chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Computerised tomogram head normal, Pyrexia, Seizure, Tremor
Clinical narrative: Seizure 7 days after 4 mo immunizations. Day 8-9 2 more episodes of shaking - fever day after shots. Mild temp day 7 child had 6 month immun. No adverse RXN except fever.
Age: 76.0
Sex: F
Vaccine: PPV
Symptoms: Adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a currently 81 year old female patient with drug reactions/allergies to tetracycline and CIPRO. On an unknown date in September 2011, the patient was vaccinated with PNEUMOVAX 23 injection (exact dose, anatomical location, route of administration, lot # and expiration date were not provided). There were no concomitant medications provided. The reported stated, that on an unknown date, the patient had an unspecified reaction to PNEUMOVAX 23. The outcome of adverse event was reported as recovered/resolved, on an unknown date. The reporter considered adverse event to be related PNEUMOVAX 23. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a register nurse and refers to multiple unspecified patients of unknown age and gender. The register nurse reported that the shipping of GARDASIL 9 was received "last within 3 days, instead of 2 days, however, the checkmark indicator enclosed in the shipment was checked as OK, indicating that the temperature conditions were maintained". The nurse also reported that multiple patients on multiple unspecified dates, were vaccinated with GARDASIL 9 (dose, route, lot number and expiration date were not reported) that may had been improperly stored during the shipping as the temperature during the shipment could not be determined. No adverse effects reported. No product quality complaint was involved. Additional information is not expected because reported refused additional contact.
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
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 concomitant medications, concurrent conditions, pertinent medical history, drug reactions or allergies was reported. On an unspecified date in approximately 2015 (reported as "approximately one year ago"), the patient was vaccinated with the first dose of ZOSTAVAX (dose, route of administration, lot # and expiration date were not reported). On an unspecified date, after the first dose administration, the patient was vaccinated with the second dose of ZOSTAVAX (dose, route of administration, lot # and expiration date were not reported). No adverse symptoms were reported. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site eczema
Clinical narrative: This spontaneous report was received from a nurse practitioner, via a company representative, referring to a 14 years old female patient. The patient's medical history and concurrent conditions were not reported. In August 2016, the patient was vaccinated with her first dose of GARDASIL 9, 0.5 ml, intramuscularly, (strength, anatomical location of administration, lot # and expiration date were unknown). Concomitant therapies were not reported. On an unspecified date in 2016, the patient developed eczema at the injection site. No product quality complaint was involved. At the time of reporting, the outcome of the injection site eczema was unknown. The causality assessment between the injection site eczema and GARDASIL 9 was not provided. Additional information has been requested.
Age: 1.58
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Rash, Urticaria
Clinical narrative: WCC in am-PENTACEL given. Child had a cold prior to visit -2:30 call child with rash on leg- injection site fine no fever. Returned to office-hives on both legs, arms, some chest. Called 10/21/16 rash almost gone.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a vaccine coordinator refers to unspecified number of patients of unknown age and gender. The patients' pertinent medical history, drug reactions, allergies and concomitant medications were not reported. On an unknown date the patients were vaccinated with improperly stored doses of GARDASIL 9 (dose and route were not reported) lot # L040054 and expiry date: 26-DEC-2017. The vaccine was exposed to a temperature frame of 33.20 Fahrenheit for 20 minutes. There were no previous excursions and there was no data logger involved. No adverse events were reported and there was no product quality complaint (PQC). This is one of the two reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a vaccine coordinator refers to unspecified number of patients of unknown age and gender. The patients' pertinent medical history, drug reactions, allergies and concomitant medications were not reported. On an unknown date the patients were vaccinated with improperly stored doses of ROTATEQ (dose and route were not reported) lot # L033548, expiry date: 14-MAY-2017 and lot# M002254, expiry date: 15-NOV-2017. The vaccine was exposed to a temperature frame of 33.20 Fahrenheit for 20 minutes. There were no previous excursions and there was no data logger. No adverse events were reported and there was no product quality complaint (PQC). This is one of the two reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant and refers to a patient of unknown age and gender. The patient's relevant medical history, drug history, and concomitant medications were unknown. On an unknown date the patient was vaccinated with PROQUAD lot # M007961 (exp 15-AUG-2017), subcutaneous in back of arm. The patient received the vaccination which had undergone a temperature excursion. The patient did not experience an adverse event. It was unknown if there was any relevant laboratory data. As of 06-OCT-2016 it was unknown if the patient was continued with PROQUAD. The outcome of patient received vaccination that underwent temperature excursion was unknown. This is one of several reports received from the same source. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a pharmacist and refers to a 66 year old female patient. In 2015 the patient was vaccinated with PNEUMOVAX 23. On 06-OCT-2016 the patient was again vaccinated with PNEUMOVAX 23 lot # L026033 exp 27-MAR-2017 instead of receiving PREVNAR. No adverse event was reported. The outcome of wrong drug administered and no adverse event is unknown. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Needle issue, No adverse event, Underdose
Clinical narrative: This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 18-OCT-2016, the patient was vaccinated with a dose of ZOSTAVAX lot # M032141; expiration date 02-OCT-2017 (dose, dose number and anatomical location were not reported). Concomitant medications were not reported. It was reported that the patient received less than a full dose of ZOSTAVAX due to a needle leakage. No adverse effect was reported. A Product Quality Complain was not involved. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Flushing, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report was received from a pharmacist referring to a currently 61 year old female patient. The patient's pertinent medical history, drug reactions and allergies included: "histamine reactions" to other injections of unspecified medications, "Season Allergies" and other unspecified environmental allergies. The patient received "Allergy shots" on both arms on 09-OCT-2016 and received ZOSTAVAX (lot # M024698, expiration date 27-JUN-2016) subcutaneously, eighteen (18) hours later on 10-OCT-2016. Other concomitant therapies included vitamin D and SINGULAIR. On an unspecified date in October 2016, the patient had 3 inches of redness, warmth to the touch, and swelling around the ZOSTAVAX injection and unspecified redness around the allergy shot injection site on the same arm. The opposite arm did not have a reaction. The patient was also feeling flushed. The symptoms have not improved as of 11-OCT-2016 (not recovered). It was also reported that the patient did not receive treatment for the adverse events, that no laboratory diagnostic studies were performed, that she did not seek for medical attention nor was hospitalized, that no laboratory diagnostic studies were performed, that she did not seek for medical attention nor was hospitalized, that no intervention to prevent serious criteria was necessary and that the adverse events were not significant disability nor life threatening. The causality between the adverse events and ZOSTAVAX was not assessed. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Injection site mass, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a pharmacist via a company representative concerning to a 69 year old female patient with no pertinent medical history. On 10-OCT-2016, (reported as "3 days ago") was vaccinated with a dose of PNEUMOVAX 23 (dose, route and lot number not reported). Concomitant therapies included gabapentin. In October 2016, the patient experienced an injection site reaction which consisted of a warm lump and swelling in the injection site. There were not lab diagnostics studies performed. The patient visited the pharmacy and the pharmacist recommended the patient to take ADVIL or TYLENOL for treatment. There was no intervention to prevent serious criteria. No cancer, death, disability, hospitalization, life threatening or overdose were reported. At the time of the report the patient felt better and the reaction had resolved. No product quality complaint was involved. The relationship between injection site reaction and therapy with PNEUMOVAX 23 was not reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received on 07-OCT-2016 from a other health professional referring to a patient of unknown age and gender. Medical history and concomitant medications were not reported. On 05-OCT-2016 the patient was vaccinated with PNEUMOVAX 23 lot # K010465 expiration date 23-MAR-2016, which was expired. No adverse effects were reported. No further information was reported. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product preparation error, Product quality issue
Clinical narrative: This spontaneous report was received from a registered nurse referring to an unknown number of patients of unknown age and gender. The patients' medical history and concurrent conditions were not reported. On an unknown date, the patients were vaccinated with PEDVAXHIB (dosage, route of administration, lot # and expiration date were not reported). Concomitant therapies were not reported. On an unspecified date (reported as "for a long time"), in the office had been using a "3 mm syringe blunt plastic cannula" to insert into rubber vial stopper to draw up PEDVAXHIB, then switching to a needle to administer it to the patients. No adverse effects were reported. Additionally, on an unknown date (reported as "recently"), some rubber was going into vial upon entering vial with blunt needle cannula on the PEDVAXHIB vial with lot # M014927, so the vial was not used. A product quality complaint (PQC) was filled. Additional information has been requested.
