chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 75.0
Sex: M
Vaccine: FLUA3, PPV
Symptoms: Rheumatoid factor negative, West Nile virus test negative
Clinical narrative: Swelling in arm reported and upper left arm. Hand real sore and sensitive, swelled up and couldn't even seen knuckles. Burning only when laid down in knuckles. Knuckles still swollen, but prednisone did help.
Age: 85.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Pt came to pharmacy with swelling and redness from injection site almost to elbow. She said it started after injection. She's been using hydrocortisone cream. I advised she go to doctor. Nurse practitioner saw her, gave DECADRON IM, ZANTAC PO and told her to continue hydrocortisone.
Age: 70.0
Sex: F
Vaccine: PNC13
Symptoms: Limb discomfort, Swelling
Clinical narrative: Pt has a red swollen arm that is warm to the touch, painful and spreading down to the elbow.
Age: 73.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Post herpetic neuralgia, Rash, Rash pruritic
Clinical narrative: Rash, itching, Diagnosed as Herpes zoster without complication at urgent care facility on 7/16/2018.  and was Prescribed Valcyclovir. At a subsequent visit to the doctor,  gabapentin was prescribed.  Itching and sensitivity is still present as of 12/24/ 2018.
Age: 73.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Hyperaesthesia, Pruritus, Rash
Clinical narrative: Rash, itching, Diagnosed as Herpes zoster without complication at urgent care facility on 7/16/2018.  and was Prescribed Valcyclovir. At a subsequent visit to the doctor,  gabapentin was prescribed.  Itching and sensitivity is still present as of 12/24/ 2018.
Age: 1.08
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: No adverse event, Wrong product administered
Clinical narrative: This spontaneous report was received from patient's father refers to his son who was 13 month old male. The patient's medical history, concurrent condition and concomitant medications were not reported. On 22-NOV-2018, the patient's father reported that his son was wrongly vaccinated with ZOSTAVAX for prophylaxis (strength, dose, frequency, route, lot#  and expiry were not reported) instead of VARIVAX (wrong product administered). No adverse events were reported.
Age: 19.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: C-reactive protein, Differential white blood cell count, Full blood count, Gait disturbance, Metabolic function test
Clinical narrative: Lower Extremity Temporary Paralysis 1 hour after receiving vaccination. Patient currently in physical therapy to help his symptoms.
Age: 19.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Mobility decreased, Red blood cell sedimentation rate, Sensory disturbance
Clinical narrative: Lower Extremity Temporary Paralysis 1 hour after receiving vaccination. Patient currently in physical therapy to help his symptoms.
Age: 19.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Paralysis
Clinical narrative: Lower Extremity Temporary Paralysis 1 hour after receiving vaccination. Patient currently in physical therapy to help his symptoms.
Age: 37.0
Sex: M
Vaccine: PPV, FLU3, PPV
Symptoms: Inappropriate schedule of product administration
Clinical narrative: This spontaneous report was received from a pharmacist via Pfizer refers to a 37 year old male patient. The patient's medical history included hepatic cirrhosis. The patient's concomitant medications was not reported. On 24-DEC-2012, the patient was vaccinated with the first dose of PNEUMOVAX 23 and second dose was administered on 14-FEB-2016 with a lot # L017406 and expiry date 26-FEB-2017 in left deltoid and 3rd and 4th dose was administered on 08-AUG-2016 and 29-OCT-2016 with a lot number M018624 M023460 and expiry date 01-JAN-2017 and 24-NOV-2017 for prophylaxis. Other suspect therapies included influenza virus vaccine (unspecified).
Age: 37.0
Sex: M
Vaccine: PPV, FLU3, PPV
Symptoms: Extra dose administered, Inappropriate schedule of product administration
Clinical narrative: This spontaneous report was received from a pharmacist via Pfizer refers to a 37 year old male patient. The patient's medical history included hepatic cirrhosis. The patient's concomitant medications was not reported. On 24-DEC-2012, the patient was vaccinated with the first dose of PNEUMOVAX 23 and second dose was administered on 14-FEB-2016 with a lot # L017406 and expiry date 26-FEB-2017 in left deltoid and 3rd and 4th dose was administered on 08-AUG-2016 and 29-OCT-2016 with a lot number M018624 M023460 and expiry date 01-JAN-2017 and 24-NOV-2017 for prophylaxis. Other suspect therapies included influenza virus vaccine (unspecified).
Age: 81.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site discolouration, Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site tenderness in a 81-year-old female patient who received SHINGRIX for prophylaxis. On 28th November 2018, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced injection site tenderness, injection site itching and injection site swelling. On an unknown date, the outcome of the injection site tenderness, injection site itching and injection site swelling were not recovered/not resolved. It was unknown if the reporter considered the injection site tenderness, injection site itching and injection site swelling to be related to SHINGRIX. Additional details were provided as follows: The events were still ongoing. The reporter already filled out a VAERS form for this patient on 6th December 2018. The reporter consented to follow-up.
