chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. On an unknown date, the patients were vaccinated with improperly stored doses of VAQTA lot # reported as: K014696 with expiration date: 11-NOV-2015, L001445 with expiration date: 15-FEB-2016 and L004439 with expiration date: 15-FEB-2016 (dose and route of administration were not reported). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. No information on patients' concurrent conditions and medical history was provided. On the unknown dates, multiple unspecified patients were vaccinated with improperly stored ROTATEQ oral (dose, lot # and expiration date were not provided). No adverse effects were reported. This is the one of several reports from the same reporter source. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to unspecified patients of unknown age and gender. There were no concomitant medications, concurrent condition and medical history reported. On unknown dates, the patients were inadvertently administered with 7 doses of improperly stored ROTATEQ, oral, lot # K013661, exp. 26-MAY-2016 (dose was not reported). No adverse effects were reported. Additional information has been requested.
Age: 13.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a 13 years old patient of unknown gender. No information on patient's medical history or concurrent conditions was provided. On 16-JAN-2015, the patient was vaccinated with the dose of GARDASIL lot # K008213 (dose, strength, route of administration and expiration date were not reported) which had temperature excursion. No information on patient's concomitant medication was provided. Nurse practitioner confirmed that no adverse events were reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to unspecified patients of unknown age and gender. There were no concomitant medications, concurrent condition and medical history reported. On unknown dates, the patients were inadvertently administered with 6 doses of improperly stored RECOMBIVAX HB lot # J013394, exp. 25-AUG-2016 (dose was not reported). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to unspecified patients of unknown age and gender. There were no concomitant medications, concurrent condition and medical history reported. On unknown dates, the patients were inadvertently administered with 10 doses of improperly stored VAQTA lot # K005958 (dose and expiration date were not reported). No adverse effects were reported. 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 registered nurse and refers to a patient of unknown age and gender. Pertinent medical history or drug allergies/drug reactions were not reported. On 26-MAR-2015, the patient was vaccinated with an improperly stored dose of VARIVAX (Merck) (dose, route, lot number and expiration date were not provided). Concomitant medication was not provided. No adverse effect was reported. No product quality complaint (PQC) was involved. This is one of nine reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. No information on patients' concurrent conditions and medical history was provided. On an unknown dates, multiple unspecified patients were vaccinated with improperly stored GARDASIL (dose, route, lot # and expiration date were not provided). No adverse effects were reported. This is one of the several reports from the same reporter source. 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 registered nurse and refers to a patient of unknown age and gender. Pertinent medical history or drug allergies/drug reactions were not reported. On 26-MAR-2015, the patient was vaccinated with an improperly stored dose of VARIVAX (Merck) (dose, route, lot number and expiration date were not provided). Concomitant medication was not provided. No adverse effect reported. No product quality complaint (PQC) was involved. This is one of nine reports from the same reporter. Additional information has been requested.
Age: 12.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a 12 years old patient of unknown gender. No information on patient's medical history or concurrent conditions was provided. On 20-JAN-2015, the patient was vaccinated with the dose of GARDASIL lot # K008213 (dose, strength, route of administration and expiration date were not reported) which had temperature excursion (incorrect product storage). No information on patient's concomitant medication was provided. Nurse practitioner confirmed that no adverse events were reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to unspecified patients of unknown age and gender. There were no concomitant medications, concurrent condition and medical history reported. On unknown dates, the patients were inadvertently administered with 6 doses of improperly stored GARDASIL lot # K005881 exp. 14-JAN-2017 (dose was not reported). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an infant patient of unknown age. No information about medical history, concurrent conditions was reported for the patient. On 04-JUN-2015 the infant patient was inadvertently administered a dose of the Adult, RECOMBIVAX HB, 10/1mcrg/ml, intramuscularly in the leg instead of the pediatric formulation. This was the first dose of the hepatitis b vaccination series this infant has been administered. No adverse effects reported. The outcome of events reported is unknown. No product quality complaint was involved. Additional information has been requested.
Age: 13.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a 13 years old patient of unknown gender. No information on patient's medical history or concurrent conditions was provided. On 18-DEC-2014, the patient was vaccinated with the dose of GARDASIL lot # K006191 (dose, strength, route of administration and expiration date were not reported) which had temperature excursion. No information on patient's concomitant medication was provided. Nurse practitioner confirmed that no adverse events were reported. This is one of several reports from the same reporter. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HEP
Symptoms: Vision blurred, Vomiting
Clinical narrative: Employee states after leaving work and going home she vomited a few times throughout the night. Employee also states she has had blurred vision.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Injection site erythema, Injection site rash, Rash erythematous
Clinical narrative: Red, bumps/spots, mild rash, on torso, back, neck and thighs no treatment given did not know what to use: doctor did not suggest anything.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Local redness, swelling, pain.
