chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 35.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Injection site discomfort, Injection site pain, Injection site paraesthesia, Paraesthesia
Clinical narrative: Pain and tingling/burning immediately in left arm following injection. Since then experienced tingling and same sensation in other arm, and started in legs about a month ago. Also had squeezing pressure at injection site. Doctor med NSAIDs.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5
Symptoms: Abdominal distension, Enema administration, Intussusception, Urinary system X-ray, X-ray abnormal
Clinical narrative: Fussiness started 4/23 pt presented to PCP and referred to Hospital on 4/24 with bilious Emesis and gross bloody stool.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5
Symptoms: Abdominal X-ray, Haematochezia, Intestinal obstruction, Intussusception, Irritability
Clinical narrative: Fussiness started 4/23 pt presented to PCP and referred to Hospital on 4/24 with bilious Emesis and gross bloody stool.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5
Symptoms: Vomiting, X-ray abnormal
Clinical narrative: Fussiness started 4/23 pt presented to PCP and referred to Hospital on 4/24 with bilious Emesis and gross bloody stool.
Age: 33.0
Sex: F
Vaccine: HEP, HEP
Symptoms: Headache, Irritability
Clinical narrative: Symptoms included headache and irritability. Was seen in the emergency room. Her physician counseled her that he didn't believe that her symptoms were due to the vaccine. Failed to obtain further information as donor was irritable.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Abdominal pain upper, Dizziness, Headache, Nausea, Pain
Clinical narrative: HEADACHE, DIZZY FAINT FEELING, STOMACH PAINS, FEVER, BODY ACHE, NAUSEOUS, SLEEPIESS.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Pyrexia, Somnolence
Clinical narrative: HEADACHE, DIZZY FAINT FEELING, STOMACH PAINS, FEVER, BODY ACHE, NAUSEOUS, SLEEPIESS.
Sex: F
Vaccine: MMRV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to a 17 year old female patient. There was no information provided about the patient's concurrent conditions, medical history, concomitant medications, drug reactions or allergies. On 17-JAN-2017 and on 23-FEB-2017, the patient received properly stored doses of injectable PROQUAD FOR prophylaxis (lot # M031943 with expiration date on 27-DEC-2017 and lot# M033216 with expiration date on 09-JAN-2018, respectively) (strength, dose, frequency, route of administration, anatomical location and albumin status were not reported). No adverse effects were reported. Additional information is not expected because the reporter did not consent for further follow up.
Age: 59.0
Sex: M
Vaccine: UNK
Symptoms: Chills, Injection site pain, Injection site warmth, Musculoskeletal stiffness, Neck pain
Clinical narrative: This spontaneous report was received from the patient's wife, concerning a 59 year-old male patient. He did not have any medical history; however, his concurrent conditions included back pain and he presented a codeine reaction/allergy on an unspecified date. His concomitant medications included glyburide, metformin, tramadol, ZOCOR, ZYRTEC, tamsolusin hydrochloride and ibuprofen. On 31-MAR-2017, the patient was vaccinated with a dose of PNEUMOVAX 23 injection (dose, frequency, lot # and expiration date were not reported) for prevention of pneumococcal disease. On 01-APR-2017 (reported as "a day after being vaccinated"), he developed "bad neck pain, chills, pain and fever on the injection site"; he did not seek medical attention and no treatment was given for the adverse events. Additionally, no laboratory diagnostics studies were performed. On an unspecified date in 2017, he presented fever. On an unspecified date, the patient got physical therapy on his back. After going to bed on 05-APR-2017, the patient recovered from the neck pain on 06-APR-2017. On an unspecified date in 2017, the patient had "stiffness in his neck". At the time of the report, the patient's chills, pyrexia and musculoskeletal stiffness had not recovered. Also, the outcome of the patient's injection site pain and injection site warmth was unknown. The causality between the injection site pain, injection site warmth and the musculoskeletal stiffness and PNEUMOVAX 23 was unknown. The causality between the neck pain, chills and pyrexia and PNEUMOVAX 23 was considered as related due to they were mentioned as result of the vaccination. Additional information has been requested.