Age: 81.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site tenderness in a 81-year-old female patient who received SHINGRIX for prophylaxis. On 28th November 2018, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced injection site tenderness, injection site itching and injection site swelling. On an unknown date, the outcome of the injection site tenderness, injection site itching and injection site swelling were not recovered/not resolved. It was unknown if the reporter considered the injection site tenderness, injection site itching and injection site swelling to be related to SHINGRIX. Additional details were provided as follows: The events were still ongoing. The reporter already filled out a VAERS form for this patient on 6th December 2018. The reporter consented to follow-up.
Sex: M
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a nurse, referring to a male patient of unknown age. Concomitant therapy included sterile diluent (lot # M028330 and expiration date 24-FEB-2019). Information of concurrent condition and medical history was not provided. On 26-NOV-2018, the patient received an expired dose of PROQUAD (recombinant Human albumin) (strength was unknown; lot # N014950 and expiration date 11-NOV-2018) subcutaneously for prophylaxis (expired product administered). No adverse effect reported.
Age: 15.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Information has been received from a pharmacy technician referring to a 15 year old patient of unknown gender. The patient's pertinent medical history, concomitant medication and drug reactions/allergies were not provided. In approximately October 2018 (reported as "about a month ago"), the patient was vaccinated with PROQUAD (strength, dose, lot #, expiration date were not reported) for prophylaxis (product administered to patient of inappropriate age). The vaccine was reconstituted with sterile diluent (lot # and expiration date were unknown by reporter). No adverse effects were reported.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to a patient of unknown age and gender. Information about concomitant medication, drug reactions/allergies and pertinent medical history was not provided. On 27-NOV-2018, the patient inadvertently received an expired dose of VAQTA (lot # N028743, expiration date was 23-NOV-2018; strength and route were not reported) for prophylaxis. No adverse effect was reported.
Age: 16.0
Sex: U
Vaccine: UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a medical assistant referring to a currently 16 years old patient of unknown gender. The patient's medical history, current condition and concomitant therapy were not provided. On an unknown date, the patient received dose of improperly stored PROQUAD (lot number R017628 with expiration date 18-DEC-2019) subcutaneously for prophylaxis or VARIVAX (route was unknown, lot number R018931 with expiration date 02-JUL-2020; lot number R018777 with expiration date 01-JUL-2020) for prophylaxis(product storage error). The administered doses experienced a temperature excursion ranged from -14 degree Celsius to -10 degree Celsius for 1 hour and 30 minutes. No previous excursions were reported. The temperature excursions were detected by a data logger. No adverse effects were reported in the patient. This is one of three reports received from the same reporter. Sender's Comments: US-009507513-1812USA000015: US-009507513-1812USA000016.
Age: 14.0
Sex: U
Vaccine: UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a medical assistant referring to a currently 14 years old patient of unknown gender. The patient's medical history, current condition and concomitant therapy were not provided. On an unknown date, the patient received dose of improperly stored PROQUAD (lot number R017628 with expiration date 18-DEC-2019) subcutaneously for prophylaxis or VARIVAX (route was unknown, lot number R018931 with expiration date 02-JUL-2020; lot number R018777 with expiration date 01-JUL-2020) for prophylaxis(product storage error). The administered doses experienced a temperature excursion ranged from -14 degree Celsius to -10 degree Celsius for 1 hour and 30 minutes. No previous excursions were reported. The temperature excursions were detected by a data logger. No adverse effects were reported in the patient.  This is one of three reports received from the same reporter. Sender's Comments: US-009507513-1812USA000016: US-009507513-1811USA012273.
Age: 17.0
Sex: U
Vaccine: UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a medical assistant referring to a currently 17 years old patient of unknown gender. The patient's medical history, current condition and concomitant therapy were not provided. On an unknown date, the patient received dose of improperly stored PROQUAD (lot number R017628 with expiration date 18-DEC-2019) subcutaneously for prophylaxis or VARIVAX (route was unknown, lot number R018931 with expiration date 02-JUL-2020; lot number R018777 with expiration date 01-JUL-2020) for prophylaxis(product storage error). The administered doses experienced a temperature excursion ranged from -14 degree Celsius to -10 degree Celsius for 1 hour and 30 minutes. No previous excursions were reported. The temperature excursions were detected by a data logger. No adverse effects were reported in the patient. This is one of three reports received from the same reporter. Sender's Comments: US-009507513-1812USA000015: US-009507513-1811USA012273.
