chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 16.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Arthralgia, Dizziness, Fatigue, Joint swelling, Laboratory test abnormal
Clinical narrative: Completed GARDASIL vaccine series. Dose #1 GARDASIL 4 - no symptoms - Dose #2 GARDASIL 4 - fatigue, weight loss, mild joint pain. Dose # 3 GARDASIL 9 bilateral ankle swelling, joint pain, dizziness, abnormal labs, referred to pediatric Rheumatologist - attached notes.
Age: 16.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Weight decreased
Clinical narrative: Completed GARDASIL vaccine series. Dose #1 GARDASIL 4 - no symptoms - Dose #2 GARDASIL 4 - fatigue, weight loss, mild joint pain. Dose # 3 GARDASIL 9 bilateral ankle swelling, joint pain, dizziness, abnormal labs, referred to pediatric Rheumatologist - attached notes.
Age: 16.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Adenovirus test, Anti-cyclic citrullinated peptide antibody negative, Antinuclear antibody positive, Arthralgia, Arthritis reactive
Clinical narrative: Completed GARDASIL vaccine series. Dose #1 GARDASIL 4 - no symptoms - Dose #2 GARDASIL 4 - fatigue, weight loss, mild joint pain. Dose # 3 GARDASIL 9 bilateral ankle swelling, joint pain, dizziness, abnormal labs, referred to pediatric Rheumatologist - attached notes.
Age: 16.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Bacterial test negative, Blood albumin decreased, Blood calcium decreased, Blood thyroid stimulating hormone normal, Bordetella test positive
Clinical narrative: Completed GARDASIL vaccine series. Dose #1 GARDASIL 4 - no symptoms - Dose #2 GARDASIL 4 - fatigue, weight loss, mild joint pain. Dose # 3 GARDASIL 9 bilateral ankle swelling, joint pain, dizziness, abnormal labs, referred to pediatric Rheumatologist - attached notes.
Age: 16.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: C-reactive protein increased, Chlamydia test negative, Complement factor C4, Complement factor normal, Connective tissue disorder
Clinical narrative: Completed GARDASIL vaccine series. Dose #1 GARDASIL 4 - no symptoms - Dose #2 GARDASIL 4 - fatigue, weight loss, mild joint pain. Dose # 3 GARDASIL 9 bilateral ankle swelling, joint pain, dizziness, abnormal labs, referred to pediatric Rheumatologist - attached notes.
Age: 16.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Culture throat, Dizziness, Enterovirus test negative, Epstein-Barr virus antibody negative, Fatigue
Clinical narrative: Completed GARDASIL vaccine series. Dose #1 GARDASIL 4 - no symptoms - Dose #2 GARDASIL 4 - fatigue, weight loss, mild joint pain. Dose # 3 GARDASIL 9 bilateral ankle swelling, joint pain, dizziness, abnormal labs, referred to pediatric Rheumatologist - attached notes.
Age: 16.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Fibromyalgia, Haematocrit decreased, Haemoglobin decreased, Joint stiffness, Joint swelling
Clinical narrative: Completed GARDASIL vaccine series. Dose #1 GARDASIL 4 - no symptoms - Dose #2 GARDASIL 4 - fatigue, weight loss, mild joint pain. Dose # 3 GARDASIL 9 bilateral ankle swelling, joint pain, dizziness, abnormal labs, referred to pediatric Rheumatologist - attached notes.
Age: 16.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Laboratory test normal, Lymphocyte count decreased, Malaise, Mean cell haemoglobin concentration normal, Mean platelet volume decreased
Clinical narrative: Completed GARDASIL vaccine series. Dose #1 GARDASIL 4 - no symptoms - Dose #2 GARDASIL 4 - fatigue, weight loss, mild joint pain. Dose # 3 GARDASIL 9 bilateral ankle swelling, joint pain, dizziness, abnormal labs, referred to pediatric Rheumatologist - attached notes.
Age: 16.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Monocyte count increased, Monocyte percentage increased, Mononucleosis heterophile test negative, Musculoskeletal pain, Musculoskeletal stiffness
Clinical narrative: Completed GARDASIL vaccine series. Dose #1 GARDASIL 4 - no symptoms - Dose #2 GARDASIL 4 - fatigue, weight loss, mild joint pain. Dose # 3 GARDASIL 9 bilateral ankle swelling, joint pain, dizziness, abnormal labs, referred to pediatric Rheumatologist - attached notes.
Age: 16.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Mycoplasma test negative, Nasal discomfort, Neutrophil count increased, Nodule, Oropharyngeal pain
Clinical narrative: Completed GARDASIL vaccine series. Dose #1 GARDASIL 4 - no symptoms - Dose #2 GARDASIL 4 - fatigue, weight loss, mild joint pain. Dose # 3 GARDASIL 9 bilateral ankle swelling, joint pain, dizziness, abnormal labs, referred to pediatric Rheumatologist - attached notes.
