chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 78.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Vaccination site pain, Vaccination site swelling
Clinical narrative: SEVERE PAIN AND SWELLING ON ARM WHERE VACCINE WAS ADMINISTERED.
Age: 71.0
Sex: M
Vaccine: PPV
Symptoms: Laboratory test, Peripheral swelling, Skin warm
Clinical narrative: Full arm swelling, warm to touch.
Age: 83.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Peripheral swelling
Clinical narrative: The evening after receiving the immunization, pt reported to son and daughter that arm was swelling and red.  Pt was taken to urgent care the next day. Pt was prescribed Prednisone taper for 6 days.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Rash erythematous, Skin swelling
Clinical narrative: RAISED AREA OF SKIN WITH PROGRESSING RED RASH OVER 2 DAYS.
Age: 4.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Chicken pox out break, greater than 59 spots.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Skin warm
Clinical narrative: Patient experienced minor redness and warmth on her left upper forearm. She reported no pain associated with it. She treated with acetaminophen which helped a bit, but planned on also trying diphenhydramine. She stated there was no progression or spread during the timeline of the reaction, but would consult a physician if it did not improve or if worsened.
Age: 57.0
Sex: F
Vaccine: HEP, HEPA, PPV, TDAP
Symptoms: Headache, Pain in extremity, Peripheral swelling, Tenderness
Clinical narrative: Right arm is swelled and painful to touch, also headache present around 6:00 AM. Throughout the day the symptoms have gone down and around 3:30 PM able to move arms but its not fully better still a bit swelled and bit painful will continue monitoring.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: Rash, swollen, red, hot on upper arm surrounding injection site.
Age: 18.0
Sex: F
Vaccine: MNQ, TDAP, MNQ, TDAP
Symptoms: Hyperhidrosis, Pallor, Syncope
Clinical narrative: On 06/05/2017 at 3:14 PM received MENVEO and TDAP IM. 3:20 PM escorted to front for check out. 3:24 PM client and mother went to leave and she became syncopal - did not lose consciousness. Pale/diaphoretic. 3:25 placed into waiting room chair and feet elevated to another chair - provided wet paper towel to forehead, cold water to drink BP 68/45 with HR 67. 3:30 PM Repeat BP 84/56 HR 68. 3:35 PM color returned to face/lips pink BP 85/70 HR 70. 3:45 PM repeat BP 10/70 HR 63. Client and mother were explained vasovagal response and adverse reactions as described in the VIS received prior to the vaccination. Felt well enough to leave - left with mother.
Age: 18.0
Sex: F
Vaccine: MNQ, TDAP, MNQ, TDAP
Symptoms: Hyperhidrosis, Pallor, Presyncope
Clinical narrative: On 06/05/2017 at 3:14 PM received MENVEO and TDAP IM. 3:20 PM escorted to front for check out. 3:24 PM client and mother went to leave and she became syncopal - did not lose consciousness. Pale/diaphoretic. 3:25 placed into waiting room chair and feet elevated to another chair - provided wet paper towel to forehead, cold water to drink BP 68/45 with HR 67. 3:30 PM Repeat BP 84/56 HR 68. 3:35 PM color returned to face/lips pink BP 85/70 HR 70. 3:45 PM repeat BP 10/70 HR 63. Client and mother were explained vasovagal response and adverse reactions as described in the VIS received prior to the vaccination. Felt well enough to leave - left with mother.
Age: 12.0
Sex: M
Vaccine: HEPA, VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Patient was administered ZOSTAVAX in error when the VARIVAX vaccine was ordered. No adverse reaction noted and clinical follow up via phone call the next day with father who reported no adverse reactions.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 71-year-old female patient. The patient's concurrent conditions included asthma, hypertension and hypercholesterolaemia. She did not have any drug reactions or allergies. On 27-NOV-2013, the patient was vaccinated with one dose of ZOSTAVAX subcutaneous injection (lot # J006153, expiration date 30-AUG-2014), for prophylaxis. Then, on 17-MAY-2017, the patient received a second dose of ZOSTAVAX subcutaneous injection (lot # M038863, expiration date 12-DEC-2017), reconstituted with a sterile diluent (STERILE DILUENT) subcutaneous injection (dose, lot number and expiration date were not reported), for the same indication. Concomitant therapies included alprazolam (XANAX) and unspecified medications for hypertension, asthma and hypercholesterolaemia. On 17-MAR-2017 (also reported as on an unknown date), after the patient received the second dose of ZOSTAVAX, she experienced itching at the injection site, lasting for an unknown duration of time. No treatment was given for this. The patient did not seek medical attention or had any lab diagnostic studies performed. The outcome of itching at the injection site was unknown by the reporter. The relatedness between the event and therapy with ZOSTAVAX was not reported. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV9
Symptoms: Pruritus, Pyrexia
Clinical narrative: This spontaneous report has been received from the patient's father concerning his 16 year old daughter. The patient did not have any relevant medical history, concurrent conditions and concomitant therapies to be reported. On 24-MAY-2017, the patient was vaccinated with the first dose of GARDASIL 9 0.5 ml (strength, route of administration, lot number, and expiration date were not reported) for the prevention of human papillomavirus. Subsequently, on that day, the patient experienced fevers and Itching. The patient did not seek medical attention, received treatment for the events, nor had laboratory diagnostic laboratory tests performed. At the time of this report, the patient had not recovered from pyrexia and pruritus. The causality assessment between pyrexia and pruritus with GARDASIL 9 was unknown. Additional information is not expected as there was no follow up consent provided.