Age: 57.0
Sex: F
Vaccine: DTAP, PPV
Symptoms: Chills, Epistaxis, Headache, Injection site erythema, Injection site pruritus
Clinical narrative: Headache, body aches, fever, pain and soreness at the site of vaccine. symptoms lifted somewhat with the use of a 600 mg Ibuprofen pill at about 05:00 AM, but at about 10:00 AM onset of chills and a 100.6  fever that went up to 103.6 before another 600 mg Ibuprofen was taken at the recommendation of the Doctor, and another 6 hours later, and another 6 hours after that for 3 days. Sequelae: Odd Headaches, traces of blood in snot after blowing nose, pain in the right side of back of neck, large area around the site of vaccine still red and tender with slight itch, 5 days later.
Age: 57.0
Sex: F
Vaccine: DTAP, PPV
Symptoms: Neck pain, Pain, Pyrexia, Vaccination site pain
Clinical narrative: Headache, body aches, fever, pain and soreness at the site of vaccine. symptoms lifted somewhat with the use of a 600 mg Ibuprofen pill at about 05:00 AM, but at about 10:00 AM onset of chills and a 100.6  fever that went up to 103.6 before another 600 mg Ibuprofen was taken at the recommendation of the Doctor, and another 6 hours later, and another 6 hours after that for 3 days. Sequelae: Odd Headaches, traces of blood in snot after blowing nose, pain in the right side of back of neck, large area around the site of vaccine still red and tender with slight itch, 5 days later.
Age: 67.0
Sex: F
Vaccine: PNC13, TDAP, VARZOS
Symptoms: Contusion, Erythema
Clinical narrative: Redness, slight bruising.
Age: 4.0
Sex: M
Vaccine: MMR
Symptoms: Abdominal pain upper, Confusional state, Cough, Decreased appetite, Dyspnoea
Clinical narrative: Fever, swollen glands, sore throat, ear pain, itchy, trouble breathing, listless, achy body, confused & spacey, forgetful, emotional, irritable, loss of appetite, laryngitis, stomach pain, cough.
Age: 4.0
Sex: M
Vaccine: MMR
Symptoms: Ear pain, Emotional disorder, Feeling abnormal, Irritability, Laryngitis
Clinical narrative: Fever, swollen glands, sore throat, ear pain, itchy, trouble breathing, listless, achy body, confused & spacey, forgetful, emotional, irritable, loss of appetite, laryngitis, stomach pain, cough.
Age: 4.0
Sex: M
Vaccine: MMR
Symptoms: Listless, Lymphadenopathy, Memory impairment, Oropharyngeal pain, Pain
Clinical narrative: Fever, swollen glands, sore throat, ear pain, itchy, trouble breathing, listless, achy body, confused & spacey, forgetful, emotional, irritable, loss of appetite, laryngitis, stomach pain, cough.
Age: 4.0
Sex: M
Vaccine: MMR
Symptoms: Pruritus, Pyrexia
Clinical narrative: Fever, swollen glands, sore throat, ear pain, itchy, trouble breathing, listless, achy body, confused & spacey, forgetful, emotional, irritable, loss of appetite, laryngitis, stomach pain, cough.
Age: 4.0
Sex: F
Vaccine: DPP
Symptoms: Erythema, Pain, Peripheral swelling, Pruritus, Skin warm
Clinical narrative: Her right arm was very swollen from elbow to shoulder, hot to touch, red, itching and painful when touched.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Erythema, swelling, warmth and tenderness covering extensive area surrounding the site of injection. Symptoms slight day of injection (6/19/15) and gradually increased until patient sought medical attention on 6/21/15. Patient reports no diagnostic tests were done to confirm infection, but KEFLEX 500mg PO TID x10 days prescribed anyway. I counseled to apply ice.