Age: 16.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Pharyngeal erythema, Pharyngitis, Pyrexia, Rash, Rash erythematous
Clinical narrative: Completed GARDASIL vaccine series. Dose #1 GARDASIL 4 - no symptoms - Dose #2 GARDASIL 4 - fatigue, weight loss, mild joint pain. Dose # 3 GARDASIL 9 bilateral ankle swelling, joint pain, dizziness, abnormal labs, referred to pediatric Rheumatologist - attached notes.
Age: 16.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Rash maculo-papular, Red blood cell count decreased, Red blood cell sedimentation rate increased, Red cell distribution width normal, Rheumatoid factor negative
Clinical narrative: Completed GARDASIL vaccine series. Dose #1 GARDASIL 4 - no symptoms - Dose #2 GARDASIL 4 - fatigue, weight loss, mild joint pain. Dose # 3 GARDASIL 9 bilateral ankle swelling, joint pain, dizziness, abnormal labs, referred to pediatric Rheumatologist - attached notes.
Age: 16.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Skin lesion, Skin mass, Streptococcus test negative, Tendonitis, Thyroxine normal
Clinical narrative: Completed GARDASIL vaccine series. Dose #1 GARDASIL 4 - no symptoms - Dose #2 GARDASIL 4 - fatigue, weight loss, mild joint pain. Dose # 3 GARDASIL 9 bilateral ankle swelling, joint pain, dizziness, abnormal labs, referred to pediatric Rheumatologist - attached notes.
Age: 16.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Treponema test negative, Urine analysis normal, Vaccination complication, Viral test negative, Weight decreased
Clinical narrative: Completed GARDASIL vaccine series. Dose #1 GARDASIL 4 - no symptoms - Dose #2 GARDASIL 4 - fatigue, weight loss, mild joint pain. Dose # 3 GARDASIL 9 bilateral ankle swelling, joint pain, dizziness, abnormal labs, referred to pediatric Rheumatologist - attached notes.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Erythema, Pruritus, Skin warm
Clinical narrative: 11/29/2016 9:15 am MENACTRA administered itchy right after shot by 6 pm very red and itchy, redness spreading. 11/30/16 Morning itchy-red, warm went to walk in clinic RX BENADRYL and cephalexin to ER at 9 PM redness spreading RX BENADRYL.
Age: 70.0
Sex: F
Vaccine: PNC13
Symptoms: Arthralgia, C-reactive protein normal, Injection site joint pain, Red blood cell sedimentation rate normal
Clinical narrative: Severe joint pain-shoulders and elbows-persisting x2 months (1.5).
Age: 71.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Redness and pain at injection site and it get bigger. Ice pack, Ibuprofen, and antihistamine.
Age: 0.25
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Injection site urticaria, Urticaria
Clinical narrative: Somewhere between 8 to 17 hours post-vaccinations, pt developed urticarial without angioedema or respiratory symptoms. By 24 hrs. Urticaria were nearly resolved (one patch on neck  and on each leg on exam ).
Age: 9.0
Sex: F
Vaccine: HIBV, PNC13
Symptoms: Rash, Rash generalised, Rash pruritic
Clinical narrative: Developed a raised, patchy, pruritic rash all over body.
Age: 0.17
Sex: M
Vaccine: RV1, RV1
Symptoms: Enema administration, Gastrointestinal sounds abnormal, Intussusception, Syncope, Ultrasound abdomen abnormal
Clinical narrative: This case was reported by a nurse via other manufacturer and described the occurrence of intussusception in a 11-week-old male patient who received ROTARIX. On 26th October 2016, the patient received the 1st dose of ROTARIX (oral). On 1st November 2016, 6 days after receiving ROTARIX, the patient experienced intussusception (serious criteria hospitalization, GSK medically significant and life threatening) and vomiting. On 2nd November 2016, the outcome of the intussusception and vomiting were recovered/resolved. It was unknown if the reporter considered the intussusception and vomiting to be related to ROTARIX. Additional details were provided as follows: This case was reported by other company sales representative (Merck). The patient had no relevant medical history, drug reactions and allergies. Concomitant medication was unknown. The patient was following 3 dose schedule for ROTARIX. The patient was seen in the hospital after the 1st dose of ROTARIX. On 1st November 2016, the patient was seen in the office for vomiting. The patient was treated and sent home. The patient's mother called back around 4 in the afternoon and said that the patient was vomiting yellow. The patient went to the unspecified emergency room. The ultrasound was performed in the emergency room was inconclusive. The patient hospitalized for intussusception. Another ultrasound was performed which showed that the intussusception was just beginning. The intussusception was considered as life threatening. Surgery was performed and the patient was recovered on 2nd November 2016.