Age: 59.0
Sex: M
Vaccine: UNK
Symptoms: Pyrexia
Clinical narrative: This spontaneous report was received from the patient's wife, concerning a 59 year-old male patient. He did not have any medical history; however, his concurrent conditions included back pain and he presented a codeine reaction/allergy on an unspecified date. His concomitant medications included glyburide, metformin, tramadol, ZOCOR, ZYRTEC, tamsolusin hydrochloride and ibuprofen. On 31-MAR-2017, the patient was vaccinated with a dose of PNEUMOVAX 23 injection (dose, frequency, lot # and expiration date were not reported) for prevention of pneumococcal disease. On 01-APR-2017 (reported as "a day after being vaccinated"), he developed "bad neck pain, chills, pain and fever on the injection site"; he did not seek medical attention and no treatment was given for the adverse events. Additionally, no laboratory diagnostics studies were performed. On an unspecified date in 2017, he presented fever. On an unspecified date, the patient got physical therapy on his back. After going to bed on 05-APR-2017, the patient recovered from the neck pain on 06-APR-2017. On an unspecified date in 2017, the patient had "stiffness in his neck". At the time of the report, the patient's chills, pyrexia and musculoskeletal stiffness had not recovered. Also, the outcome of the patient's injection site pain and injection site warmth was unknown. The causality between the injection site pain, injection site warmth and the musculoskeletal stiffness and PNEUMOVAX 23 was unknown. The causality between the neck pain, chills and pyrexia and PNEUMOVAX 23 was considered as related due to they were mentioned as result of the vaccination. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a male patient in his "60's", who is also a physician, via a field representative. The patient's medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On an unspecified date when the patient was in his "50's", he was vaccinated with ZOSTAVAX (Lot #, expiration date, strength, dose and anatomical location of administration were not provided), administered through injection, in combination with a sterile diluent (manufacturer unknown) (lot #, expiration date, strength and dose were not provided) for the prevention of shingles. Then a couple years later (date unspecified), the patient developed shingles. It was unknown if the patient received treatment for the event. It was stated that the patient did not seek medical attention. No further adverse event (AE) information was reported. At the reporting time, the patient had recovered from the shingles. The causal relationship between the event and the vaccine was not provided. Additional information is not expected as there was no consent to contact the reporter.
Sex: F
Vaccine: PNC13
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a Certified Medical Assitant refferring to a 74 year old female patient. The patient's medical history, concurrent conditions, drugs reactions or allergies and concomitant therapies were not provided. On an unknown date, the patient was inadvertenly administrated a second dose of PREVNAR 13 (route of admistration, lot number, expiration date, dose, dosage and anatomical location were unknown) instead of an intended dose of PNEUMOVAX23 for prophylaxis (route of administration, lot number, expiration date, dose, dosage and anatomical location were unknown). The reporter stated that this occurred by mistake and it was not confimed if the event ocurred due to product confusion.  Addittionally, there were no adverse effects reported. There was not Product Quality Complaint involved. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No information on the patient's concurrent conditions, medical history and concomitant therapies was reported. On 06-APR-2017, the patient was inadvertently vaccinated with a dose of expired M-M-R II injection, lot # L009213 with expiry date on 17-MAR-2017 (dose and route of administration were not reported) for prophylaxis. The M-M-R II was given with sterile diluent (manufacturer unknown) (reported as "diluent MRK injection"; dose, lot # and expiry date were not reported). Product quality complaint (PQC) was not involved. Additional information is not expected, as there was no consent for further contact.
Sex: M
Vaccine: HEP
Symptoms: No adverse event, Underdose
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 35 year old patient of unknown gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 11-APR-2017, the patient was vaccinated with pediatric dose of RECOMBIVAX HB strength: 5/0.5 mcrg/ml for prophylaxis (route and site of administration, lot # and expiration date were not reported), at an unspecified local health department. The pharmacist did not known why the error occurred and he was not aware of any adverse effects. Additional information has been requested.
