chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 34.0
Sex: F
Vaccine: FLU4
Symptoms: Joint range of motion decreased, Pain in extremity, Pyrexia
Clinical narrative: Patient states she had mild fever that resolved the next day, however, arm was still hurting as of 11/1/2017 with limited range of motion in arm. Patient called pharmacy to ask if this was normal and to find out what to do. Pharmacist advised her to ice it and call physician.
Age: 12.0
Sex: M
Vaccine: FLU4
Symptoms: Loss of consciousness, Nausea, Pallor, Seizure, Vomiting
Clinical narrative: After receiving the vaccine, patient passed out with some convulsion activity. We called 911 and while on the call, patient regained his consciousness but was very nauseated and skin was pale. Patient proceeded to throw up a few times and continued to look pale. The police and fire department came. Patient was feeling a better but still pale and nauseous. Patient was then being transported out of the store on a stretcher but not sure where patient is being transported to.
Age: 0.75
Sex: F
Vaccine: HEP
Symptoms: Blood culture negative, Full blood count normal, Pyrexia, Seizure, Urine analysis normal
Clinical narrative: My daughter received her 9 month hep B vaccine, the following day she woke up with a fever, which eventually lead to a seizure and transport to the local ER. Blood work/urine came back normal.
Age: 67.0
Sex: F
Vaccine: FLU4, PPV, TDAP
Symptoms: Injection site rash
Clinical narrative: Pt received Immunization for PPV 23, Tdap and Influenza on 10/30/17, returned to clinic on 10/31/17 with c/o rash to (L) upper arm assessed by provider and given Loratadine 10mg.
Age: 16.0
Sex: F
Vaccine: FLU4, MNQ
Symptoms: Back pain, Myalgia, Neck pain, Pain
Clinical narrative: Body aches, myalgias, neck and back pain. No fevers.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Fatigue, Headache, Influenza like illness, Night sweats
Clinical narrative: Flu type symptoms on and off x 5 days fatigue, headache, chills, night sweats, low grade fever.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: Flu type symptoms on and off x 5 days fatigue, headache, chills, night sweats, low grade fever.
Age: 19.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Erythema, Injection site discomfort, Pyrexia, Tenderness
Clinical narrative: Discomfort at injection site beginning 10/28. Fever evening of 10/29. 10/31 (L) arm with well circumscribed 7cm x 5cm reddened area with fullness and tenderness.
Age: 15.0
Sex: F
Vaccine: TDAP, VARCEL
Symptoms: Cellulitis
Clinical narrative: Suspected cellulitis, treated with antibiotic, unaware of outcome.
Age: 26.0
Sex: M
Vaccine: FLU3, TDAP
Symptoms: Blood glucose decreased, Hypoglycaemia, Immediate post-injection reaction, Syncope
Clinical narrative: Patient fainted approximately 3 sec after receiving 2nd TDAP vaccine.
Age: 17.0
Sex: F
Vaccine: FLUX
Symptoms: Blood glucose decreased, Syncope
Clinical narrative: Patient fainted after the shot. She would come in out though 911 was called and they checked her sugar (blood sugar) it registered as 67. Mom said that they didn't go to the ER and patient recovered and is now well.
Age: 61.0
Sex: F
Vaccine: PNC13
Symptoms: Pruritus, Rash
Clinical narrative: The patient came in today and I was able to check the injection site. She developed a rash near the injection site and she complained of itching.
Age: 69.0
Sex: M
Vaccine: FLU3, PPV, VARZOS
Symptoms: Insomnia, Musculoskeletal pain, Pain, Pain in extremity, Rash macular
Clinical narrative: Started feeling pain scale of 1 - 10 - 15, couldn't move arm w/o tremendous pain, trouble sleeping, then blotchy red spots on arm and shoulder. Pain was in shoulder and arm to elbow. Next day blotchy redness spots gone, and pain went from 9 to 7. Occurred approximately 6 hrs after shot received. Pt will go to MD 11/2/17.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Anaphylactic shock
Clinical narrative: Anaphylactic shock.
Age: 58.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injection site erythema, Injection site rash, Injection site reaction, Injection site warmth, Rash macular
Clinical narrative: Red blotchy semi warm rash distal to injection site.
Age: 32.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injection site erythema, Injection site warmth, Pain in extremity
Clinical narrative: Left arm is red below injection site. Hot to touch and pt is c/o a lot of pain in entire arm. Advised warm compress and alternate TYLENOL and ibuprofen. Go to ER if has any drainage, develops fever or red streaks.