Age: 81.0
Sex: F
Vaccine: UNK
Symptoms: Injection site erythema, Injection site haemorrhage, Injection site swelling, Rash erythematous
Clinical narrative: Vaccine given top of shoulder-Bleeding - covered with BANDAID and repeated x 1. Injection site swollen with erythema x 2 days. 5 cm below site developed red rash mid arm. Still present day 4.
Age: 2.0
Sex: M
Vaccine: HEPA, HIBV
Symptoms: Abnormal behaviour, Facial pain, Irritability, Pain in extremity
Clinical narrative: Child took 3 hr. nap about 1 hr. after visit, woke up late then grabbed left arm and left check like he was hurting. Child was fussy and rolling around on ground, not himself. Behavior lasted 3 hrs. then he was fine, no seizure activity.
Sex: F
Vaccine: FLU3, PPV
Symptoms: Drug administration error, Injection site erythema, Injection site pain
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a female patient of unknown age. No information about the patient's pertinent medical history, concomitant medications and drug reactions or allergies was reported. On 07-OCT-2016, the patient was vaccinated with PNEUMOVAX 23 injection, in the upper arm, lot # L035686, expiry date 16-FEB-2017 (dose, route of administration and anatomical location were not specified). Other suspect therapies included FLUZONE HIGH-DOSE, lot # UI666AB, expiry date 13-APR-2017 (dose, route of administration and anatomical location were not reported), in the same arm, administered on the same day. On 07-OCT-2016, later that day, the patient experienced same soreness and a red area on her upper arm in the area of the injections. It was reported that the red area increased in size until 10-OCT-2016 and was extending from the injection sites down to the patient's elbow. The reporter stated that the soreness disappeared on an unspecified date in October 2016, but the redness remained. The causality assessment between the events and suspect vaccines was not provided. Additional information is not expected as there was no consent for further contact.
Age: 0.3
Sex: U
Vaccine: PPV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Information has been received from a medical assistant concerning a 4 month old patient with unknown gender. No relevant medical condition or concomitant medication was reported. On 11-OCT-2016, the patient was vaccinated with PNEUMOVAX 23 (dose unknown) (route: intramuscular; Lot# and expiration date were unknown) in error. No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed nurse practitioner refers to unspecified number of patients of unknown age and gender. The patients' pertinent medical history, drug reactions and allergies were not reported. On unspecified dates, the patients were vaccinated with improperly stored PNEUMOVAX 23 (dose and route were not reported) lot # M026317 and expiry date: 11-JAN-2018. No concomitant medications and no adverse effects were reported. The call was due to a data logger. No further information was available. There was no product quality complaint (PQC) involved. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from an other healthcare worker refers to an unspecified number of patients of unknown age and gender. No information on patients' pertinent medical history, drug reactions or allergies was provided. On an unknown date, multiple unspecified patients were vaccinated with a doses of RECOMBIVAX HB (lot # M0101671, expiry date 02-JUN-2018) that were improperly stored. Concomitant therapies were not provided. No adverse effects were reported. This is one of several reports from the same reporter source. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to an adult patient of unknown age and gender. No information regarding the patient's medical history and concurrent conditions was provided. In September 2016 (reported as "a month ago on an unspecified date"), the patient was vaccinated with a dose of PROQUAD injection (dose, dose number, route of administration, injection site, lot number and expiration date were not provided). There were no concomitant medications reported. No adverse effects were reported. No product quality complaint (PQC) was involved. Additional information is not expected because the reporter refused additional contact.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified patients of unknown age and gender. The patient's medical history and concurrent conditions were not provided. On an unknown date, the patient was vaccinated with improperly stored dose of VARIVAX (dose, frequency, route of administration and indication were not reported, lot # M004330 with expiration date: 26-JAN-2018). Concomitant medications were not reported. No adverse symptoms reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified patients of unknown age and gender. The patient's medical history and concurrent conditions were not provided. On an unknown date, the patient was orally vaccinated with improperly stored dose of ROTATEQ (dose, frequency, and indication were not reported, lot # (L048854 with expiration date: 31-AUG-2017). Concomitant medications were not reported. No adverse symptoms reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On unknown dates, the patients were vaccinated with the improperly stored (in 30.7F for 3 hours and 30 minutes and in 57.9F for 11 hours and 45 minutes) doses of GARDASIL 9 (lot # L016428, expiration date 30-JUL-2017; dose and route of administration were not reported). No adverse effects were reported. The call was made because of a data logger. This is one of two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On unknown dates, the patients were vaccinated with the improperly stored (in 30.7F for 3 hours and 30 minutes and in 57.9F for 11 hours and 45 minutes) doses of PNEUMOVAX 23 (lot # L018503, expiration date 16-MAR-2017; dose and route of administration were not reported). No adverse effects were reported. The call was made because of the data logger. This is one of two reports received from the same reporter. Additional information has been requested.