Sex: U
Vaccine: HPV9
Symptoms: Syncope
Clinical narrative: This spontaneous report has been received from a medical assistance via company representative referring to multiple patients of unknown demographics. Information regarding the patients' medical history, current conditions, drug and allergy history and concomitant therapies were not provided. On an unknown date the patients were vaccinated with GARDASIL 9 injection, intramuscularly (dose, anatomical location, lot number and expiration date were not provided) for Human Papilloma Virus (HPV). It was reported that on an unknown date, after GARDASIL 9 vaccination, the patients fainted at standing up after being sitting for 30 minutes. The patients, outcome was unknown at the reporting time. The causality between the event and therapy with GARDASIL 9 was unknown. Additional information has been requested.
Sex: F
Vaccine: HPV9
Symptoms: Headache
Clinical narrative: This spontaneous report was received from a physician via a company representative concerning a female patient of unknown age. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with a dose of GARDASIL 9 injection (strength, dose, route, lot number and expiration date were not reported) for prophylaxis. On an unknown date, after vaccination, the patient developed a prolonged headache. At the time of the report, the outcome of the event was unknown. The causality between the event and the GARDASIL 9 was not reported. Additional information has been requested.
Age: 0.17
Sex: F
Vaccine: RV5
Symptoms: Expired product administered, Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to an 8 week old female patient. The patient's pertinent medical history, concurrent conditions, concomitant therapies and past drug reactions/allergies were not reported. On 13-MAY-2017 the patient was vaccinated with her first dose of ROTATEQ orally (strength, lot # and expiration date were not reported) for prophylaxis. Subsequently, on 03-MAY-2017, the patient was vaccinated in error with her second dose of ROTATEQ orally, lot # M038717 and expiration date: 24-APR-2017 (strength, was not reported) for prophylaxis. The reporter stated that the patient had not exhibited any adverse effects. Additional information has been requested.
Sex: F
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information was received on 31-MAY-2017 from a medical assistant who reported that a female patient (age unknown) received an expired dose of PROQUAD (lot# L046507, expiration 17-MAY-2017) (dose and frequency not reported) on 30-MAY-2017 which was reconstituted with sterile diluent that was not expired. No adverse effects reported. No further information was provided. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from the daughter of a patient via a social media site.  The patient was an 85 year old female.  The patients medical history, concurrent conditions and concomitant medication use were not provided.  On an unspecified date the patient was vaccinated with ZOSTAVAX, for prophylaxis (lot# and route were unknown). The consumer stated the following; ZOSTAVAX needs to be pulled and reworked into a safer drug. My mother is 85 and proof that it can and does cause shingles. The consumer reported that the patient came down with illness five months after the vaccination was administered. No additional information was provided. Additional information is not expected.