Age: 37.0
Sex: F
Vaccine: VARZOS
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: This spontaneous prospective pregnancy report was received from a physician and refers to a 37 year old female patient The patient's medical history and concomitant medications were not reported.  On 05-APR-2017, the patient was vaccinated with a dose of ZOSTAVAX (dose, route of administration, anatomical location, lot# and expiration date were not reported). On 12-APR-2017, the patient discovered she was pregnant. The patient became pregnant with last menstrual period (LMP) of 13-MAR-2017 and estimated date of delivery (EDD) of 18-DEC-2017. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 30-APR-2016, the patient was vaccinated with a first dose of GARDASIL 9 lot # M034195, expiration date: 14-APR-2019 for prophylaxis (route and site of administration were not reported). On 11-APR-2017, the patient was vaccinated with a second dose of GARDASIL 9 lot # M034195, expiration date: 14-APR-2019 for prophylaxis (route and site of administration were not reported). No adverse effects was reported. Additional information has been requested.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to a 61 year old patient of unknown gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 29-MAR-2017, the patient was vaccinated with expired dose of ZOSTAVAX lot # M003486, expiration date: 27-MAR-2017 for prophylaxis (route and site of administration were not reported). No adverse effects were reported. No product quality complain (PQC) was involved. Additional information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: Vaccination failure, Varicella post vaccine
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a female patient of unknown age. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On an unknown date, the patient was vaccinated with VARIVAX injection (subcutaneously; dose, lot# and expiration date were not provided). On an unknown date,the patient developed chickenpox, despite that she was vaccinated with VARIVAX when she was younger. It was unknown if the patient received any treatment or had lab diagnostic studies performed. The outcome of vaccination failure and chickenpox was not provided. The relatedness between adverse events and VARIVAX was not provided. This is one of two reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1704USA011849:
Sex: F
Vaccine: VARCEL
Symptoms: Contraindication to vaccination, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to a 24 year old female patient. The patient's medical history, concurrent conditions and drug reactions/allergies were not reported.  On an unknown date, the patient was vaccinated with a properly-stored dose of VARIVAX, reconstituted with a properly-stored diluent, for prophylaxis (dose, frequency, route of administration, lot number and expiration date were not reported). It was reported that the patient had been receiving unspecified doses of certolizumab pegol (CIMZIA) for Crohn's disease. The reporter did not know whether the certolizumab pegol (CIMZIA) therapy was discontinued prior to the administration of VARIVAX, or when the last dose of certolizumab pegol (CIMZIA) was given. No adverse effect was reported. No product quality complaint was involved. Additional information is not expected since there was no consent to contact the reporter.
Sex: F
Vaccine: VARCEL
Symptoms: Vaccination failure, Varicella post vaccine
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a female patient of unknown age. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions, or allergies was provided. On an unknown date, the patient was vaccinated with VARIVAX injection (subcutaneously; dose, lot# and expiration date were not provided). On an unknown date,the patient developed chickenpox, despite that she was vaccinated with VARIVAX when she was younger. The reporter stated, that a school nurse reported the patient's mother that it is not unusual to see chickenpox in females even if with immunization around puberty. It was unknown if the patient received any treatment or had lab diagnostic studies performed. The outcome of vaccination failure and chickenpox was not provided. The relatedness between adverse events and VARIVAX was not provided. This is one of two reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1704USA009251:
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a vaccine coordinator referring to an unspecified number of patients whose on an unknown dates were vaccinated with improperly stored doses of VAQTA, (lot # M033611, expiry date 02-MAR-2018). The vaccine was stored in refrigerator at a temperature of 47°F to 77°F (48 °F) for current excursion, but data not available for prior excursions. The time frame was 45 minutes. No previous temperature excursions were reported. No datalogger reported. No adverse effects reported. No adverse effects reported. The outcome of incorrect product storage and no adverse event was unknown. This is one of five cases from the same reporter source, (linked to MARRS # 1704USA013566 to 1704USA013569). Additional information is not expected as no information to obtain follow up was provided.; Sender's Comments: US-009507513-1704USA013566: US-009507513-1704USA013567: US-009507513-1704USA013568: US-009507513-1704USA013569:
Sex: M
Vaccine: HPV9
Symptoms: Arthralgia, Fatigue, Headache, Loss of consciousness, Loss of personal independence in daily activities
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act and refers to a 12 year old male patient. His medical history and concurrent conditions were unknown. On unknown dates, the patient was vaccinated with GARDASIL 9 (first and second doses) (route, lot number and expiration date unknown) for prophylaxis. On 04-FEB-2016, the patient was vaccinated with GARDASIL 9 (lot # L020015, dose 3, in arm) (route and expiration date unknown) for prophylaxis. Concomitant therapies included methylphenidate hydrochloride (CONCERTA). On 14-FEB-2016, the patient's throat felt like closing (disability) and then he passed out (disability). On the same day, the patient experienced severe headaches (disability), muscle pain (disability), joint pain (disability). The patient now had seizures (disability), was constantly tired with fatigue (disability). On some days, the patient could not get out of bed (disability) and could not play sports he was involved in or even go to school (disability). On an unknown date, the patient required emergency visit for the events. On an unknown date, the patient was hospitalized for the events. The outcome of activities of daily living impaired, throat tightness, seizure, myalgia, mobility decreased, loss of consciousness, headache, fatigue and arthralgia was reported as not recovered/not resolved. The causality of the events was unknown. Additional information is not expected, as the case is from agency and we are unable to do follow up.
