chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 15.0
Sex: M
Vaccine: VARCEL
Symptoms: Vaccination site pain
Clinical narrative: 4 x 4 cm indurated, erythematous eruption present on posterior side of (R) arm. Pain at site of vaccination and in axilla area. Minimal itching. No edema in axilla. Normal range of motion. Little bit of neck pain on 9/10/17 but none today. VS signs-afebrile. Used ice and Ibuprofen to treat pain axilla area started 9/10/17. Pt denies chest pain, breathing problems, swelling in tongue or throat, seizures and rash in other areas if body. Conservative treatment continued with ice and Ibuprofen 400 mg every 6 hours for pain. Can take a histamine to help with itching. 9/12/2017 Induration still present erythema, per mother, about the same maybe slightly improved used ice x 1 last night with Ibuprofen. Will continue with conservative treatment. Child in school this am. Will call with update PRN.
Age: 5.0
Sex: F
Vaccine: FLU4, IPV
Symptoms: Pyrexia
Clinical narrative: Fevers up to 105.2 began 2 days after vaccination. Mom gave TYLENOL and IBU. As of 9/13/17, mom reported fevers have decreased to 100.5.
Age: 76.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Mobility decreased, Pain in extremity, Pruritus, Swelling
Clinical narrative: Severe swelling, pain in arm, unable to lift easily and extreme itching. Help was sought on Wednesday, September 13. Given prescription for Methylprednisolone 4mg dose pack. Medication is helping the redness and swelling but itching is still bad on September 14. Perhaps by weekend will be better.
Age: 33.0
Sex: M
Vaccine: FLU3
Symptoms: Wrong drug administered
Clinical narrative: Patient is 33 y/o male. He was given a high dose flu shot versus quadrivalent flu shot.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Back pain, Fatigue, Muscle spasms, Muscle tightness, Pain
Clinical narrative: Patient had mild runny nose and baseline intermittent "growing pain" achy pain in legs and lower back prior to vaccination. Received HPV in the morning 9/11. Played volleyball game that evening. Some leg cramps and spasms later that night. Woke up tired and achy 9/12. Played volleyball that night and was exhausted that night. Woke up several times the night of 9/12 with significant leg pain, muscles "locking up," different from usual achy growing pains 9/14 AM with legs "really tight" and pain with walking, tactile fevers. Unclear if symptoms related to vaccine or concurrent viral syndrome.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Pain in extremity, Pyrexia, Rhinorrhoea
Clinical narrative: Patient had mild runny nose and baseline intermittent "growing pain" achy pain in legs and lower back prior to vaccination. Received HPV in the morning 9/11. Played volleyball game that evening. Some leg cramps and spasms later that night. Woke up tired and achy 9/12. Played volleyball that night and was exhausted that night. Woke up several times the night of 9/12 with significant leg pain, muscles "locking up," different from usual achy growing pains 9/14 AM with legs "really tight" and pain with walking, tactile fevers. Unclear if symptoms related to vaccine or concurrent viral syndrome.
Age: 22.0
Sex: F
Vaccine: HEP
Symptoms: Diarrhoea, Injection site nodule, Injection site pain
Clinical narrative: C/O A KNOT AT THE SITE, PAIN AT THE SITE, AND DIARRHEA STARTING X2 DAYS POST SHOT AND CONT THROUGH THE PRESENT.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Redness and slight swelling at the injection site. Slightly warm to the touch. Her symptoms have decreased from yesterday.
Age: 72.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Arthralgia, Chills, Injection site bruising, Injection site erythema, Malaise
Clinical narrative: Local and systemic symptoms. Fever, chills, malaise, body aches, joint pain, large painful bruising and erythema left upper arm at injection site.
Age: 72.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pain, Pyrexia
Clinical narrative: Local and systemic symptoms. Fever, chills, malaise, body aches, joint pain, large painful bruising and erythema left upper arm at injection site.