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling
Clinical narrative: Information has been received from medical assistant via Pfizer concerning a female patient of unknown age. The patient's medical conditions, other medications and investigations were unknown. On an unknown date the patient was vaccinated with PNEUMOVAX 23 (lot #, expiration date, dose and route unknown) for prophylaxis. On approximately 05-MAY-2017 (reported as two weeks ago from Pfizer awareness date of 19-MAY-2017), the patient experienced injection site swelling. The outcome of injection site swelling was unknown. The causality between injection site swelling and PNEUMOVAX 23) was not provided. Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Skin lesion, Varicella post vaccine
Clinical narrative: Information was received on 05-JUN-2017 from a company representative regarding a 13 month old female child who was born prematurely at 33 weeks gestation. The physician told the representative that the patient was given VARIVAX (lot# M024675, expiration unknown) 0.5ml one time to prevent chickenpox on 18-APR-2017. The patient was brought to the physician's office today (05-JUN-2017) with chickenpox that began "a couple days ago". The patient had about 10 lesions and was otherwise healthy. Unspecified treatment was given to patient for chickenpox. Outcome of chickenpox was unknown. No additional adverse event information was provided. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information was received on 02-JUN-2017 from a physician who was reporting on a patient of unknown age and gender. No medical history or concomitant medications were reported. The physician reported that this patient received a dose of VARIVAX (lot M054882, expires 17-DEC-2017) on an unknown recent date following a temperature excursion of 34 degrees F for 5 hours. No adverse effects were reported. No other information is available. On 05-JUN-2017, the office manager called to report a correction to the temperature/time frame date. The VARIVAX was actually exposed to 15 degrees F to 46 degrees F for 3.5 hours. All of the data listed was reconfirmed with the reporter. On 05-JUN-2017, an e-mail was received from the physician that stated: "There is a 30 minute period that the vaccines were in a box with an ice pack in the car at a comfortable temperature for a person driving to the deep freezer. They started at 34 degrees F at the beginning of that 30 minutes. It is possible that they were still under 44 degrees F but it is possible they went over that during the 30 minute time period." The physician inquired "would they still be supported for use by Merck if they were in the next range for 30 minutes?" A call was made to the physician to clarify temperature for this 30 minute period. Physician stated she would like the vaccine evaluated at the room temperature range for 47 degrees F-77 degrees F for 30 minutes, in additional to the 3.5 hours in the 15 degrees F- to 46 degrees F temperature range "just to be safe". Re-evaluation was performed and outcome provided to physician. (Not specified). No adverse effects reported. No other information was provided. Lot number M054882 is not a valid lot number for VARIVAX. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician concerning an unspecified number of patients of unknown age and gender. There was no information about the patients' pertinent medical history, concurrent conditions, concomitant medications or drug reactions/allergies. On an unknown date, the patients were vaccinated with an improperly stored dose of VARIVAX (lot # M034583 and expiration date 27-JUL-2018) and (lot # N000682 and expiration date 06-JAN-2019) for prophylaxis (dose and route of administration were not reported). The vaccines were stored in temperature between 15°F and 46°F for 3 hours and for 30 minutes the temperature was between 47°F and 77°F. The vaccines did not have a previous temperature excursion and the call was done because of the data logger. No adverse effects were reported.      Additional information has been requested.
Sex: M
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: This initial spontaneous report was received from a Certified Medical Assistant (CMA) and refers to a male patient of unknown age.  Medical history, concurrent conditions and concomitant medications were not provided. On 07-JUN-2017, the patient was administered an expired dose of VAQTA 50/1.0 U/ml (route not provided) (lot # M022556; expiration 26-MAY-2017). No adverse reactions were reported. No further information was provided. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not reported.  On 24-MAY-2017, the patient was vaccinated with an expired dose of M-M-R II rHA, lot # L015282, expiration date: 30-APR-2017, as prophylaxis (strength, dose and route were not reported). No adverse effects were reported.    Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacy technician referring to multiple unspecified patients of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On unknown dates, the patients may had received improperly stored doses of RECOMBIVAX HB "2.5/0.5" (units not provided), lot number: M037248, expiration date 01-FEB-2019 and lot number reported as M040423, expiration date 03-JUL-2019 (dose and route of administration were not reported) for prophylaxis. There was no adverse effect reported.  Administered doses of RECOMBIVAX HB were exposed to a temperature excursion of 47°F to 77°F for 2 hours. There were no previous excursions reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacy intern concerning a patient of unknown age and gender. There was no information about the patient's pertinent medical history, concurrent conditions, concomitant medications or drug reactions/allergies. On 09-JUN-2017, the patient was inadvertently vaccinated with an expired dose of M-M-R II (lot number L012482 and expiration date 10-APR-2017), subcutaneously for prophylaxis (dose was not reported). No adverse effects were reported.    Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to two unspecified patients of unknown age and gender. The patients' concomitant medications, concurrent conditions, pertinent medical histories, drug reactions or allergies were not provided. On 08-JUN-2017, the patients were administered improperly stored doses of VAQTA injection, strength reported as 25/0.5 (units not provided), lot # M047658, expiry date on 25-OCT-2017 (exact dose, dose number and route of administration were not provided). No adverse effect was reported. Administered doses of vaccine experienced a temperature excursion of 78 degrees Fahrenheit or above, which lasted for 200 hours. No previous temperature excursion was reported. The digital data logger was not involved in recording the excursion. Additional information has been requested.