Sex: U
Vaccine: HEP
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Information has been received from a physician, referring to an adult patient of unknown age. Information of concurrent condition, medical history and concomitant therapy was not provided. On an unknown date, the patient was vaccinated with a 40mcg dose of RECOMBIVAX HB (strength, route, lot# and expiration date were unknown) for prophylaxis (incorrect dose administered). No adverse symptoms reported.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from an administrator referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies, current condition and concomitant medication were not provided. On 29-NOV-2018, the patient received an expired dose of VAQTA 25/0.5 (lot # N023953 with expiration date 05-NOV-2018) intramuscularly for prophylaxis(expired product administered). No adverse effects were reported in the patient.
Age: 79.0
Sex: F
Vaccine: PPV
Symptoms: Injection site reaction
Clinical narrative: This spontaneous report was received from a physician via a company representative referring to a 79 year old female patient. Information about pertinent medical history, concurrent conditions, concomitant medication and drug reactions/allergies was not provided. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 (strength, dose, frequency, route, lot # and expiration date were not reported) for prophylaxis. The physician noted that the patient had injection site reaction while on PNEUMOVAX 23. The patient was seen by the physician and unspecified treatment was given due to the event. It was not provided if the patient performed lab diagnostics/studies. The outcome of injection site reaction was reported as recovering/resolving. The causality between PNEUMOVAX 23 and injection site reaction was not provided.
Age: 0.08
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Information has been received from a registered nurse referring to a 36 day old patient of unknown gender. The patient's pertinent medical history, drug reactions/allergies, current condition and concomitant medication were not provided. On 29-NOV-2018 the patient was administered the first dose of ROTATEQ (lot # R007992 with expiration date 19-OCT-2019) orally for prophylaxis (inappropriate age at vaccine administration). No adverse effects were reported.
Age: 5.0
Sex: F
Vaccine: MMR
Symptoms: Pyrexia
Clinical narrative: This spontaneous report was received from a consumer referring to her 5 year old daughter.  Information about pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medication was not reported. On an unknown date, the patient was vaccinated with the second dose of M-M-R II (dose detail, route, lot # and expiration date were not reported) for prophylaxis. On 30-NOV-2018, after received this second dose of M-M-R II, the reporter stated the patient experienced a low grade fever. The reporter will speak with pediatrician later in regard to the fever of the patient. The outcome of event was reported as not recovered. The causality assessment between event and M-M-R II was not reported.
Sex: M
Vaccine: PPV
Symptoms: Blood immunoglobulin A decreased, Blood immunoglobulin G normal, Blood immunoglobulin M normal, Condition aggravated, Selective IgA immunodeficiency
Clinical narrative: Information has been received from the authors in a published literature article. This literature report refers to a 7-year old male with Williams Syndrome and a history of recurrent infections (otitis media, sinusitis, bronchiolitis, and upper respiratory infections) since infancy presented for immune evaluation. He had congenital heart disease, renal disease, and recurrent nephrocalcinosis. His immunoglobulin G (IgG) and immunoglobulin M (IgM) were normal, but his immunoglobulin A (IgA) was low (8 mg/dL). Initially low S. pneumoniae antibodies responded well to PNEUMOVAX 23 (strength, dose, route, lot # and expiration date unknown, for prophylaxis) (product use issue). He was diagnosed with selective IgA deficiency (immunodeficiency).
Sex: U
Vaccine: HEP
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to an adult patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated with RECOMBIVAX HB, 40 mcg (route of administration, lot # and expiry date were not provided) for prophylaxis. The physician reported that she gave an adult (non dialysis) patient a 40 mcg dose of RECOMBIVAX HB (incorrect dose administered). No adverse symptoms reported.
Age: 69.0
Sex: M
Vaccine: PPV
Symptoms: Pain in extremity
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 69 year old male patient. The patient's medical history was not reported. Historical drugs included PREVNAR 13. Concomitant therapies and medical history was not reported. On 21-NOV-2018, the patient was vaccinated with a dose of PNEUMOVAX 23 (lot # N013521, expiration date 23-JAN-2019, dose information not reported) intramuscularly. On 01-DEC-2018 (reported as 10 days after being vaccinated), the patient developed sore arm. He sought medical attention as he went to the pharmacy, where he also reported that his arm was sore from his shoulder to his wrist. No more information was provided. The causality between the vaccine and the event was not provided.
