chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 78.0
Sex: M
Vaccine: FLU3
Symptoms: Blood test normal, Chest X-ray normal, Computerised tomogram head normal, Dizziness, Spinal X-ray normal
Clinical narrative: Severe vertigo, dizziness, faintness. Many occurrences. Went to Emergency Room and examined, all tests negative as to cause. Meclizine 25mg prescribed.
Age: 78.0
Sex: M
Vaccine: FLU3
Symptoms: Urine analysis normal, Vertigo
Clinical narrative: Severe vertigo, dizziness, faintness. Many occurrences. Went to Emergency Room and examined, all tests negative as to cause. Meclizine 25mg prescribed.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist referring to two unspecified patients of unknown age and gender. Medical history, concurrent conditions and concomitant medications were not reported. On an unknown dates, the patients were vaccinated with ZOSTAVAX, 19400 PFU, for prophylaxis, (Lot#, expiry date, dose, frequency and route of administration were unknown). ZOSTAVAX might have been improperly stored. No adverse effects reported. No product quality complaint (PQC) was involved. All telephone attempts to obtain follow-up information have been unsuccessful. Additional information has been requested. Narrative has been updated. Sender's Comments: MERCK 1608USA003112:Mfr number.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant therapy were not reported. On an unspecified dates in 2012, the patient was vaccinated with the first and the second (0.5 ml each) dose of GARDASIL (route of administration, lot numbers and expiration dates were not reported). On the day of the report (26-SEP-2016), the patient visited the physician's office to receive the 3rd dose of GARDASIL. Follow-up information has been received from the registered nurse on 13-DEC-2016. The vaccine was purchased with private funds and vaccine at private doctor's office. She called with a question about spacing of GARDASIL if patient refused third dose for 2 years. She was told to give the third dose not to start immunization schedule over. There was no adverse event. Additional information is not expected as all follow-up information had been received. Reporter, event and narrative were updated.; Sender's Comments: MERCK 1609USA012654: Mfr number.
Age: 17.0
Sex: F
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a certified medical assistant concerning an unspecified patient (unknown age and gender). Information about concurrent condition, concomitant medication and medical history was not provided. It was reported that on 27-SEP-2016, the patient was administered an improperly stored dose of VARIVAX lot # M025867, expiration date 24-MAY-2018, (dosage was not provided), administered per subcutaneous route, for prophylaxis. No adverse effects were reported. No product quality complaint (PQC) was involved. Follow-up information has been received on 06-DEC-2016 from the medical assistant referring to the 17 year old female patient. On 22-SEP-2016, a total of 40 doses of VARIVAX (lot # M025867, expiration date 24-MAY-2018) was shipped and delivered to the clinic. The day it was delivered, it was given to the pharmacy. During that time, the shipment remained there for a total of 4 days and/or 96 hours, still in the original shipped packaging. It was never placed in the proper storage setting, the freezer. The vaccine was left out in its original shipped packaging at room temperature estimated at worst case scenario of 70 F for 4 days and/or 96 hours. On the evening/close of the 4th day (18:00), it was placed in the refrigerator rather than the freezer. After speaking to the pharmacy, the reporter learned that the refrigerator was estimated to be at 40 F overnight. Therefore, the VARIVAX vaccine was in the refrigerator for a total of 13 hours at 40 F. On the 5th day, 27-SEP-2016, it was informed by the pharmacy that the shipment of VARIVAX was located there, in the refrigerator. Thereafter, the VARIVAX was immediately counted and stored back in the freezer, its proper location. On 27-SEP-2016 at 8:20 AM, 1 dose of the improperly stored vaccine was actually given to the patient (first dose) in her right arm. Additional information is not expected because all follow ups requested to complete the case were received. Patient, product, AE information and narrative were updated. Sender's Comments: MERCK 1609USA013452:Mfr number.