Sex: M
Vaccine: HPV9
Symptoms: Mobility decreased, Myalgia, Seizure, Throat tightness
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act and refers to a 12 year old male patient. His medical history and concurrent conditions were unknown. On unknown dates, the patient was vaccinated with GARDASIL 9 (first and second doses) (route, lot number and expiration date unknown) for prophylaxis. On 04-FEB-2016, the patient was vaccinated with GARDASIL 9 (lot # L020015, dose 3, in arm) (route and expiration date unknown) for prophylaxis. Concomitant therapies included methylphenidate hydrochloride (CONCERTA). On 14-FEB-2016, the patient's throat felt like closing (disability) and then he passed out (disability). On the same day, the patient experienced severe headaches (disability), muscle pain (disability), joint pain (disability). The patient now had seizures (disability), was constantly tired with fatigue (disability). On some days, the patient could not get out of bed (disability) and could not play sports he was involved in or even go to school (disability). On an unknown date, the patient required emergency visit for the events. On an unknown date, the patient was hospitalized for the events. The outcome of activities of daily living impaired, throat tightness, seizure, myalgia, mobility decreased, loss of consciousness, headache, fatigue and arthralgia was reported as not recovered/not resolved. The causality of the events was unknown. Additional information is not expected, as the case is from agency and we are unable to do follow up.
Age: 0.5
Sex: M
Vaccine: MMRV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse concerning a 6 months old male patient. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 21-APR-2017, the patient was vaccinated "too early" with his first dose of PROQUAD, lot # reported as M041083, expiration date 04-APR-2018, for prophylaxis (route and anatomical location of administration were unknown). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant concerning an unknown number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On unknown dates, the patients were vaccinated with doses of ROTATEQ, orally for prophylaxis (dose number, lot # and expiration date were unknown), which were improperly stored at 1 Celsius degree for 17 minutes. There was no previous temperature excursion. A digital data logger was involved. No adverse symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1704USA013570: US-009507513-1704USA013571: US-009507513-1704USA013572:
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report was received from a pharmacist refers to a currently 60 years old female patient. The patient's concurrent condition included asthma and diabetes mellitus. The patient's medical history and concomitant therapies were not reported. On 22-APR-2017, the patient was vaccinated with ZOSTAVAX 19400 PFU, 0.65 ml, subcutaneously, with a lot # of M019645 and 18-JUL-2017 (anatomical place of vaccination was not provided), for prophylaxis.  Other suspect therapies included sterile diluent which had a lot # reported as "N003193", an expiration date of 02-JUL-2019. Approximately in April 2017, the patient developed swelling and redness near the injection site. No rash was reported. Therefore, the patient seek for medical attention by calling the pharmacist. Nevertheless, no treatment was provided for the adverse events. At the time of reporting, the patient did not recover from injection site swelling and injection site erythema. The reporter did not provide a causality assessment between ZOSTAVAX, sterile diluent and the events. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report was received from a Registered Nurse concerning a patient of an unknown age and gender. The patient's concurrent conditions, medical history, historical drugs and concomitant therapies were not reported. On an unknown date, the patient began the HPV vaccination series with GARDASIL lot number K006960, expiration date 19-FEB-2017, then, on an unknown date, the patient received GARDASIL 9 lot number L020015, expiration date 16-AUG-2016 (dose and route were not reported) both for prophylaxis; as a second dose in the HPV vaccination series (interchange of vaccine products). It was reported that the patient received both vaccines before their respective expiration dates. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received form a pharmacist regarding a patient of unknown age and gender. The patient's medical history, concurrent conditions, or drug allergies were not reported. On 24-APR-2017, the patient was inadvertently vaccinated with an expired dose of VARIVAX injection (dose and anatomical location were not reported) lot number: L009206; expiration date 17-MAR-2017, for prophylaxis. The vaccine was reconstituted with a sterile diluent (manufacturer unknown) injection that was not expired and had no previous temperature excursions (lot number and expiration date were not provided). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a vaccine coordinator referring to an unspecified number of patients whose on an unknown dates were vaccinated with improperly stored doses of LIQUID PEDVAXHIB, (lot # L030868, expiry date 09-JUN-2018). The vaccine was stored in refrigerator at a temperature of 47°F to 77°F (48 °F) for current excursion, but data not available for prior excursions. The time frame was 45 minutes. No previous temperature excursions were reported. No datalogger reported. No adverse effects reported. The outcome of incorrect product storage and no adverse event was unknown. This is one of five cases from the same reporter source, (linked to MARRS # 1704USA012566 and 1704USA013567 to 1704USA013569). Additional information is not expected as no information to obtain follow up was provided.; Sender's Comments:  US-009507513-1704USA012566: US-009507513-1704USA013567: US-009507513-1704USA013568: US-009507513-1704USA013569:
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a vaccine coordinator referring to an unspecified number of patients whose on an unknown dates were vaccinated with improperly stored doses of M-M-R II, (rHA, lots #s L043703, expiry date 03-NOV-2017; M022407, expiry date 02-MAY-2018 and M029230, expiry date 08-JUN-2018). The vaccine was stored in refrigerator at a temperature of 47°F to 77°F (48 °F) for current excursion, but data not available for prior excursions. The time frame was 45 minutes. No previous temperature excursions were reported. No datalogger reported. No adverse effects reported. The outcome of incorrect product storage and no adverse event was unknown. This is one of five cases from the same reporter source, (linked to MARRS # 1704USA012566, 1704USA013566, 1704USA013568 an 1704USA013569). Additional information is not expected as no information to obtain follow up was provided.; Sender's Comments:  US-009507513-1704USA012566: US-009507513-1704USA013566: US-009507513-1704USA013568: US-009507513-1704USA013569:
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a vaccine coordinator referring to an unspecified number of patients whose on an unknown dates were vaccinated with improperly stored doses of ROTATEQ), (lots #s L033543, expiry date 30-MAY-2017; M034799, expiry date 01-FEB-2018 and M038744, expiry date 26-APR-2018). The vaccine was stored in refrigerator at a temperature of 47°F to 77°F (48 °F) for current excursion, but data not available for prior excursions. The time frame was 45 minutes. No previous temperature excursions were reported. No datalogger reported. No adverse effects reported. The outcome of incorrect product storage and no adverse event was unknown. This is one of five cases from the same reporter source, (linked to MARRS # 1704USA012566, 1704USA013566, 1704USA013567 and 1704USA013569). Additional information is not expected as no information to obtain follow up was provided.; Sender's Comments:  US-009507513-1704USA012566: US-009507513-1704USA013566: US-009507513-1704USA013567: US-009507513-1704USA013569:
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a vaccine coordinator referring to an unspecified number of patients whose on an unknown dates were vaccinated with improperly stored doses of VARIVAX, (lots #s L031066, expiry date 18-AUG-2017; M022103, expiry date 04-MAY-2018; M034583, expiry date 27-JUL-2018; M038859, expiry date 14-SEP-2018 and L016127, expiry date 06-MAY-2017). The vaccine was stored in freezer at a temperature of 6°F to 14°F (6 °F) for current excursion, but data not available for prior excursions. The time frame was 6 minutes. No previous temperature excursions were reported. It was a datalogger reported. No adverse effects reported. The outcome of incorrect product storage and no adverse event was unknown. This is one of five cases from the same reporter source, (linked to MARRS # 1704USA012566 and 1704USA013566 to 1704USA013568). Additional information is not expected as no information to obtain follow up was provided.; Sender's Comments: US-009507513-1704USA012566: US-009507513-1704USA013566: US-009507513-1704USA013567: US-009507513-1704USA013568:
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant concerning an unknown number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On unknown dates, the patients were vaccinated with doses of VAQTA, for prophylaxis (dose number, route, lot # and expiration date were unknown), which were improperly stored at 1 Celsius degree for 17 minutes. There was no previous temperature excursion. A digital data logger was involved. No adverse symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1704USA013334: US-009507513-1704USA013571:  US-009507513-1704USA013572:
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant concerning an unknown number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On unknown dates, the patients were vaccinated with doses of RECOMBIVAX HB, for prophylaxis (dose number, route, lot # and expiration date were unknown), which were improperly stored at 1 Celsius degree for 17 minutes. There was no previous temperature excursion. A digital data logger was involved. No adverse symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1704USA013334: US-009507513-1704USA013570: US-009507513-1704USA013572:
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant concerning an unknown number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On unknown dates, the patients were vaccinated with doses of GARDASIL 9, for prophylaxis (dose number, route, lot # and expiration date were unknown), which were improperly stored at 1 Celsius degree for 17 minutes. There was no previous temperature excursion. A digital data logger was involved. No adverse symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1704USA013334: US-009507513-1704USA013570: US-009507513-1704USA013571.