Age: 1.25
Sex: F
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Information has been received from a medical assistant, referring to an 18 month old female patient. Information about medical history, concurrent condition and concomitant therapy was unknown. On 01-MAR-2018, the patient (at 15 months) was vaccinated with the first dose of VAQTA (strength:25/0.5(unit unknown), lot # N026997, expiration date 10-NOV-2018; dose and frequency were unknown) intramuscularly for prophylaxis. On 01-JUN-2018, the patient was vaccinated with the second dose of VAQTA (strength:25/0.5(unit unknown), lot # N026997, expiration date 10-NOV-2018; dose and frequency were unknown) intramuscularly for prophylaxis (inappropriate schedule of product administration). No adverse effect was reported.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a physician and refers to a currently 11 month old patient of unknown gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated with improperly stored dose of ROTATEQ lot # R002516, expiry date 13-SEP-2018, oral for prophylaxis. It was reported that the vaccines were stored at temperature 9 - 25 degrees Celsius for 12.5 hours. Temperature excursion was detected by digital data logger. 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-009507513-1812USA005223: US-009507513-1812USA006406.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a physician and refers to a patient of unknown gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated with improperly stored ROTATEQ dose 1, lot # R002516, expiry date 13-SEP-2018, oral for prophylaxis. On an unknown date, the patient received dose 2, of the same vaccine. It was reported that the vaccines were stored at temperature 9 - 25 degrees Celsius for 12.5 hours. Temperature excursion was detected by digital data logger. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same reporter (MARRS# 1812USA006405, 1812USA005223). Sender's Comments: US-009507513-1812USA006405: US-009507513-1812USA005223.
Age: 49.0
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, Product administered to patient of inappropriate age
Clinical narrative: This spontaneous report was received from a consumer and refers to a 49-year-old patient of unknown gender. No information regarding the patient's concurrent condition, medical history, concomitant medications and drug reactions or allergies was provided. On an unknown date, the patient was vaccinated with two 0,5 milliliter doses of GARDASIL 9 (route of administration, lot number and expiration date were not reported) for prophylaxis. The patient wanted to know if GARDASIL 9 was safe to take if you are "49 going on 50 years old".
Age: 69.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 69 year old female patient. The patient's concurrent conditions, medical history, concomitant medications and drug allergies were not reported. On 28-NOV-2018, the patient was vaccinated with PNEUMOVAX 23 (dose, strength, route of administration, lot # and expiry date were not reported) for prophylaxis. Other suspect therapy included unspecified flu shot. On 29-NOV-2018 (reported as one day after vaccination), the patient experienced a 2 to 3 inch raised, red band around the injection (reported as insertion) site. The patient did not notify her physician, did not seek any medical attention and did not received any treatment for adverse event. The event lasted 3 days and the outcome of it was reported as recovered on an approximately 01-DEC-2018. The causality between the event and the suspect therapies was not reported.
Age: 33.0
Sex: F
Vaccine: HPV9
Symptoms: Deep vein thrombosis, Disability, Hypoaesthesia, Peripheral artery thrombosis, Ultrasound Doppler abnormal
Clinical narrative: Information has been received from a nurse referring to a 33 years old female patient who was not pregnant. The patient's concurrent condition included allergy with erythromycin and penicillin. The patient had no medical history or concomitant therapies. Information about the patient' concurrent condition was unknown. On 31-OCT-2018, the patient received her first dose of GARDASIL 9 (0.5 milliliter, lot # R023608, expiration date 30-APR-2021; strength and frequency were not provided) intramuscular for prophylaxis (reported as prevent against human papillomavirus (HPV)). On an unknown date in 2018 (reported as an unspecified time after receiving), the patient developed numbness in her right arm. On 06-DEC-2018, the patient went to hospital due to the numbness and an ultrasound venous doppler was performed of the right arm. The result of the ultrasound showed a deep vein thrombosis (DVT) in her right brachial artery. The patient was not admitted to the hospital and was prescribed XARELTO 15 mg (unspecified frequency). The nurse stated that the patient would be following up with an unspecified vascular surgeon due to the DVT on an unspecified date. At the time of reported, the patient was still experiencing numbness in her right arm, that was determined to be significant disability by the reporter. The outcome of the numbness in her right arm and DVT in her right brachial artery was reported as not recovered. The causality for the events was not reported. Upon internal review, DVT in her right brachial artery was determined to be medically significant.
Age: 16.0
Sex: M
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: This spontaneous report was received from a nurse and refers to a 16 years old male patient. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On an unspecified date, the patient was vaccinated with PROQUAD by subcutaneous route, for prophylaxis (dose, lot number and expiration date were not reported). Was reported as in approximately 2017, the patient was inadvertently vaccinated (product administered to patient of inappropriate age) with PROQUAD. The patient did not sought medical attention. No adverse effects were reported.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a other health care professional (nurse) regarding a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant medications and drug/allergies were not reported. On 12-DEC-2018, the patient was vaccinated with improperly stored M-M-R II (dose, route of administration not reported) lot # N032427and expiration date: 16-NOV-2019 for prophylaxis (product storage error) which was reconstituted with properly stored Merck sterile diluent. No adverse event was reported. Temperature was reported as 9 °C to 25°C with time frame 1.5 hours, there was no previous temperature excursion. Data logger was present. This is one of several reports received from the same reporter.