Age: 76.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Loss of consciousness
Clinical narrative: Initial unsolicited report received from a consumer on 24-Oct-2017 and additional information received on 24-Oct-2017. This case involves a 75-year-old female patient who was vaccinated with a single dose of FLUZONE HD (batch number, expiry date and site of administration were not reported) via intramuscular route on 18-Oct-2017. The patient had a medical history of allergy to latex and IV dye. The patient's medical history and concomitant medications were not reported. On 20-Oct-2017, two days following the vaccination, the patient was so scared, felt completely numb and while driving on main highway about 5 pm and she "blacked out" and when she woke up, she was sitting at a traffic light waiting to turn, but in the wrong lane. Patient saw a car heading toward her in her lane. Luckily the woman driving stopped the car. The other car stopped less than a car length in front of her. Patient just remembers seeing a little boy in the same car waving both hands at her. Traffic stopped and allowed her to turn. Patient remembered how to get home and she got home okay. Patient kept trying to remember what happened, but she could not. Patient states this has never happened before. Patient was crying while on the phone with MIS. Patient was still very upset over the incident. Patient unable to recall what happened to her until the next day. The patient's laboratory data and corrective treatment were not reported. On an unknown date the patient was recovered from Loss of consciousness and outcome of other event was not reported. Upon internal review the case was considered as serious because of important medical event: Loss of consciousness. List of documents held by sender: none.; Sender's Comments: This is poorly documented case, of patient who developed loss of consciousness 2 day after vaccination with FLUZONE HD. Detail history regarding, immune status at the time of vaccination, medical history, technique used for vaccination, any neurological disorder are needed to further assess the case.
Age: 76.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Crying, Emotional distress, Fear, Hypoaesthesia, Loss of consciousness
Clinical narrative: Initial unsolicited report received from a consumer on 24-Oct-2017 and additional information received on 24-Oct-2017. This case involves a 75-year-old female patient who was vaccinated with a single dose of FLUZONE HD (batch number, expiry date and site of administration were not reported) via intramuscular route on 18-Oct-2017. The patient had a medical history of allergy to latex and IV dye. The patient's medical history and concomitant medications were not reported. On 20-Oct-2017, two days following the vaccination, the patient was so scared, felt completely numb and while driving on main highway about 5 pm and she "blacked out" and when she woke up, she was sitting at a traffic light waiting to turn, but in the wrong lane. Patient saw a car heading toward her in her lane. Luckily the woman driving stopped the car. The other car stopped less than a car length in front of her. Patient just remembers seeing a little boy in the same car waving both hands at her. Traffic stopped and allowed her to turn. Patient remembered how to get home and she got home okay. Patient kept trying to remember what happened, but she could not. Patient states this has never happened before. Patient was crying while on the phone with MIS. Patient was still very upset over the incident. Patient unable to recall what happened to her until the next day. The patient's laboratory data and corrective treatment were not reported. On an unknown date the patient was recovered from Loss of consciousness and outcome of other event was not reported. Upon internal review the case was considered as serious because of important medical event: Loss of consciousness. List of documents held by sender: none.; Sender's Comments: This is poorly documented case, of patient who developed loss of consciousness 2 day after vaccination with FLUZONE HD. Detail history regarding, immune status at the time of vaccination, medical history, technique used for vaccination, any neurological disorder are needed to further assess the case.
Age: 76.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Memory impairment
Clinical narrative: Initial unsolicited report received from a consumer on 24-Oct-2017 and additional information received on 24-Oct-2017. This case involves a 75-year-old female patient who was vaccinated with a single dose of FLUZONE HD (batch number, expiry date and site of administration were not reported) via intramuscular route on 18-Oct-2017. The patient had a medical history of allergy to latex and IV dye. The patient's medical history and concomitant medications were not reported. On 20-Oct-2017, two days following the vaccination, the patient was so scared, felt completely numb and while driving on main highway about 5 pm and she "blacked out" and when she woke up, she was sitting at a traffic light waiting to turn, but in the wrong lane. Patient saw a car heading toward her in her lane. Luckily the woman driving stopped the car. The other car stopped less than a car length in front of her. Patient just remembers seeing a little boy in the same car waving both hands at her. Traffic stopped and allowed her to turn. Patient remembered how to get home and she got home okay. Patient kept trying to remember what happened, but she could not. Patient states this has never happened before. Patient was crying while on the phone with MIS. Patient was still very upset over the incident. Patient unable to recall what happened to her until the next day. The patient's laboratory data and corrective treatment were not reported. On an unknown date the patient was recovered from Loss of consciousness and outcome of other event was not reported. Upon internal review the case was considered as serious because of important medical event: Loss of consciousness. List of documents held by sender: none.; Sender's Comments: This is poorly documented case, of patient who developed loss of consciousness 2 day after vaccination with FLUZONE HD. Detail history regarding, immune status at the time of vaccination, medical history, technique used for vaccination, any neurological disorder are needed to further assess the case.
Age: 57.0
Sex: F
Vaccine: FLUC4, FLU3
Symptoms: Musculoskeletal pain
Clinical narrative: Right shoulder and arm pain started on day of injection, still having pain a month later.
Age: 57.0
Sex: F
Vaccine: FLUC4, FLU3
Symptoms: Injection site pain, Pain in extremity, X-ray limb normal
Clinical narrative: Right shoulder and arm pain started on day of injection, still having pain a month later.