Age: 50.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site joint swelling, Injection site joint warmth
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of injection site joint warmth in a 50-year-old female patient who received FLUARIX QUADRIVALENT (batch number unknown, expiry date June 2015) and (batch number AS457), expiry date June 2015). Previously experienced adverse reactions included similar reaction on previous exposure to drug. On 24th September 2014 07:30, the patient received FLURARIX (intramuscular). On an unknown date, the dose was an unknown dose. On 24th September 2014 20:00, 12 hrs 30 min after receiving FLUARIX, the patient experienced injection site joint warmth and injection site joint swelling. On an unknown date, the outcome of the injection site joint warmth and injection site joint swelling were recovering/resolving. The reporter considered the injection site joint warmth and injection site joint swelling to be unrelated to FLUARIX. Additional information received: Patient received .5 ml of FLUARIX QUADRIVALENT vaccine at 7:30 in the morning on the 24th of September. At 8 pm on that same day patient noticed that the collar bone was warm and collar bone was a little swollen. Patient did not have any fever. Patient only spoke to a nurse at the school where she works. Patient did not receive any other vaccines on that day. Reporter does not know if patient is taking other medications. Reporter does not believe that the event is related to FLUARIX; however, the patient does. Following GSK internal checks on lot number, on 11 May 2015 the reported suspect vaccine FLUARIX has been corrected and replaced by FLUARIX QUADRIVALENT. Case Comment: Patient received a .5 ml of FLUARIX QUADRIVALENT vaccine at 7:30 in the morning on the 24th of September. At 8 pm on that same day patient noticed that the collar bone was warm and collar bone was a little swollen. Patient did not have any fever. Patient only spoke to a nurse at the school where she works. Patient did not receive any other vaccines on that day. Reporter does not know if patient is taking other medications. Reporter does not believe that the event is related to FLUARIX; however, the patient does.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from registered nurse refers to a female patient of unknown age. On an unknown date in July 2013, the patient was vaccinated with first dose of GARDASIL (dose, frequency and route were not reported). On an unknown date in November 2013 the patient was vaccinated with second and not received her third dose yet (09-JUN-2015). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unknown age and unknown gender. On 10-JUN-2015, the patient was vaccinated with second dose of M-M-R II (lot# J006140 and expiry date: 17-APR-2015) subcutaneously which was expired. On an unknown date, the patient was vaccinated with first dose of M-M-R II which was not expired. No adverse effects were reported. No product quality complaint was reported for M-M-R II. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a Registered Nurse regarding a patient of unknown demographics. There was no information about concurrent condition and historical medication. On 15-OCT-2012, the patient was vaccinated with GARDASIL dose 1 and on 09-NOV-2013, was vaccinated with the dose 2 (inappropriate schedule of drug administration). Patient present status was reported as no adverse effects. No product quality complaint was involved. The outcome of the event was unknown. Additional information has been requested.
Age: 1.3
Sex: F
Vaccine: PNC13, VARCEL
Symptoms: Chest X-ray, Irritability, Laboratory test, Pneumonia, Pyrexia
Clinical narrative: Information has been received from a consumer (the mother of the unspecified patient) referring to an almost 15 months old female patient. The patient had a low grade fever reaction to every (unspecified) vaccine she'd been administered. On 06-APR-2015 the patient was vaccinated with VARIVAX (Merck) (injection, 1 shot, lot#, dose, frequency and route not reported). On the same day, the patient was vaccinated with PREVNAR 13 (dose, frequency and route not reported). The reporter reported after her daughter was administered VARIVAX (Merck) on 06-APR-2015, she was "fussy, and had a low grade fever for the next few days" and that on 10-APR-2015 the fever spiked to 106F. Patient was taken to the ER at a Hospital and diagnosed with pneumonia. She was released the same day (not admitted). The patient was treated with an unspecific antibiotic and ibuprofen. The patient performed chest X-ray and unspecified tests (results unspecified). The outcome of the events were unknown. Additional information is not expected for no contact information was available.
Age: 32.0
Sex: M
Vaccine: ANTH
Symptoms: Allergy to animal, Arthralgia, Dermatitis allergic, House dust allergy, Hypersensitivity
Clinical narrative: Patient states that he developed hives within 48 hours of receiving the anthrax vaccine. He reports he was covered in hives from the neck down as well as had aching joints in the hands, knees, elbows and wrists; additionally his finger joints were swollen. This was the first time he had experienced any allergic skin conditions; subsequently he was given a permanent exemption to the anthrax vaccine. He denies this skin reaction after any other vaccination or medication. He did not receive the smallpox vaccine. Patient reports that he has continued to have urticarial outbreaks with the same characteristics and in the same locations, approximately every 2-4 months since this initial episode. The hives are dime to half dollar size and extremely pruritic, when "flattened out" they are yellowish in color. Episodes can last from a couple days to several weeks. He has attempted to define a pattern to their occurrence over the last 15 years, but cannot identify consistent triggers.
Age: 32.0
Sex: M
Vaccine: ANTH
Symptoms: Joint swelling, Mycotic allergy, Pruritus, Rhinitis, Seasonal allergy
Clinical narrative: Patient states that he developed hives within 48 hours of receiving the anthrax vaccine. He reports he was covered in hives from the neck down as well as had aching joints in the hands, knees, elbows and wrists; additionally his finger joints were swollen. This was the first time he had experienced any allergic skin conditions; subsequently he was given a permanent exemption to the anthrax vaccine. He denies this skin reaction after any other vaccination or medication. He did not receive the smallpox vaccine. Patient reports that he has continued to have urticarial outbreaks with the same characteristics and in the same locations, approximately every 2-4 months since this initial episode. The hives are dime to half dollar size and extremely pruritic, when "flattened out" they are yellowish in color. Episodes can last from a couple days to several weeks. He has attempted to define a pattern to their occurrence over the last 15 years, but cannot identify consistent triggers.