Age: 0.33
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This non-valid, spontaneous report was received from a registered nurse, referring to an unspecified number of patients of unknown age and gender. No information was provided regarding the patients' medical history, previous drug reactions, allergies, concurrent medical conditions or concomitant medications. On unknown dates, the patients were vaccinated with improperly stored doses of LIQUID PEDVAXHIB lot number N034005 (expiration date 31-JAN-2020) and lot number reported as "N021920" (expiration date 07-FEB-2020) for prophylaxis (doses, routes and anatomical locations of administration were not reported). Additionally, the patients were vaccinated with ROTATEQ by oral route, lot number N005078 (expiration dates 22-NOV-2018 and 04-OCT-2018) for prophylaxis (doses were unknown), GARDASIL 9 lot number N020352 (expiration date 10-APR-2020) for prophylaxis (doses, routes and anatomical locations of administration were not provided) and M-M-R II for prophylaxis (dose numbers, routes and anatomical locations of administration were not provided; lot numbers N010496 [expiration date 31-MAR-2019], N014485 [expiration date 10-MAY-2019], and N023149 [expiration date 24-AUG-2019]). The vaccines were reconstituted with sterile diluent which was reported to be properly stored. The doses of all vaccines were exposed to a temperature excursion below 32 degrees Fahrenheit (F) (also reported as 31F) during a time frame of 15 days, which was detected by the Digital Data Logger. There was no previous temperature excursion and no adverse effects were reported. Follow-up information was received from the nurse on 17-DEC-2018. The reporter provided patients' demographics which made the case valid. This report refers to a 4-month-old patient of unknown gender. On 21-FEB-2018, the patient was vaccinated with an improperly stored dose of (LIQUID PEDVAXHIB lot number N034005 (expiration date: 31-JAN-2020). This is one of multiple reports received from the same reporter. Sender's Comments: US-009507513-1807USA011661.
Age: 0.42
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This non-valid, spontaneous report was received from a registered nurse, referring to an unspecified number of patients of unknown age and gender. No information was provided regarding the patients' medical history, previous drug reactions, allergies, concurrent medical conditions or concomitant medications. On unknown dates, the patients were vaccinated with improperly stored doses of LIQUID PEDVAXHIB lot number N034005 (expiration date 31-JAN-2020) and lot number reported as "N021920" (expiration date 07-FEB-2020) for prophylaxis (doses, routes and anatomical locations of administration were not reported). Additionally, the patients were vaccinated with ROTATEQ by oral route, lot number N005078 (expiration dates 22-NOV-2018 and 04-OCT-2018) for prophylaxis (doses were unknown), GARDASIL 9 lot number N020352 (expiration date 10-APR-2020) for prophylaxis (doses, routes and anatomical locations of administration were not provided) and M-M-R II for prophylaxis (dose numbers, routes and anatomical locations of administration were not provided; lot numbers N010496 [expiration date 31-MAR-2019], N014485 [expiration date 10-MAY-2019], and N023149 [expiration date 24-AUG-2019]). The vaccines were reconstituted with sterile diluent which was reported to be properly stored. The doses of all vaccines were exposed to a temperature excursion below 32 degrees Fahrenheit (F) (also reported as 31F) during a time frame of 15 days, which was detected by the Digital Data Logger. There was no prior temperature excursion and no adverse effects were reported. Follow-up information was received from the nurse on 17-DEC-2018. The reporter provided patients' demographics which made the case valid. This report refers to a 5-month-old patient of unknown gender. On 02-MAR-2018, the patient was vaccinated with an improperly stored dose of LIQUID PEDVAXHIB lot number N020352 (expiration date: 31-JAN-2020). This is one of multiple reports received from the same reporter. Sender's Comments: US-009507513-1807USA011661.