Age: 17.0
Sex: F
Vaccine: HPV9
Symptoms: Immediate post-injection reaction, Injection site paraesthesia, Paraesthesia
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a patient of an unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 03-OCT-2016, the patient was vaccinated with GARDASIL 9 intramuscularly, lot # L043214 with expiration date: 03-OCT-2017 (dose was not reported). Immediately after vaccination, the patient began experiencing tingling from injection site radiating up the neck. The medical assistant requested a lot check for GARDASIL 9 (lot # L043214, expiration date: 03-OCT-2017). The outcome of the event was not reported. The relatedness between the event and GARDASIL 9 was not provided. This is one of two reports received from the same reporter. As of 28-NOV-2016 All telephone attempts to obtain follow-up information have been unsuccessful. Follow up information has been received on 28-NOV-2016 from a physician referring to a 17 year old female with Poland Syndrome and learning/cognitive difficulties. On 03-OCT-2016 9:03 am, the patient was vaccinated with GARDASIL 9 lot number L04321 intramuscularly in the right deltoid. On 03-OCT-2016, the patient experienced a tingling sensation up into her neck on side where injection was given during a 15 minute waiting period. On 03-OCT-2016, the sensation resolved prior to the patient leaving the office. The outcome of tingling sensation was reported as resolved on 03-OCT-2016. An investigation into the manufacture of lot L04321 was completed and confirmed that all in-process quality checks were satisfactory. The results indicated that the lot was manufactured in accordance with manufacturing site standard operating procedures. The lot was confirmed to have met the requirements for market release. Following medical review of the AE report and the Quality investigation, there were no identified concerns related to quality within the results of the investigation. Additional information has been requested. Sender's Comments: US-009507513-1610USA003491: MERCK 1610USA002868: Mfr number.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to a patient of unknown age and gender. Patient's pertinent medical history, concurrent condition and concomitant medication were not reported. No previous drug reactions/ allergies were reported. On an unknown date in OCT-2016, the patient was vaccinated with improperly stored dose of GARDASIL 9 (lot # L048237 and expiry date 18-MAY-2017) for prophylaxis (strength, dosing details, anatomical location were unknown). No adverse effects were reported. The GARDASIL 9 experienced multiple temperature excursions. Currently (unknown date) the vaccine temperature excursion was minimum of 1 degree Celsius and maximum of 5 degree Celsius for time frame of 40 hours. The vaccine had previous temperature excursions on 06-SEP-2016 exposed to 1 degree Celsius for 72 hours and on 07-SEP-2016 exposed to 1 degree Celsius for 17 hours. Data logger was not involved. No product quality complaint was involved. Follow-up information has been received from the registered nurse on 13-DEC-2016. She stated there was no adverse event. Additional information is not expected as all follow-up information had been received. Reporter, event and narrative were updated. Sender's Comments:  MERCK 1610USA008843: Mfr number.
Age: 12.0
Sex: F
Vaccine: HEPA, HPV9
Symptoms: Eye movement disorder, Fall, Pallor, Posture abnormal, Seizure
Clinical narrative: This spontaneous report was received from a nurse, via a company representative, referring to a 14 year old female patient. The patient's medical history and concurrent conditions were not reported. On approximately 05-OCT-2016 (reported as "about 2 weeks ago"), the patient was vaccinated with GARDASIL 9 injection, for prophylaxis (strength, dose number, route of administration, lot # and expiration date were unknown). Concomitant therapies were not reported. On approximately the same date (reported as "about 2 weeks ago"), the patient fainted and then had a seizure like reaction after receiving GARDASIL 9. The patient was in the physician office at the time of the events and received medical attention. No product quality complaint was involved. At the time of reporting, the outcome of the seizure and the syncope was unknown. The causality assessment between the seizure and the syncope with GARDASIL 9 was not provided. Upon internal review, the seizure was determined to be medically significant event. Follow up information has been received from the Medical Assistant (previously reported as a "nurse") on 13-DEC-2016, concerning the 12 year old (previously reported as a "14") female patient. The patient had not eaten at all day and was nervous. The patient had not intake recent alcohol, large amounts of coffee or energy boosting supplements, she had not sleep deprivation or was exposed to flashes of light. On 14-OCT-2014 at 15:10 (previously reported as a "05-OCT-2016"), the patient was vaccinated with GARDASIL 9 dose 1 in the left deltoid for prophylaxis (lot number reported as "M018644") and with VAQTA dose 2 in the right deltoid for prophylaxis (lot number "L023232") (route and expiration date were not reported). There were no concomitant medications. On 14-OCT-2014, after the vaccination, the patient got pale head, dropped and started convulsing while eye rolled to the back of the head. The same episode happened about 20 minutes later. The duration of the seizures was 20 seconds. On the same date, the patient recovered from the adverse events. The causality assessment between the seizure and the syncope with GARDASIL 9 and VAQTA was not provided. Additional information is not expected as all follow up information was received. Sender's Comments: MERCK 1610USA010870: Mfr number.