Age: 0.17
Sex: M
Vaccine: RV1, RV1
Symptoms: Vomiting
Clinical narrative: This case was reported by a nurse via other manufacturer and described the occurrence of intussusception in a 11-week-old male patient who received ROTARIX. On 26th October 2016, the patient received the 1st dose of ROTARIX (oral). On 1st November 2016, 6 days after receiving ROTARIX, the patient experienced intussusception (serious criteria hospitalization, GSK medically significant and life threatening) and vomiting. On 2nd November 2016, the outcome of the intussusception and vomiting were recovered/resolved. It was unknown if the reporter considered the intussusception and vomiting to be related to ROTARIX. Additional details were provided as follows: This case was reported by other company sales representative (Merck). The patient had no relevant medical history, drug reactions and allergies. Concomitant medication was unknown. The patient was following 3 dose schedule for ROTARIX. The patient was seen in the hospital after the 1st dose of ROTARIX. On 1st November 2016, the patient was seen in the office for vomiting. The patient was treated and sent home. The patient's mother called back around 4 in the afternoon and said that the patient was vomiting yellow. The patient went to the unspecified emergency room. The ultrasound was performed in the emergency room was inconclusive. The patient hospitalized for intussusception. Another ultrasound was performed which showed that the intussusception was just beginning. The intussusception was considered as life threatening. Surgery was performed and the patient was recovered on 2nd November 2016.
Age: 0.17
Sex: M
Vaccine: RV1, RV1
Symptoms: Intussusception, Ultrasound abdomen abnormal, Vomiting
Clinical narrative: This case was reported by a nurse via other manufacturer and described the occurrence of intussusception in a 11-week-old male patient who received ROTARIX. On 26th October 2016, the patient received the 1st dose of ROTARIX (oral). On 1st November 2016, 6 days after receiving ROTARIX, the patient experienced intussusception (serious criteria hospitalization, GSK medically significant and life threatening) and vomiting. On 2nd November 2016, the outcome of the intussusception and vomiting were recovered/resolved. It was unknown if the reporter considered the intussusception and vomiting to be related to ROTARIX. Additional details were provided as follows: This case was reported by other company sales representative (Merck). The patient had no relevant medical history, drug reactions and allergies. Concomitant medication was unknown. The patient was following 3 dose schedule for ROTARIX. The patient was seen in the hospital after the 1st dose of ROTARIX. On 1st November 2016, the patient was seen in the office for vomiting. The patient was treated and sent home. The patient's mother called back around 4 in the afternoon and said that the patient was vomiting yellow. The patient went to the unspecified emergency room. The ultrasound was performed in the emergency room was inconclusive. The patient hospitalized for intussusception. Another ultrasound was performed which showed that the intussusception was just beginning. The intussusception was considered as life threatening. Surgery was performed and the patient was recovered on 2nd November 2016.
Age: 59.0
Sex: M
Vaccine: FLU3, FLUX, FLU3
Symptoms: Hypoaesthesia, Injection site hypoaesthesia
Clinical narrative: Guillain-Barre Syndrome. Reported to us on 12/7/16 (who previously submitted to VAERS #665950). Date of onset & outcome unknown (Nurse was not forthcoming).
Age: 59.0
Sex: M
Vaccine: FLU3, FLUX, FLU3
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Guillain-Barre Syndrome. Reported to us on 12/7/16 (who previously submitted to VAERS #665950). Date of onset & outcome unknown (Nurse was not forthcoming).
Age: 59.0
Sex: M
Vaccine: FLU3, FLUX, FLU3
Symptoms: Guillain-Barre syndrome
Clinical narrative: Guillain-Barre Syndrome. Reported to us on 12/7/16 (who previously submitted to VAERS #665950). Date of onset & outcome unknown (Nurse was not forthcoming).
Age: 66.0
Sex: F
Vaccine: FLU4, PPV, PPV
Symptoms: Pain in extremity, Peripheral swelling, Vomiting
Clinical narrative: PATIENT COMPLAINED OF SWELLING, REDNESS, HOT IN AREA OF INJECTION, AND PAIN THROUGH HER ELBOW WHICH NOT RESPOND TO IBUPROFEN OR COLD COMPRESS AFTER FEW DAYS.
Age: 66.0
Sex: F
Vaccine: FLU4, PPV, PPV
Symptoms: Arthralgia, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: PATIENT COMPLAINED OF SWELLING, REDNESS, HOT IN AREA OF INJECTION, AND PAIN THROUGH HER ELBOW WHICH NOT RESPOND TO IBUPROFEN OR COLD COMPRESS AFTER FEW DAYS.