Age: 0.33
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This non-valid, spontaneous report was received from a registered nurse, referring to an unspecified number of patients of unknown age and gender. No information was provided regarding the patients' medical history, previous drug reactions, allergies, concurrent medical conditions or concomitant medications. On unknown dates, the patients were vaccinated with improperly stored doses of LIQUID PEDVAXHIB lot number N034005 (expiration date 31-JAN-2020) and lot number reported as "N021920" (expiration date 07-FEB-2020) for prophylaxis (doses, routes and anatomical locations of administration were not reported). Additionally, the patients were vaccinated with ROTATEQ by oral route, lot number N005078 (expiration dates 22-NOV-2018 and 04-OCT-2018) for prophylaxis (doses were unknown), GARDASIL 9 lot number N020352 (expiration date 10-APR-2020) for prophylaxis (doses, routes and anatomical locations of administration were not provided) and M-M-R II for prophylaxis (dose numbers, routes and anatomical locations of administration were not provided; lot numbers N010496 [expiration date 31-MAR-2019], N014485 [expiration date 10-MAY-2019], and N023149 [expiration date 24-AUG-2019]). The vaccines were reconstituted with sterile diluent which was reported to be properly stored. The doses of all vaccines were exposed to a temperature excursion below 32 degrees Fahrenheit (F) (also reported as 31F) during a time frame of 15 days, which was detected by the Digital Data Logger. There was no prior temperature excursion and no adverse effects were reported. Follow-up information was received from the nurse on 17-DEC-2018. The reporter provided patients' demographics which made the case valid. This report refers to a 4-month-old patient of unknown gender. On 05-MAR-2018, the patient was vaccinated with an improperly stored dose of LIQUID PEDVAXHIB lot number N020352 (expiration date: 31-JAN-2020). This is one of multiple reports received from the same reporter. Sender's Comments: US-009507513-1807USA011661.
Age: 0.17
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This non-valid, spontaneous report was received from a registered nurse, referring to an unspecified number of patients of unknown age and gender. No information was provided regarding the patients' medical history, previous drug reactions, allergies, concurrent medical conditions or concomitant medications. On unknown dates, the patients were vaccinated with improperly stored doses of LIQUID PEDVAXHIB lot number N034005 (expiration date 31-JAN-2020) and lot number reported as "N021920" (expiration date 07-FEB-2020) for prophylaxis (doses, routes and anatomical locations of administration were not reported). Additionally, the patients were vaccinated with ROTATEQ by oral route, lot number N005078 (expiration dates 22-NOV-2018 and 04-OCT-2018) for prophylaxis (doses were unknown), GARDASIL 9 lot number N020352 (expiration date 10-APR-2020) for prophylaxis (doses, routes and anatomical locations of administration were not provided) and M-M-R II for prophylaxis (dose numbers, routes and anatomical locations of administration were not provided; lot numbers N010496 [expiration date 31-MAR-2019], N014485 [expiration date 10-MAY-2019], and N023149 [expiration date 24-AUG-2019]). The vaccines were reconstituted with sterile diluent which was reported to be properly stored. The doses of all vaccines were exposed to a temperature excursion below 32 degrees Fahrenheit (F) (also reported as 31F) during a time frame of 15 days, which was detected by the Digital Data Logger. There was no previous temperature excursion and no adverse effects were reported. Follow-up information was received from the nurse on 17-DEC-2018. The reporter provided patients' demographics which made the case valid. This report refers to a 9-week-old patient of unknown gender. On 05-MAR-2018, the patient was vaccinated with an improperly stored dose of LIQUID PEDVAXHIB lot number N020352 (expiration date 31-JAN-2020). On 17-MAY-2018, the patient was vaccinated with an improperly stored dose of LIQUID PEDVAXHIB lot number N031492 (expiration date 02-MAY-2020). This is one of multiple reports received from the same reporter. Sender's Comments: US-009507513-1807USA011661.
Age: 0.17
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This non-valid, spontaneous report was received from a registered nurse, referring to an unspecified number of patients of unknown age and gender. No information was provided regarding the patients' medical history, previous drug reactions, allergies, concurrent medical conditions or concomitant medications. On unknown dates, the patients were vaccinated with improperly stored doses of LIQUID PEDVAXHIB lot number N034005 (expiration date 31-JAN-2020) and lot number reported as "N021920" (expiration date 07-FEB-2020) for prophylaxis (doses, routes and anatomical locations of administration were not reported). Additionally, the patients were vaccinated with ROTATEQ by oral route, lot number N005078 (expiration dates 22-NOV-2018, and 04-OCT-2018) for prophylaxis (doses were unknown), hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot number N020352 (expiration date 10-APR-2020) for prophylaxis (doses, routes and anatomical locations of administration were not provided) and M-M-R II for prophylaxis (dose numbers, routes and anatomical locations of administration were not provided; lot numbers N010496 [expiration date 31-MAR-2019], N014485 [expiration date 10-MAY-2019], and N023149 [expiration date 24-AUG-2019]). The vaccines were reconstituted with sterile diluent which was reported to be properly stored. The doses of all vaccines were exposed to a temperature excursion below 32 degrees Fahrenheit (F) (also reported as 31F) during a time frame of 15 days, which was detected by the Digital Data Logger. There was no previous temperature excursion and no adverse effects were reported. Follow-up information was received from the nurse on 17-DEC-2018. The reporter provided patients' demographics which made the case valid. This report refers to a 9-week-old patient of unknown gender. On 12-MAR-2018, the patient was vaccinated with an improperly stored dose of LIQUID PEDVAXHIB lot number N020352 (expiration date 31-JAN-2020). This is one of multiple reports received from the same reporter. Sender's Comments: US-009507513-1807USA011661.
