chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a nurse refers to a multiple unspecified patients of unknown age and gender. The patient's medical history, concurrent condition and concomitant medications were not reported. On multiple unspecified date the patients were vaccinated with improperly stored RECOMBIVAX HB (lot N005996 expiry date 07-JUL-2019) or (lot N006321 expiry date 08-NOV-2019) or (lot: M044032, expiry date: 03-JUL-2019) (incorrect product storage) for prophylaxis. No adverse effects reported with any patients. The vaccine was exposed to temperature of 0°C to 1°C for a time frame of 35 minutes. Previous temperature excursion was reported. The call because of a data logger. No PQC involved. No further information provided. This is one of the several reports linked via same reporter link.; Sender's Comments: US-009507513-1708USA008711: US-009507513-1708USA008710: US-009507513-1708USA008409: US-009507513-1708USA008709: US-009507513-1708USA008709: US-009507513-1708USA008709: US-009507513-1708USA008409:
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacy technician refers to a patient of unknown age or gender. On 10-AUG-2015 and 23-SEP-2015, the patient was vaccinated with the first and second dose of GARDASIL (dose, route of administration, lot number and expiration date were not reported), for prophylaxis. On 18-AUG-2017, the patient was vaccinated with GARDASIL 9 (dose, route of administration, lot number and expiration date were not reported), for prophylaxis. The patient experienced interchange of vaccine products, no adverse event, inappropriate schedule of drug administration and off label use.
Sex: U
Vaccine: HEP
Symptoms: Drug dose omission, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. The patient missed receiving a scheduled dose of RECOMBIVAX HB (unknown lot, unknown expiration date) "due to the product being on back order" (product quality issue). The patient was scheduled to receive the 2nd Dose of RECOMBIVAX HB on 14-AUG-2017. No adverse effects reported.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse referring to a patient of unknown age and gender. On an unknown date the patient was vaccinated with a dose of improperly stored PROQUAD (dose, frequency, lot #, expiration date and indication not reported), which was mixed with sterile diluent (manufacturer unknown) (Lot number, and Expiration date unspecified). It was verified the diluent was properly stored. No adverse effects were reported. The PROQUAD was exposed to temperature of - 13.6 degree centigrade for 50 minutes.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On 22-AUG-2017 the patient was vaccinated with an expired dose of VARIVAX (lot # L021215, expiration date 10-JUN-2017) that was mixed with STERILE DILUENT (Lot number and expiration date unspecified) for prophylaxis. Verified diluent was not expired. No adverse effects were reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report refers to multiple unspecified patients of unknown age and gender. The patients' pertinent medical history, drug reaction or allergies and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX (lot # M047661, Expiry date: 02-DEC-2018; lot #N008828 expiry date: 16-MAR-2019). On an unknown date, the vaccine was exposed to temperature of -11 degrees C for 50 minutes. No adverse effects reported. No previous temperature excursion was reported. This case was reported because of a data logger. No product quality complaint (PQC) was reported. No further information to report. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1708USA011303:
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report refers to a patient of unknown age. On 23-AUG-2017 the patient was vaccinated an expired dose of ZOSTAVAX, 1 DF (invalid lot# reported as M0415510, expiration date: 27-JUL-2017) for prophylaxis. Concomitant therapies included sterile diluent (manufacturer unknown).   No adverse event reported.
Sex: U
Vaccine: HIBV
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. On unknown dates, the patients were vaccinated with an improperly stored dose of LIQUID PEDVAXHIB lot # N003698 and expiration date: 31-OCT-2019. The LIQUID PEDVAXHIB was reconstituted with sterile diluent (manufacturer unknown) which did not undergo a temperature excursion. No adverse effects were reported. The digital data logger was involved in recording the temperature excursion. This is one of four reports received from the same reporter.; Sender's Comments: US-009507513-1708USA008059: US-009507513-1708USA010647: US-009507513-1708USA010656:
Sex: U
Vaccine: RV5
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. On unknown dates, the patients were vaccinated with an improperly stored dose of ROTATEQ lot # N000172 and expiration date: 10-JUN-2018. No adverse effects were reported. The digital data logger was involved in recording the temperature excursion. This is one of four reports received from the same reporter.; Sender's Comments: US-009507513-1708USA010646: US-009507513-1708USA008059: US-009507513-1708USA010656:
Age: 17.0
Sex: M
Vaccine: HPV9
Symptoms: Ear disorder
Clinical narrative: This spontaneous report as received from a other health professional refers to a 17 year old male patient with osteogenesis imperfecta, pathological fracture and food allergy. On 22-JUN-2017 the patient was vaccinated with GARDASIL 9 lot # N004798 dose 1, 1 DF for prophylaxis. On 2017 the patient experienced ear disorder. The outcome of ear disorder was reported as not recovered/not resolved.