Age: 13.0
Sex: M
Vaccine: HPV9, HPV9, HPV9
Symptoms: Immunoglobulin therapy, Paediatric autoimmune neuropsychiatric disorders associated with streptococcal infection, Vaccination complication
Clinical narrative: This spontaneous report was received from the patient's mother and refers to her son, an approximately 13 year old male patient. The patient had no concomitant medications, medical history or drug reactions/allergies. The patient's concurrent conditions was not provided. On 14-APR-2017, the patient was vaccinated with a dose of GARDASIL 9 (lot # M016193, with an expiration date in 24-APR-2018), intramuscular, for prevention of human papillomavirus (HPV) disease (dose, dose number and frequency were not provided). Since the vaccination on 14-APR-2017, the patient had not been right, and it was reported that the patient could no longer write, had major obsessive-compulsive disorder (OCD), could not go to school, and could not do anything on his own, and on an unspecified day in May 2017, the patient was diagnosed with pediatric autoimmune neuropsychiatric disorders associated with streptococcal infection (pandas). The patient sought medical attention on unspecified dates by visiting the doctor and specialists (unspecified), and went to the emergency room on 29-JUL-2017, where "several test including an electrocardiogram (EKG), strep screen follow up, eve with differential, and urinalysis auto scope" (results were not provided) where performed. Furthermore, it was reported that no treatment was prescribed. At the time of reporting, the outcome of pediatric autoimmune neuropsychiatric disorders associated with streptococcal infection was reported as not recovered. The causal relationship between GARDASIL 9 and pediatric autoimmune neuropsychiatric disorders associated with streptococcal infection was not provided. Upon internal review, the event pediatric autoimmune neuropsychiatric disorders associated with streptococcal infection was determined to be disabling because the patient could not return to the school, and also he cannaot do anything for his own.
Age: 13.0
Sex: M
Vaccine: HPV9, HPV9, HPV9
Symptoms: Differential white blood cell count, Dysgraphia, Electrocardiogram, Loss of personal independence in daily activities, Obsessive-compulsive disorder
Clinical narrative: This spontaneous report was received from the patient's mother and refers to her son, an approximately 13 year old male patient. The patient had no concomitant medications, medical history or drug reactions/allergies. The patient's concurrent conditions was not provided. On 14-APR-2017, the patient was vaccinated with a dose of GARDASIL 9 (lot # M016193, with an expiration date in 24-APR-2018), intramuscular, for prevention of human papillomavirus (HPV) disease (dose, dose number and frequency were not provided). Since the vaccination on 14-APR-2017, the patient had not been right, and it was reported that the patient could no longer write, had major obsessive-compulsive disorder (OCD), could not go to school, and could not do anything on his own, and on an unspecified day in May 2017, the patient was diagnosed with pediatric autoimmune neuropsychiatric disorders associated with streptococcal infection (pandas). The patient sought medical attention on unspecified dates by visiting the doctor and specialists (unspecified), and went to the emergency room on 29-JUL-2017, where "several test including an electrocardiogram (EKG), strep screen follow up, eve with differential, and urinalysis auto scope" (results were not provided) where performed. Furthermore, it was reported that no treatment was prescribed. At the time of reporting, the outcome of pediatric autoimmune neuropsychiatric disorders associated with streptococcal infection was reported as not recovered. The causal relationship between GARDASIL 9 and pediatric autoimmune neuropsychiatric disorders associated with streptococcal infection was not provided. Upon internal review, the event pediatric autoimmune neuropsychiatric disorders associated with streptococcal infection was determined to be disabling because the patient could not return to the school, and also he cannaot do anything for his own.
Age: 13.0
Sex: M
Vaccine: HPV9, HPV9, HPV9
Symptoms: Paediatric autoimmune neuropsychiatric disorders associated with streptococcal infection, Streptococcus test, Urine analysis
Clinical narrative: This spontaneous report was received from the patient's mother and refers to her son, an approximately 13 year old male patient. The patient had no concomitant medications, medical history or drug reactions/allergies. The patient's concurrent conditions was not provided. On 14-APR-2017, the patient was vaccinated with a dose of GARDASIL 9 (lot # M016193, with an expiration date in 24-APR-2018), intramuscular, for prevention of human papillomavirus (HPV) disease (dose, dose number and frequency were not provided). Since the vaccination on 14-APR-2017, the patient had not been right, and it was reported that the patient could no longer write, had major obsessive-compulsive disorder (OCD), could not go to school, and could not do anything on his own, and on an unspecified day in May 2017, the patient was diagnosed with pediatric autoimmune neuropsychiatric disorders associated with streptococcal infection (pandas). The patient sought medical attention on unspecified dates by visiting the doctor and specialists (unspecified), and went to the emergency room on 29-JUL-2017, where "several test including an electrocardiogram (EKG), strep screen follow up, eve with differential, and urinalysis auto scope" (results were not provided) where performed. Furthermore, it was reported that no treatment was prescribed. At the time of reporting, the outcome of pediatric autoimmune neuropsychiatric disorders associated with streptococcal infection was reported as not recovered. The causal relationship between GARDASIL 9 and pediatric autoimmune neuropsychiatric disorders associated with streptococcal infection was not provided. Upon internal review, the event pediatric autoimmune neuropsychiatric disorders associated with streptococcal infection was determined to be disabling because the patient could not return to the school, and also he cannaot do anything for his own.