Sex: M
Vaccine: FLU4
Symptoms: Respiratory arrest
Clinical narrative: Upon internal review, a significant correction was performed on 26 April 2017 to add the correct product INFLUENZA QUADRIVAL A-B VACCINE and Class priority changed from Class 3 to Class 1. Initial report was received on 03 October 2013 from a nurse. A 68 year-old male patient with a history of asthma had received FLUZONE QUADRIVALENT (lot number, route, site and date of administration not reported) and 12 hours later experienced respiratory arrest and was hospitalized. The patient was stable but was still hospitalized. No further information was available at the time of the report. The patient's outcome was not recovered. Documents held by sender: none. Addendum: 02 March 2017 Upon second medical examination of the case during internal review, a significant correction was performed on 26 April 2017 to add the correct product INFLUENZA QUADRIVAL A-B VACCINE and Class priority changed from Class 3 to Class 1. Sender's Comments: Limited information provided in this case is not sufficient for the case assessment. A description of the event, final diagnosis and complementary investigation results are needed to fully assess the case.
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Erythema, Pruritus generalised
Clinical narrative: Initial unsolicited report received from a consumer on 17-APR-2017. This case involves a female patient (unknown age) who was vaccinated with a dose of INFLUENZA VACCINE (FLU SHOT) (manufacturer unknown, batch number, dose, dose in series, expiration date, route and site of administration not reported), on an unspecified date. The patient had a medical history of a pre-cancerous condition that involves her esophagus that is now stable and depression and being bi-polar and is also losing weight due to breaking out after eating. It was reported that the patient has been using Xyzal (generic version) in the past couple of months for respiratory allergic conditions. Concomitant medications were not reported. On an unspecified date, following the vaccination, the patient had redness in the face and itching all over. Lab data and corrective treatment were not reported. The outcome of the event was reported as unknown. List of documents held by sender: none.
Age: 70.0
Sex: F
Vaccine: HEP, MMR, VARCEL
Symptoms: No adverse event, Underdose
Clinical narrative: Hep B vaccine pediatric dose used, not adult dose. No adverse effects reported. Repeated Hbv Adult dose on 4-27-17.
Age: 11.0
Sex: F
Vaccine: DTAP, MEN
Symptoms: Diarrhoea, Fatigue, Feeling abnormal, Pyrexia, Urticaria
Clinical narrative: Body completely covered in hives.  Hives were layered on top of hives.  In her ears.  Fever of 100 degrees, water diarrhea, extreme fatigue, weird feeling in arm of vaccination spot.
Age: 11.0
Sex: F
Vaccine: DTAP, MEN
Symptoms: Vaccination site reaction
Clinical narrative: Body completely covered in hives.  Hives were layered on top of hives.  In her ears.  Fever of 100 degrees, water diarrhea, extreme fatigue, weird feeling in arm of vaccination spot.
Age: 11.0
Sex: M
Vaccine: FLU4, HPV9, MNQ, TDAP
Symptoms: Dizziness, Fall, Tongue biting
Clinical narrative: Pt got up from bed, moved to sit on a bench. Said felt dizzy. Fell forward and mom caught him. Sat him back up and he was biting his tongue. No abnormal movements of extremities. Mom was able to put her finger in his mouth to open jaw to stop him. I walked in 3-5 seconds after she started doing that and he was responsive, admitted feeling dizzy. Was moved back to the bed (able to stand), laid down, bp was 105/59, was given some juice. After 5 min tried to sit up, felt dizzy and lied back down for 5 more minutes. Then able to sit up with out dizziness and bp was 115/69. HR normal throughout. No emesis. Only reporting due to the tongue biting which was witnessed by mom and MA and lasted 5-6 sec before mom put finger in his mouth and was able to open jaw easily.
Age: 0.25
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC13, RV1
Symptoms: Hydrocephalus, Mental status changes, Ventriculo-peritoneal shunt
Clinical narrative: Infant developed acute hydrocephalus and altered mental status within 24 hours of immunization. Required emergency VP shunt.
