, the patient was vaccinated with her second dose of GARDASIL, (Lot number 667194/1271Z expiration 11-DEC-2012). On 12-DEC-2011, the patient was vaccinated with her third dose of GARDASIL, (Lot number 670049/1261AA, expiration 11-NOV-2013). It was reported that on 30-MAR-2011, almost immediately after the first injection, the patient began to experience stomach pain, bloating, feeling full, nauseated and bladder infection-like symptoms. After the completion of the three vaccinations, the symptoms worsened, and she began to suffer additional symptoms of insomnia, night sweats, day sweats, and chills. On an unknown date, she developed headaches, fatigue, fever, light sensitivity, blurred vision, personality changes, back pain itchiness, dizziness, chest pains and racing heart, spasms in her limbs, tingling and numbness in the hand and feet, confusion, and other mental abnormalities, all of which were reported to be caused by GARDASIL. The patient was told for over three years by her physician that her symptoms she experienced were post-operative symptoms. The patient's symptoms worsened and medical advice from another physician on 20-NOV-2014, reported that the patient "is vaccine injured". The patient's mother found medical literature regarding a finding of contamination of GARDASIL in nine different countries, and unfortunately, one of the listed GARDASIL contaminated lots was GARDASIL Lot # 1437Z, which is the lot number of the patient's first injection of GARDASIL on 30-MAR-2011. The patient's conditions were reported directly and proximately caused by the GARDASIL and are permanent. The conditions the patient has experienced has continued for over five years and are presumed to be permanent. Stomach pain, bloating/feeling full, nauseated and bladder infection-like symptoms, insomnia, night sweats, day sweats, chills, headaches, fatigue, fever, light sensitivity, blurred vision, personality changes, back pain itchiness, dizziness, chest pain and racing heart, spasms in her limbs, tingling and numbness in the hand and feet, confusion, and other mental abnormalities are considered disabling. Upon internal review, mental abnormalities was determined to be important medical event. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Nausea, Night sweats, Palpitations, Paraesthesia, Personality change
Clinical narrative: Information was received from a lawyer regarding a case in litigation regarding an 11 year old female with history of a twisted and necrotic ovary with surgery (January 2011). It was reported that the patient followed her physician's advice and on 30-MAR-2011 was vaccinated with her first dose of GARDASIL, (Lot number 667866/1437Z, expiration 25-FEB-2013). On 08-AUG-2011, the patient was vaccinated with her second dose of GARDASIL, (Lot number 667194/1271Z expiration 11-DEC-2012). On 12-DEC-2011, the patient was vaccinated with her third dose of GARDASIL, (Lot number 670049/1261AA, expiration 11-NOV-2013). It was reported that on 30-MAR-2011, almost immediately after the first injection, the patient began to experience stomach pain, bloating, feeling full, nauseated and bladder infection-like symptoms. After the completion of the three vaccinations, the symptoms worsened, and she began to suffer additional symptoms of insomnia, night sweats, day sweats, and chills. On an unknown date, she developed headaches, fatigue, fever, light sensitivity, blurred vision, personality changes, back pain itchiness, dizziness, chest pains and racing heart, spasms in her limbs, tingling and numbness in the hand and feet, confusion, and other mental abnormalities, all of which were reported to be caused by GARDASIL. The patient was told for over three years by her physician that her symptoms she experienced were post-operative symptoms. The patient's symptoms worsened and medical advice from another physician on 20-NOV-2014, reported that the patient "is vaccine injured". The patient's mother found medical literature regarding a finding of contamination of GARDASIL in nine different countries, and unfortunately, one of the listed GARDASIL contaminated lots was GARDASIL Lot # 1437Z, which is the lot number of the patient's first injection of GARDASIL on 30-MAR-2011. The patient's conditions were reported directly and proximately caused by the GARDASIL and are permanent. The conditions the patient has experienced has continued for over five years and are presumed to be permanent. Stomach pain, bloating/feeling full, nauseated and bladder infection-like symptoms, insomnia, night sweats, day sweats, chills, headaches, fatigue, fever, light sensitivity, blurred vision, personality changes, back pain itchiness, dizziness, chest pain and racing heart, spasms in her limbs, tingling and numbness in the hand and feet, confusion, and other mental abnormalities are considered disabling. Upon internal review, mental abnormalities was determined to be important medical event. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Photophobia, Pruritus, Pyrexia, Vaccination complication, Vision blurred