Age: 12.0
Sex: F
Vaccine: HEPA, HPV9
Symptoms: Seizure like phenomena, Syncope
Clinical narrative: This spontaneous report was received from a nurse, via a company representative, referring to a 14 year old female patient. The patient's medical history and concurrent conditions were not reported. On approximately 05-OCT-2016 (reported as "about 2 weeks ago"), the patient was vaccinated with GARDASIL 9 injection, for prophylaxis (strength, dose number, route of administration, lot # and expiration date were unknown). Concomitant therapies were not reported. On approximately the same date (reported as "about 2 weeks ago"), the patient fainted and then had a seizure like reaction after receiving GARDASIL 9. The patient was in the physician office at the time of the events and received medical attention. No product quality complaint was involved. At the time of reporting, the outcome of the seizure and the syncope was unknown. The causality assessment between the seizure and the syncope with GARDASIL 9 was not provided. Upon internal review, the seizure was determined to be medically significant event. Follow up information has been received from the Medical Assistant (previously reported as a "nurse") on 13-DEC-2016, concerning the 12 year old (previously reported as a "14") female patient. The patient had not eaten at all day and was nervous. The patient had not intake recent alcohol, large amounts of coffee or energy boosting supplements, she had not sleep deprivation or was exposed to flashes of light. On 14-OCT-2014 at 15:10 (previously reported as a "05-OCT-2016"), the patient was vaccinated with GARDASIL 9 dose 1 in the left deltoid for prophylaxis (lot number reported as "M018644") and with VAQTA dose 2 in the right deltoid for prophylaxis (lot number "L023232") (route and expiration date were not reported). There were no concomitant medications. On 14-OCT-2014, after the vaccination, the patient got pale head, dropped and started convulsing while eye rolled to the back of the head. The same episode happened about 20 minutes later. The duration of the seizures was 20 seconds. On the same date, the patient recovered from the adverse events. The causality assessment between the seizure and the syncope with GARDASIL 9 and VAQTA was not provided. Additional information is not expected as all follow up information was received. Sender's Comments: MERCK 1610USA010870: Mfr number.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant 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 51.3 F for 30,75 hours and in 59.4 F for 4,5 hours) doses of PNEUMOVAX 23 (lot # L048264, expiration date 10-JUN-2017; dose and route of administration were not reported) for prophylaxis. No adverse effect and no previous excursion were reported. The call was made because of the data logger. This is one of several reports received from the same reporter. Follow up information has been received on 13-DEC-2016. All telephone attempts to obtain follow up information have been unsuccessful. Additional information has been requested. Sender's Comments: US-009507513-1611USA001103: US-009507513-1611USA001105: US-009507513-1611USA001102: US-009507513-1611USA001104: MERCK 1610USA011275:Mfr number.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse and refers to an unspecified number of patients of unknown age and gender. The patients' concurrent conditions, concomitant medication and medical history were not provided. On unknown dates, the patients were vaccinated with unspecified number of improperly stored doses of VARIVAX, lot # reported as M105731, expiration date 30-MAR-2018 and lot # M009766, expiration date 23-FEB-2018 (dose, route and site of administration were not reported) for prophylaxis. No adverse effects were reported. Product quality complaint was not involved. The administered doses of VARIVAX were stored in the temperature of 10 degrees Fahrenheit for 3 hours and in the temperature of 14 degrees Fahrenheit for 17 minutes. Data logger was involved. At the time of reporting, no further information was available. Lot number M105731 is an invalid lot number for VARIVAX. Follow-up information has been received from the licensed practical nurse on 12-DEC-2016. It was reported that since 03-NOV-2016, there had been no adverse effects reported. Additional information has been requested. Narrative had been updated. Sender's Comments: MERCK 1611USA001989:Mfr number.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse practitioner regarding a patient of unknown demographics. There was no information about concurrent condition and historical medication. On an unknown date in 2016 the patient was vaccinated with improperly stored ZOSTAVAX lot # M020071/ expiration date-18-JUL-2017 for prophylaxis (incorrect product storage). No adverse event was reported. Temperature excursion of -5C, Time frame of 75 days as of 11-NOV-2016. There was no previous temperature excursion and call was not because of the data logger. The outcome of the event was unknown. No product quality complaint was involved. Follow up information received from the nurse prescriber on 09-DEC-2016. The nurse prescriber reported that, on 22-SEP-2016, the patient was administered with improperly stored ZOSTAVAX, 0.65 ml, subcutaneously, lot # M020071/ expiration date-18-JUL-2017. The vaccine was exposed to a temperature range of -14.3 degree Centigrade up to a maximum of -7.22 degree Centigrade for a time frame of 14 days (336 hours) prior to the administration. The remaining vials of the vaccine in stock were not administered to a patients were exposed to a time frame of 90 days (2160 hours). It had no previous excursions. Additional information has been requested. Patient initials, vaccine information, event date and narrative updated. Sender's Comments: MERCK 1611USA006614:Mfr number.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Injection site erythema