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: This spontaneous prospective pregnancy report as received from a physician refers to a female patient of unknown age.     On 15-DEC-2016, the patient was subcutaneously vaccinated with VARIVAX (dose, frequency were not reported, lot # M033212 with expiration date 13-JUL-2018) for prophylaxis. The patient became pregnant with LMP of approximately 2016. Initial exposure to VARIVAX was at 13 weeks. The pregnancy outcome was outcome pending.  No adverse effect reported. Additional information has been requested.
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Exposure during pregnancy
Clinical narrative: This spontaneous prospective pregnancy report as received from a physician refers to a female patient of unknown age.     On 15-DEC-2016, the patient was subcutaneously vaccinated with VARIVAX (dose, frequency were not reported, lot # M033212 with expiration date 13-JUL-2018) for prophylaxis. The patient became pregnant with LMP of approximately 2016. Initial exposure to VARIVAX was at 13 weeks. The pregnancy outcome was outcome pending.  No adverse effect reported. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse and refers to an unknown number of patients of unknown age and gender. There was no information about the patients' pertinent medical history, concurrent conditions, concomitant therapies, and drug reactions or allergies. The reporter mentioned that on an unknown date, this indeterminate number of patients received a dose of RECOMBIVAX HB (strength, anatomical location, dose, frequency, route of administration, lot number, and expiration date were not provided) for prophylaxis; which had been exposed to excursion temperatures of 8.6 Celsius degrees on two different occasions (one for 15 minutes and the other for 3 hours). No adverse effects were reported. There was no product quality complaint involved. This is one of four reports received from the same source. Additional information has been requested.; Sender's Comments: US-009507513-1704USA014012: US-009507513-1704USA014013: US-009507513-1704USA014014:
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from an office manager, concerning multiple unspecified patients of an unknown gender and age. There were no concurrent conditions, medical history, drug reactions or allergies or concomitant medications reported. On an unspecified dates, the patients were vaccinated with improperly stored doses of PNEUMOVAX23 (dose, frequency, route, lot # and expiration date were not reported) for prophylaxis. The temperature of the PNEUMOVAX23 was 29 °F for a time frame of 1 hour; it was unknown if a previous temperature excursion occurred. No adverse effects were reported and no product quality complaint (PQC) or data logger was involved. This is one of two reports received from the same reporter. Additional information is not expected, as no consent to contact the reporter was granted; Sender's Comments: US-009507513-1704USA006972:
Sex: U
Vaccine: HPV9
Symptoms: Drug administered to patient of inappropriate age, Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from pharmacy intern and refers to an over 26 year old patient of unknown gender. There was no information regarding patient's concomitant medications, medical history, concurrent conditions, drug reactions or allergies provided. In approximately August 2016, the patient was vaccinated with GARDASIL 9 (dose, route of administration, lot number, expiration date were not provided) dose 1, for prophylaxis. In April 2017, the patient visited pharmacy and asked to receive second dose of GARDASIL 9. It was unknown if the second dose of the vaccine was administered. No adverse event was reported. No product quality complaint was involved in this case. Additional information has been requested.
Age: 77.0
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to an unspecified number of patients of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions, or allergies was provided. On unknown dates, the patients were vaccinated with improperly stored doses of ZOSTAVAX 19400 plaque-forming units (PFU) (dose and route of administration were not provided; lot # M037014, expiration date 22-NOV-2017) reconstituted with properly stored sterile diluent (DILUENT MRK) (lot# and expiration date were not provided). There was no adverse effect reported. Administered doses of vaccine experienced the temperature excursion of 30 degrees Fahrenheit for 4 hours. The doses of vaccine experienced also previous temperature excursion: from 15 to 46 degrees Fahrenheit for 15 minutes. Digital data logger was involved. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from an office manager, concerning multiple unspecified patients of an unknown gender and age. There were no concurrent conditions, medical history, drug reactions or allergies or concomitant medications reported. On an unspecified dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 (dose, frequency, route, lot # and expiration date were not reported) for prophylaxis. The temperature of the GARDASIL 9 was 29 °F for a time frame of 1 hour; it was unknown if a previous temperature excursion occurred. No adverse effects were reported and no product quality complaint (PQC) or data logger was involved. This is one of two reports received from the same reporter. Additional information is not expected, as no consent to contact the reporter was granted. Sender's Comments: US-009507513-1704USA003989.