Age: 0.42
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This non-valid, spontaneous report was received from a registered nurse, referring to an unspecified number of patients of unknown age and gender. No information was provided regarding the patients' medical history, previous drug reactions, allergies, concurrent medical conditions or concomitant medications. On unknown dates, the patients were vaccinated with improperly stored doses of LIQUID PEDVAXHIB lot number N034005 (expiration date 31-JAN-2020) and lot number reported as "N021920" (expiration date 07-FEB-2020) for prophylaxis (doses, routes and anatomical locations of administration were not reported). Additionally, the patients were vaccinated with ROTATEQ by oral route, lot number N005078 (expiration dates 22-NOV-2018 and 04-OCT-2018) for prophylaxis (doses were unknown), GARDASIL 9 lot number N020352 (expiration date 10-APR-2020) for prophylaxis (doses, routes and anatomical locations of administration were not provided) and M-M-R II for prophylaxis (dose numbers, routes and anatomical locations of administration were not provided; lot numbers N010496 [expiration date 31-MAR-2019], N014485 [expiration date 10-MAY-2019], and N023149 [expiration date 24-AUG-2019]). The vaccines were reconstituted with sterile diluent which was reported to be properly stored. The doses of all vaccines were exposed to a temperature excursion below 32 degrees Fahrenheit (F) (also reported as 31F) during a time frame of 15 days, which was detected by the Digital Data Logger. There was no prior temperature excursion and no adverse effects were reported. Follow-up information was received from the nurse on 17-DEC-2018. The reporter provided patients' demographics which made the case valid. This report refers to a 5-month-old patient of unknown gender. On 27-MAR-2018, the patient was vaccinated with an improperly stored dose of LIQUID PEDVAXHIB lot number N020352 (expiration date 31-JAN-2020). This is one of multiple reports received from the same reporter. Sender's Comments: US-009507513-1807USA011661.
Age: 0.17
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This non-valid, spontaneous report was received from a registered nurse, referring to an unspecified number of patients of unknown age and gender. No information was provided regarding the patients' medical history, previous drug reactions, allergies, concurrent medical conditions or concomitant medications. On unknown dates, the patients were vaccinated with improperly stored doses of LIQUID PEDVAXHIB lot number N034005 (expiration date 31-JAN-2020) and lot number reported as "N021920" (expiration date 07-FEB-2020) for prophylaxis (doses, routes and anatomical locations of administration were not reported). Additionally, the patients were vaccinated with ROTATEQ by oral route, lot number N005078 (expiration dates 22-NOV-2018 and 04-OCT-2018) for prophylaxis (doses were unknown), GARDASIL 9 lot number N020352 (expiration date 10-APR-2020) for prophylaxis (doses, routes and anatomical locations of administration were not provided) and M-M-R II for prophylaxis (dose numbers, routes and anatomical locations of administration were not provided; lot numbers N010496 [expiration date 31-MAR-2019], N014485 [expiration date 10-MAY-2019], and N023149 [expiration date 24-AUG-2019]). The vaccines were reconstituted with sterile diluent which was reported to be properly stored. The doses of all vaccines were exposed to a temperature excursion below 32 degrees Fahrenheit (F) (also reported as 31F) during a time frame of 15 days, which was detected by the Digital Data Logger. There was no previous temperature excursion and no adverse effects were reported. Follow-up information was received from the nurse on 17-DEC-2018. The reporter provided patients' demographics which made the case valid. This report refers to a 8-week-old patient of unknown gender. On 03-APR-2018, the patient was vaccinated with an improperly stored dose of LIQUID PEDVAXHIB lot number N020352 (expiration date 10-APR-2020). On 18-JUN-2018, the patient was vaccinated with the next dose of improperly stored LIQUID PEDVAXHIB lot number N031492, expiration date: 02-MAY-2018. This is one of multiple reports received from the same reporter. Sender's Comments: US-009507513-1807USA011661.