Age: 13.0
Sex: M
Vaccine: HPV9, HPV9, HPV9
Symptoms: Blood bilirubin increased, Blood folate normal, Blood immunoglobulin G normal, Blood urea nitrogen/creatinine ratio, Dysgraphia
Clinical narrative: This spontaneous report was received from the patient's mother and refers to her son, an approximately 13 year old male patient. The patient had no concomitant medications, medical history or drug reactions/allergies. The patient's concurrent conditions was not provided. On 14-APR-2017, the patient was vaccinated with a dose of GARDASIL 9 (lot # M016193, with an expiration date in 24-APR-2018), intramuscular, for prevention of human papillomavirus (HPV) disease (dose, dose number and frequency were not provided). Since the vaccination on 14-APR-2017, the patient had not been right, and it was reported that the patient could no longer write, had major obsessive-compulsive disorder (OCD), could not go to school, and could not do anything on his own, and on an unspecified day in May 2017, the patient was diagnosed with pediatric autoimmune neuropsychiatric disorders associated with streptococcal infection (pandas). The patient sought medical attention on unspecified dates by visiting the doctor and specialists (unspecified), and went to the emergency room on 29-JUL-2017, where "several test including an electrocardiogram (EKG), strep screen follow up, eve with differential, and urinalysis auto scope" (results were not provided) where performed. Furthermore, it was reported that no treatment was prescribed. At the time of reporting, the outcome of pediatric autoimmune neuropsychiatric disorders associated with streptococcal infection was reported as not recovered. The causal relationship between GARDASIL 9 and pediatric autoimmune neuropsychiatric disorders associated with streptococcal infection was not provided. Upon internal review, the event pediatric autoimmune neuropsychiatric disorders associated with streptococcal infection was determined to be disabling because the patient could not return to the school, and also he cannaot do anything for his own.
Age: 13.0
Sex: M
Vaccine: HPV9, HPV9, HPV9
Symptoms: Loss of personal independence in daily activities, Mean cell haemoglobin normal, Mean cell volume normal, Neutrophil count decreased, Obsessive-compulsive disorder
Clinical narrative: This spontaneous report was received from the patient's mother and refers to her son, an approximately 13 year old male patient. The patient had no concomitant medications, medical history or drug reactions/allergies. The patient's concurrent conditions was not provided. On 14-APR-2017, the patient was vaccinated with a dose of GARDASIL 9 (lot # M016193, with an expiration date in 24-APR-2018), intramuscular, for prevention of human papillomavirus (HPV) disease (dose, dose number and frequency were not provided). Since the vaccination on 14-APR-2017, the patient had not been right, and it was reported that the patient could no longer write, had major obsessive-compulsive disorder (OCD), could not go to school, and could not do anything on his own, and on an unspecified day in May 2017, the patient was diagnosed with pediatric autoimmune neuropsychiatric disorders associated with streptococcal infection (pandas). The patient sought medical attention on unspecified dates by visiting the doctor and specialists (unspecified), and went to the emergency room on 29-JUL-2017, where "several test including an electrocardiogram (EKG), strep screen follow up, eve with differential, and urinalysis auto scope" (results were not provided) where performed. Furthermore, it was reported that no treatment was prescribed. At the time of reporting, the outcome of pediatric autoimmune neuropsychiatric disorders associated with streptococcal infection was reported as not recovered. The causal relationship between GARDASIL 9 and pediatric autoimmune neuropsychiatric disorders associated with streptococcal infection was not provided. Upon internal review, the event pediatric autoimmune neuropsychiatric disorders associated with streptococcal infection was determined to be disabling because the patient could not return to the school, and also he cannaot do anything for his own.
Age: 13.0
Sex: M
Vaccine: HPV9, HPV9, HPV9
Symptoms: Platelet count normal, Streptococcus test positive
Clinical narrative: This spontaneous report was received from the patient's mother and refers to her son, an approximately 13 year old male patient. The patient had no concomitant medications, medical history or drug reactions/allergies. The patient's concurrent conditions was not provided. On 14-APR-2017, the patient was vaccinated with a dose of GARDASIL 9 (lot # M016193, with an expiration date in 24-APR-2018), intramuscular, for prevention of human papillomavirus (HPV) disease (dose, dose number and frequency were not provided). Since the vaccination on 14-APR-2017, the patient had not been right, and it was reported that the patient could no longer write, had major obsessive-compulsive disorder (OCD), could not go to school, and could not do anything on his own, and on an unspecified day in May 2017, the patient was diagnosed with pediatric autoimmune neuropsychiatric disorders associated with streptococcal infection (pandas). The patient sought medical attention on unspecified dates by visiting the doctor and specialists (unspecified), and went to the emergency room on 29-JUL-2017, where "several test including an electrocardiogram (EKG), strep screen follow up, eve with differential, and urinalysis auto scope" (results were not provided) where performed. Furthermore, it was reported that no treatment was prescribed. At the time of reporting, the outcome of pediatric autoimmune neuropsychiatric disorders associated with streptococcal infection was reported as not recovered. The causal relationship between GARDASIL 9 and pediatric autoimmune neuropsychiatric disorders associated with streptococcal infection was not provided. Upon internal review, the event pediatric autoimmune neuropsychiatric disorders associated with streptococcal infection was determined to be disabling because the patient could not return to the school, and also he cannaot do anything for his own.