Age: 20.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site pain
Clinical narrative: Pt. c/o mild pain in L upper arm the evening she got the shot. Pain has increased and decreased in intensity daily but has not resolved completely. Pt prescribed ibuprofen 600 mg TID for 5-7 days. Ice vs heat to area for 20 minutes BID or once daily. F/U prn.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse and refers to unspecified patients of unknown age and gender. No information about the patients' medical history, concurrent conditions and drug reactions or allergies was provided. Between 01-JUN-2017 and 05-SEP-2017, the patients were vaccinated with improperly stored doses of VARIVAX lot # L029472 with expiration date 06-AUG-2017 and lot# M049127 with expiration date 15-DEC-2018 (dose and route of administration were not reported) reconstituted with sterile diluent (manufacturer unknown). The temperature excursion ranged from minus 14 to minus 10 degrees Celsius for 630 minutes and from minus 9 to plus 8 degrees Celsius for 3 hours. No adverse effects were reported. There was no previous temperature excursion. Digital data logger was used. Product quality complaint was not involved. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1709USA007213.
Age: 11.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from medical assistant refers to multiple unspecified patients of unknown age and gender. Information on pertinent medical history and concurrent condition was not provided. On an unspecified dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 lot # N004799, expiry 15-NOV-2019 (dose and route not reported) for prophylaxis.  It was reported that on unspecified dates, the vaccine was exposed to a temperature between 2 Centigrade degrees and 8 Centigrade degrees (1.8C) for 42 minutes. There was previous temperature excursion between 0 Centigrade degrees and 1 Centigrade degree for 1 hour and 56 minutes and another excursion between 9 and 25 Centigrade degrees (11.4C) for 1 hour and 41 minutes. The call was placed because of a Digital Data logger report. No adverse effects reported. As of 01-SEP-2017, all telephone attempts to obtain follow up information had been unsuccessful. Follow up information has been received from the medical assistant on 05-SEP-2017. The patient's age was confirmed as 11 years. It was also confirmed that on 21-JUL-2017 the patient was vaccinated with the improperly stored GARDASIL 9. This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1709USA005737: US-009507513-1709USA005738: US-009507513-1709USA005747: US-009507513-1709USA005740: US-009507513-1709USA005741: US-009507513-1709USA005742: US-009507513-1709USA005743: US-009507513-1709USA005744: US-009507513-1709USA005745: US-009507513-1708USA001768: US-009507513-1709USA005736: US-009507513-1709USA005735: US-009507513-1709USA005748: US-009507513-1709USA005739:
Age: 11.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report has been received from a medical assistant referring to a 11year old patient of unknown gender. Information about concurrent condition, concomitant medication and medical history was not provided. In 2017 (reported as someday during 31-JUL-2017 to 22-AUG-2017), the patient was vaccinated with GARDASIL 9 lot # N000326 / N002720, expiration date 14-OCT-2019 (dose and route unknown) for prophylaxis. The vaccine was exposed to temperature excursion of 34.6 degree Fahrenheit (F) to 34.9 F for 255 hours from 31-JUL-2017 to 22-AUG-2017. Data logger involved. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1708USA010748:
Age: 16.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report has been received from a medical assistant referring to a 16 year old patient of unknown gender. Information about concurrent condition, concomitant medication and medical history was not provided. In 2017 (reported as someday during 31-JUL-2017 to 22-AUG-2017), the patient was vaccinated with GARDASIL 9 lot # N000326 / N002720, expiration date 14-OCT-2019 (dose and route unknown) for prophylaxis. The vaccine was exposed to temperature excursion of 34.6 degree Fahrenheit (F) to 34.9 F for 255 hours from 31-JUL-2017 to 22-AUG-2017. Data logger involved. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1708USA010748:
Age: 12.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report has been received from a medical assistant referring to a 12 year old patient of unknown gender. Information about concurrent condition, concomitant medication and medical history was not provided. In 2017 (reported as someday during 31-JUL-2017 to 22-AUG-2017), the patient was vaccinated with GARDASIL 9 lot # N000326 / N002720, expiration date 14-OCT-2019 (dose and route unknown) for prophylaxis. The vaccine was exposed to temperature excursion of 34.6 degree Fahrenheit (F) to 34.9 F for 255 hours from 31-JUL-2017 to 22-AUG-2017. Data logger involved. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1708USA010748:
Age: 16.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report has been received from a medical assistant referring to a 16 year old patient of unknown gender. Information about concurrent condition, concomitant medication and medical history was not provided. In 2017 (reported as someday during 31-JUL-2017 to 22-AUG-2017), the patient was vaccinated with GARDASIL 9 lot # N000326 / N002720, expiration date 14-OCT-2019 (dose and route unknown) for prophylaxis. The vaccine was exposed to temperature excursion of 34.6 degree Fahrenheit (F) to 34.9 F for 255 hours from 31-JUL-2017 to 22-AUG-2017. Data logger involved. There was no previous temperature excursion. No adverse effects were reported.  This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1708USA010748:
Age: 14.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report has been received from a medical assistant referring to a 14 year old patient of unknown gender. Information about concurrent condition, concomitant medication and medical history was not provided. In 2017 (reported as someday during 31-JUL-2017 to 22-AUG-2017), the patient was vaccinated with GARDASIL 9 lot # N000326 / N002720, expiration date 14-OCT-2019 (dose and route unknown) for prophylaxis. The vaccine was exposed to temperature excursion of 34.6 degree Fahrenheit (F) to 34.9 F for 255 hours from 31-JUL-2017 to 22-AUG-2017. Data logger involved. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1708USA010748.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Emotional distress, Herpes zoster, Ophthalmic herpes zoster, Pain
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. Information regarding the patient's past medical history, concurrent conditions, or concomitant medication was not provided. The patient was inoculated with ZOSTAVAX (lot number, dosage, and route of administration not provided) on or about 11-JUN-2014, at a medical group as recommended for routine adult health maintenance for the prevention of shingles. It was reported that the ZOSTAVAX did not prevent shingles as intended, but rather caused the patient to contract a persistent and chronic strain of herpes zoster. On or about 08-JUL-2016, the patient was treated by a physician for a blistering ocular outbreak which was diagnosed as severe herpes zoster, or shingles. The patient has been prescribed VALTREX to attempt to manage and relieve her painful symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Upon internal review, ophthalmic herpes zoster was considered medically significant. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information was received on 12-SEP-2017 from a lawyer regarding a case in litigation concerning a female patient of unknown age. Medical history, concurrent conditions, and concomitant medications were not provided. It was reported that the patient was vaccinated with a dose of ZOSTAVAX (lot number, dosage, and route of administration not provided) on or about 19-JAN-2010 by a physician as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent and chronic strain of herpes zoster. On or about 16-MAR-2016, the patient was treated at an Urgent Care Center for a blistering vesicular outbreak that was diagnosed as herpes zoster, or shingles. The patient was prescribed VALTREX for management of her painful symptoms and outbreaks. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result the patient has suffered and will continue to suffer significant medical expenses, pain and suffering and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information was received on 12-SEP-2017 from a lawyer regarding a case in litigation concerning a female patient of unknown age. Medical history, concurrent conditions, and concomitant medications were not provided. It was reported that the patient was vaccinated with a dose of ZOSTAVAX (lot number, dosage, and route of administration not provided) on or about 17-OCT-2013 at a physicians office as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 08-JUN-2016, the patient was treated by a physician for a blistering vesicular outbreak, which was diagnosed as shingles. The patient was prescribed valacyclovir for management of her painful and persistent symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result the patient has suffered and will continue to suffer significant medical expenses, pain and suffering and other damages. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report has been received from a nurse and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ lot # M042170, expiration date 22-JUN-2018; lot # M044397, expiration date 20-JUN-2018 and lot # N009948, expiration date 21-OCT-2018 (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 0.8 degrees Celsius for 52 minutes and 10.9 degrees Celsius for 3 hours and 17 minutes. Digital data logger was involved. There were no previous excursions reported. No product quality complaint has been filled. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA007137: US-009507513-1709USA007138: US-009507513-1709USA004848.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse and refers to unspecified patients of unknown age and gender. No information about the patients' medical history, concurrent conditions and drug reactions or allergies was provided. Between 01-JUN-2017 and 05-SEP-2017, the patients were vaccinated with improperly stored doses of PROQUAD lot # M044022 with expiration date 01-MAY-2018 (albumin status: recombinant human albumin (rHA)) and lot# N000336 with expiration date 03-JUL-2018 (also reported as 02-JUL-2018) (albumin status: recombinant human albumin (rHA)) (dose and route of administration were not reported) reconstituted with sterile diluent (manufacturer unknown). The temperature excursion ranged from minus 14 to minus 10 degrees Celsius for 630 minutes and from minus 9 to plus 8 degrees Celsius for 3 hours. No adverse effects were reported. There was no previous temperature excursion. Digital data logger was used. Product quality complaint was not involved. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1709USA002044.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Tremor
Clinical narrative: Initial unsolicited report received from a consumer (patient's husband) on 05-Sep-2017. This case involves a 73-year-old female patient who was vaccinated with a dose of FLUZONE HD (batch number, route and site of administration were reported as unknown, expiration date, dose and dose in series were not reported) on an unspecified date in Oct-2016 in the morning (reported as A.M.). Patient's medical history as preexisting physician diagnosed allergies, birth defects, medical conditions (specify) was reported as the reporter refuses to give allergies or medical conditions and illness at the time of vaccination. Concomitant medications were not reported. On an unknown date in Oct-2016 in the afternoon, few hours following the vaccination, the patient's arms were shaking. She went to the emergency room (ER). Laboratory investigations were not reported. As corrective treatment, the patient was given intravenous (IV) fluids. On an unknown date in Oct-2016, the patient recovered from the event (reported as the shaking stopped). List of documents held by sender: none.