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a Administrator and refers to a 12 months old infant patient of unknown gender. No medical history, concurrent condition and concomitant medications were reported. On 19-MAY-2016, the patient was vaccinated with improperly stored dose of VARIVAX lot # L048468 (strength, dosing details, anatomical location were unknown). All the VARIVAX vaccines with lot # L048468, were moved to the backup freezer on 15-APR-2016 and moved back at the end of AUG-2016. This is one of the several reports reported by the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a state immunization official (also a healthcare worker) referring to 6 or 7 patients of unknown age and gender. Information regarding concomitant medication, medical history and drug reactions/allergies was not reported. On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX (lot # was reported as M025865, expiration date 24-MAY-2018; dose and route were not reported). The vaccine was improperly stored at 17.5 Fahrenheit (F) for 1.5 hours and 14 F for 2 hours. There was no previous temperature excursion. Data logger was involved. No symptoms were reported. Additional information has been requested.
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a IR Administrator of the clinic, and refers to a 12 months old infant patient of unknown gender. No medical history, concurrent condition and concomitant medications were reported. On 09-MAY-2016, the patient was vaccinated with improperly stored dose of VARIVAX lot # L048468 (strength, dosing details, anatomical location were unknown). All the VARIVAX vaccines with lot # L048468, were moved to the backup freezer on 15-APR-2016 and moved back at the end of AUG-2016. This is one of the several reports reported by the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician assistant concerning unspecified patients. The patients' concomitant medications, pertinent medical history, and drug reactions and allergies have not been provided. On unspecified dates these patients were administered improperly stored ROTATEQ (lot # M004883, expired date 02-DEC-2017 and lot # M025568, expired date 07-NOV-2017) (dose and frequency were unknown) oral. The rotavirus vaccine, live, oral, ROTATEQ was stored at 46.8 F for 4 hours 30 minutes. No adverse effects reported. This is one of several reports from the same reporter. Additional information has been requested.
Age: 2.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a Administrator and refers to a 2 years old patient of unknown gender. No medication history, concurrent condition and concomitant medications were reported. On 25-MAY-2016, the patient was vaccinated with improperly stored dose of VARIVAX lot # L048468 (strength, dosing details, anatomical location were unknown). All the VARIVAX vaccines with lot # L048468, were moved to the backup freezer on 15-APR-2016 and moved back at the end of AUG-2016. This is one of the several reports reported by the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 05-SEP-2014 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 (strength: 0.5 ml, lot # K005957, expiration date 08-MAR-2015, route unspecified). This specified lot number vaccine was exposed to temperature excursion once. The total cumulative excursion time was 2064 hours with lowest recorded temperature of 20 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician assistant concerning unspecified patients. The patients' concomitant medications, pertinent medical history, and drug reactions and allergies have not been provided. On unspecified dates these patients were administered improperly stored M-M-R II (rHA) (lot # M004063, expired date 25-JAN-2018, and lot # L039613, expired date 08-OCT-2017) (dose and frequency were unknown). No adverse effects reported. M-M-R II was stored at 46.8 F for 4 hours 30 minutes. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician assistant concerning unspecified patients. The patients' concomitant medications, pertinent medical history, and drug reactions and allergies have not been provided. On unspecified dates these patients were administered improperly stored GARDASIL 9 (lot # L038503, expired date 18-DEC-2017) (dose and frequency were unknown). The GARDASIL 9 was stored at 46.8 F for 4 hours and 30 minutes. No adverse effects reported. This is one of several reports from the same reporter. Additional information has been requested.