Clinical narrative: This spontaneous report was received from a pharmacist concerning a 62 year old female patient. The patient's medical history included headaches, drug reactions/allergies included redness to other vaccinations, allergic to penicillin and sulfa. On 12-NOV-2016, the patient was vaccinated with a dose of ZOSTAVAX 19400 plaque forming units (PFU), lot # M030140, expiration date: 18-AUG-2017, via subcutaneous, as prophylaxis (Dose was not reported). On 12-NOV-2016, immediately after vaccination with ZOSTAVAX the patient developed redness at the injection site. The pharmacist monitored the patient for 20 minutes after receiving the dose of ZOSTAVAX and the redness at the injection site did not develop into a rash. The pharmacist advised the patient to apply an unspecified cortisone cream (manufacturer unknown) topically to the injection site. The patient reported to the pharmacist that she took an unspecified amount of ALLEGRA, which helped to alleviate her injection site redness. During this report, the pharmacist reported that "it was not uncommon for patients (unspecified) to developed redness at the injection site of any vaccine (unspecified)". The pharmacist reported that none lab diagnostics studies were performed to the patient. The patient sought medical attention consulting the pharmacist. The outcome of injection site erythema was recovering. The reporter did not assess the causality between ZOSTAVAX and injection site erythema. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a patient of unknown demographics. On an unknown date in February 2016, the patient was vaccinated with a dose of ZOSTAVAX injection (dose, route of administration, lot # and expiration date were not reported) to prevent shingles. On an unknown date in October 2016 (reported as "about a month ago"), the patient developed a mild case of shingles. The outcome of the mild case of shingles and the relatedness between the mild case of shingles and ZOSTAVAX were not reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Extra dose administered, Inappropriate schedule of drug administration, Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions, allergies and concomitant therapy were not reported. On an unspecified date in July 2012 and in August 2013, the patient was vaccinated with the first and second doses of GARDASIL (dose, frequency, route of administration, lot # and expiration date were not reported) (reported as the patient received the series outside of the prescirbing information schedule). Then, in May 2015, the patient was vaccinated with an unidentified hpv vaccine (GARDASIL 9) (dose, frequency, route of administration, lot # and expiration date were not reported) or (GARDASIL) (dose, frequency, route of administration, lot # and expiration date were not reported)). Subsequently, in October 2016, the reporting pharmacist also reported that a fourth dose of GARDASIL 9 was administered. No adverse effects and no product quality complaints were reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of unspecified patients. The patients' demographics, concomitant medications, pertinent medical histories and drug reactions or allergies were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX (lot # L024252, expiry date 30-JUN-2017; lot # M006729, expiry date 08-FEB-2018; lot # M017292, expiry date 07-APR-2018; lot # M025869, expiry date 24-MAY-2018; lot # M032494, expiry date 06-JUL-2018; dose and route of administration were not reported) for prophylaxis. The doses of the vaccine were exposed to a temperature excursion of -4.8 degrees Celsius for a time frame of 1 hour 20 minutes (date unspecified). A digital data logger was involved. There were no previous temperature excursions. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1611USA008843.
Sex: F
Vaccine: HPV9
Symptoms: Rash
Clinical narrative: Information has been received from a nurse practitioner referring to a female patient of unknown age. The patient's pertinent medical history, drug reactions/allergies and concomitant medication were not reported. On unknown dates, the patient was vaccinated with two doses of GARDASIL 9 for prophylaxis (each dose on a separate unspecified date) (dose, route and lot# were not reported). On an unspecified date, after receiving both doses of GARDASIL 9, the patient developed an unspecified rash on her stomach. The outcome of the event was unknown. The causality was not reported. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a female patient of an unknown age. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 22-NOV-2016, the patient was vaccinated with a dose of PNEUMOVAX 23 0.5 ml, intramuscularly, lot # M040004, expiry date 20-MAY-2018 (frequency reported as once, site of administration was not reported) for prophylaxis. On an unknown date in November 2016, the patient experienced injection site reaction described by the patient as hot and red. Either on 24-NOV-2016 or on 25-NOV-2016 (reported as either on Thursday or on Friday afterwards), the patient sought medical attention at an unspecified Urgent Care facility and was prescribed prednisone (manufacturer unknown) for treatment of injection site reactions. The outcome of the events was considered to be recovering/resolving as the reporter stated that the patient was getting better and did not contact the physician's office further as instructed at the Urgent Care facility if she got worse. The relatedness between the events and PNEUMOVAX 23 was not reported. This is one of two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1611USA013894.