Age: 1.58
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Gait disturbance, Injected limb mobility decreased, Injection site nodule, Injection site warmth, Pyrexia
Clinical narrative: 2 inch knot around injection site, warm to touch. Fever of 103. Favoring left leg and limping.
Age: 1.58
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: X-ray limb normal
Clinical narrative: 2 inch knot around injection site, warm to touch. Fever of 103. Favoring left leg and limping.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Peripheral swelling, Skin warm
Clinical narrative: Pt came in with warm, swollen left arm. she stated all week (2 days since the shot).
Age: 68.0
Sex: M
Vaccine: UNK
Symptoms: Lip swelling, Pruritus, Urticaria
Clinical narrative: Extremely swollen lips and hives on much of my body. After talking to my doctor, I began taking Benadryl  36 hours after the vaccine shot. Lips and hives reduced somewhat but swelling and itching persists.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Genital herpes zoster
Clinical narrative: This spontaneous report as received from a physician refers to a 80 year old female patient with immunisation. On 27-MAY-2015, the patient was vaccinated with ZOSTAVAX, 1 DF for prophylaxis. On 05-JUN-2015, 10 days after onset of therapy the patient experienced genital herpes zoster. The outcome of genital herpes zoster was reported as recovered/resolved. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a certified medical assistant referring to an unspecified number of patients of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On an unknown dates, the patients were vaccinated with an improperly store dose of ROTATEQ lot # L033548 and expiration date of 05-MAY-2017 oral for prophylaxis (dose and route of administration were not reported) reconstituted with properly stored sterile diluent. It could not be confirmed whether or not any doses of improperly stored of ROTATEQ were administered past the expiration date. No symptoms were reported. The vaccine was exposed to a temperature excursion of 47.5°F with a time frame of 30 minutes. There was no previous temperature excursion. A "data logger" was involved. Sender's Comments: US-009507513-1709USA004156.
Sex: F
Vaccine: MMR
Symptoms: Oral surgery
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a female patient of unknown age. Concurrent condition, medical history and concomitant medication were unknown. On 05-SEP-2017, reported as "3 days ago" the patient was vaccinated with a dose M-M-R II indicated to prevention of measles, mumps and rubella (strength, dosage schedule, route of administration, expiration date and lot number were not provided). On an unknown date on September 2017, the patient had had an unspecified oral surgery, and after the procedure she was prescribed an unknown dose of MEDROL. It was unknown if laboratory diagnostics studies were performed. The outcome to oral surgery was unknown and the causal relationship between the M-M-R II and the adverse event was not provided.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On an unknown dates, the patients were vaccinated with improperly stored doses of PROQUAD lot# N002915 and expiration date 24-JUL-2018 (dose, frequency and route of administration were not reported) reconstituted with properly stored sterile diluent. There were no adverse effects reported. Administered doses of vaccine experienced the temperature excursion from 6 to 14 degrees Fahrenheit for 1 hour. Data logger was not involved. There were no previous excursions reported.
Age: 15.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from medical assistant refers to multiple unspecified patients of unknown age and gender. Information on pertinent medical history and concurrent condition was not provided. On an unspecified dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 lot # N004799, expiry 15-NOV-2019 (dose and route not reported) for prophylaxis. It was reported that on unspecified dates, the vaccine was exposed to a temperature between 2 Centigrade degrees and 8 Centigrade degrees (1.8C) for 42 minutes. There was previous temperature excursion between 0 Centigrade degrees and 1 Centigrade degree for 1 hour and 56 minutes and another excursion between 9 and 25 Centigrade degrees (11.4C) for 1 hour and 41 minutes. The call was placed because of a Digital Data logger report. No adverse effects reported. As of 01-SEP-2017, all telephone attempts to obtain follow up information had been unsuccessful. Follow up information has been received from the medical assistant on 05-SEP-2017. The patient's age was confirmed as 15 years. It was also confirmed that on 13-JUL-2017 the patient was vaccinated with the improperly stored GARDASIL 9. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA005737: US-009507513-1709USA005738: US-009507513-1709USA005747: US-009507513-1709USA005740: US-009507513-1709USA005741: US-009507513-1708USA001768: US-009507513-1709USA005743: US-009507513-1709USA005744: US-009507513-1709USA005745: US-009507513-1709USA005746: US-009507513-1709USA005736: US-009507513-1709USA005735: US-009507513-1709USA005748: US-009507513-1709USA005739.