Age: 50.0
Sex: F
Vaccine: FLUX, FLU4
Symptoms: Injected limb mobility decreased, Injection site pain, Nuclear magnetic resonance imaging, X-ray
Clinical narrative: 9/22/17 VACCINE GIVEN, 10/3/17 WENT TO ED AND URGENT CARE C/O PAIN, GIVE PAIN MEDS AND STEROIDS. 11/1/17 CURRENTLY GOING TO PT.
Age: 50.0
Sex: F
Vaccine: FLUX, FLU4
Symptoms: Nuclear magnetic resonance imaging, Pain
Clinical narrative: 9/22/17 VACCINE GIVEN, 10/3/17 WENT TO ED AND URGENT CARE C/O PAIN, GIVE PAIN MEDS AND STEROIDS. 11/1/17 CURRENTLY GOING TO PT.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Computerised tomogram normal, Headache
Clinical narrative: Non stop headache since receiving the vaccine. Headache started the evening of sept 26th (same day as receiving vaccine) and still have headache today.
Sex: U
Vaccine: FLU4
Symptoms: Drug administered at inappropriate site, Injected limb mobility decreased, Injection site pain, Loss of personal independence in daily activities, Pain
Clinical narrative: Shot was given extremely high in the arm, almost at shoulder joint. Pain in upper left arm for two days, becoming worse over the next four weeks. Now pain is severe and I can barely move my arm.  Everyday task, like getting dressed and washing hair have become almost impossible without extreme pain.
Age: 1.25
Sex: M
Vaccine: MMR
Symptoms: Vomiting
Clinical narrative: This spontaneous report was received from a licensed referring to a 15 month old male patient. The patient did not have concurrent conditions, drug reactions or allergies or medical history. The patient was not taking any concomitant medications. On 26-JUN-2017, the patient was vaccinated with the first dose of M-M-R II, for prophylaxis (dose, route of administration , lot #, and expiration date were not reported) diluted in sterile diluent (MRK) (dose, route of administration, lot number and expiration date were not reported) at age of 12 months. On 03-OCT-2017, the patient received the second dose of M-M-R II, lot # reported as N004933 with expiration date of 07-FEB-2019, for prophylaxis (dose, and route of administration were not reported) diluted in sterile diluent (MRK) (dose, route of administration, lot number and expiration date were not reported), when he was 15 months old. Then, 2 hours after the injection on the same day, the patient vomited for 5 times. No treatment was given for the adverse events and no laboratory tests were performed. No product quality complaint was involved. At the time of reporting, the outcome of the event of vomiting was unknown and its causal relationship between it and therapies with M-M-R II and sterile diluent (MRK) was not reported.
Age: 0.17
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, RV5
Symptoms: Gastrointestinal motility disorder
Clinical narrative: This spontaneous report was received from patient's father referring to a her infant daughter. The patient did not have concomitant medications, pertinent medical history and neither drug reactions or allergies. The patient's mother took prednisone (manufacturer unknown) tablets orally (strength, dose, frequency, indication were not reported) during her entire pregnancy (reported in MARRS # 1711USA000292) and continued to take this while nursing. On 29-SEP-2017, the patient was vaccinated with the first ROTATEQ, orally (strength, dose, lot # and expiration date were not provided) for prophylaxis. Other suspect vaccines included diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid, haemophilus B conjugate vaccine (meningococcal protein conjugate)(manufacturer unknown) orally, poliovirus vaccine inactivated (unspecified), diphtheria toxoid, tetanus toxoid, and hepatitis B vaccine (recombinant) (manufacturer unknown) (strength, dose, route of administration, lot # and expiration date were not provided for the vaccines) for prophylaxis. Other suspect therapies included prednisone (manufacturer unknown). The father stated that, since that date (29-SEP-2017), she had had one assisted and two unassisted bowel movements. The outcome of gastrointestinal motility disorder was reported as not resolved. The causality assessment between suspect drugs and the event of gastrointestinal motility disorder was not provided. This is one of two reports received from the same source. Sender's Comments: US-009507513-1711USA000292.