Age: 66.0
Sex: F
Vaccine: FLU3, FLU4
Symptoms: Influenza like illness, Pyrexia, Vomiting
Clinical narrative: Tightness in sternum area/throat; vomiting; VERY severe headache; aches and pains head to toe;  combo of chills/hot sweats.
Age: 66.0
Sex: F
Vaccine: FLU3, FLU4
Symptoms: Chest discomfort, Chills, Feeling hot, Headache, Hyperhidrosis
Clinical narrative: Tightness in sternum area/throat; vomiting; VERY severe headache; aches and pains head to toe;  combo of chills/hot sweats.
Age: 66.0
Sex: F
Vaccine: FLU3, FLU4
Symptoms: Pain, Throat tightness, Vomiting
Clinical narrative: Tightness in sternum area/throat; vomiting; VERY severe headache; aches and pains head to toe;  combo of chills/hot sweats.
Sex: F
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Injection site pain, Pyrexia
Clinical narrative: Information has been received from a pharmacist referring to a 73 years old female patient. The patient's medical history, concurrent condition and concomitant therapy were unknown. On 07-SEP-2016, the patient was vaccinated with PNEUMOVAX 23 (lot# M024673, expiration date 17-NOV-2017, dose unknown) intramuscularly for prophylaxis. On the same day, 2 hours after the injection, the patient experienced extreme pain at the injection site with inability to lift the affected arm, and also experienced fever of 102 Fahrenheit degree (F). The patient was advised by pharmacist to take ADVIL and applied ice compresses. No lab diagnosis was performed. The outcome of the events was unknown. The causality assessment between the events and PNEUMOVAX 23 was not reported. The pharmacist was requesting a lot check of lot # M024673. This is one of several reports received from the same reporter. An investigation into the manufacture of lot number: M024673 was completed and confirmed that all in-process quality checks were satisfactory. The results indicated that the lot was manufactured in accordance with manufacturing site standard operating procedures. The lot was confirmed to have met the requirements for market release. Following medical review of the AE report and the Quality investigation, there were no identified concerns related to quality within the results of the investigation. Additional information has been requested. Sender's Comments: US-009507513-1609USA005896: US-009507513-1609USA006593: MERCK 1609USA006594:Mfr number.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to an unspecified number of patients of unknown age and gender. There was no information regarding the patients' pertinent medical histories, drug reactions, allergies or concomitant therapies provided. On unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ (lot # L035637, expiration date 09-JUN-2017 and lot # L039638, expiration date 23-AUG-2017, orally; exact doses were not reported). No adverse effect was reported. This is one of the several reports received from the same reporter. Follow up information was received on 07-DEC-2016. All telephone attempts to obtain follow up information have been unsuccessful. Additional information has been requested. Sender's Comments: US-009507513-1610USA009070: US-009507513-1610USA009068: US-009507513-1610USA009071: US-009507513-1610USA009069: MERCK 1610USA001492:Mfr number.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician referring to multiple unspecified patients of unknown age and gender. The patients' medical history, concurrent condition and concomitant medication were not reported. On unknown dates, the patients were vaccinated with improperly stored ROTATEQ (lot # L046318 with expiration date 28-SEP-2017, lot# M007125 with expiration date 06-OCT-2017, lot# M002252 with expiration date 28-FEB-2017, dose not reported) orally for prophylaxis. The vaccines had been stored under the temperature of 34 Fahrenheit degrees for 72 hours and 35 Fahrenheit degrees for 72 hours. A data logger was used to log the temperatures. No adverse effects were reported. Follow-up information was received on 07-DEC-2016, indicating that all telephone attempts to obtain follow-up information have been unsuccessful. No additional information was available. This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1610USA005661: US-009507513-1610USA005662: US-009507513-1610USA005663: MERCK 1610USA005022:Mfr number.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a licensed practical nurse referring to multiple, unspecified patients of unknown age and gender. The patients' medical history, concurrent condition and concomitant therapy were not reported. On unknown dates, the patients received improperly stored doses of ROTATEQ (lot # L042215, expiration date 02-JUN-2017; dose was not reported) orally for prophylaxis. No adverse effect was reported. Follow-up information has been received on 02-DEC-2016. All telephone attempts to obtain follow-up information have been unsuccessful. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1609USA012350: MERCK 1610USA005649:Mfr number.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On unknown dates, the patients were vaccinated with the incorrectly stored (33.1 F for 90 minutes) doses of ROTATEQ (orally, lot # M012495, expiration date 09-OCT-2017; dose was not reported) for prophylaxis. No previous excursion was reported. The call was made because of the data logger. No adverse effects were reported. As of 30-NOV-2016, all telephone attempts to obtain follow-up information have been unsuccessful. This is one of several reports received form the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1610USA005657: US-009507513-1610USA005658: US-009507513-1610USA005157: MERCK 1610USA005656:Mfr number.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On unknown dates, the patients were vaccinated with the incorrectly stored (33.1 F for 90 minutes) doses of RECOMBIVAX HB (lot # M023718, expiration date 09-AUG-2018; dose and route of administration were not reported) for prophylaxis. No previous excursion was reported. The call was made because of the data logger. No adverse effects were reported. As of 30-NOV-2016, all telephone attempts to obtain follow-up information have been unsuccessful. This is one of several reports received form the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1610USA005657: US-009507513-1610USA005157: US-009507513-1610USA005656: MERCK 1610USA005658:Mfr number.