Age: 32.0
Sex: M
Vaccine: ANTH
Symptoms: Sinusitis, Urticaria, Wheezing, Yellow skin
Clinical narrative: Patient states that he developed hives within 48 hours of receiving the anthrax vaccine. He reports he was covered in hives from the neck down as well as had aching joints in the hands, knees, elbows and wrists; additionally his finger joints were swollen. This was the first time he had experienced any allergic skin conditions; subsequently he was given a permanent exemption to the anthrax vaccine. He denies this skin reaction after any other vaccination or medication. He did not receive the smallpox vaccine. Patient reports that he has continued to have urticarial outbreaks with the same characteristics and in the same locations, approximately every 2-4 months since this initial episode. The hives are dime to half dollar size and extremely pruritic, when "flattened out" they are yellowish in color. Episodes can last from a couple days to several weeks. He has attempted to define a pattern to their occurrence over the last 15 years, but cannot identify consistent triggers.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site cellulitis, Injection site erythema, Pyrexia
Clinical narrative: Rash Hives and itching at the injection site.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pruritus, Injection site rash, Injection site urticaria
Clinical narrative: Rash Hives and itching at the injection site.
Age: 67.0
Sex: M
Vaccine: PNC13
Symptoms: Cough, Dyspnoea, Impaired work ability, Pulmonary oedema, Rash generalised
Clinical narrative: Coughing, Wheezing and Trouble Breathing and a body Rash. The next two days, I could not go to work. I also had fluid in my lungs. I never had this before.
Age: 67.0
Sex: M
Vaccine: PNC13
Symptoms: Rash pruritic, Wheezing
Clinical narrative: Coughing, Wheezing and Trouble Breathing and a body Rash. The next two days, I could not go to work. I also had fluid in my lungs. I never had this before.
Age: 13.0
Sex: F
Vaccine: MEN
Symptoms: Cardiac disorder, Cough, Ear infection, Eye infection, Pyrexia
Clinical narrative: Fever, tonsil infection, cough, hearing problem, ear infection, eye infection. Tylenol was given to reduce fever.
Age: 13.0
Sex: F
Vaccine: MEN
Symptoms: Tonsillitis
Clinical narrative: Fever, tonsil infection, cough, hearing problem, ear infection, eye infection. Tylenol was given to reduce fever.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain lower, Abdominal pain upper, Body temperature increased, Computerised tomogram normal, Hyperhidrosis
Clinical narrative: Information has been received from a female concerning her 13 year old granddaughter with no pertinent medical history and no history of drug reactions or allergies who on unspecified dates was vaccinated with the complete series of GARDASIL. There was no concomitant medication. Subsequently, in April 2008, the patient experienced severe pain on the bottom of her stomach on both sides and she was having blood clots. Because of these symptoms, the patient was hospitalized for 4 days. The patient also developed cyst. Ultrasound was performed (results not reported). As of 16-JUL-2008, the patient was at home but still complaining about severe pain in the lower part of her stomach and still has blood clots. This is one of three reports from the same source. (WAES: 0807USA03551 and 0807USA03552). Additional information has been requested. 8/21/08-ER records for DOS 4/2-4/4/08-presented with C/O abdominal pain and cramping. Menses began 3-4 days prior. Pale diaphoretic. Impression: abdominal pain, syncope. Temperature elevated. Urine culture E. coli. Seen in OB/GYN office 4/8/08-C/O continuous bleeding and abdominal pain. Follicular cyst of ovary. 6/4/08-continues to have heavy bleeding with cramps. Prescribed Ortho Novum 1/35. Seen on 7/15/08-last period without problems no longer taking birth control pills. Office did not administer Gadasil to client.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Menorrhagia, Muscle spasms, Ovarian cyst, Pallor, Syncope
Clinical narrative: Information has been received from a female concerning her 13 year old granddaughter with no pertinent medical history and no history of drug reactions or allergies who on unspecified dates was vaccinated with the complete series of GARDASIL. There was no concomitant medication. Subsequently, in April 2008, the patient experienced severe pain on the bottom of her stomach on both sides and she was having blood clots. Because of these symptoms, the patient was hospitalized for 4 days. The patient also developed cyst. Ultrasound was performed (results not reported). As of 16-JUL-2008, the patient was at home but still complaining about severe pain in the lower part of her stomach and still has blood clots. This is one of three reports from the same source. (WAES: 0807USA03551 and 0807USA03552). Additional information has been requested. 8/21/08-ER records for DOS 4/2-4/4/08-presented with C/O abdominal pain and cramping. Menses began 3-4 days prior. Pale diaphoretic. Impression: abdominal pain, syncope. Temperature elevated. Urine culture E. coli. Seen in OB/GYN office 4/8/08-C/O continuous bleeding and abdominal pain. Follicular cyst of ovary. 6/4/08-continues to have heavy bleeding with cramps. Prescribed Ortho Novum 1/35. Seen on 7/15/08-last period without problems no longer taking birth control pills. Office did not administer Gadasil to client.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Thrombosis, Ultrasound pelvis abnormal