Sex: U
Vaccine: HPV9
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 ages and genders. The patients' concurrent conditions and medical history were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 lot # M044717, expiration date 30-JUL-2017, (dose and route were not reported) for prophylaxis. The vaccines were stored at a temperature of 34.6 Fahrenheit degrees during 23 days. There were no previous temperature excursions. The call was made because of a data logger. No adverse effects were reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Neuralgia, Ophthalmic herpes zoster, Post herpetic neuralgia
Clinical narrative: Information was received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received concerning the patient's past medical history, concurrent conditions, or concomitant medication. On or about 20-NOV-2009, the patient was inoculated with ZOSTAVAX (lot number, dosage, and route of administration not provided), 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 17-AUG-2015, the patient was treated by a physician for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster and herpes zoster Keratitis. On or about 11-SEP-2015, the patient received subsequent treatment for ongoing and worsening symptoms of shingles, and was further diagnosed with post-herpetic neuralgia, a chronic condition of nerve pain and damage secondary to zoster infections. On or about 15-JAN-2014, the patient was treated for new and worsening outbreaks of shingles and uncontrolled pain. On or about 31-JAN-2014, the patient sought additional treatment for persistent shingles and escalating pain, and was referred by his physicians to seek pain management evaluation. On or about 30-AUG-2016, the patient was treated for severe neuropathic pain secondary to post-herpetic neuralgia. The patient was subsequently treated on or about 28-FEB-2017 for uncontrolled and persistent outbreaks of shingles and severe neuropathic pain. The patient has been prescribed NEURONTIN, lidocaine, LIDODERM patches, hydrocodone, tramadol and gabapentin in escalating dosages in attempts to manage his painful symptoms. The patient has also undergone cryogenic therapy for treatment of his shingles-related injuries. As a direct and proximate result of these malfunctions, the patient has 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, the events of Herpes zoster Keratitis was determined to be medically significant. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Rash vesicular
Clinical narrative: Information was received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received concerning the patient's past medical history, concurrent conditions, or concomitant medication. On or about 20-NOV-2009, the patient was inoculated with ZOSTAVAX (lot number, dosage, and route of administration not provided), 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 17-AUG-2015, the patient was treated by a physician for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster and herpes zoster Keratitis. On or about 11-SEP-2015, the patient received subsequent treatment for ongoing and worsening symptoms of shingles, and was further diagnosed with post-herpetic neuralgia, a chronic condition of nerve pain and damage secondary to zoster infections. On or about 15-JAN-2014, the patient was treated for new and worsening outbreaks of shingles and uncontrolled pain. On or about 31-JAN-2014, the patient sought additional treatment for persistent shingles and escalating pain, and was referred by his physicians to seek pain management evaluation. On or about 30-AUG-2016, the patient was treated for severe neuropathic pain secondary to post-herpetic neuralgia. The patient was subsequently treated on or about 28-FEB-2017 for uncontrolled and persistent outbreaks of shingles and severe neuropathic pain. The patient has been prescribed NEURONTIN, lidocaine, LIDODERM patches, hydrocodone, tramadol and gabapentin in escalating dosages in attempts to manage his painful symptoms. The patient has also undergone cryogenic therapy for treatment of his shingles-related injuries. As a direct and proximate result of these malfunctions, the patient has 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, the events of Herpes zoster Keratitis was determined to be medically significant. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a other health professional refers to patients of unknown age and gender. On unknown dates, the patients were vaccinated with PROQUAD lot # N008824 for prophylaxis. Concomitant therapies included sterile diluent. On unknown dates, the patients experienced incorrect product storage and no adverse event. The outcome of incorrect product storage and no adverse event were unknown. The reporter considered incorrect product storage and no adverse event to be not related to PROQUAD. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1708USA011267: US-009507513-1708USA005004.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a other health professional refers to patients of unknown age and gender. On unknown dates, the patiente were vaccinated with VARIVAX lot # N001527 and lot # N007930 for prophylaxis. Concomitant therapies included sterile diluent (STERILE DILUENT). On unknown dates, the patiente experienced incorrect product storage and no adverse event. The outcome of incorrect product storage and no adverse event were unknown. The reporter considered incorrect product storage and no adverse event to be not related to VARIVAX. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1708USA005004: US-009507513-1708USA011266:
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a health care professional refers to multiple unspecified patients of unknown ages and genders. On unknown dates, the patients were vaccinated with improperly stored doses of GARDSIL 9 (lot # N042853, expiry date: 17-JUL-2019). The vaccines were stored at a temperature of 9°C to 25°C (10.4°C) for 1 Hour 22 Minutes. Previous temperature excursion was 9°C to 25°C (13.1°C) for 1 Hour 39 Minutes. Data logger was involved. No adverse effects reported. Sender's Comments: US-009507513-1708USA011300.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a health care professional refers to multiple unspecified patients of unknown ages and genders. On unknown dates, the patients were vaccinated with improperly stored doses of LIQUID PEDVAXHIB (lot # N000238, expiry date: 25-OCT-2019, lot # N001348, expiry date: 31-OCT-2019) (incorrect product storage). The vaccines were stored at a temperature of 9°C (degree celsius) to 25°C (10.4°C) for 1 Hour 22 Minutes. Previous temperature excursion was 9°C to 25°C (13.1°C) for 1 Hour 39 Minutes. Data logger was involved. No adverse effects reported.; Sender's Comments: US-009507513-1708USA011296:
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report from a registered nurse refers to multiple unspecified patients of unknown age and gender. The patients' pertinent medical history, drug reaction or allergies and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of PROQUAD (lot # N002325, Expiry date: 19-JUL-2018). On an unknown date, the vaccine was exposed to temperature of -11 degrees C for 50 minutes. No adverse effects reported. No previous temperature excursion was reported. This case was reported because of a data logger. No product quality complaint (PQC) was reported. No further information to report. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1708USA010249.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Rash
Clinical narrative: Information has been received from a 60 year old female patient who was not pregnant with allergy to loratadine (CLARITIN) concerning herself. The patient's concurrent conditions included diabetes, high blood pressure, high cholesterol and bronchitis. Concomitant therapies included metoprolol, vitamin D, sacubitril, valsartan (ENTRESTO) and atorvastatin. On 11-JUL-2017, the patient was vaccinated with a dose of ZOSTAVAX (lot #, expiration date, dose and route were unknown), for prophylaxis. On approximately 10-AUG-2017 (reported as two weeks ago), the patient experienced symptoms of diarrhea. On approximately 13-AUG-2017 (reported as a week and a half ago), the patient experienced a mild skin rash. On an unknown date, the patient performed unspecified lab diagnostics. The patient did not seek medical attention and did not receive any treatment. The outcome of the events was unknown. The reporter did not assess the causality.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from an X-ray technician concerning an unspecified number of patients of unknown age and gender. On unknown dates, the patients were vaccinated with improperly stored doses of PNEUMOVAX 23 (dose, frequency, lot #, expiration date and indication unknown). No adverse symptoms were reported. The vaccines were exposed to temperature of 47 F to 77F for an unspecified period of time, there was also a previous temperature excursion of 47 F to 77F for an unspecified period of time. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1708USA004979.
Age: 58.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Some swelling  and redness at injection site on evening of 24th. Larger area of swelling and reddness on the 25th continuing to expand to involve the area from the injection site to the elbow on the 26th. Patient called pharmacy on the 27th to inform that the area of swelling had not increased but still involved the entire area of the arm from the injection site to the elbow. Patient verbally described the area, has not been seen by pharmacist or MD.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Back pain, Chills, Headache, Pyrexia
Clinical narrative: None stated.
Age: 20.0
Sex: M
Vaccine: HEPA, HPV4
Symptoms: Body temperature increased, Injection site rash, Rash
Clinical narrative: Rash from injection site to hands, bilateral arms. Temperature of 100.5
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, HEP, HEPA, PNC13, RV1
Symptoms: Asthma, Blister, Hypersensitivity, Rash, Rash vesicular
Clinical narrative: Showed a allergic reaction in the whole body, rash and blisters, it looks like varicella. The child is hospitalized every time is vaccinated and Benadryl is administered. At the 6 month vaccination the child developed the rash and also asthma.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Patient went to employee health for the development of rash that occurred after being administered the ZOSTAVAX Vaccine. He was treated with a 5 day course of Prednisone.