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a IR Administrator of the clinic, and refers to a 12 months old infant patient of unknown gender. No medical history, concurrent condition and concomitant medications were reported. On 23-MAY-2016, the patient was vaccinated with improperly stored dose of VARIVAX lot # L048468 (strength, dosing details, anatomical location were unknown). All the VARIVAX vaccines with lot # L048468, were moved to the backup freezer on 15-APR-2016 and moved back at the end of AUG-2016. This is one of the several reports reported by the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 21-AUG-2014 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 (strength: 0.5ml, lot # K005957, expiration date 08-MAR-2015, route unspecified). This specified lot number vaccine was exposed to temperature excursion once. The total cumulative excursion time was 1704 hours with lowest recorded temperature of 20 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 26-SEP-2014 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 (strength: 0.5ml, lot # K005957, expiration date 08-MAR-2015, route unspecified). This specified lot number vaccine was exposed to temperature excursion once. The total cumulative excursion time was 2568 hours with lowest recorded temperature of 20 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 25-AUG-2014 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 (strength: 0.5ml, lot # K005957, expiration date 08-MAR-2015, route unspecified). This specified lot number vaccine was exposed to temperature excursion once. The total cumulative excursion time was 1800 hours with lowest recorded temperature of 20 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to unspecified number of patient of unknown age and gender. The patients' medical history and concurrent conditions were not reported. On an unknown dates, the patients were vaccinated with improperly stored doses of VAQTA lot #M002268, expiration date 20-SEP-2017 (dose and route of administration were not reported). There was no adverse event reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 24-SEP-2014 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 (strength: 0.5ml, lot # K005957, expiration date 08-MAR-2015, route unspecified). This specified lot number vaccine was exposed to temperature excursion once. The total cumulative excursion time was 2520 hours with lowest recorded temperature of 20 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 31-JUL-2014 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 (strength: 0.5ml, lot # K005957, expiration date 08-MAR-2015, route unspecified). This specified lot number vaccine was exposed to temperature excursion once. The total cumulative excursion time was 1200 hours with lowest recorded temperature of 20 Fahrenheit degree. No adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 25-SEP-2014 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 (strength: 0.5ml, lot # K005957, expiration date 08-MAR-2015, route unspecified). This specified lot number vaccine was exposed to temperature excursion once. The total cumulative time was 2544 hours with lowest recorded temperature of 20 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 22-JUL-2014 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 (strength: 0.5ml, lot # K005957, expiration date 08-MAR-2015, route unspecified). This specified lot number vaccine was exposed to temperature excursion once. The total cumulative excursion time was 984 hours with lowest recorded temperature of 20 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 01-JUL-2014 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 (strength: 0.5ml, lot # K005957, expiration date 08-MAR-2015, route unspecified). This specified lot number vaccine was exposed to temperature excursion once. The total cumulative excursion time was 480 hours with lowest recorded temperature of 20 Fahrenheit degree. No adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 0.83