Clinical narrative: Information has been received from a female concerning her 13 year old granddaughter with no pertinent medical history and no history of drug reactions or allergies who on unspecified dates was vaccinated with the complete series of GARDASIL. There was no concomitant medication. Subsequently, in April 2008, the patient experienced severe pain on the bottom of her stomach on both sides and she was having blood clots. Because of these symptoms, the patient was hospitalized for 4 days. The patient also developed cyst. Ultrasound was performed (results not reported). As of 16-JUL-2008, the patient was at home but still complaining about severe pain in the lower part of her stomach and still has blood clots. This is one of three reports from the same source. (WAES: 0807USA03551 and 0807USA03552). Additional information has been requested. 8/21/08-ER records for DOS 4/2-4/4/08-presented with C/O abdominal pain and cramping. Menses began 3-4 days prior. Pale diaphoretic. Impression: abdominal pain, syncope. Temperature elevated. Urine culture E. coli. Seen in OB/GYN office 4/8/08-C/O continuous bleeding and abdominal pain. Follicular cyst of ovary. 6/4/08-continues to have heavy bleeding with cramps. Prescribed Ortho Novum 1/35. Seen on 7/15/08-last period without problems no longer taking birth control pills. Office did not administer Gadasil to client.
Age: 15.0
Sex: M
Vaccine: HEP, IPV, MMR, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Mycobacterium tuberculosis complex test positive
Clinical narrative: Redness and swelling at injection site.
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Eye movement disorder, Fall
Clinical narrative: Pt had a lab drawn and one immunization. He acknowledged verbally through that he was ok when asked. He came out to hallway and we checked his college form. As I turned to say something, his eyes rolled and I was able to catch him as he went down. Leg elevation and water. His parent was called and came and got him.
Age: 32.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Diarrhoea, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: 6/19/15 office visit notes: History: The symptoms are reported as being moderate. The symptoms occur daily. He states the symptoms are acute and are of new onset. Here with swelling to right deltoid after having immunization on Wednesday (17th). Has not had fever. Has pain and swelling, with pink area and warm to site. Has diarrhea since then. Has not tried anything for pain. Assessment/Plan: Swelling of arm. Ice to warm, raised area on the right upper arm.  10-15 minutes of ice them remove. Ibuprofen for pain Return as needed. Swelling should reduce over the next 48 hours. 6/22/15 at 9:47 am.  I called patient via interpreter. He said onset of symptoms was almost immediate. Arm became uncomfortable to move. Arm is much better now. Last dose of ibuprofen was last night, doesn't need today. Can move arm freely without pain. Swelling almost all gone, some firmness in the center. Still some tenderness when push on area.  To return call if symptoms get worse.
Age: 32.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Limb discomfort, Peripheral swelling, Tenderness
Clinical narrative: 6/19/15 office visit notes: History: The symptoms are reported as being moderate. The symptoms occur daily. He states the symptoms are acute and are of new onset. Here with swelling to right deltoid after having immunization on Wednesday (17th). Has not had fever. Has pain and swelling, with pink area and warm to site. Has diarrhea since then. Has not tried anything for pain. Assessment/Plan: Swelling of arm. Ice to warm, raised area on the right upper arm.  10-15 minutes of ice them remove. Ibuprofen for pain Return as needed. Swelling should reduce over the next 48 hours. 6/22/15 at 9:47 am.  I called patient via interpreter. He said onset of symptoms was almost immediate. Arm became uncomfortable to move. Arm is much better now. Last dose of ibuprofen was last night, doesn't need today. Can move arm freely without pain. Swelling almost all gone, some firmness in the center. Still some tenderness when push on area.  To return call if symptoms get worse.
Age: 1.26
Sex: F
Vaccine: DTAP, HIBV, PNC13
Symptoms: Body temperature increased, Chest X-ray normal, Chills, Computerised tomogram head normal, Cyanosis
Clinical narrative: Per Mom, 102.5 axillary temp, chills, jerking, convulsing movements to upper body. Mom called 911. Patients lips turned blue and patient started foaming at the mouth. Per mom seizure lasted about 2 minutes. Patient taken to ER. On 06/19/2015 patient developed a rash on stomach and back was diagnosed with Roseola.