Sex: F
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from an office manager concerning multiple unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not reported. On unknown dates, the patients were vaccinated with imporperly stored doses of VARIVAX lot # M045204, expiration date: 11-NOV-2018, lot # M046924, expiration date: 28-NOV-2018, lot # M042858, expiration date: 26-OCT-2018, lot # M036272, expiration date: 17-AUG-2018 and lot #M043305, expiration date: 26-OCT-2018, as prophylaxis (Strength, dose and route were not reported), which experienced a temperature excursion between -14 and - 10 Celsius degrees for 14 days. No previous temperature excursion were reported. Data logger was involved. No adverse symptoms were reported. Lot number M045204, M046924 and M043305 have been verified to be a valid lot number for varicella virus vaccine live (oka/merck). Additional information has been requested. Follow-up information was received for this spontaneous report on 01-JUN-2017 from a registered pediatric nurse regarding patients (23) who received VARIVAX from 19-APR-2017 - 03-MAY-2017, while the vaccine may have been improperly stored (temperature issue). On 27-APR-2017, VARIVAX (Strength, dose, route, and site of administration were not reported), while the vaccine may have been improperly stored (temperature issue), was administered to a female patient of unknown age for prophylaxis. [It was not further specified which Lot number the patient received.] The patient had not experienced any adverse side effects of any kind. No additional information is expected. This is one of several reports from the same reporter. This is an amended report, as corrected. The reference type for US-009507513-1705USA002199 was changed to E2B Linked Report (previously reported as E2B company number). Sender's Comments: US-009507513-1705USA002199: Original source case.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Lymphadenopathy
Clinical narrative: This spontaneous report as received from a 69 year old pharmacist referring himself. The patient had no pertinent medical history, drug reactions/allergies and concomitant medications. On an unknown date in July 2017 (reported as" two and a half weeks ago") the patient was vaccinated with ZOSTAVAX (strength, dose, route of administration, lot/batch# and expiration date were not reported) for vaccination and Sterile diluent (lot# and expiration date were not provided) was used to reconstitute the vaccine. On an unknown date in July 2017 (reported as 5 days after the vaccine administration) the patient developed "a swollen lymph node behind his left ear, width is a "dime" size." On an unspecified date, the patient developed a "swollen gland behind his right ear" and he had never had this issue before. No lab diagnostics/studies were performed. The outcome of swollen lymph node behind his left ear was reported as not recovered. The outcome of swollen gland behind his right ear was unknown.  The causality assessment was not provided by the reporter.
Sex: M
Vaccine: VARCEL
Symptoms: Rash generalised
Clinical narrative: This spontaneous report has been received from a medical assistant concerning a male patient of unknown age. The patient had no concomitant medications, no pertinent medical history and no drug reactions/allergies. On 18-JUL-2017, the patient was administered VARIVAX (lot # M049126, expiration date 15-DEC-2018; dose and route unknown) reconstituted with sterile diluent (dose, route, lot # and expiration date unknown) to prevent chickenpox. On 20-JUL-2017, the patient experienced a "full body rash". The medical assistant reported the patient was seen by physician on an unspecified date in 2017, who treated the rash with an unspecified amount of "witch hazel". The medical assistant reported that the unspecified parent of the patient called the office "five days after being seen and stated the rash was gone". The causality between the event and VARIVAX was unknown.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Syncope
Clinical narrative: This spontaneous report as received from a other health professional refers to a 11 year old male patient with type 1 diabetes mellitus and prophylaxis. On 08-AUG-2017 the patient was vaccinated with GARDASIL 9, 0.5 ml, intramuscular for prophylaxis. Other suspect therapies included diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid and MENACTRA. Concomitant therapies included NOVOLOG)] and LEVEMIR. On 08-AUG-2017, the patient experienced syncope. The outcome of syncope was reported as recovered/resolved. Additional information is not expected.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and refers to multiple unspecified patients of unknown age and gender. On unknown dates, the patients were vaccinated with improperly stored ROTATEQ orally, lot # M045546 with expiration date on 12-JUN-2018 or lot # M040271 with expiration date on 30-APR-2018. Administered doses of vaccines underwent following temperature excursions: twice an excursion from 47 degrees Fahrenheit to 77 degrees Fahrenheit, which each lasted for 12 hours and ten excursions from 32 degrees Fahrenheit to 35 degrees Fahrenheit, which each lasted for 12 hours (total timeframe of excursions was 144 hours). A digital data logger was involved in recording the excursions. No adverse effects were reported. Product quality complaint was not involved. This is one of three reports received from the same reporter. Sender's Comments: US-009507513-1708USA011555: US-009507513-1708USA011556.
Sex: M
Vaccine: HEPA
Symptoms: Hepatitis A virus test positive
Clinical narrative: This spontaneous report as received from a healthcare worker and refers to a male patient of unknown age. On an unknown date, the patient was vaccinated with VAQTA for prophylaxis. On an unknown date, the patient experienced hepatitis A virus test positive. The outcome of hepatitis a virus test positive was unknown. Causality assessment was not provided. Additional information is not expected, since there was no consent to contact reporter.