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to unspecified patients of unknown age and gender. The patients' medical history, drug reactions or allergies and concurrent conditions were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ, orally, lot number M025565, expiration date 06-NOV-2017, (dose was not reported) for prophylaxis (incorrect product storage). There was no concomitant medication reported. No adverse effects were reported. This is one of two reports from the same reporter. All telephone attempts to obtain follow-up information have been unsuccessful. Additional information has been requested. Narrative was updated. Sender's Comments: US-009507513-1610USA009463: MERCK 1610USA006200:Mfr number.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to an unspecified number of patients of unknown age and gender. There was no information about patients' concurrent condition, medical history and concomitant medication. On unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB (lot # M010671, expiration date 02-JUN-2018; lot # M026309, expiration date 11-NOV-2018; lot # M018625, expiration date 11-AUG-2018; lot # M023892, expiration date 15-SEP-2017; lot # M028322, expiration date 31-MAY-2018, dose and route not reported) for prophylaxis. No adverse effect was reported. This is one of several reports received from the same reporter. Telephone attempt on 07-DEC-2016 to obtain follow up information had been unsuccessful. Additional information has been requested. Sender's Comments: US-009507513-1610USA009515: US-009507513-1610USA009514: US-009507513-1610USA009512: US-009507513-1610USA009513: MERCK 1610USA008911:Mfr number.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to an unspecified number of patients of unknown age and gender. There was no information about patients' concurrent condition, medical history and concomitant medication. On unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ (lot # M005733, expiration date 01-OCT-2017, lot # M006111, expiration date 18-NOV-2017, lot # M016238, expiration date 07-DEC-2017, dose not reported) orally for prophylaxis. No adverse effect was reported. This is one of several reports received from the same reporter. Telephone attempt on 07-DEC-2016 to obtain follow up information had been unsuccessful. Additional information has been requested. Narrative was updated. Sender's Comments: US-009507513-1610USA008911: US-009507513-1610USA009514: US-009507513-1610USA009512: US-009507513-1610USA009513: MERCK 1610USA009515:Mfr number.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a Registered Nurse concerning multiple unspecified patients of unknown age and gender. No pertinent medical history, drug reactions, allergies or concurrent conditions were reported. On unknown dates, the patients were vaccinated with improperly stored unspecified doses of RECOMBIVAX HB for prophylaxis (lot number M022077 with an expiration date of 19-MAR-2019) (dose, route and anatomical location were not reported). Other suspect and concomitant medications were not provided. There was no adverse effect reported. The doses of the vaccine experienced a temperature excursion of 1 degree Celsius (C) for a time frame of 48 hours (date unspecified). A digital data logger was involved. There were no previous temperature excursions. Furthermore, no product quality complaint was involved. This is one of several reports received from the same reporter. Follow up information was received on 28-NOV-2016. On that day, a call was placed to the registered nurse, who stated that she would gather the information. Additional information has been requested. Sender's Comments: US-009507513-1610USA013756: US-009507513-1610USA013819: MERCK 1610USA013820:Mfr number.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a licensed practical nurse concerning multiple unspecified patients of unknown ages and genders. The patients' pertinent medical history, drug reactions/allergies and concurrent conditions were not informed. On unknown dates, the patients were administered improperly stored doses of ROTATEQ (lot # M004890, expiration date 10-NOV-2017; lot # L037924, expiration date 22-JUN-2017, dose and dose number were not provided) orally for prophylaxis. Concomitant therapies were not informed. No adverse effects were reported. The doses of ROTATEQ were exposed to a temperature of 24.3 degree Centigrade and were out of range for 5 minutes. A data logger was used to track the temperature and there were no prior excursions. No product quality complaint (PQC) was involved. This is one of several reports from the same source. Follow up information has been received from the nurse on 17-NOV-2016. On unknown dates, an unspecified number of patients received improperly stored doses of ROTATEQ (lot # M004890, expiration date 10-NOV-2017; lot # L037924, expiration date 22-JUN-2017, dose and dose number were not provided) orally for prophylaxis. No adverse effect was reported. More temperature excursion details were provided: the vaccines had been exposed under temperature -17.7 degree Centigrade for 7 hours 50 minutes ("2nd cycle"). Previous excursion included: on 03-OCT-2016, 11.1 degree Centigrade for 1 hour 40 minutes; on 10-OCT-2016, 9.8 degree Centigrade for 14 hours 17 minutes; on 01-NOV-2016, -10.1 degree Centigrade for 1 hour 36 minutes ("1 cycle"). Data logger was involved. Additional information has been requested. Reporter, adverse event information and narrative were updated. Sender's Comments: US-009507513-1611USA004924: US-009507513-1611USA004925: US-009507513-1611USA004926: US-009507513-1611USA004927: US-009507513-1611USA004928: US-009507513-1611USA004929: US-009507513-1611USA004930: US-009507513-1611USA004931: US-009507513-1611USA013266: MERCK 1611USA004908:Mfr number.