Age: 1.26
Sex: F
Vaccine: DTAP, HIBV, PNC13
Symptoms: Dyskinesia, Foaming at mouth, Laboratory test normal, Rash, Roseola
Clinical narrative: Per Mom, 102.5 axillary temp, chills, jerking, convulsing movements to upper body. Mom called 911. Patients lips turned blue and patient started foaming at the mouth. Per mom seizure lasted about 2 minutes. Patient taken to ER. On 06/19/2015 patient developed a rash on stomach and back was diagnosed with Roseola.
Age: 1.26
Sex: F
Vaccine: DTAP, HIBV, PNC13
Symptoms: Seizure
Clinical narrative: Per Mom, 102.5 axillary temp, chills, jerking, convulsing movements to upper body. Mom called 911. Patients lips turned blue and patient started foaming at the mouth. Per mom seizure lasted about 2 minutes. Patient taken to ER. On 06/19/2015 patient developed a rash on stomach and back was diagnosed with Roseola.
Age: 1.06
Sex: M
Vaccine: HIBV, MMR, PNC13, VARCEL
Symptoms: Injection site rash, Rash, Streptococcus test negative
Clinical narrative: Received vaccination 6/12. Very next evening rash started on thighs. Throughout the following week rash spread to legs, trunk and arms. Seen by provider, 6/22/15.
Age: 87.0
Sex: M
Vaccine: PNC13
Symptoms: Blood test abnormal, Leukopenia, White blood cell count decreased
Clinical narrative: This is a spontaneous report obtained from a contactable physician that reported about himself. A 87 year-old male patient received, on 10Jun2015, intramuscular PREVNAR 13 0.5 ml, single dose. Relevant medical history included ongoing macular degeneration. Concomitant medications included LUPRON, injections twice a year, every 6 months for the past 10-15 years and an unspecified eye injections. On 11Jun2015, the patient experienced moderate leukocytopenia. The patient did not recover from the event at time of this report. Patient's clinical course was the following: patient received PREVNAR 13 vaccination by his own physician on 10Jun2015. He did not receive any other injections that day. He didn't feel any different. Routine blood work performed on 11Jun2015 showed moderate leukocytopenia.
Age: 0.23
Sex: M
Vaccine: HIBV, PNC13
Symptoms: Anaemia, Haemoglobin decreased, Petechiae, Platelet count decreased, Thrombocytopenia
Clinical narrative: Petechiae, thrombocytopenia, anemia.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Autoantibody positive, Autonomic nervous system imbalance, Complex regional pain syndrome, Fatigue, Impaired gastric emptying
Clinical narrative: Within 2 weeks of the vaccine, patient developed significant right leg pain and fatigue. Within 3 weeks, she was unable to bear any weight on her right leg and was diagnosed with CRPS. She developed dysautonomia (POTS, gastroparesis) within 4 or 5 weeks of the vaccine. She has tested positive for anti-B1 and B2 adrenergic receptor autoantibodies plus M2 muscarinic and ganglionic receptor autoantibodies. Her case was written up. Of note, she also developed extreme fatigue and right leg pain after GARDASIL #1, though did not have full blown CRPS symptoms or dysautonomia symptoms until after vaccine #2.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Pain in extremity, Postural orthostatic tachycardia syndrome, Weight bearing difficulty
Clinical narrative: Within 2 weeks of the vaccine, patient developed significant right leg pain and fatigue. Within 3 weeks, she was unable to bear any weight on her right leg and was diagnosed with CRPS. She developed dysautonomia (POTS, gastroparesis) within 4 or 5 weeks of the vaccine. She has tested positive for anti-B1 and B2 adrenergic receptor autoantibodies plus M2 muscarinic and ganglionic receptor autoantibodies. Her case was written up. Of note, she also developed extreme fatigue and right leg pain after GARDASIL #1, though did not have full blown CRPS symptoms or dysautonomia symptoms until after vaccine #2.
Age: 18.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, VARCEL
Symptoms: Electroencephalogram abnormal, Eye movement disorder, Hypotonia, Muscle twitching, Opisthotonus
Clinical narrative: While traveling in car with mother her eyes rolled back, her back arched and head tilted back. Hands began to twitch and she then went limp in car. Mother drove her to hospital. She was treated with KEPPRA IV for seizure. Had another seizure since. Tested at neurologist office put on 24 hr monitor which still showed seizure activity.
Age: 18.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, VARCEL
Symptoms: Posture abnormal, Seizure
Clinical narrative: While traveling in car with mother her eyes rolled back, her back arched and head tilted back. Hands began to twitch and she then went limp in car. Mother drove her to hospital. She was treated with KEPPRA IV for seizure. Had another seizure since. Tested at neurologist office put on 24 hr monitor which still showed seizure activity.