Age: 68.0
Sex: M
Vaccine: PPV
Symptoms: Discomfort, Erythema, Skin warm
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 68 year old male patient. There were no pertinent medical history and concomitant medications. The patient was not allergic to any drugs. On 21-AUG-2017 the patient was vaccinated with PNEUMOVAX 23 (dosing details were not reported) (lot # N000508, expiry date: 19-OCT-2018) for prophylaxis. On 22-AUG-2017, the patient visited the pharmacy and stated that he was experiencing redness and warmth on his left arm located under his arm down to his elbow". Patient did "feel a little discomfort" (erythema, discomfort and feeling of warmth). The patient had undergone treatment for the events. The outcome of the events was reported as not recovered/not resolved. The reporter did not provide the causality assessment between the events and the suspect therapy. There was no product quality complaint involved.
Sex: F
Vaccine: HPV9
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 18 year old female patient. On 12-AUG-2017 the patient was vaccinated with GARDASIL 9 dose 4 for prophylaxis. On 12-AUG-2017, 10 months 29 days after onset of therapy the patient experienced extra dose administered. On an unknown date the patient experienced no adverse event.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a physician via company representative refers to an elderly male patient of unknown age. The patient's concurrent conditions included hypertension and diabetes mellitus. The patient's concomitant medications included medications for hypertension. Approximately in 2016 (reported as a year and a half ago), the patient was vaccinated with ZOSTAVAX, (lot#, expiry date, route were unknown) 0.65 ml once for prophylaxis. At the time of vaccination the patient was 70 years of age. On an unknown date approximately in 2017, the patient experienced severe case of shingles herpes zoster on his right leg. On 30-JUL-2017, the patient visited the physician's office. Treatment was given for the event. The outcome of the event was unknown. There were no product quality complaints (PQC) involved. Causality assessment was not reported.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and refers to multiple unspecified patients of unknown age and gender. On unknown dates, the patients were vaccinated with improperly stored GARDASIL 9 lot # N000326 with expiration date on 14-OCT-2019. Administered doses of vaccines underwent following temperature excursions: twice an excursion from 47 degrees Fahrenheit to 77 degrees Fahrenheit, which each lasted for 12 hours and ten excursions from 32 degrees Fahrenheit to 35 degrees Fahrenheit, which each lasted for 12 hours (total timeframe of excursions was 144 hours). A digital data logger was involved in recording the excursions. No adverse effects were reported. Product quality complaint was not involved. This is one of three reports received from the same reporter. Sender's Comments: US-009507513-1708USA011556: US-009507513-1708USA008052.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and refers to multiple unspecified patients of unknown age and gender. On unknown dates, the patients were vaccinated with improperly stored LIQUID PEDVAXHIB lot # N003698 with expiration date on 31-OCT-2019 or lot # M046140 with expiration date on 27-SEP-2019. Administered doses of vaccines underwent following temperature excursions: twice an excursion from 47 degrees Fahrenheit to 77 degrees Fahrenheit, which each lasted for 12 hours and ten excursions from 32 degrees Fahrenheit to 35 degrees Fahrenheit, which each lasted for 12 hours (total timeframe of excursions was 144 hours). A digital data logger was involved in recording the excursions. No adverse effects were reported. Product quality complaint was not involved. This is one of three reports received from the same reporter.; Sender's Comments:  US-009507513-1708USA008052: US-009507513-1708USA011555:
Age: 4.0
Sex: F
Vaccine: HIBV
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: No adverse events known at this time. Patient given accidental dose of HIB instead of the Polio dose that was needed. Doctor and Parents aware of situation. Patient contacted and aware of mistake. Advised us to make sure to fill out VAERS. Parents of Patient advised to bring patient in if any adverse reactions arise but none at this time.
Age: 0.17
Sex: M
Vaccine: HEP
Symptoms: Urticaria
Clinical narrative: Full body hives on back then spread to stomach and neck. Mom gave Benadryl every 6 hrs for two days until it was gone. Took to doctor about 15 hrs after reaction started and doctor said to keep giving Benadryl and watch for breathing difficulties. Mom and doctor decided to give vaccinations separately.  given Hep B on 8/22/17 and infant broke out in hives on 8/24/17 on back. Gave Benadryl one dose and rash went away.
Age: 0.75
Sex: M
Vaccine: PNC13
Symptoms: Pyrexia, Seizure
Clinical narrative: The child was vaccinated in the morning and by the afternoon of the same date he developed a high fever. During the next morning the high fever continued and the child convulsed. The child was taken to the ER were he was treated and discharged the same day.