Age: 21.0
Sex: F
Vaccine: HPVX
Symptoms: Back pain, Injection site pain
Clinical narrative: This spontaneous report as received from a physician refers to a 21-years-old, non-pregnant female patient. The patient had no pertinent medical history, drug reactions, or allergies. On 17-NOV-2016, the patient was vaccinated with the first dose of GARDASIL 9 or GARDASIL injection (dose, route of administration, lot# and expiration date were not provided) as routine vaccine. The physician did not know which one of these human papillomavirus vaccines the patient received. The patient's concomitant therapy included an unspecified oral contraceptive. On 17-NOV-2016, she experienced injection site pain and later, the same day, also back pain. The physician suggested the patient to apply heat to the affected areas and to take TYLENOL or MOTRIN. On 18-NOV-2016, the patient e-mailed the physician's office again to state that "back pain had not gotten any better". No laboratory diagnostics studies were performed. The outcome of injection site pain and back pain was reported as not recovered at the time of reporting. The relatedness between the adverse events and GARDASIL 9 or GARDASIL was not reported. Additional information has been requested.
Sex: F
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Registered Nurse (RN) who refers to a female patient of unknown age. No pertinent medical history, drug reactions, allergies or concurrent conditions were reported. On an unknown date the patient was vaccinated with improperly stored dose of GARDASIL 9, intramuscular, lot # M018810, expiration date: 28-MAY-2018 (strength, dosage, and anatomical location were not reported) for prophylaxis.  Other suspect and concomitant medications were not provided. No PQC was involved. No adverse effects were reported. This is one of three reports from  the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA004135: US-009507513-1612USA004136.
Age: 0.33
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to a 4 month old patient of an unknown gender. There was no information about the patient's pertinent medical history, concomitant medications and drug reactions or allergies provided. On 15-SEP-2016, the patient was vaccinated with the first dose of ROTATEQ orally (lot # M005732; exact dose and expiry date were not reported). The patient did not experience an adverse effect. No additional doses of ROTATEQ were administered, at the time of the report. Additional information has been requested.
Age: 1.0
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to a 12 month old patient of unknown gender. The patient's medical history, concurrent condition and concomitant therapy were not reported. On an unknown date, the patient was inadvertently administered a dose of PROQUAD injection (lot # L044055, expiration date 02-MAY-2017, rHA (recombinant human albumin); dose and route were unknown, for prophylaxis), instead of an intended dose of measles, M-M-R II. The patient was also administered VARIVAX injection (lot # L015045, expiration date 29-APR-2017; dose and route were unknown, for prophylaxis). M-M-R II was not administered. The reporter stated that she confused the PROQUAD for M-M-R II, because they were stored in the same compartment of her freezer. When she read "measles, mumps, rubella", she thought it was M-M-R II. The reporter remarked she did not notice the difference because the type on the vaccine labels was so small. No adverse effect was reported. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Pneumonia
Clinical narrative: This spontaneous report as received from a pharmacist via a company representative refers to a patient of unknown age and gender. The patient's concomitant medications, pertinent medical history and known drug reactions or allergies were not reported. On an unknown date, the patient was vaccinated with a dose of PNEUMOVAX23 (dose, route, lot # and expiry date were not reported) for prophylaxis. On an unknown date, reported as later on, the patient got pneumonia. The reporting pharmacist wanted to know if the patient needed another dose of PNEUMOVAX23. The outcome of the event was unknown. The reporter did not provide the causal relationship between the event and PNEUMOVAX23. Upon internal review, the event of pneumonia was considered to be medically significant. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous case received from a medical assistant referred to unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. From 18-NOV-2016 to 30-NOV-2016, the patients were administered improperly stored PROQUAD (lot number: M029598, expiry date: 10-DEC-2017). No adverse events were reported by the patients. The vaccine was stored at 0.1C for 1 hour and 16 minutes. There was no previous temperature excursions and call was because of data logger. This is one of the two reported received from the same reporter. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: FLUX, HEPA, MMR, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Information has been received from a pharmacy intern referring to a patient of unknown age and gender. The patient's pertinent medical history and concomitant therapy were not reported. The patient's drug reaction/allergy was unknown. On 01-DEC-2016, the patient was given PROQUAD injection and VARIVAX (both lot #, expiration date, dose and route were unknown, for prophylaxis) (overdose). No adverse reaction was reported. Additional information has been requested.