Clinical narrative: Information was received from a lawyer regarding a case in litigation regarding an 11 year old female with history of a twisted and necrotic ovary with surgery (January 2011). It was reported that the patient followed her physician's advice and on 30-MAR-2011 was vaccinated with her first dose of GARDASIL, (Lot number 667866/1437Z, expiration 25-FEB-2013). On 08-AUG-2011, the patient was vaccinated with her second dose of GARDASIL, (Lot number 667194/1271Z expiration 11-DEC-2012). On 12-DEC-2011, the patient was vaccinated with her third dose of GARDASIL, (Lot number 670049/1261AA, expiration 11-NOV-2013). It was reported that on 30-MAR-2011, almost immediately after the first injection, the patient began to experience stomach pain, bloating, feeling full, nauseated and bladder infection-like symptoms. After the completion of the three vaccinations, the symptoms worsened, and she began to suffer additional symptoms of insomnia, night sweats, day sweats, and chills. On an unknown date, she developed headaches, fatigue, fever, light sensitivity, blurred vision, personality changes, back pain itchiness, dizziness, chest pains and racing heart, spasms in her limbs, tingling and numbness in the hand and feet, confusion, and other mental abnormalities, all of which were reported to be caused by GARDASIL. The patient was told for over three years by her physician that her symptoms she experienced were post-operative symptoms. The patient's symptoms worsened and medical advice from another physician on 20-NOV-2014, reported that the patient "is vaccine injured". The patient's mother found medical literature regarding a finding of contamination of GARDASIL in nine different countries, and unfortunately, one of the listed GARDASIL contaminated lots was GARDASIL Lot # 1437Z, which is the lot number of the patient's first injection of GARDASIL on 30-MAR-2011. The patient's conditions were reported directly and proximately caused by the GARDASIL and are permanent. The conditions the patient has experienced has continued for over five years and are presumed to be permanent. Stomach pain, bloating/feeling full, nauseated and bladder infection-like symptoms, insomnia, night sweats, day sweats, chills, headaches, fatigue, fever, light sensitivity, blurred vision, personality changes, back pain itchiness, dizziness, chest pain and racing heart, spasms in her limbs, tingling and numbness in the hand and feet, confusion, and other mental abnormalities are considered disabling. Upon internal review, mental abnormalities was determined to be important medical event. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Received HPV #3 6/2/16. Presented in our office with (L) shoulder pain, upper arm swelling, warmth at site. Started clindamycin 300mg TID.
Age: 80.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Left deltoid - redness, soreness, warm to touch.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: 0845) arrived at clinic eating peanut butter and jelly sandwich. 0901) vaccines given. 0913) to check out desk. No reactions noted: 1015) clinic called to eye clinic by their staff. Pt awake, alert. Hives/rash to face, torso, legs, itchy. No wheeze or resp concerns. 1030) BENADRYL 15 mg given PO. 1105) Reassess - rash/hives have decreased. No itching. Pt awake, alert, interactive. Mother reports pt has eaten peanut butter for 3 years with no reaction.
Age: 8.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Asthma, Cough, Dyspnoea, Erythema, Petechiae
Clinical narrative: 5 minutes after vaccine, patient told mother that he could not breathe and had persistent cough, redness of face, arms, chest, legs, VSS with tachycardia. Still with cough. Lungs clear. Oxsats = 94% RA. Albuterol neb x 1. Erythema resolved: within 5 minutes. Cough diminished. Petechiae noted on neck, arms, chest. VSS. D/C'd home after 30 min observation.
Age: 8.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Tachycardia
Clinical narrative: 5 minutes after vaccine, patient told mother that he could not breathe and had persistent cough, redness of face, arms, chest, legs, VSS with tachycardia. Still with cough. Lungs clear. Oxsats = 94% RA. Albuterol neb x 1. Erythema resolved: within 5 minutes. Cough diminished. Petechiae noted on neck, arms, chest. VSS. D/C'd home after 30 min observation.
Age: 8.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Dyspnoea, Erythema, Heart rate increased, Oxygen saturation decreased, Petechiae
Clinical narrative: 5 minutes after vaccine, patient told mother that he could not breathe and had persistent cough, redness of face, arms, chest, legs, VSS with tachycardia. Still with cough. Lungs clear. Oxsats = 94% RA. Albuterol neb x 1. Erythema resolved: within 5 minutes. Cough diminished. Petechiae noted on neck, arms, chest. VSS. D/C'd home after 30 min observation.
Age: 8.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Productive cough
Clinical narrative: 5 minutes after vaccine, patient told mother that he could not breathe and had persistent cough, redness of face, arms, chest, legs, VSS with tachycardia. Still with cough. Lungs clear. Oxsats = 94% RA. Albuterol neb x 1. Erythema resolved: within 5 minutes. Cough diminished. Petechiae noted on neck, arms, chest. VSS. D/C'd home after 30 min observation.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Chest pain, Dyspnoea, Panic attack, Paraesthesia
Clinical narrative: Patient developed chest pains, shortness of breath with tingling to her extremities about one hour after injection. Seen at ER, diagnosed with panic attack.