Age: 21.0
Sex: F
Vaccine: FLU4, HPV9
Symptoms: Asthenia, Syncope
Clinical narrative: This spontaneous report was received from a nurse practitioner and refers to a 21-year-old non-pregnant female patient. Her concurrent conditions included hypothyroidism. Concomitant medications included an unspecified thyroid medication and unspecified birth control pills. She did not have any drug reactions or allergies. On 24-OCT-2016, the patient was vaccinated with the first dose of GARDASIL 9 (exact dose was not reported, lot # reported as M026306, expiration date: 30-APR-2018, intramuscularly). The nurse practitioner reported that within 2 minutes after receiving the GARDASIL 9, the patient fainted. Within 30 seconds after she fainted, she recovered, but she felt weak for the rest of the day. No medical treatment was provided, except observation after the patient fainted (it was also reported that there was a treatment given for thr adverse events). No laboratory tests were performed. The patient recovered the following day, on 25-OCT-2016. The relatedness between the events and GARDASIL 9 was not reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a multiple unspecified patients of unknown ages and genders. The patients' pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On an unknown dates, (reported as "before 12-AUG-2016"), the patients were vaccinated with improperly stored M-M-R II, lot number K011188, expiration date 12-AUG-2016, and lot number L003858, expiration date 05-FEB-2017, (route, anatomical location and frequency were not reported), for prophylaxis. The temperature was 8.7 Celsius degrees, time frame 1.5 hours without previous temperature excursions. Digital data logger was involved. No adverse effects were reported and no product quality complain was involved. This is on of two reports from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA007299.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant regarding a patient of unknown demographics. There was no information about concurrent condition and historical medication. On 28-NOV-2016 the patient was vaccinated with improperly stored PNEUMOVAX 23 lot # M042599/ expiration date-17-JUN-2018, for prophylaxis (incorrect product storage). No adverse event was reported. The outcome of the event was unknown. Temperature and time frame was 77 F for 6 hours. Call was not because of a data logger and there was no previous temperature excursion. No PQC (product quality complaint) was involved. 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 practice nurse refers to two patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of PNEUMOVAX 23 lot # L029306, expiration date 26-MAR-2017 (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 50 degrees Fahrenheit for 6 minutes, 59.8 degrees Fahrenheit for 29 minutes, 59.9 degrees Fahrenheit for 49 minutes, 48.2 degrees Fahrenheit for 5 minutes, 48.6 degrees Fahrenheit for 4 minutes, 48.1 degrees Fahrenheit for 4 minutes, 56.2 degrees Fahrenheit for 18 minutes, 49.4 degrees Fahrenheit for 5 minutes, 47.7 degrees Fahrenheit for 3 minutes, 54.4 degrees Fahrenheit for 9 minutes, 60.5 degrees Fahrenheit for 28 minutes, 49 degrees Fahrenheit for 2 minutes, 49.6 degrees Fahrenheit for 5 minutes and 48.5 degrees Fahrenheit for 7 minutes. Data logger was not involved. There were no previous excursions reported. Additional information is not expected.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to three unspecified patients of unknown age and gender. No information about the patient's pertinent medical history, concomitant medications and drug reactions or allergies was reported. On 03-NOV-2016, the patients were vaccinated with improperly stored doses of VARIVAX injection, subcutaneously, lot # M027886 with expiry date 03-JUN-2018 and lot # M028547 with expiry date 07-JUN-2018 (dose and anatomical location were not specified) for prophylaxis. The administered doses of VARIVAX underwent temperature excursion at -13 Fahrenheit degrees for 1 hour. There was no previous temperature excursion. No adverse effects were reported. Product quality complaint (PQC) was not involved. Additional information has been requested.
Age: 63.0
Sex: M
Vaccine: TDAP, VARZOS
Symptoms: Rash, Skin warm
Clinical narrative: Information was received from a pharmacist via a company representative concerning a 63 year old male patient with no pertinent medical history and no known drug reactions/allergies. On 19-NOV-2016, the patient was vaccinated with ZOSTAVAX 19400 PFU (lot # M018453, expiration date 28-JUN-2017), 0.65 ml, subcutaneously for shingles prevention. Concomitant therapy received the same day included TDAP. On 21-NOV-2016, the patient started to experience a "rash on his right calf and the rash was very hot to the touch."  It was also reported that the rash might have spread to the patient's neck area. No treatment was given. The outcome of the events was reported as not recovered. 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 practitioner refers to multiple patients of unknown age and gender. The patients' medical history, current conditions and concomitant medications were unknown. On unknown dates the patients were vaccinated with improperly stored VAQTA lot # L045713 and expiry date: 14-JAN-2017 (dose and route were not reported) for prophylaxis. The call was because of a data logger. There were no adverse effects reported. There was no product quality complaint involved. No further information was provided. This is one of the several reports from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA007518: US-009507513-1612USA007517: US-009507513-1612USA007519.