Age: 10.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from medical assistant refers to multiple unspecified patients of unknown age and gender. Information on pertinent medical history and concurrent condition was not provided. On an unspecified dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 lot # N004799, expiry 15-NOV-2019 (dose and route not reported) for prophylaxis. It was reported that on unspecified dates, the vaccine was exposed to a temperature between 2 Centigrade degrees and 8 Centigrade degrees (1.8C) for 42 minutes. There was previous temperature excursion between 0 Centigrade degrees and 1 Centigrade degree for 1 hour and 56 minutes and another excursion between 9 and 25 Centigrade degrees (11.4C) for 1 hour and 41 minutes. The call was placed because of a Digital Data logger report. No adverse effects reported. As of 01-SEP-2017, all telephone attempts to obtain follow up information had been unsuccessful. Follow up information has been received from the medical assistant on 05-SEP-2017. The patient's age was confirmed as 10 years. It was also confirmed that on 27-JUL-2017 the patient was vaccinated with the improperly stored GARDASIL 9. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA005737: US-009507513-1709USA005738: US-009507513-1708USA001768: US-009507513-1709USA005740: US-009507513-1709USA005741: US-009507513-1709USA005742: US-009507513-1709USA005743: US-009507513-1709USA005744: US-009507513-1709USA005745: US-009507513-1709USA005746: US-009507513-1709USA005736: US-009507513-1709USA005735: US-009507513-1709USA005748: US-009507513-1709USA005739.
Age: 14.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from medical assistant refers to multiple unspecified patients of unknown age and gender. Information on pertinent medical history and concurrent condition was not provided. On an unspecified dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 lot # N004799, expiry 15-NOV-2019 (dose and route not reported) for prophylaxis. It was reported that on unspecified dates, the vaccine was exposed to a temperature between 2 Centigrade degrees and 8 Centigrade degrees (1.8C) for 42 minutes. There was previous temperature excursion between 0 Centigrade degrees and 1 Centigrade degree for 1 hour and 56 minutes and another excursion between 9 and 25 Centigrade degrees (11.4C) for 1 hour and 41 minutes. The call was placed because of a Digital Data logger report. No adverse effects reported. As of 01-SEP-2017, all telephone attempts to obtain follow up information had been unsuccessful. Follow up information has been received from the medical assistant on 05-SEP-2017. The patient's age was confirmed as 14 years. It was also confirmed that on 28-JUL-2017 the patient was vaccinated with the improperly stored GARDASIL 9. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA005737: US-009507513-1709USA005738: US-009507513-1709USA005747: US-009507513-1709USA005740: US-009507513-1709USA005741: US-009507513-1709USA005742: US-009507513-1709USA005743: US-009507513-1709USA005744: US-009507513-1709USA005745: US-009507513-1709USA005746: US-009507513-1709USA005736: US-009507513-1709USA005735: US-009507513-1708USA001768: US-009507513-1709USA005739.
Age: 10.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report has been received from a medical assistant referring to a 14 year old patient of unknown gender. Information about concurrent condition, concomitant medication and medical history was not provided. In 2017 (reported as someday during 31-JUL-2017 to 22-AUG-2017), the patient was vaccinated with GARDASIL 9 lot # N000326 / N002720, expiration date 14-OCT-2019 (dose and route unknown) for prophylaxis. The vaccine was exposed to temperature excursion of 34.6 degree Fahrenheit (F) to 34.9 F for 255 hours from 31-JUL-2017 to 22-AUG-2017. Data logger involved. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1708USA010748.