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Body temperature increased, Erythema, Induration, Mass, Skin warm
Clinical narrative: Swollen, hot to touch, red in color, hard lump. Temperature 99.8 - tympanic.
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Swelling
Clinical narrative: Swollen, hot to touch, red in color, hard lump. Temperature 99.8 - tympanic.
Age: 69.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site nodule, Injection site pruritus, Injection site swelling
Clinical narrative: Patient received the vaccine on 6/17/16. She came in complaining of redness, swelling, knots and itching at the site of injection. Recommended BENADRYL by mouth and hydrocortisone cream topically. On 6/21/16 patient said it was getting better.
Age: 1.01
Sex: F
Vaccine: MMR, PNC13, VARCEL
Symptoms: Injection site rash, Joint swelling, Pyrexia, Rash, Serum sickness
Clinical narrative: 10 days post vaccination, pt developed rash centered around injection site that was also present on upper and lower extremities. 11 days post-vaccination, pt developed fever and joint swelling consistent w/serum sickness.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report received from a healthcare worker refers to 7 patients of unknown age and gender. No medical history and concurrent conditions were reported. On an unknown date the patients were vaccinated with a dose of improperly stored PROQUAD (incorrect product storage) (lot # L024125, expiry date 30-DEC-2016) (dosing regimen and frequency unknown). It was reported that the PROQUAD experienced a temperature of 19.9 degrees Fahrenheit for a 525 hours time frame. It was also reported that there was no previous temperature excursion. It was also reported that the healthcare worker called to report because of a data logger. No adverse effects were reported. No product quality complaint was reported. The action taken with the therapy with PROQUAD was unknown. The outcome of the events was unknown. This case is linked to case number 1606USA008705 via same reporter link. Additional information has been requested.
Age: 49.0
Sex: M
Vaccine: HPV4
Symptoms: Drug administered to patient of inappropriate age, Incorrect route of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a nurse practitioner and refers to a 49 year old male patient. The patient's medical history and concurrent conditions were not reported. On 03-JUN-2016, the patient was inadvertently vaccinated with a 0.1 ml dose of GARDASIL (Lot number reported as L042837, expiry date: 27-MAY-2017) via intradermal route. Concomitant therapy was not reported. No adverse effect was reported. Additional information has been requested.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Abscess, Localised infection
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 70 year old male patient with no drug reactions or allergies. The patient's medical history included port placement possibly for pneumonia. On 20-MAY-2016, the patient received a dose of ZOSTAVAX (lot # L048452, expiration date: 01-MAR-2017) 0.65 ml, subcutaneously as vaccination. There was no concomitant medication. On approximately 27-MAY-2016 (reported as "about a week later"), an abscess was on patient's left chest, where his daughter stated he had a port placed in the past. The patient sought medical attention and wen to healthcare professional, who sent him to the emergency room (ER), where the infection was cut out. No lab diagnostic studies were performed. The outcome of the events was reported as recovering. The relatedness between the events and ZOSTAVAX was not reported. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patents were vaccinated with the improperly stored doses of RECOMBIVAX HB lot #: L040458, expiration date on 04-FEB-2018 (strength, dose number, route and anatomical location were not provided). No adverse events were reported. Administered doses of vaccines experienced the temperature excursion of 31.6 degrees Fahrenheit for 2 hours 15 minutes. Data logger was involved. There were no previous excursions reported. This is one of two reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a healthcare worker and refers to a multiple unspecified patients of unknown age and gender with no pertinent medical history, concurrent condition or drug reaction/allergy. On an unknown date, the patients were vaccinated with improperly stored doses of GARDASIL (intramuscularly,  lot number reported as L044475, expiry date: 12-MAY-2017). There was no concomitant therapy. Reported temperature excursion was 34F within 8 hours. Data logger was involved. There was no previous temperature excursion. No treatment was given and no laboratory test diagnostic was performed. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed Practical Nurse refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not specified. On 13-JUN-2016, the patient was vaccinated with improperly stored VARIVAX (lot # L019128, expiry date: 27-MAY-2017, dose, strength, route, vaccination site unspecified). The temperature excursion for # lot L019128 was reported as 13.5 C for 96 hours. On an unknown date, the patient was also vaccinated with improperly stored VARIVAX (lot # L029466, expiry date: 06-AUG-2017, dose, strength, route, vaccination site unspecified). The temperature excursion for # lot L029466 was reported as -13.5 C for 16 hours. Digital data logger was involved. There was no previous temperature excursion. No adverse events were reported. Product quality complaint (PQC) was not involved. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician referring to unknown number of patients of unknown age and gender. Information about concurrent condition, medical history and concomitant medication was not provided. On unknown dates the patients were vaccinated with GARDASIL 9 (lot # L044475, expiration date 12-MAY-2017, dose, dose# and route unknown). The vaccines were stored under 34F for 13 hours and the vaccines were back in range without previous excursion (incorrect product storage). No adverse reactions reported. This is one of two reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. The patients' concurrent conditions and medical history were not reported. In approximately 2016 (reported as on or after 23-APR-2016), the patients were vaccinated with improperly stored doses of M-M-R II lot # L026553, expiration date reported as 16-JUL-2107, lot # L030162, expiration date reported as 11-AUG-2017 (therapy type, dose, frequency, route and site administration were not reported). There was no adverse effect reported. Administered doses of vaccine experienced the temperature excursion of 34.8 degrees Fahrenheit for 6 hours and 43 minutes and 53.2 degrees Fahrenheit for 8 minutes. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia, Dizziness, Fatigue, Headache, Myalgia
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse regarding a 13 year old female patient. There was no information about concurrent condition and historical medication. On an unknown 2014 the patient completed her GARDASIL series. No concomitant medication was reported. On an unknown date the patient experienced headaches, tiredness, joint and muscle pain, and dizziness. Treatment was given for the event. Reporter did not know if adverse events occurred after each shot, or after completing the series. Patient visited specialist office to seek medical attention. No PQC (product quality complaint). It was reported that the therapy with GARDASIL was not discontinued. The outcome of headaches, tiredness, joint and muscle pain, and dizziness was unknown. Causality was unknown. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Immediate post-injection reaction, Injection site pain
Clinical narrative: This spontaneous report was received from healthcare worker and refers to a multiple unspecified patients of unknown age and gender with no pertinent medical history or drug reaction/allergies. On an unknown date, the patients were vaccinated with a doses of GARDASIL (intramuscularly, multiple lot numbers and expiry dates were not reported). There was no concomitant therapy. On an unknown date, immediately following the administration of GARDASIL, the patients complained of pain at the injection site. No treatment was given for the adverse event for the patients and no laboratory test diagnostic was performed. The patients recovered from pain at the injection site (unknown date). Relatedness between pain at the injection site and the vaccination with GARDASIL was not reported. This is one of several reports from the same reporter. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: VARCEL
Symptoms: Contraindication to vaccination, No adverse event
Clinical narrative: Information has been received from a physician to a 19 year old female patient with immunosuppression. On 16-JUN-2016, at 11 am Mountain Time, the patient was vaccinated with VARIVAX (lot # L046885, expiration date 23-NOV-2017, in the right arm; route unknown) while on HUMIRA (which the physician reported to be an immunosuppression medication, which was other-than-indicated in the Prescribing information) (product use issue). The patient had not experienced any adverse effects. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to multiple patients of unknown age and gender. On unknown dates the patients were vaccinated with improperly stored LIQUID PEDVAXHIB (lot # L051124 with expiration date of 14-OCT-2018; strength, dosage, frequency and route unspecified). No adverse effects were reported. The vaccine was exposed at 31.5 F for 75 hours 30 minutes. There was no previous temperature excursions. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to two patients of unknown demographics. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with doses of improperly stored ZOSTAVAX (lot # L048452, expiration date: 01-MAR-2017; dose and route were not provided). The vaccine underwent a temperature excursion of 55 degrees Fahrenheit for 800 hours, which was not detected by a data logger. There was no previous temperature excursion. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a physician referring to three patients of unknown age and gender. The medical history and concurrent condition of the three patients were not reported. On an unknown date, the three patients were vaccinated with ZOSTAVAX. Strength, dose, frequency, route of administration, lot number and expiration date were not provided. No concomitant therapies were reported. On an unknown date, the three patients got shingles (herpes zoster) after getting ZOSTAVAX. No Product Quality Complaint (PQC) was involved. The outcome of the event of shingles for the three patients was unknown at the time of the report. The causality of shingles (herpes zoster) with ZOSTAVAX was not provided. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with the improperly stored dose of VAQTA lot #: M009377, expiration date on 17-JUN-2017 (strength, dose number, route and anatomical location were not provided). No adverse events were reported. Administered doses of vaccines experienced the temperature excursion of 31.6 degrees Fahrenheit for 2 hours 15 minutes. Data logger was involved. There were no previous excursions reported. This is one of two reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant medications were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 (lot # L019297, expiry date 18-AUG-2017, lot # L026602, expiry date 19-OCT-2017, lot # L043213, expiry date 28-AUG-2017, lot # L019297, expiry date 19-FEB-2017 (dose, route and site of administration were not reported). No adverse effect was reported. Administered doses of vaccines experienced the temperature excursion of 0.2 degrees Celsius for 48 hours. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.