Age: 13.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Chills, Dizziness, Feeling cold, Gait disturbance, Immediate post-injection reaction
Clinical narrative: At 09:05 administered Tdap, MENACTRA, and GARDASIL 9, immediately following last injection (GARDASIL 9), patient became lethargic and pale with eyes closed. Able to answer questions appropriately but speech slow. Cool pack placed to back of neck. When asked, mom stated he had not had anything to eat or drink yet that morning. Obtained juice pack and assisted to sip occasionally. Client able to sip juice when offered. At 09:10, status unchanged and head began nodding to front and side. Assisted to transfer to cot and placed in supine position with knees bent. Cool pack to back of neck and bilateral axilla. Fan positioned to blow on client. Continued to be able to answer questions appropriately but speech slow, eyes closed, and pale. Occasional shivering; no diaphoresis. When asked, stated he was cold. Fan removed but cool packs left to back on neck and axilla. After approximately 20 minutes, client appeared more alert, eyes open, and stated he felt like he could sit up. Assisted to sitting position on cot and continued to sip juice when offered. After approximately 5 minutes in sitting position, client stated he was beginning to feel lightheaded. Assisted back to supine position with knees bent. Remained in this position for 10 minutes. At 09:45, stated he felt that he could sit up again so assisted into sitting position on cot for 5 minutes. Continued to sip juice when offered. Assisted to chair for 5 minutes until he agreed he felt well enough to stand. Walked around workup room with assistance. Gait slightly unsteady. Assisted to mom's car without difficulty. Instructed mom to stop for food after leaving public health department.
Age: 13.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Lethargy, Pallor, Speech disorder
Clinical narrative: At 09:05 administered Tdap, MENACTRA, and GARDASIL 9, immediately following last injection (GARDASIL 9), patient became lethargic and pale with eyes closed. Able to answer questions appropriately but speech slow. Cool pack placed to back of neck. When asked, mom stated he had not had anything to eat or drink yet that morning. Obtained juice pack and assisted to sip occasionally. Client able to sip juice when offered. At 09:10, status unchanged and head began nodding to front and side. Assisted to transfer to cot and placed in supine position with knees bent. Cool pack to back of neck and bilateral axilla. Fan positioned to blow on client. Continued to be able to answer questions appropriately but speech slow, eyes closed, and pale. Occasional shivering; no diaphoresis. When asked, stated he was cold. Fan removed but cool packs left to back on neck and axilla. After approximately 20 minutes, client appeared more alert, eyes open, and stated he felt like he could sit up. Assisted to sitting position on cot and continued to sip juice when offered. After approximately 5 minutes in sitting position, client stated he was beginning to feel lightheaded. Assisted back to supine position with knees bent. Remained in this position for 10 minutes. At 09:45, stated he felt that he could sit up again so assisted into sitting position on cot for 5 minutes. Continued to sip juice when offered. Assisted to chair for 5 minutes until he agreed he felt well enough to stand. Walked around workup room with assistance. Gait slightly unsteady. Assisted to mom's car without difficulty. Instructed mom to stop for food after leaving public health department.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a nurse assistant regarding multiple unspecified patients with unknown demographics. Information on pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On unspecified dates, unspecified patients were administered with improperly stored PROQUAD (Lot # N013270, Expiry Date: 25-OCT-2018 and Lot # N015631, Expiry Date : 03-AUG-2019) for prophylaxis (dosing details were not reported). Concomitant therapies included sterile diluent. Temperature was reported as 6°F to 14°F (5.5°F) for 6 Hours 20 Minutes and -58°F to 5°F (1.5°F) for 5 Hours 15 Minutes (incorrect product storage). There was no previous temperature excursion. The call was due to data logger. No adverse effects were reported. No product quality complaint was involved. This is one of the two reports from to the same reporter. Sender's Comments: US-009507513-1708USA009084.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age. In MAY-2016 the patient was vaccinated with GARDASIL (dose, route of administration, lot # and expiration date were not reported) for prophylaxis. Other suspect therapies included GARDASIL 9 (dose, route of administration, lot # and expiration date were not reported). On 22-AUG-2017 the patient experienced interchange of vaccine products and off label use. On an unknown date the patient experienced inappropriate schedule of drug administration and no adverse event.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report as received from a nurse refers to a 60 year old female patient. On 17-AUG-2017, the patient was vaccinated with ZOSTAVAX, subcutaneous, 19400 PFU (plaque-forming units) for prophylaxis. In August 2017, the patient experienced, in area of 2 inch by 1 inch, injection site swelling and injection site erythema. The patient was treated with cortisone cream (brand and manufacturer unspecified) and BENADRYL. The outcome of injection site swelling and injection site erythema was reported as recovered/resolved. The relatedness between the events and ZOSTAVAX was not assessed by the reporter. Product quality complaint was not involved.