Sex: M
Vaccine: HPV4
Symptoms: Migraine, Peripheral swelling
Clinical narrative: This spontaneous report was received from a pediatrician via company representative and refers to a 13-year-old male patient. The patient's medical history included exposure to unspecified pesticide at "very young age". On an unknown date, the patient was vaccinated with GARDASIL, intramuscular injection for prevention of Human Papillomavirus (lot# and expiration date were not reported). There was no information about concomitant therapies provided. On an unknown date, reported also as for one month, the patient experienced migraine headache and significant swelling of the arm. The patient sought medical attention (date was not provided). However it was unknown if he received any treatment for the events. Action taken with GARDASIL was not applicable (however it was also reported as therapy was not discontinued). The outcome of the events was unknown. The relatedness between the events and GARDASIL was not provided. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: This spontaneous report as received from a pharmacist refers to a male patient of unknown age. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions, or allergies was provided. On an unknown date (reported as "a couple weeks ago"), the patient was vaccinated with a dose of ZOSTAVAX 19400 plaque-forming units (PFU) (dose, route of administration, lot# and expiration date were not provided) at an unspecified pharmacy. On an unknown date (reported as "a couple weeks ago"), the patient experienced a couple bumps. On 17-APR-2017, the patient presented to the pharmacy with a rash on his shoulder. Pharmacist stated, that the bumps almost look like mosquito or bug bites in a linear fashion, not resembling vesicles from shingles. There was no treatment given for the adverse event. No laboratory diagnostic studies were performed. The pharmacist stated, that the patient was referred to primary care physician. At the time of the report, the patient did not recover from the adverse event. The relatedness between the adverse event of rash on the shoulders and ZOSTAVAX was not reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse practitioner and refers to a unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical history provided. On 13-APR-2017, the patient was vaccinated with improperly stored doses of VARIVAX subcutaneously, lot# reported as M043582 with an expiration date 28-OCT-2018, lot#M041079 with an expiration date 06-ACT-2018 and lot# M042495 with an expiration date 19-OCT-2018 for prophylaxis (dose was not reported). The VARIVAX was reconstituted with properly stored sterile diluent (STERILE DILUENT) (doses, route of administration, lot# and expiration date were not reported). No side effect was reported.  Administered doses of VARIVAX experienced temperature excursion of 25.5 degrees Fahrenheit for 1 hour and 48 minutes. There was no previous temperature excursions. A digital data logger was involved. Product quality complaint (PQC) was not involved. Additional information has been requested.
Sex: M
Vaccine: HPV9
Symptoms: Oropharyngeal pain, Rhinorrhoea
Clinical narrative: This spontaneous report was received from a nurse via a company representative and refers to a 20 year old male patient. The patient's pertinent medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not reported. On 05-JAN-2017, the patient was vaccinated with the first dose of GARDASIL 9 (dose, route, lot # and expiration date were not reported) for prophylaxis. On the same date, after the vaccination the patient experienced runny nose and achy throat. On 10-MAR-2017, the patient received the second dose of GARDASIL 9 (dose, route, lot # and expiration date were not reported) for prophylaxis. On the same date, after the vaccination the patient again experienced runny nose and achy throat. It was reported that the patient recovered from all the events on an unknown date. The patient did not seek medical attention nor received any treatment for the events. None laboratory diagnostic studies were performed. The causality between the events and GARDASIL 9 was not provided. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to an unknown number of patients of unknown age and gender. No information regarding the patients' pertinent medical history, drug reactions or allergies and concomitant therapies was provided. Since an unknown date in January 2017, the patients were administered improperly stored doses of LIQUID PEDVAXHIB (doses, anatomical location, route of administration, lot # and expiration date were not reported). The administered doses of vaccine underwent a temperature excursion between 32 degrees Fahrenheit (F) to 35 degrees F, and between 47 degrees F to 77 degrees F, a time frame was not yet determined. There was no previous temperature excursion reported and a digital data logger was not involved. No adverse effect was reported. No product quality complaint (PQC) was involved. This one of two reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1704USA014024:
Sex: U
Vaccine: VARZOS
Symptoms: Death
Clinical narrative: This spontaneous report was received from a nurse via a company representative and refers to a patient of unknown demographics. No information regarding the patient's medical history, concomitant medications, concurrent conditions and drug reactions or allergies was provided. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX injection (dose, lot number and expiration date were not reported). Other suspect therapies included sterile diluent (dose, lot number an expiration date were not reported). On an unknown date, after receiving ZOSTAVAX the patient died. The cause of death was not reported. It was unknown, whether the autopsy had been performed. The relatedness between the event and ZOSTAVAX was not reported. Upon internal review, the event of death was considered to be medically significant. Additional information is not expected as there was no consent for further contact with the reporter.