Age: 5.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Wrong drug administered
Clinical narrative: Child was given Kinrix. After administering the shot and the child had left the clinic, the nurse found a note that the doctor had recommended that the child only have DT.  Primary pediatric doctor was notified as well as parent of child.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Exposure during pregnancy, Pregnancy test urine positive
Clinical narrative: This spontaneous prospective pregnancy report as received from nurse practitioner refers to a female patient of unknown age. No concurrent condition or medical history reported. On 04-JUN-2015, the patient was vaccinated with the third dose of three series (first and second dose administration dates were not confirmed by the reporter) GARDASIL lot # K023432; expiry date: 18-JUN-2016, intramuscular. On the same day, the patient had a positive pregnancy test confirmed by urine based pregnancy test. The patient's last menstrual period, gestation and estimated date of delivery was unknown. No medical attention was sought by the patient. Action taken with the suspect drug was not applicable. The outcome of the event was unknown. No product quality complaint was reported. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 62 year old elderly female patient. No information about medical history, concurrent conditions was reported for the patient. On 08-JUN-2015 the patient was vaccinated with one dose of ZOSTAVAX, lot L011529, expiration date 03-JUL-2016. 0.65 ml, subcutaneously. Concomitant therapies included CLARITIN, ZYLET and ESTRACE. On 10-JUN-2015, the patient experience3d 2 inch by 2 inch red, warm, raised, swollen rash around the site of injection. Varicella Zoster Virus Identification Program (VZVIP) package sent to pharmacist and physician assistant. The patient applied ice to the injection site as the treatment for the events reported. The outcome of events was reported as not recovered/not resolved. The patient sought medical attention. No product quality complaint was involved. The causality was not provided by the reporter. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Injection site cellulitis, Skin lesion
Clinical narrative: Significant cellulitis of upper right arm starting evening of Menveo administration, worsening over following 48 hours. Seen in ER and given po clindamycin. Seen back in provider's office 2 days later for follow-up- lesion spreading further so sent back to ER.
Age: 37.0
Sex: M
Vaccine: MMR
Symptoms: Mumps antibody test negative
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 37 year old male patient with back pain, no drug reactions and no concomitant medication. On an unknown dates, the patient was vaccinated with two doses of M-M-R II dose, route of administration, lot number and expiration date unknown. On 27-MAY-2015, the patient sought medical attention for an unspecified reason at the office of healthcare worker. The result of a mumps titer obtained on 27-MAY-2015 was Antibody (AB) Immunoglobulin G (IGG): 1,04: low. Healthcare worker additionally stated the patient's results were a negative titer for mumps. The outcome of the event was not reported. The relatedness between the event and the therapy with M-M-R II was not reported. Additional information has been requested.
Age: 11.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a 11 years old patient of unknown gender. No information on patient's medical history or concurrent conditions was provided. On 26-JAN-2015, the patient was vaccinated with the dose of GARDASIL lot # K008213 (dose, strength, route of administration and expiration date were not reported) which had temperature excursion (incorrect product storage). No information on patient's concomitant medication was provided. Nurse practitioner confirmed that no adverse events were reported. This is one of several reports from the same reporter. Additional information has been requested.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: This spontaneous report as received from a pharmacist via an other company representative refers to a 60 year old male patient. There was no information about concomitant medications and pertinent medical history reported. On 02-MAY-2015, the patient was vaccinated with a dose of ZOSTAVAX dose, route, lot #, expiration date were not reported. On 01-JUN-2015, the patient experienced an aching feeling under his arm. The patient reported that on a pain scale from 1-10 with 10 being the strong pain, he was experiencing a 2. Patient sought medical attention in an office visit on unknown date. No specific treatment or lab diagnostic tests were performed. The outcome of event was unknown. The relatedness between ZOSTAVAX and event was not reported. Additional information has been requested.