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a IR Administrator of the clinic, and refers to a 10 month old infant patient of unknown gender. No medical history, concurrent condition and concomitant medications were reported. On 07-JUN-2016, the patient was vaccinated with improperly stored dose of VARIVAX lot # L048468 (strength, dosing details, anatomical location were unknown). All the VARIVAX vaccines with lot # L048468, were moved to the backup freezer on 15-APR-2016 and moved back at the end of AUG-2016. This is one of the several reports reported by the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 15-SEP-2014 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 (strength: 0.5ml, lot # K005957, expiration date 08-MAR-2015, route unspecified). This specified lot number vaccine was exposed to temperature excursion once. The total cumulative excursion time was 2304 hours with lowest recorded temperature of 20 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to unspecified number of patients of unknown age and gender. The patients' medical history and concurrent conditions were not reported. On an unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ lot # M025563, expiration date 16-NOV-2017 orally (dose was not reported). There was no adverse event reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 25-JUN-2014 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 (strength: 0.5ml, lot # K005957, expiration date 08-MAR-2015, route unspecified). This specified lot number vaccine was exposed to temperature excursion once. The total cumulative excursion time was 336 hours with lowest recorded temperature of 20 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 29-AUG-2014 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 (strength: 0.5ml, lot # K005957, expiration date 08-MAR-2015, route unspecified). This specified lot number vaccine was exposed to temperature excursion once. The total cumulative excursion time was 1896 hours with lowest recorded temperature of 20 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: F
Vaccine: FLUX, PPV
Symptoms: Arthralgia, Vomiting
Clinical narrative: Information has been received from a nurse referring to a 68 year old female patient. The patient had no drug reactions/allergies. On 17-OCT-2016 the patient was vaccinated with a dose of PNEUMOVAX 23 (lot # M005287, expiration date: 08-OCT-2017, intramuscular). The patient was also administered an influenza virus vaccine in the same visit. At an unspecified time after the injection on 17-OCT-2016, the patient experienced pain in her arm that lasted for an unspecified amount of time. The nurse also reported that the patient vomited after she got out of the shower on the same day after administration. No treatment was given for the events and no lab diagnostic studies were performed. The current status of the patient was unknown at the time of the report. The causality was not reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 23-SEP-2014 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 (strength: 05ml, lot # K005957, expiration date 08-MAR-2015, route unspecified). This specified lot number vaccine was exposed to temperature excursion once. The total cumulative excursion time was 2490 hours with lowest recorded temperature of 20 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 25-JUL-2014 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 (strength: 0.5ml, lot # K005957, expiration date 08-MAR-2015, route unspecified). This specified lot number vaccine was exposed to temperature excursion once. The total cumulative excursion time was 1056 hours with lowest recorded temperature of 20 Fahrenheit degree. No adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a licensed practical nurse referring to unspecified patients of unknown age and gender. The patients' medical history, concurrent condition and concomitant medications were not reported. On unknown dates, the patients were vaccinated with improperly stored ROTATEQ (lot # L006181 with expiration date 13-DEC-2016, lot# L039141 with expiration date 16-AUG-2017, dose unknown) orally. The vaccine had been stored under the temperature of -0.6 Celsius degree for 361 hours and 35 minutes. Digital data logger was involved. It was unknown if there was previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On unknown dates, the patients were inadvertently vaccinated with the improperly stored doses of M-M-R II (lot # L033589) with expiration date 02-SEP-2017; dose and route of administration were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected as the reporter did not wish to be contacted.
Age: 69.0
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Injection site discolouration, Injection site pain, Injection site swelling, Pain, X-ray normal
Clinical narrative: Soreness, swelling, Black and Blue in color where vaccines was given. Left arm. Top of arm has hurt ever since vaccine was given. Where arm attaches to shoulder. Painful dressing and undressing, Raising arm, doing housework.