Age: 11.0
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from an other health professional refers to a currently 15 year old patient. On an unknown date, the patient was vaccinated with GARDASIL 9 dose 1 for prophylaxis. On an unknown date, the patient experienced inappropriate schedule of drug administration. No adverse effects were reported. The outcome of inappropriate schedule of drug administration and no adverse event was unknown.
Age: 36.0
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant refers to multiple patients of unknown age and gender. No concurrent conditions, medical history, allergy/drug reactions and concomitant medications were reported. On unknown dates, the patients were vaccinated with improperly stored PNEUMOVAX 23 lot # N011491 with expiry date: 04-NOV-2018 (dosing details, route and anatomical location were not reported) for prophylaxis. It was reported that the vaccines were exposed to a temperature range of 32 F to 35 F for a duration of 23 days. There was no previous temperature excursion. Data logger was involved. No adverse effects were reported. There were no product quality complaints (PQC) involved.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and refers to an unspecified patients of unknown age and gender. On 24-AUG-2017, the unspecified number of improperly stored doses of VARIVAX lot # N008077, expiration date 09-MAR-2019 (dose, route and anatomical location were not reported) were administered to the patients. The doses were stored in temperatures from 15 degrees Fahrenheit to 46 degrees Fahrenheit for 15 hours 38 minutes. Data logger was involved. There was no previous excursion reported. No adverse effects have been reported. Product quality complaint was not involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1708USA011737.
Age: 20.0
Sex: F
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: The medication expired on 04/07/2017. Pt. has not reported any reaction.
Age: 37.0
Sex: M
Vaccine: MENB, MNQ, PPV
Symptoms: Asthenia, Diarrhoea, Dizziness, Erythema, Fatigue
Clinical narrative: 08/24/17 - 4pm sore right arm; 08/25/17 - 12AM Fever 102 fatigue, sick to stomach; 08/25/17 - 4 am diarrhea, dizzy; 08/26/17 - fever all day up to 102, weak and sick to stomach; 08/27/17 - weak and sick to stomach, no fever; 08/28/17 - still a little tired and dizzy; 08/28/17 - reported today that his right arm is warm and has some redness.
Age: 37.0
Sex: M
Vaccine: MENB, MNQ, PPV
Symptoms: Nausea, Pain in extremity, Pyrexia, Skin warm
Clinical narrative: 08/24/17 - 4pm sore right arm; 08/25/17 - 12AM Fever 102 fatigue, sick to stomach; 08/25/17 - 4 am diarrhea, dizzy; 08/26/17 - fever all day up to 102, weak and sick to stomach; 08/27/17 - weak and sick to stomach, no fever; 08/28/17 - still a little tired and dizzy; 08/28/17 - reported today that his right arm is warm and has some redness.
Age: 17.0
Sex: F
Vaccine: HEP, HEPA, HPV9, IPV, MMR, TDAP, VARCEL
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: NO ADVERSE EVENTS- date of last menstrual period is 04/15/2017 as  per records of 08/2017 family planning visit.
Age: 0.42
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC13
Symptoms: Febrile convulsion
Clinical narrative: Mother reports infant "had a febrile seizure. I went to the emergency room and that's what they said it was." Denies any current problems or lingering symptoms/effects.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Body temperature increased, Injection site erythema, Injection site induration, Injection site swelling, Injection site urticaria
Clinical narrative: Child developed redness and swelling at the Left thigh injection site, then parents noted hives. Child was taken to the emergency room for evaluation and treatment.  Tmax was documented as 99.4 F.  Child was treated with  oral prednisolone 15mg bid x 5 days and advised to use diphenhydramine 12.5mg every 4 hours as needed for hives. Patient was seen in follow up three days after the ER visit.  No further hives were present. Left thigh injection site remained mildly indurated and  red, but no swelling was evident. No site reaction was noted on the Left arm.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity, Peripheral swelling, Pruritus
Clinical narrative: Right arm swelled by 1/4 of normal size, very painful, lasted several days before swelling subsided. I also had itching in both arms and elsewhere on my body for months afterwards (possibly unrelated).
Age: 56.0
Sex: F
Vaccine: PNC13
Symptoms: Asthenia, Dizziness, Dysphonia, Dyspnoea, Fatigue
Clinical narrative: Broke out in sweats, dizzy, migraine headache, skin infection on left arm, sick in stomach, tired and weak, body ache, red and swelling at injection site, pain radiated down arm, shortness of breath, hoarseness, unable to sleep, flu-like symptoms. Visited Convenient Care multiple times.