Sex: M
Vaccine: MMR
Symptoms: Autism
Clinical narrative: This spontaneous report as received an unspecified reporter via social media refers to an unknown number of male patients of unknown age with no medical history or concurrent conditions reported. On an unknown date, the patients were vaccinated "on-time" with MMR II (dose, route, lot number and expiration date were not reported) in accordance with the recommended centers of disease control (CDC) schedule. Concomitant therapy was unspecified. On an unknown date, the patients experienced autism. It was reported that "fraud at the CDC was uncovered, revealing 340% increased risk of autism that was hidden from the public". The outcome of autism was unknown. The reporter considered that autism was related to MMR II. Additional information is not expected as there is no contact details available for follow up. It has been determined that since this case is only reporting an increased risk for Autism, not an actual diverse event of a person developing Autism, this case should be voided.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. Medical history and concurrent conditions were not reported. On 12-JUN-2015, the patient was vaccinated with an expired dose of PNEUMOVAX23 lot # K009809, expiration date 16-MAY-2015, intramuscularly (dose was not reported). No co-suspect and concomitant therapies were reported. No adverse effects reported. This was the first dose of PNEUMOVAX drawn from this PNEUMOVAX Multi-Dose Vial. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous reprot was received from a License Practical Nurse refers to an adult patient of unknown age and gender. No pertinent emdical history was reported. On 17-JUN-2015, an adult patient was vaccinated with a pediatric dose of VAQTA 0.5 ml, intramuscular. No adverse experience was reported. No Product Quality complaint (PQC) was involved. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from the nurse refers unspecified number of patients of unspecified age and gender. Medical history and concurrent conditions were not reported. In 2015 (reported as unspecified dates since 04-MAY-2015), the patients were vaccinated with, oral, ROTATEQ (lot number: K013861 and expiry date: 18-MAY-2016) (dose, frequency and route of administration were not reported) which was exposed to temperatures outside of the recommended range. No adverse effects have been reported. The outcome of the reported event was unknown. The causality of the suspect product was considered to be not related to the event. No product quality complaint (PQC) was filed. No additional information was provided. This is one of several reports from the same reporter. Additional information has been requested.
Age: 12.0
Sex: M
Vaccine: HPV4
Symptoms: Arthralgia
Clinical narrative: This spontaneous report as received from a physician via company representative refers to a 12 year old male patient. Medical history and concurrent conditions were not reported. At the end of May 2015, the patient was vaccinated with the first dose of GARDASIL (dose, route, lot number and expiration date were not reported). No co-suspect and concomitant therapies were reported. On 07-JUN-2015, the patient experienced joint pain. The outcome of arthralgia was unknown. The causality was not reported. The patient sought medical attention (unknown if the patient had an office visit with the physician, or the patient called the physician). The physician mentioned the patient had an appointment to follow up with an unspecified neurologist on an unspecified date. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to an unspecified number of patients of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On unknown dates, the patients were vaccinated with doses of improperly stored PROQUAD (Merck), subcutaneously, dose 0.5 ml, (lot # K022447, expiration date: 13-MAY_2016, 4 doses: lot# K025766, expiration date: 08-JUN-2016, 3 doses), (injection site was not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Follow up information has been received on 18-JUN-2015. All telephone attempts to obtain follow-up information have been unsuccessful. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker, refers to unspecified number of patients of unknown age and gender. No pertinent medical history, drug reactions or allergies and concomitant medications were reported. On unspecified dates, the unspecified number of patients received doses of GARDASIL (dose, frequency, lot#, expiration date, indication were not reported) that were improperly stored. No adverse experience was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant referring to an unspecified number of unspecified patients of unknown age and gender. Concurrent conditions or pertinent medical history were not reported. It was stated by the medical assistant that on unspecified dates since 02-JUN-2015, the patients were administered with an unspecified number of improperly stored (Oka/Merck) VARIVAX (lot #, expiration date and frequency were not reported), subcutaneous injection. No adverse effects were reported. Concomitant therapies were unknown. This is one of two reports from the same source. Additional information has been requested.
Age: 0.33
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC13, RV5
Symptoms: Cytogenetic analysis, Hydrocephalus, Lethargy, Nuclear magnetic resonance imaging brain abnormal, Pallor
Clinical narrative: The following morning pt noted to be pale, decreased responsiveness, lethargic, then noted to have several seizures over proceeding few hours. Hospitalized for several days with trial of medications to control seizures.
Age: 0.33
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC13, RV5
Symptoms: Seizure, Slow response to stimuli
Clinical narrative: The following morning pt noted to be pale, decreased responsiveness, lethargic, then noted to have several seizures over proceeding few hours. Hospitalized for several days with trial of medications to control seizures.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from the nurse refers unspecified number of patients of unspecified age and gender. Medical history and concurrent conditions were not reported. On 04-MAY-2015, the patients were vaccinated with GARDASIL (lot number: K023432 and expiry date: 18-JUN-2016) (dose, frequency and route of administration was not reported) which was exposed to temperatures outside of the recommended range (incorrect product storage). No adverse effects have been reported. The outcome of the reported event was unknown. The causality of the suspect product was considered to be not related to the event. No product quality complaint (PQC) was filed. No additional information was provided. This is one of several reports from the same reporter. 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 licensed practical nurse refers to an unspecified number of patients of unknown age and gender. The patients' pertinent medical history and concurrent conditions were not provided. On unknown dates, the patients were vaccinated with doses of VAQTA (route, lot numbers and expiration dates were not provided). On unknown dates, there was incorrect product storage as an unspecified number of patients received doses of VAQTA improperly stored. No adverse effect was reported. It was unknown if the patients sought medical attention. At the time of the report, the patients status was unknown. This is one of several reports received from the same source. Additional information has been requested.