Age: 26.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Maternal exposure before pregnancy, No adverse event
Clinical narrative: This spontaneous prospective pregnancy report was received from a healthcare worker concerning a female patient of unknown age. The patient's pertinent medical history, concurrent conditions, concomitant therapies, drug reactions or allergies were not reported. On 09-DEC-2015, the patient was vaccinated with VARIVAX (dose, dose number, route, anatomical location, lot number and expiration date were unspecified). On 29-DEC-2015, the patient became pregnant; the reporter stated that it was the patient's conception day. The date of last menstrual period was 15-DEC-2015 and the estimated delivery date was 20-SEP-2016. The pregnancy outcome was pending. No adverse symptoms were reported. Follow up information has been received from nurse practitioner on 11-OCT-2016. This case refers to a 27 year old female patient with seasonal allergy and penicillin allergy. She does not smoke or consume alcohol. The patient's medical history included appendectomy, ruptured ectopic pregnancy and left laparoscopic salpingectomy. On 09-NOV-2015, her varicella antibody test was negative. On 09-DEC-2015, she was vaccinated with VARIVAX from lot # L015048 with expiry date of 29-APR-2017. On 18-JAN-2016, pregnancy test showed gestation age of 5 weeks. On 16-FEB-2016 (at 9 weeks of pregnancy), ABO/Rh and toxoplasmosis was negative, and glucose level was at 77 (units not specified). On 09-MAR-2016, ultrasound scan at 12 weeks of pregnancy was normal. On 19-APR-2016 (at 19 weeks of pregnancy), maternal serum alpha-fetoprotein screening (MSAFP) was negative. On 27-APR-2016, ultrasound scan at 19 weeks and on 03-JUN-2016, ultrasound scan at 24 weeks of pregnancy were normal. On 15-AUG-2016 (at 34 weeks of pregnancy), B-streptococcal test was positive. At 39 weeks gestation, the patient delivered a male infant weighing 4167.37 grams with a length of 21 inches via cesarean delivery and her complications during delivery included fever. The infant's APGAR scores were 8 at one minute and 9 at five minutes. It was conflictingly reported that infant was born normal and infant had congenital anomalies (not specified) (captured in 1610USA011613). On an unknown date in September 2016, she was hospitalized due to chorioamnionitis after delivery. The outcome of fever and chorioamnionitis was unknown. Causality was not provided by the reporter. Upon internal review, "caesarean section and chorioamnionitis" were determined to be medically significant. Additional information has been requested. Patient demographics, pregnancy details, suspect therapy, events and narrative were updated.
Age: 26.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Alpha 1 foetoprotein normal, Amniotic cavity infection, Antibody test negative, Blood glucose normal, Caesarean section
Clinical narrative: This spontaneous prospective pregnancy report was received from a healthcare worker concerning a female patient of unknown age. The patient's pertinent medical history, concurrent conditions, concomitant therapies, drug reactions or allergies were not reported. On 09-DEC-2015, the patient was vaccinated with VARIVAX (dose, dose number, route, anatomical location, lot number and expiration date were unspecified). On 29-DEC-2015, the patient became pregnant; the reporter stated that it was the patient's conception day. The date of last menstrual period was 15-DEC-2015 and the estimated delivery date was 20-SEP-2016. The pregnancy outcome was pending. No adverse symptoms were reported. Follow up information has been received from nurse practitioner on 11-OCT-2016. This case refers to a 27 year old female patient with seasonal allergy and penicillin allergy. She does not smoke or consume alcohol. The patient's medical history included appendectomy, ruptured ectopic pregnancy and left laparoscopic salpingectomy. On 09-NOV-2015, her varicella antibody test was negative. On 09-DEC-2015, she was vaccinated with VARIVAX from lot # L015048 with expiry date of 29-APR-2017. On 18-JAN-2016, pregnancy test showed gestation age of 5 weeks. On 16-FEB-2016 (at 9 weeks of pregnancy), ABO/Rh and toxoplasmosis was negative, and glucose level was at 77 (units not specified). On 09-MAR-2016, ultrasound scan at 12 weeks of pregnancy was normal. On 19-APR-2016 (at 19 weeks of pregnancy), maternal serum alpha-fetoprotein screening (MSAFP) was negative. On 27-APR-2016, ultrasound scan at 19 weeks and on 03-JUN-2016, ultrasound scan at 24 weeks of pregnancy were normal. On 15-AUG-2016 (at 34 weeks of pregnancy), B-streptococcal test was positive. At 39 weeks gestation, the patient delivered a male infant weighing 4167.37 grams with a length of 21 inches via cesarean delivery and her complications during delivery included fever. The infant's APGAR scores were 8 at one minute and 9 at five minutes. It was conflictingly reported that infant was born normal and infant had congenital anomalies (not specified) (captured in 1610USA011613). On an unknown date in September 2016, she was hospitalized due to chorioamnionitis after delivery. The outcome of fever and chorioamnionitis was unknown. Causality was not provided by the reporter. Upon internal review, "caesarean section and chorioamnionitis" were determined to be medically significant. Additional information has been requested. Patient demographics, pregnancy details, suspect therapy, events and narrative were updated.