Age: 56.0
Sex: F
Vaccine: PNC13
Symptoms: Hyperhidrosis, Influenza like illness, Injection site erythema, Injection site swelling, Insomnia
Clinical narrative: Broke out in sweats, dizzy, migraine headache, skin infection on left arm, sick in stomach, tired and weak, body ache, red and swelling at injection site, pain radiated down arm, shortness of breath, hoarseness, unable to sleep, flu-like symptoms. Visited Convenient Care multiple times.
Age: 56.0
Sex: F
Vaccine: PNC13
Symptoms: Migraine, Nausea, Pain, Pain in extremity, Skin infection
Clinical narrative: Broke out in sweats, dizzy, migraine headache, skin infection on left arm, sick in stomach, tired and weak, body ache, red and swelling at injection site, pain radiated down arm, shortness of breath, hoarseness, unable to sleep, flu-like symptoms. Visited Convenient Care multiple times.
Age: 56.0
Sex: F
Vaccine: PNC13
Symptoms: X-ray
Clinical narrative: Broke out in sweats, dizzy, migraine headache, skin infection on left arm, sick in stomach, tired and weak, body ache, red and swelling at injection site, pain radiated down arm, shortness of breath, hoarseness, unable to sleep, flu-like symptoms. Visited Convenient Care multiple times.
Age: 1.25
Sex: F
Vaccine: DTAP, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Erythema, Injection site induration, Injection site rash
Clinical narrative: Patient brought in by mom with 2 bumps on each anterior thigh for 6 weeks. Redness noted on day one of vaccine placement. Mom noticed bump on legs about 1-2 weeks after vaccines. Mom seen by PA on 8/24, bumps felt on anterior thigh; firm to touch. Advised mom to try heat and message to break up mass.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site erythema, Injection site swelling
Clinical narrative: Headache, and golf ball sized swelling and redness at injection site.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Left thigh with 3x2 cm area induration, warm with 4x6 round area of redness. Prescribed KEFLEX 250mg/ml 8ml po every 6 hours for 10 days. MOTRIN as needed for pain or fever.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Full blood count, Injection site erythema, Injection site pain, Injection site warmth, White blood cell count increased
Clinical narrative: Pt complained of L upper arm pain starting the day of vaccination. On 8/18/2017, she started to notice redness and warmth to anterior and lateral aspect of left upper arm.
Age: 4.0
Sex: F
Vaccine: UNK
Symptoms: Injection site swelling, Pyrexia, Respiratory tract infection
Clinical narrative: Started having fever and then started swelling at the injection site. Then got RSV (respiratory infection).
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Pt called clinic to report her right arm developed pain, swelling, and redness at site of injection, she also reported unable to move her right arm (lift it) after receiving injection. Spoke to pt on phone today, 08/28/17, she stated all symptoms resolved.
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 4 unspecified patients of unknown ages and genders. There was no information about the patients' pertinent medical history, drug reactions or allergies provided. On unspecified dates between 08-AUG-2017 and 11-AUG-2017, the patients were vaccinated with improperly stored doses of PROQUAD, unspecified dose (lot # reported as N10114 with the expiration date of 24-SEP-2018, route of administration and albumin status were not reported), for prophylaxis. The vaccines were reconstituted with properly stored sterile diluent (lot# and expiration date were not reported). No adverse effects were reported. The administered doses of vaccines experienced a temperature excursion of minus 2 (-2) Celsius degrees for 68.5 hours. Digital data logger was not involved. There were no previous temperature excursions reported. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a other refers to a patient of unknown age. On an unknown date the patient was vaccinated with PROQUAD lot # M038862 with expiration date of 13-MAR-2018 for prophylaxis. Other suspect therapies included sterile diluent (manufacturer unknown). On an unknown date the patient experienced incorrect product storage and no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage to be not related to PROQUAD and sterile diluent. The reporter considered no adverse event to be not related to sterile diluent and PROQUAD. Additional information has been requested. Sender's Comments: US-009507513-1708USA011842.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age. On an unknown date, the patient was vaccinated with VAQTA for prophylaxis. On an unknown date, the patient experienced incorrect product storage and no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage and no adverse event to be not related to VAQTA. Additional information has been requested. Sender's Comments: US-009507513-1708USA011860: US-009507513-1708USA011858: US-009507513-1708USA011859: US-009507513-1708USA011856: US-009507513-1708USA011857.