Age: 20.0
Sex: M
Vaccine: HPV4
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from an office manager concerning a patient of unknown age and gender. The patient's concurrent condition, medical history and concomitant therapy information was not provided. On 06-DEC-2016, the patient was vaccinated with GARDASIL (lot # K001500, expiration date 06-NOV-2016) (strength, dose, frequency, route were not reported) for prophylaxis. No adverse effects was reported. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a physician via company representative refers to a female patient of unknown age. The patient's medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with ZOSTAVAX VIAL 19400 PFU, (route: subcutaneous) for prevention of reoccurrence of shingles. On an unknown date in December-2016, (reported as a couple of days ago), the patient had another case of shingles. The outcome and causality of the event were unknown. Additional information has been requested.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to two patients of unknown ages and genders. The patients' medical history and concurrent conditions were not reported. On an unknown date, the patients were vaccinated with improperly stored dose of ZOSTAVAX (lot # M027348, expiry date: 27-JUL-2017) (route: subcutaneous) (incorrect product storage). The vaccine was stored at a temperature of 9.4 F for 50 minutes. There was no previous temperature excursion. Digital data logger was involved. No adverse effects reported. The outcome of the events was unknown. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report received from a nurse referred to unspecified patients. The patients' medical history, concurrent conditions and concomitant medications were not reported. The nurse reported that doses of improperly stored vaccines ROTATEQ (lot M029251 expiry date: 14-MAR-2018, lot M005732 expiry date: 19-OCT-2017) were administered to unspecified patients. No adverse effects were reported. The vaccines was stored at 47.49 F for 1 hour. The vaccines had a previous excursion of 47.03 F for 1 hour. The call was because of a data logger. This is one of the two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA007382.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Human papilloma virus test positive, Smear cervix abnormal
Clinical narrative: This spontaneous report received from a nurse and physician referred to a currently 23 year old female patient. The patient's current condition included allergy to sulfa drugs. Concomitant medications were not reported. On 14-AUG-2007, the patient received the first dose of GARDASIL 0.5 ml intramuscularly (lot#0188U, unspecified expiration date), on 17-OCT-2007, the patient received the 2nd dose of GARDASIL (confirmed lot#0927U, unspecified expiration date) and on 09-FEB-2008, the patient recieved the 3rd dose of GARDASIL (lot#1487U, unspecified expiration date). The nurse stated the patient was seen in the office on 21-NOV-2016 for an annual exam and it was determined then that she had a previous ascus Pap Smear result that was HPV positive. The physician reported that after completion of GARDASIL, the patient had a "Pap Smear" performed that was ascus hpv positive. The patient had another pap smear on another unspecified date after vaccination that showed low grade squamous intraepithelial lesion (SIL). The patient did not receive treatment for the events. At the time of this report, outcome of the events was unknown and causality assessment for the events was not reported.  Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report received from a nurse referred to an unspecified patient. The patient's medical history, concurrent conditions and concomitant medications were not reported. The nurse reported that an unspecified patient was inadvertently administered PROQUAD (lot# M032497 exp. 20-JAN-2017) on an unspecified date, that had been improperly stored. No adverse effects reported. The vaccine was stored at 9.5F for 20 min. There was no previous excursion and the call was because of a data logger.  Additional information is not possible as permission to contact physician was not available.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Injection site vesicles, Laboratory test
Clinical narrative: Information has been received from a currently 70 year old female patient referring to herself. The patient had high blood pressure and was allergic to penicillin, sulfonamide medications and "Mycin" medications. Concomitant therapies included ZYRTEC blood pressure capsules and flu shot. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (strength, lot #, expiration date and dose were unknown) subcutaneously to prevent shingles. After she received the vaccine, the patient experienced blisters breaking out around the injection site, which were really itchy. The patient contacted physician seeking medical attention. Unspecified lab diagnostics studies were performed and treatment was given for the events. The outcome of the events was reported as not recovered. The causality was not reported. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report received from a nurse referred to unspecified patients. The patients' medical history, concurrent conditions and concomitant medications were not reported. The nurse reported that doses of improperly stored vaccines GARDASIL 9 (lot 030380 expiry date: 01-FEB-2019) were administered to unspecified patients. No adverse effects were reported. The vaccines was stored at 47.49 F for 1 hour. There was no any previous excursions. The call was because of a data logger. This is one of the two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA005927.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to multiple patients of unknown age and gender. The patients' medical history, current conditions and concomitant medications were unknown. On unknown dates the patients were vaccinated with improperly stored PEDVAXHIB (dose and route were not reported) lot # M032147 and expiry date: 14-APR-2019, lot # M025192 and expiry date: 21-MAR-2019 for prophylaxis. The call was because of a data logger. No adverse events were reported. There was no product quality complaint involved. No further information was provided. This is one of the several reports from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA007518: US-009507513-1612USA007519: US-009507513-1612USA001375.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to multiple patients of unknown age and gender. The patients' medical history, current conditions and concomitant medications were unknown. On unknown dates the patients were vaccinated with improperly stored M-M-R II (dose and route were not reported) lot # M000768 and expiry date: 05-JAN-2018, lot # L011528 and expiry date: 03-APR-2017 for prophylaxis. The call was because of a data logger. There were no adverse effects reported. There was no product quality complaint involved. No further information was provided. This is one of the several reports from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA007517: US-009507513-1612USA007519: US-009507513-1612USA001375.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to multiple patients of unknown age and gender. The patients' medical history, current conditions and concomitant medications were unknown. On unknown dates the patients were vaccinated with improperly stored GARDASIL 9 (dose and route were not reported) lot # M032650 and expiry date: 31-MAR-2019, lot # L037554 and expiry date: 25-DEC-2017 for prophylaxis. The call was because of a data logger. There were no adverse effects reported. There was no product quality complaint involved. No further information was provided. This is one of the several reports from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA007517: US-009507513-1612USA001375: US-009507513-1612USA007518.