Sex: F
Vaccine: HPVX
Symptoms: Death, Vaccination complication
Clinical narrative: This spontaneous report as received from an unspecified reporter, via social media, refers to a female patient of unknown age. The event was described in an online article. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with an unidentified HPV vaccine (manufacturer unknown) 1 shot (name, lot number, route and site of administration were not provided). On an unknown date, the patient died. The author of the online article had the patient's death as HPV shot related, however it was proved to be false. The reporter's causality assessment between death and unidentified HPV vaccine (manufacturer unknown) was not reported. Upon internal review, the event of death was considered to be medically significant. Additional information is not expected as no contact details were provided.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from a nurse referring to an unspecified number of patients.  Information about concurrent condition, concomitant medication and medical history was not provided. The nurse reported that an unknown number of doses of GARDASIL, (Lot # L040460 Expiration date 27-MAY-2017) experienced a temperature excursion of -4F for 4 hours 31 minutes, and an unknown number of might have been administered to an unspecified number of patients. It was unknown if any patients experienced any side effects following administration of any of the vaccines. No other information was available. This report is one of the reports from same reporter. Additional information is not expected. because no consent to contact; Sender's Comments: US-009507513-1612USA004349: US-009507513-1612USA004348.
Age: 0.33
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse via company representative refers to a 4 months old infant patient of unknown gender. The patient's medical history, current conditions and concomitant medications were not reported. On 12-SEP-2016, the patient was vaccinated with improperly stored dose of PEDVAXHIB, lot # M014926 (strength, dosing details, anatomical location and expiration date were unknown) for prophylaxis. On 01-SEP-2016, temperature excursion of the vaccines occurred in the fridge and was not discovered until 26-SEP-2016. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of the several reports received from the same reporter source. Additional information has been requested. Sender's Comments: US-009507513-1612USA003706.
Age: 8.0
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse via company representative refers to a 8 year old patient of unknown gender. The patient's medical history, current conditions and concomitant medications were not reported. On 12-SEP-2016, the patient was vaccinated with improperly stored dose of RECOMBIVAX HB (lot number: K010216, dose, frequency, expiry date were not reported) for prophylaxis. On 01-SEP-2016, temperature excursion of the vaccines occurred in the fridge and was not discovered until 26-SEP-2016. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of the several reports received from the same reporter source. Additional information has been requested.; Sender's Comments: US-009507513-1612USA003706:
Age: 0.17
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse via company representative refers to a 9 week old patient of unknown gender. The patient's medical history, current conditions and concomitant medications were not reported. On 07-SEP-2016, the patient was vaccinated with improperly stored dose of PEDVAXHIB, lot # M014926 (strength, dosing details, anatomical location and expiration date were unknown) for prophylaxis. On 01-SEP-2016, temperature excursion of the vaccines occurred in the fridge and was not discovered until 26-SEP-2016. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of the several reports received from the same reporter source. Additional information has been requested. Sender's Comments: US-009507513-1612USA003706.
Age: 0.33
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse via company representative refers to a 4 months old infant patient of unknown gender. The patient's medical history, current conditions and concomitant medications were not reported. On 07-SEP-2016, the patient was vaccinated with improperly stored dose of PEDVAXHIB, lot # M014926 (strength, dosing details, anatomical location and expiration date were unknown) for prophylaxis. On 01-SEP-2016, temperature excursion of the vaccines occurred in the fridge and was not discovered until 26-SEP-2016. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of the several reports received from the same reporter source. Additional information has been requested. Sender's Comments: US-009507513-1612USA003706.
Age: 13.0
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report received from a registered nurse via company representative refers to a 13 year old patient of unknown gender. The patient's medical history, current conditions and concomitant medications were not reported. On 02-SEP-2016, the patient was vaccinated with an improperly stored dose of GARDASIL 9, lot # M009378 (dose, frequency, expiry date were not reported), for prophylaxis. The vaccine was purchased with private funds/ insurance. On 01-SEP-2016, temperature excursion of the vaccines occurred in the fridge and was not discovered until 26-SEP-2016. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one the several reports received from  the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1609USA014830.
Age: 13.0
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report received from a registered nurse, via company representative, refers to a 13 year old patient of unknown gender. The patient's medical history, current conditions and concomitant medications were not reported. On 02-SEP-2016, the patient was vaccinated with an improperly stored dose of GARDASIL 9, lot # L043214 (dose, frequency, expiry date were not reported), for prophylaxis, under Vaccine for children program (VFC) . On 01-SEP-2016, temperature excursion of the vaccines occurred in the fridge and was not discovered until 26-SEP-2016. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one the several reports received from  the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1609USA014830.