Age: 8.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report has been received from a medical assistant referring to a 8 year old patient of unknown gender. Information about concurrent condition, concomitant medication and medical history was not provided. In 2017 (reported as someday during 31-JUL-2017 to 22-AUG-2017), the patient was vaccinated with GARDASIL 9 lot # N000326 / N002720, expiration date 14-OCT-2019 (dose and route unknown) for prophylaxis. The vaccine was exposed to temperature excursion of 34.6 degree Fahrenheit (F) to 34.9 F for 255 hours from 31-JUL-2017 to 22-AUG-2017. Data logger involved. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1708USA010748.
Age: 16.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report has been received from a medical assistant referring to a 16 year old patient of unknown gender. Information about concurrent condition, concomitant medication and medical history was not provided. In 2017 (reported as someday during 31-JUL-2017 to 22-AUG-2017), the patient was vaccinated with GARDASIL 9 lot # N000326 / N002720, expiration date 14-OCT-2019 (dose and route unknown) for prophylaxis. The vaccine was exposed to temperature excursion of 34.6 degree Fahrenheit (F) to 34.9 F for 255 hours from 31-JUL-2017 to 22-AUG-2017. Data logger involved. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1708USA010748.
Age: 11.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report has been received from a medical assistant referring to a 11 year old patient of unknown gender. Information about concurrent condition, concomitant medication and medical history was not provided. In 2017 (reported as someday during 31-JUL-2017 to 22-AUG-2017), the patient was vaccinated with GARDASIL 9 lot # N000326 / N002720, expiration date 14-OCT-2019 (dose and route unknown) for prophylaxis. The vaccine was exposed to temperature excursion of 34.6 degree Fahrenheit (F) to 34.9 F for 255 hours from 31-JUL-2017 to 22-AUG-2017. Data logger involved. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1708USA010748.
Age: 15.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report has been received from a medical assistant referring to a 15 year old patient of unknown gender. Information about concurrent condition, concomitant medication and medical history was not provided. In 2017 (reported as someday during 31-JUL-2017 to 22-AUG-2017), the patient was vaccinated with GARDASIL 9 lot # N000326 / N002720, expiration date 14-OCT-2019 (dose and route unknown) for prophylaxis. The vaccine was exposed to temperature excursion of 34.6 degree Fahrenheit (F) to 34.9 F for 255 hours from 31-JUL-2017 to 22-AUG-2017. Data logger involved. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1708USA010748.
Age: 0.33
Sex: U
Vaccine: HIBV, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report has been received from a medical assistant referring to a 14 year old patient of unknown gender. Information about concurrent condition, concomitant medication and medical history was not provided. In 2017 (reported as someday during 31-JUL-2017 to 22-AUG-2017), the patient was vaccinated with ROTATEQ lot # M041768, expiration date 25-JUN-2018, orally (dose unknown) and PEDVAXHIB lot # N003701, expiration date 01-NOV-2019 (dose and route unknown) for prophylaxis. The vaccines were exposed to temperature excursion of 34.6 degree Fahrenheit (F) to 34.9 F for 255 hours from 31-JUL-2017 to 22-AUG-2017. Data logger involved. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1708USA010748.
Age: 0.25
Sex: U
Vaccine: HIBV, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report has been received from a medical assistant referring to a 14 year old patient of unknown gender. Information about concurrent condition, concomitant medication and medical history was not provided. In 2017 (reported as someday during 31-JUL-2017 to 22-AUG-2017), the patient was vaccinated with ROTATEQ lot # M041768, expiration date 25-JUN-2018, orally (dose unknown) and LIQUID PEDVAXHIB lot # N003701, expiration date 01-NOV-2019 (dose and route unknown) for prophylaxis. The vaccines were exposed to temperature excursion of 34.6 degree Fahrenheit (F) to 34.9 F for 255 hours from 31-JUL-2017 to 22-AUG-2017. Data logger involved. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1708USA010748:
Sex: U
Vaccine: HIBV, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report has been received from a medical assistant referring to a 14 year old patient of unknown gender. Information about concurrent condition, concomitant medication and medical history was not provided. In 2017 (reported as someday during 31-JUL-2017 to 22-AUG-2017), the patient was vaccinated with ROTATEQ lot # M041768, expiration date 25-JUN-2018, orally (dose unknown) and PEDVAXHIB lot # N003701, expiration date 01-NOV-2019 (dose and route unknown) for prophylaxis. The vaccines were exposed to temperature excursion of 34.6 degree Fahrenheit (F) to 34.9 F for 255 hours from 31-JUL-2017 to 22-AUG-2017. Data logger involved. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1708USA010748.