Age: 73.0
Sex: M
Vaccine: FLU3
Symptoms: Guillain-Barre syndrome, Mechanical ventilation, Muscular weakness, Respiratory failure
Clinical narrative: Muscle weakness. G-B Syndrome. Resp. failure. Mechanical ventilation.
Age: 27.0
Sex: F
Vaccine: HEPA
Symptoms: Dyspnoea, Feeling hot, Heart rate increased, Hyperhidrosis
Clinical narrative: Rapid Heart Rate, Difficulty breathing, sweating "really hot".
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Adverse reaction, Inflammation, Limb operation, Pain in extremity, Peripheral swelling
Clinical narrative: L deltoid injection was painless. Extreme swelling and pain of entire deltoid followed. Next day swelling ruptured resulting in swollen inflamed biceps area. Was scheduled for surgery on day 3 so saw orthopedic surgeon on day 2 who told me that I had a severe reaction and to never again get that vaccine. (PPSV23). Surgery was on opposite arm successful following day after taking antibiotics for possible cellulitis.
Age: 35.0
Sex: M
Vaccine: FLU3
Symptoms: Dry skin
Clinical narrative: Developed dry scaling patches on face, neck, and trunk a few days after receiving the flu vaccine. Symptoms are slowly resolving. Using OTC emollient for dryness. Pt is unsure if vaccine is the cause or aggravating factor.
Age: 47.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: Pt describes pain and soreness to her left arm post vaccination. While she expected this as she has received vaccinations in the past, the pain and soreness has continued and increased to today (12/15/2016). Per pt she is taking anti-inflammatory's and is having difficulties lifting her arm above 90 degrees.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant, referring to an unspecified number of patients of unknown age and gender. Information about patients' medical history, concurrent conditions and concomitant medication were not reported. On unspecified dates, the patients were administered doses of improperly stored PEDVAXHIB (lot # M014926, expiration date 17-FEB-2019; lot # M020102, expiration date 08-MAR-2019); which were exposed to temperature of 49F for 1 hour and 48F for 1 additional hour. There was not previous temperature excursion and the call was because of a data logger. No adverse effects were reported. This is one of the several reports received from the same reporter. As of 13-DEC-2016, all telephone attempts to obtain follow-up information have been unsuccessful. Additional information has been requested. Sender's Comments: US-009507513-1610USA015290: US-009507513-1610USA015314: US-009507513-1610USA015316: US-009507513-1610USA015317: MERCK 1610USA015315:Mfr number.
Sex: U
Vaccine: MMR
Symptoms: Needle issue, No adverse event, Underdose
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 30-NOV-2016, the patient was inadvertently vaccinated with partial dose of M-M-R II, subcutaneously (dose, lot # and expiry date not reported) for prophylaxis due to leakage from needle (underdose, needle issue). No adverse effects were reported. No product quality complaint was involved. Additional information is not expected as consent to contact was not provided.