Age: 0.33
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This non-valid, spontaneous report was received from a registered nurse, referring to an unspecified number of patients of unknown age and gender. No information was provided regarding the patients' medical history, previous drug reactions, allergies, concurrent medical conditions or concomitant medications. On unknown dates, the patients were vaccinated with improperly stored doses of LIQUID PEDVAXHIB lot number N034005 (expiration date 31-JAN-2020) and lot number reported as "N021920" (expiration date 07-FEB-2020) for prophylaxis (doses, routes and anatomical locations of administration were not reported). Additionally, the patients were vaccinated with ROTATEQ by oral route, lot number N005078 (expiration dates 22-NOV-2018 and 04-OCT-2018) for prophylaxis (doses were unknown), GARDASIL 9 lot number N020352 (expiration date 10-APR-2020) for prophylaxis (doses, routes and anatomical locations of administration were not provided) and M-M-R II for prophylaxis (dose numbers, routes and anatomical locations of administration were not provided; lot numbers N010496 [expiration date 31-MAR-2019], N014485 [expiration date 10-MAY-2019], and N023149 [expiration date 24-AUG-2019]). The vaccines were reconstituted with sterile diluent which was reported to be properly stored. The doses of all vaccines were exposed to a temperature excursion below 32 degrees Fahrenheit (F) (also reported as 31F) during a time frame of 15 days, which was detected by the Digital Data Logger. There was no previous temperature excursion and no adverse effects were reported. Follow-up information was received from the nurse on 17-DEC-2018. The reporter provided patients' demographics which made the case valid. This report refers to a 4-month-old patient of unknown gender. On 11-APR-2018, the patient was vaccinated with an improperly stored dose of LIQUID PEDVAXHIB lot number N034005 (expiration date 31-JAN-2020). This is one of multiple reports received from the same reporter. Sender's Comments: US-009507513-1807USA011661.
Age: 0.5
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This non-valid, spontaneous report was received from a registered nurse, referring to an unspecified number of patients of unknown age and gender. No information was provided regarding the patients' medical history, previous drug reactions, allergies, concurrent medical conditions or concomitant medications. On unknown dates, the patients were vaccinated with improperly stored doses of LIQUID PEDVAXHIB lot number N034005 (expiration date 31-JAN-2020) and lot number reported as "N021920" (expiration date 07-FEB-2020) for prophylaxis (doses, routes and anatomical locations of administration were not reported). Additionally, the patients were vaccinated with ROTATEQ by oral route, lot number N005078 (expiration dates 22-NOV-2018 and 04-OCT-2018) for prophylaxis (doses were unknown), hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot number N020352 (expiration date 10-APR-2020) for prophylaxis (doses, routes and anatomical locations of administration were not provided) and M-M-R II for prophylaxis (dose numbers, routes and anatomical locations of administration were not provided; lot numbers N010496 [expiration date 31-MAR-2019], N014485 [expiration date 10-MAY-2019], and N023149 [expiration date 24-AUG-2019]). The vaccines were reconstituted with sterile diluent which was reported to be properly stored. The doses of all vaccines were exposed to a temperature excursion below 32 degrees Fahrenheit (F) (also reported as 31F) during a time frame of 15 days, which was detected by the Digital Data Logger. There was no previous temperature excursion and no adverse effects were reported. Follow-up information was received from the nurse on 17-DEC-2018. The reporter provided patients' demographics which made the case valid. This report refers to a 6-month-old patient of unknown gender. On 18-APR-2018, the patient was vaccinated with an improperly stored dose of LIQUID PEDVAXHIB lot number N012920 (expiration date 07-FEB-2020). This is one of multiple reports received from the same reporter. Sender's Comments: US-009507513-1807USA011661.
Age: 0.33
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This non-valid, spontaneous report was received from a registered nurse, referring to an unspecified number of patients of unknown age and gender. No information was provided regarding the patients' medical history, previous drug reactions, allergies, concurrent medical conditions or concomitant medications. On unknown dates, the patients were vaccinated with improperly stored doses of LIQUID PEDVAXHIB lot number N034005 (expiration date 31-JAN-2020) and lot number reported as "N021920" (expiration date 07-FEB-2020) for prophylaxis (doses, routes and anatomical locations of administration were not reported). Additionally, the patients were vaccinated with ROTATEQ by oral route, lot number N005078 (expiration dates 22-NOV-2018 and 04-OCT-2018) for prophylaxis (doses were unknown), hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot number N020352 (expiration date 10-APR-2020) for prophylaxis (doses, routes and anatomical locations of administration were not provided) and M-M-R II for prophylaxis (dose numbers, routes and anatomical locations of administration were not provided; lot numbers N010496 [expiration date 31-MAR-2019], N014485 [expiration date 10-MAY-2019], and N023149 [expiration date 24-AUG-2019]). The vaccines were reconstituted with sterile diluent which was reported to be properly stored. The doses of all vaccines were exposed to a temperature excursion below 32 degrees Fahrenheit (F) (also reported as 31F) during a time frame of 15 days, which was detected by the Digital Data Logger. There was no previous temperature excursion and no adverse effects were reported. Follow-up information was received from the nurse on 17-DEC-2018. The reporter provided patients' demographics which made the case valid. This report refers to a 4-month-old patient of unknown gender. On 23-APR-2018, the patient was vaccinated with an improperly stored dose of LIQUID PEDVAXHIB lot number N034005 (expiration date: 31-JAN-2020). This is one of multiple reports received from the same reporter. Sender's Comments: US-009507513-1807USA011661.