Age: 13.0
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report received from a registered nurse, via company representative, refers to a 13 year old patient of unknown gender. The patient's medical history, current conditions and concomitant medications were not reported. On 02-SEP-2016, the patient was vaccinated with an improperly stored dose of GARDASIL 9, lot # M009378 (dose, frequency, expiry date were not reported), for prophylaxis. The vaccine was purchased with private funds/ insurance. On 01-SEP-2016, temperature excursion of the vaccines occurred in the fridge and was not discovered until 26-SEP-2016. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one the several reports received from  the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1609USA014830.
Age: 13.0
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report received from a registered nurse, via company representative, refers to a 13 year old patient of unknown gender. The patient's medical history, current conditions and concomitant medications were not reported. On 08-SEP-2016, the patient was vaccinated with an improperly stored dose of GARDASIL 9, lot # L043214 (dose, frequency, expiry date were not reported), for prophylaxis, under Vaccine for children program (VFC). On 01-SEP-2016, temperature excursion of the vaccines occurred in the fridge and was not discovered until 26-SEP-2016. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1609USA014830.
Age: 14.0
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report received from a registered nurse, via company representative, refers to a 14 year old patient of unknown gender. The patient's medical history, current conditions and concomitant medications were not reported. On 12-SEP-2016, the patient was vaccinated with an improperly stored dose of GARDASIL 9, lot # L043214 (dose, frequency, expiry date were not reported), for prophylaxis, under Vaccine for children program (VFC). On 01-SEP-2016, temperature excursion of the vaccines occurred in the fridge and was not discovered until 26-SEP-2016. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one the several reports received from  the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1609USA014830.
Age: 14.0
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report received from a registered nurse, via company representative, refers to a 14 year old patient of unknown gender. The patient's medical history, current conditions and concomitant medications were not reported. On 12-SEP-2016, the patient was vaccinated with an improperly stored dose of GARDASIL 9, lot # M009378 (dose, frequency, expiry date were not reported), for prophylaxis. The vaccine was purchased with private funds/ insurance. On 01-SEP-2016, temperature excursion of the vaccines occurred in the fridge and was not discovered until 26-SEP-2016. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1609USA014830.
Age: 13.0
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report received from a registered nurse, via company representative, refers to a 13 year old patient of unknown gender. The patient's medical history, current conditions and concomitant medications were not reported. On 13-SEP-2016, the patient was vaccinated with an improperly stored dose of GARDASIL 9, lot # L043214 (dose, frequency, expiry date were not reported), for prophylaxis, under Vaccine for children program (VFC). On 01-SEP-2016, temperature excursion of the vaccines occurred in the fridge and was not discovered until 26-SEP-2016. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one the several reports received from  the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1609USA014830.
Age: 13.0
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report received from a registered nurse, via company representative, refers to a 13 year old patient of unknown gender. The patient's medical history, current conditions and concomitant medications were not reported. On 14-SEP-2016, the patient was vaccinated with an improperly stored dose of GARDASIL 9, lot # M009378 (dose, frequency, expiry date were not reported), for prophylaxis. The vaccine was purchased with private funds/ insurance. The vaccine was purchased with private funds/ insurance. On 01-SEP-2016, temperature excursion of the vaccines occurred in the fridge and was not discovered until 26-SEP-2016. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1609USA014830.
Age: 13.0
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report received from a registered nurse, via company representative, refers to a 13 year old patient of unknown gender. The patient's medical history, current conditions and concomitant medications were not reported. On 14-SEP-2016, the patient was vaccinated with an improperly stored dose of GARDASIL 9, lot # M009378 (dose, frequency, expiry date were not reported), for prophylaxis. The vaccine was purchased with private funds/ insurance. On 01-SEP-2016, temperature excursion of the vaccines occurred in the fridge and was not discovered until 26-SEP-2016. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one the several reports received from  the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1609USA014830.
Age: 15.0
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report received from a registered nurse, via company representative, refers to a 15 year old patient of unknown gender. The patient's medical history, current conditions and concomitant medications were not reported. On 14-SEP-2016, the patient was vaccinated with an improperly stored dose of GARDASIL 9, lot # M009378 (dose, frequency, expiry date were not reported), for prophylaxis. The vaccine was purchased with private funds/ insurance. No adverse effects were reported. On 01-SEP-2016, temperature excursion of the vaccines occurred in the fridge and was not discovered until 26-SEP-2016. No product quality complaint (PQC) was involved. This is one the several reports received from  the same reporter.  Additional information has been requested. Sender's Comments: US-009507513-1609USA014830.