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Product preparation error
Clinical narrative: This spontaneous report as received from a practitioner refers to a female patient of unknown age.  There was no information about the patient's concurrent conditions, medical history or concomitant medication. On 10-DEC-2010, the patient was vaccinated with a dose of M-M-R II for prophylaxis (dose, route of administration, lot number and expiration date were not reported). On 24-DEC-2017, the patient was inadvertently vaccinated with a dose of VARIVAX for prophylaxis (dose, route of administration, lot number and expiration date were not reported). Subsequently, in January 2014, the patient was vaccinated with the second dose of M-M-R II for prophylaxis and in January 2015 the patient was vaccinated with the second dose of VARIVAX. The vaccines were mostly reconstituted with sterile diluent (MERCK). No adverse effects were reported.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. No information on the patient's pertinent medical history, concurrent conditions, concomitant medications drug reactions or allergies was provided. On 05-OCT-2017, the patient was vaccinated with improperly stored dose of PNEUMOVAX 23 injection, lot # M043987, expiry date: 14-OCT-2017 (strength, dose, frequency, route of administration were not reported) for prophylaxis. The temperature excursion and the time frames were unknown by the reporter. No previous temperature excursion was noted, data logger was not involved. No adverse effects reported. Product quality complaint (PQC) was not involved. This is one of 2 reports from the same reporter. Sender's Comments: US-009507513-1710USA013048.
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report was received from a pharmacist via a company representative, regarding a to a female patient of unknown age (over the age of 65). The patient's concurrent conditions, medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 intramuscularly, which had a lot # N022303 with an expiry date on 01-MAR-2018, (dose, frequency, anatomical location of administration were not provided) for prophylaxis. On an unspecified date after vaccination the patient experienced an injection site reaction" that consisted of "redness, swelling, and warmth to touch. She received BENADRYL as a treatment and fully recovered in about a day. The causal relationship between vaccination with PNEUMOVAX 23 and the events was not mentioned. This is one of two reports received from the same source. Sender's Comments: US-009507513-1711USA000350.
Sex: F
Vaccine: PPV
Symptoms: Hypoaesthesia, Injected limb mobility decreased, Injection site hypoaesthesia
Clinical narrative: This spontaneous report has been received from a 63 year old female registered nurse, reporting on herself with no concurrent conditions, allergies, drug reactions or pertinent medical history reported. There were no concomitant medications. On 06-NOV-2016 the patient was vaccinated with PNEUMOVAX 23 in the arm (dose, frequency, route of administration, lot number and expiration date were not provided) for vaccination. On 06-NOV-2016 (reported as 5 hours later), the patient experienced  in the arm where was given the vaccine of PNEUMOVAX 23 that the whole arm was numb (hypoesthesia) and could not move it (vaccination site movement impairment). The reporter states that the adverse events lasted an hour. No laboratories were performed; the patient monitored by herself the symptoms and did no sought medical attention. At the time of the reporting, the outcome of hypoesthesia and vaccination site movement impairment was reported as recovered. The causal relationship between the hypoesthesia and vaccination site movement impairment and the therapy with PNEUMOVAX 23 was not assessed.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. No information on the patient's pertinent medical history, concurrent conditions, concomitant medications drug reactions or allergies was provided. On 05-OCT-2017, the patient was vaccinated with improperly stored dose of PNEUMOVAX 23 injection, lot # M043987, expiry date: 14-OCT-2017 (strength, dose, frequency, route of administration were not reported) for prophylaxis. The temperature excursion and the time frames were unknown by the reporter. No previous temperature excursion was noted, data logger was not involved. No adverse effects reported. Product quality complaint (PQC) was not involved. This is one of 2 reports from the same reporter. Sender's Comments: US-009507513-1710USA007815.
Age: 11.0
Sex: M
Vaccine: HPV9
Symptoms: Blood aluminium, Blood mercury, Blood selenium, Computerised tomogram thorax abnormal, Cough
Clinical narrative: This spontaneous report has been received from a registered nurse, concerning an 11 year old male patient. It was reported that the patient had no drug reactions, allergies or pertinent medical history as well as concurrent conditions. Concomitant medications included prednisone, iron, MIRALAX, famotidine and amitriptyline. On 27-SEP-2016, the patient was vaccinated with the first dose of GARDASIL 9 lot number M009116 (strength, frequency, route of administration and expiration were not provided) for prophylaxis (reported as recommended for age group). Later, in November 2016 (reported as 2 months later), the patient developed a dry spasmodic cough. On 28-NOV-2016, the patient received the second dose of GARDASIL 9 (strength, frequency, route of administration, lot number and expiration were not provided) for prophylaxis (reported as recommended for age group) and on an unknown date, the patient developed generalized muscle weakness, pain and inability to walk that required the use of a wheelchair. On 10-MAY-2017, the patient was admitted a Hospital and on an unknown date, the patient was diagnosed with dysfunctional neurologic disorder. On an unknown date approximately in 2017, the patient had a computerized tomography (CT) scan of his chest that showed a left lower lobe consolidation that started on an unknown date. In addition, other laboratory studies were performed: complete blood count (CBC), complete metabolic panel, urinalysis, mercury level, vitamin D, lipid panel, aluminum and selenium level with unspecified results. The patient was treated with unspecified antibiotics. On 03-JUN-2017, the patient was discharged from the hospital. On an unknown date approximately in 2017, the reporter stated that the patient suffered from depression. At the time of reporting, outcome for dry spasmodic cough, dysfunctional neurologic disorder, left lower lobe consolidation and depression was unknown. The causal relationship between these adverse events and the therapy with GARDASIL 9 was not assessed. The event dysfunctional neurologic disorder was considered as a disabling event.