Age: 0.33
Sex: U
Vaccine: HIBV, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report has been received from a medical assistant referring to a 14 year old patient of unknown gender. Information about concurrent condition, concomitant medication and medical history was not provided. In 2017 (reported as someday during 31-JUL-2017 to 22-AUG-2017), the patient was vaccinated with ROTATEQ lot # M041768, expiration date 25-JUN-2018, orally (dose unknown) and LIQUID PEDVAXHIB lot # N003701, expiration date 01-NOV-2019 (dose and route unknown) for prophylaxis. The vaccines were exposed to temperature excursion of 34.6 degree Fahrenheit (F) to 34.9 F for 255 hours from 31-JUL-2017 to 22-AUG-2017. Data logger involved. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1708USA010748:
Age: 0.58
Sex: U
Vaccine: HIBV, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report has been received from a medical assistant referring to a 14 year old patient of unknown gender. Information about concurrent condition, concomitant medication and medical history was not provided. In 2017 (reported as someday during 31-JUL-2017 to 22-AUG-2017), the patient was vaccinated with ROTATEQ lot # M041768, expiration date 25-JUN-2018, orally (dose unknown) and LIQUID PEDVAXHIB lot # N003701, expiration date 01-NOV-2019 (dose and route unknown) for prophylaxis. The vaccines were exposed to temperature excursion of 34.6 degree Fahrenheit (F) to 34.9 F for 255 hours from 31-JUL-2017 to 22-AUG-2017. Data logger involved. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1708USA010748:
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse and refers to a 3 patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. The patients received improperly stored (in refrigerator) PROQUAD lot # N010115, expiration date 24-SEP-2018, therapy type: rHA (dose and route of administration were not reported). One was administered on 11-SEP-2017 and two were administered on unspecified dates. There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion from 15 to 46 degrees Fahrenheit for unknown length of time. Data logger was involved. There were no previous excursions reported.
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information has been received on 12-SEP-2017 regarding a case in litigation from a lawyer and a male consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medication were not reported. On or about 14-APR-2014, the patient was inoculated with ZOSTAVAX (lot number and expiration not reported) subcutaneous at a pharmacy, as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent and chronic strain of herpes zoster. On or about 14-MAY-2016, the patient was treated by a health care professional for a persistent blistering vesicular outbreak that was diagnosed as severe herpes zoster. The patient has been prescribed VALTREX, MOTRIN and ibuprofen for management of his painful symptoms and herpetic complications. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information has been received on 12-SEP-2017 regarding a case in litigation from a lawyer and a female consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medication were not reported. On or about 30-MAY-2012, the patient was inoculated with ZOSTAVAX (lot number and expiration not reported) subcutaneous by a physician, as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 10-SEP-2014, the patient was treated by a physician for a vesicular outbreak, which was diagnosed as shingles. The patient has been prescribed sulfamethoxazole, trimethoprim (BACTRIM) for management of her painful and persistent symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Depression, Herpes zoster, Pain, Post herpetic neuralgia
Clinical narrative: Information was received on 12-SEP-2017 from a lawyer regarding a case in litigation concerning a female patient of unknown age. Medical history, concurrent conditions, and concomitant medications were not provided. It was reported that the patient was vaccinated with a dose of ZOSTAVAX (lot number, dosage, and route of administration not provided) on or about 19-APR-2016 at a pharmacy as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 04-NOV-2016, the patient was treated by a physician for a blistering vesicular outbreak that was diagnosed as herpes zoster, or shingles. On or about 06-APR-2017, the patient sought further treatment from another physician (Neurologist) for ongoing and worsening symptoms, which were diagnosed as thoracic post-herpetic neuralgia and depression fueled by zoster misery. The patient was prescribed VALTREX, Gabapentin, Lidocaine, LYRICA and LIPODERM for management of her painful symptoms and outbreaks. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result the patient has suffered and will continue to suffer significant medical expenses, pain and suffering and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Rash vesicular
Clinical narrative: Information was received on 12-SEP-2017 from a lawyer regarding a case in litigation concerning a female patient of unknown age. Medical history, concurrent conditions, and concomitant medications were not provided. It was reported that the patient was vaccinated with a dose of ZOSTAVAX (lot number, dosage, and route of administration not provided) on or about 19-APR-2016 at a pharmacy as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 04-NOV-2016, the patient was treated by a physician for a blistering vesicular outbreak that was diagnosed as herpes zoster, or shingles. On or about 06-APR-2017, the patient sought further treatment from another physician (Neurologist) for ongoing and worsening symptoms, which were diagnosed as thoracic post-herpetic neuralgia and depression fueled by zoster misery. The patient was prescribed VALTREX, Gabapentin, Lidocaine, LYRICA and LIPODERM for management of her painful symptoms and outbreaks. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result the patient has suffered and will continue to suffer significant medical expenses, pain and suffering and other damages. Additional information has been requested.