Age: 84.0
Sex: F
Vaccine: FLUX, PNC13, FLUX, PNC13
Symptoms: Intensive care, Monoplegia, Oxygen saturation, Pain
Clinical narrative: This is a spontaneous report from a contactable consumer who reported for his wife. A 84-year-old female patient received PREVNAR 13, at single dose for pneumonia pneumococcal and a yearly influenza vaccine, both in her left arm (about a half inch away from each other) on 10Oct2016. The patient took influenza vaccine in the last four or five years and normally had just a sore arm for a little while.  The patient, who was in the hospital for four days for pneumonia in her right lung, received both vaccines (first pneumococcal 13-val conj vaccine and after influenza vaccine) when she was in the ICU department and then she was discharged from the hospital. On 10Oct2016 the patient experienced left arm paralyzed and within a half hour of receiving the products (always on 10Oct2016) she started complaining about pain (sharp pain). In Oct2016 (not sure if on 10Oct2016 or 11Oct2016) oxygen deficiency occurred and patient was hospitalized from 11Oct2016 to 21Oct2016. Reporter was not sure if while at the hospital they got the oxygen deficiency back up to normal or got rid of the pneumonia. The patient was on oxygen at Medical Center before she was given the products; prior to her discharge from hospital, her oxygen tubes were removed and the IV's disconnected. Patient has been on oxygen for the last two months, she has the oxygen on hand, it was just as needed. Patient has been doing therapy on arm paralyzed at least once or twice a week. Her left arm has not improved period, the range of motion was zero.  Final outcome of the events was not recovered.
Age: 84.0
Sex: F
Vaccine: FLUX, PNC13, FLUX, PNC13
Symptoms: Injection site nerve damage, Mobility decreased, Monoplegia, Oxygen saturation decreased, Pain in extremity
Clinical narrative: This is a spontaneous report from a contactable consumer who reported for his wife. A 84-year-old female patient received PREVNAR 13, at single dose for pneumonia pneumococcal and a yearly influenza vaccine, both in her left arm (about a half inch away from each other) on 10Oct2016. The patient took influenza vaccine in the last four or five years and normally had just a sore arm for a little while.  The patient, who was in the hospital for four days for pneumonia in her right lung, received both vaccines (first pneumococcal 13-val conj vaccine and after influenza vaccine) when she was in the ICU department and then she was discharged from the hospital. On 10Oct2016 the patient experienced left arm paralyzed and within a half hour of receiving the products (always on 10Oct2016) she started complaining about pain (sharp pain). In Oct2016 (not sure if on 10Oct2016 or 11Oct2016) oxygen deficiency occurred and patient was hospitalized from 11Oct2016 to 21Oct2016. Reporter was not sure if while at the hospital they got the oxygen deficiency back up to normal or got rid of the pneumonia. The patient was on oxygen at Medical Center before she was given the products; prior to her discharge from hospital, her oxygen tubes were removed and the IV's disconnected. Patient has been on oxygen for the last two months, she has the oxygen on hand, it was just as needed. Patient has been doing therapy on arm paralyzed at least once or twice a week. Her left arm has not improved period, the range of motion was zero.  Final outcome of the events was not recovered.
Age: 84.0
Sex: F
Vaccine: FLUX, PNC13, FLUX, PNC13
Symptoms: X-ray limb normal
Clinical narrative: This is a spontaneous report from a contactable consumer who reported for his wife. A 84-year-old female patient received PREVNAR 13, at single dose for pneumonia pneumococcal and a yearly influenza vaccine, both in her left arm (about a half inch away from each other) on 10Oct2016. The patient took influenza vaccine in the last four or five years and normally had just a sore arm for a little while.  The patient, who was in the hospital for four days for pneumonia in her right lung, received both vaccines (first pneumococcal 13-val conj vaccine and after influenza vaccine) when she was in the ICU department and then she was discharged from the hospital. On 10Oct2016 the patient experienced left arm paralyzed and within a half hour of receiving the products (always on 10Oct2016) she started complaining about pain (sharp pain). In Oct2016 (not sure if on 10Oct2016 or 11Oct2016) oxygen deficiency occurred and patient was hospitalized from 11Oct2016 to 21Oct2016. Reporter was not sure if while at the hospital they got the oxygen deficiency back up to normal or got rid of the pneumonia. The patient was on oxygen at Medical Center before she was given the products; prior to her discharge from hospital, her oxygen tubes were removed and the IV's disconnected. Patient has been on oxygen for the last two months, she has the oxygen on hand, it was just as needed. Patient has been doing therapy on arm paralyzed at least once or twice a week. Her left arm has not improved period, the range of motion was zero.  Final outcome of the events was not recovered.
Age: 42.0
Sex: M
Vaccine: FLU3
Symptoms: Guillain-Barre syndrome
Clinical narrative: Per patient's wife, patient has been hospitalized due to Guillain-Barre syndrome.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site swelling, Pain
Clinical narrative: L upper arm + swelling and redness, since yest, day after received vaccines can use arm, but c/o pain, no itching swelling and redness less than yest as per mom received KINRIX in affected arm 2 d ago.