Age: 11.0
Sex: M
Vaccine: HPV9
Symptoms: Depression, Full blood count, Gait inability, Lipids, Lung consolidation
Clinical narrative: This spontaneous report has been received from a registered nurse, concerning an 11 year old male patient. It was reported that the patient had no drug reactions, allergies or pertinent medical history as well as concurrent conditions. Concomitant medications included prednisone, iron, MIRALAX, famotidine and amitriptyline. On 27-SEP-2016, the patient was vaccinated with the first dose of GARDASIL 9 lot number M009116 (strength, frequency, route of administration and expiration were not provided) for prophylaxis (reported as recommended for age group). Later, in November 2016 (reported as 2 months later), the patient developed a dry spasmodic cough. On 28-NOV-2016, the patient received the second dose of GARDASIL 9 (strength, frequency, route of administration, lot number and expiration were not provided) for prophylaxis (reported as recommended for age group) and on an unknown date, the patient developed generalized muscle weakness, pain and inability to walk that required the use of a wheelchair. On 10-MAY-2017, the patient was admitted a Hospital and on an unknown date, the patient was diagnosed with dysfunctional neurologic disorder. On an unknown date approximately in 2017, the patient had a computerized tomography (CT) scan of his chest that showed a left lower lobe consolidation that started on an unknown date. In addition, other laboratory studies were performed: complete blood count (CBC), complete metabolic panel, urinalysis, mercury level, vitamin D, lipid panel, aluminum and selenium level with unspecified results. The patient was treated with unspecified antibiotics. On 03-JUN-2017, the patient was discharged from the hospital. On an unknown date approximately in 2017, the reporter stated that the patient suffered from depression. At the time of reporting, outcome for dry spasmodic cough, dysfunctional neurologic disorder, left lower lobe consolidation and depression was unknown. The causal relationship between these adverse events and the therapy with GARDASIL 9 was not assessed. The event dysfunctional neurologic disorder was considered as a disabling event.
Age: 11.0
Sex: M
Vaccine: HPV9
Symptoms: Metabolic function test, Muscular weakness, Nervous system disorder, Pain, Urine analysis
Clinical narrative: This spontaneous report has been received from a registered nurse, concerning an 11 year old male patient. It was reported that the patient had no drug reactions, allergies or pertinent medical history as well as concurrent conditions. Concomitant medications included prednisone, iron, MIRALAX, famotidine and amitriptyline. On 27-SEP-2016, the patient was vaccinated with the first dose of GARDASIL 9 lot number M009116 (strength, frequency, route of administration and expiration were not provided) for prophylaxis (reported as recommended for age group). Later, in November 2016 (reported as 2 months later), the patient developed a dry spasmodic cough. On 28-NOV-2016, the patient received the second dose of GARDASIL 9 (strength, frequency, route of administration, lot number and expiration were not provided) for prophylaxis (reported as recommended for age group) and on an unknown date, the patient developed generalized muscle weakness, pain and inability to walk that required the use of a wheelchair. On 10-MAY-2017, the patient was admitted a Hospital and on an unknown date, the patient was diagnosed with dysfunctional neurologic disorder. On an unknown date approximately in 2017, the patient had a computerized tomography (CT) scan of his chest that showed a left lower lobe consolidation that started on an unknown date. In addition, other laboratory studies were performed: complete blood count (CBC), complete metabolic panel, urinalysis, mercury level, vitamin D, lipid panel, aluminum and selenium level with unspecified results. The patient was treated with unspecified antibiotics. On 03-JUN-2017, the patient was discharged from the hospital. On an unknown date approximately in 2017, the reporter stated that the patient suffered from depression. At the time of reporting, outcome for dry spasmodic cough, dysfunctional neurologic disorder, left lower lobe consolidation and depression was unknown. The causal relationship between these adverse events and the therapy with GARDASIL 9 was not assessed. The event dysfunctional neurologic disorder was considered as a disabling event.