Sex: U
Vaccine: DTAP, MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a physician concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions and drug reactions or allergies were not reported. On 13-SEP-2017, the patient was vaccinated with VARIVAX (dose, lot number and expiration date were not reported) and PROQUAD (dose, lot number and expiration date were not reported) both for prophylaxis. Other suspect vaccine included diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid. The patient's concomitant therapies included sterile diluent (manufacturer unknown). No side effects were reported.
Age: 0.33
Sex: M
Vaccine: RV5
Symptoms: Product storage error
Clinical narrative: This spontaneous report as received from a nurse refers to a 4 month old male patient. On 22-JUN-2017 the patient was vaccinated with an improperly stored dose of ROTATEQ (lot# M031802, expiration date 09-NOV-2017, oral) for prophylaxis. It was reported that the refrigerator was out of temperature range. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1707USA006507.
Age: 65.0
Sex: F
Vaccine: FLU4, PNC13
Symptoms: Dizziness, Immediate post-injection reaction, Throat irritation, Throat tightness
Clinical narrative: Immediately after vaccinations given patient began to feel dizzy and throat itchy and "like it was closing". Patient was given 25 mg BENADRYL - refused EMS - waited 20 mins and recovered.
Age: 16.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Immediate post-injection reaction, Loss of consciousness
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of passed out in a 16-year-old male patient who received BEXSERO. Concomitant products included MENACTRA. On an unknown date, the patient received BEXSERO. On an unknown date, immediately after receiving BEXSERO, the patient experienced passed out (serious criteria GSK medically significant). On an unknown date, the outcome of the passed out was unknown. It was unknown if the reporter considered the passed out to be related to BEXSERO. Additional details were provided as follows: The patient passed out almost immediately after receiving the BEXSERO. No hospitalization or intervention was required. The patient also received MENACTRA.
Age: 64.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain
Clinical narrative: Localized red and painful, lasted for more than 2 days (redness starting to get better @ day 4).
Age: 5.0
Sex: M
Vaccine: FLU4
Symptoms: Erythema, Hypersensitivity, Pruritus, Swelling
Clinical narrative: Redness/swelling/itching - allergic reaction 24 hours later.
Age: 19.0
Sex: F
Vaccine: MNQ, TYP, YF
Symptoms: Abdominal pain upper, Diarrhoea, Head banging, Pyrexia
Clinical narrative: CT C/O THAT AFTER RECEIVING VACCINES ON 9/6/2017 CT HAD STOMACH ACHE AND DIARRHEA 9/8/17 TO 9/10/17. THEN ON 9/11/2017 CT C/O OF FEVER AND HEADACHE- FEVER AND HEADACHE STILL ONGOING. CT RECEIVED TYPHOID AND MCV4 VACCINES ON THE SAME DATE ALSO.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Rash pruritic
Clinical narrative: Pt developed itchy rash on left side of back.
Sex: F
Vaccine: HPV4
Symptoms: Anxiety, Bacterial test negative, Bladder hydrodistension, Cardiac dysfunction, Culture urine
Clinical narrative: My daughter had UTI symptoms starting in March of 2016. Had third dose of GARDASIL in June of 2016. Doctor kept treating her with antibiotics even though no bacteria showed up in urine. She was better until July of 2016 when she thought she had another UTI and was given more antibiotics. Was ok until Dec of  2016 when the symptoms came roaring back. More antibiotics to no avail and GP told her to see a urologist. Urologist paid basically no attention to her but gave her more antibiotics even though no bacteria and also URIBEL. The pain and frequency was so horrendous that she went to her GP for something for her anxiety. The mixture of the URIBEL and PROZAC sent her into serotonin syndrome causing seizures and possible death. She was hospitalized for 6 days and had an EF fraction of 30. As soon as I got her out of hospital I took her to Clinic for heart and bladder. Her heart function is still low and she was diagnosed with interstitial cystitis. The doctor could not believe that a 19 year old would have this condition.