Age: 11.0
Sex: M
Vaccine: HPV9
Symptoms: Vitamin D, Wheelchair user
Clinical narrative: This spontaneous report has been received from a registered nurse, concerning an 11 year old male patient. It was reported that the patient had no drug reactions, allergies or pertinent medical history as well as concurrent conditions. Concomitant medications included prednisone, iron, MIRALAX, famotidine and amitriptyline. On 27-SEP-2016, the patient was vaccinated with the first dose of GARDASIL 9 lot number M009116 (strength, frequency, route of administration and expiration were not provided) for prophylaxis (reported as recommended for age group). Later, in November 2016 (reported as 2 months later), the patient developed a dry spasmodic cough. On 28-NOV-2016, the patient received the second dose of GARDASIL 9 (strength, frequency, route of administration, lot number and expiration were not provided) for prophylaxis (reported as recommended for age group) and on an unknown date, the patient developed generalized muscle weakness, pain and inability to walk that required the use of a wheelchair. On 10-MAY-2017, the patient was admitted a Hospital and on an unknown date, the patient was diagnosed with dysfunctional neurologic disorder. On an unknown date approximately in 2017, the patient had a computerized tomography (CT) scan of his chest that showed a left lower lobe consolidation that started on an unknown date. In addition, other laboratory studies were performed: complete blood count (CBC), complete metabolic panel, urinalysis, mercury level, vitamin D, lipid panel, aluminum and selenium level with unspecified results. The patient was treated with unspecified antibiotics. On 03-JUN-2017, the patient was discharged from the hospital. On an unknown date approximately in 2017, the reporter stated that the patient suffered from depression. At the time of reporting, outcome for dry spasmodic cough, dysfunctional neurologic disorder, left lower lobe consolidation and depression was unknown. The causal relationship between these adverse events and the therapy with GARDASIL 9 was not assessed. The event dysfunctional neurologic disorder was considered as a disabling event.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a medical assistant referring to a 4 year old patient of unknown gender. Information about concurrent condition, concomitant medication and medical history was not provided. On 25-AUG-2017, the patient was vaccinated with an improperly stored PROQUAD (dose, route, lot # and expiration date were not reported) for prophylaxis. No adverse effects were reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA004852: US-009507513-1710USA014164.
Age: 1.5
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a medical assistant referring to a 18 months old patient of unknown gender. Information about concurrent condition, concomitant medication and medical history was not provided. On 13-SEP-2017, the patient was vaccinated with an improperly stored PROQUAD (dose, route, lot # and expiration date were not reported) for prophylaxis. No adverse effects were reported. This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1709USA004852: US-009507513-1710USA014163:
Age: 5.0
Sex: M
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 5 year old male patient. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 18-SEP-2017, the patient was vaccinated with improperly stored PROQUAD lot # M036295, expiration date 13-FEB-2018, (strength, dose, dose number and route of administration were not provided) for prophylaxis (incorrect product storage). The vaccines were reconstituted with properly stored doses of sterile diluent (MERCK STERILE DILUENT). The vaccines were exposed to temperature range of 6 degree Fahrenheit (F) to 14 degree F for 1 hour and 20 minutes. This report was because of a digital data logger. There was no previous temperature excursion. No adverse effects were reported. Product quality complaint was not involved. This is one of the several reports received from the same reporter.; Sender's Comments: US-009507513-1709USA008861:
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 4 year old female patient. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 14-SEP-2017, the patient was vaccinated with improperly stored PROQUAD lot # M036295, expiration date 13-FEB-2018, (dose, dose number and route of administration were not provided) for prophylaxis. The vaccines were reconstituted with properly stored doses of sterile diluent (MERCK). The vaccines were exposed to temperature range of 6 degree Fahrenheit (F) to 14 degree F for 1 hour and 20 minutes. This report was because of a digital data logger. There was no previous temperature excursion. No adverse effects were reported. Product quality complaint was not involved. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1709USA008861: US-009507513-1709USA008666.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 4 year old male patient. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 07-OCT-2017, the patient was vaccinated with improperly stored PROQUAD lot # M036295, expiration date 13-FEB-2018, (strength, dose, dose number and route of administration were not provided) for prophylaxis. The vaccines were reconstituted with properly stored doses of sterile diluent (MERCK). The vaccines were exposed to temperature range of 6 degree Fahrenheit (F) to 14 degree F for 1 hour and 20 minutes. This report was because of a digital data logger. There was no previous temperature excursion. No adverse effects were reported. Product quality complaint was not involved. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1709USA008666: US-009507513-1709USA008861.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 4 year old male patient. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 18-SEP-2017, the patient was vaccinated with improperly stored PROQUAD lot # M036295, expiration date 13-FEB-2018, (strength, dose, dose number and route of administration were not provided) for prophylaxis. The vaccines were reconstituted with properly stored doses of sterile diluent (MERCK). The vaccines were exposed to temperature range of 6 degree Fahrenheit (F) to 14 degree F for 1 hour and 20 minutes. This report was because of a digital data logger. There was no previous temperature excursion. No adverse effects were reported. Product quality complaint was not involved. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1709USA008666: US-009507513-1709USA008861.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse concerning a currently 3 months old  patient with unspecified gender. The patient's pertinent medical history, concomitant medication and drug allergies/reactions were not provided. On an unspecified date, the patient was vaccinated with an improperly stored doses of LIQUID PEDVAXHIB (incorrect product storage) lot# M047666, expiration date: 24-OCT-2019 for prophylaxis (dose, frequency, route of administration were not reported). The administered dose of the vaccine experienced a temperature excursion 32 degree Fahrenheit to 35 degree Fahrenheit for 6 hours. There were no adverse effects reported. There was no previous temperature excursion. Data logger was involved. The outcome were unknown. No product quality complaint was involved. This is one of several reports received from the same reporter.