Sex: F
Vaccine: HPV9, TDAP
Symptoms: Loss of consciousness
Clinical narrative: This spontaneous report was received from a physician via company representative concerning a to an 11 year old female patient. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported. The patient did not had any drug reactions or allergies. On 09-JUN-2017, the patient was vaccinated with  a dose of GARDASIL 9 (route, dose, dose number, frequency, anatomical location, lot # and expiration date were unknown) for prevention of human papillomavirus infection (HPV) and also was vaccinated with a dose of diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid (TDAP) (route, dose, frequency, anatomical location, indication, lot # and expiration date were unknown). Subsequently, on the same date, reported as "shortly after" receiving the vaccines the patient passed out. It was unknown how long did the patient was unconscious, or if any specific treatment was given to her. No laboratory diagnostic tests were performed. At the time of reporting, the outcome of syncope was unknown. The physician stated that it was not known whether the patient pass out due to the GARDASIL 9 or the diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid (TDAP) or both. There was no product quality involved. Additional information has been requested.
Sex: U
Vaccine: HPVX
Symptoms: Small fibre neuropathy
Clinical narrative: Information has been received from the authors of the published literature abstract, regarding to a patient of unknown age and gender who on an unknown date, was vaccinated with a dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (manufacturer unknown) (lot # and expiry date were not reported). On an unknown date, the patient was confirmed to have small fiber neuropathy (SFN) by history, clinical exam and low intra-epidermal nerve fiber density (INFD). No involvement of the large fiber was confirmed by clinical exam and electrophysiological tests. Possible triggering factors were identified to be Human Papilloma Virus (HPV) vaccination in one patient. At the time of reporting the outcome of small fiber neuropathy was unknown. The reporter considered small fiber neuropathy to be related to Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (manufacturer unknown). Additional information has been requested.
Age: 2.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site rash
Clinical narrative: This spontaneous report was received from a nurse practitioner via company representative regarding a 2-year and 11 months old male patient. There was no information about patient's concomitant medications and pertinent medical history reported. On 13-JUN-2017, the patient was vaccinated with the first dose of VARIVAX, subcutaneously (dose,  anatomical location, lot number and expiration date were not reported) for prevention of varicella. On 14-JUN-2017 one day after vaccination, the patient had a rash from their shoulder to their elbow on the arm that received the injection (rash). The patient sought medical attention by seeing the physician and none treatment was given for the event. At the time of the report, the outcome of the rash was unknown. The relatedness between the event and therapy with VARIVAX was not reported. 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 registered nurse referring to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, beginning sometime in 2016, the patients were vaccinated with improperly stored doses of GARDASIL 9 lot # M031557, expiration date 07-APR-2019 (dose and route of administration were not reported) for prophylaxis. There were no symptoms reported. Administered doses of GARDASIL 9 were exposed to a temperature excursion of 0°C to 1°C for 20 hours 75 minutes. Data logger was involved. There were previous excursions but the reporter did not have the details. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse, referring to an unspecified number of patients (ages and genders not reported). The patients' medical history, concurrent conditions and concomitant therapies were not reported. On unspecified dates in June 2017 (reported as "on 13-JUN-2017 and 14-JUN-2017"), the patients were vaccinated with improperly stored doses of LIQUID PEDVAXHIB lot number M046140 with expiration date on 27-SEP-2019 (strength, dose, anatomical location and administration route were not reported) for prophylaxis. No adverse effects were reported and no additional information was provided. The vaccines had a temperature excursion of 0 Celsius (C) to 1 C during 30 minutes, it was also confirmed that the vaccines did not have previous temperature excursions and a digital data logger was involved. This is one of several reports received from the same source. Additional information has been requested.; Sender's Comments:  US-009507513-1706USA007425:
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from an office manager refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' pertinent medical history, concomitant medications and drug reactions or allergies was provided. On unknown dates in March 2017, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB injection, lot number M042322, expiration date: 21-FEB-2019, (dose, dose number, route of administration and injection site were not provided) for prophylaxis. According to the reporting office manager, the vaccine was exposed to the excursion conditions of 49.5 degrees Fahrenheit for 144 hours (from 16-FEB-2017 to 21-FEB-2017), 46.4 degrees Fahrenheit for 8 hours (from 27-FEB-2017 to 28-FEB-2017), 46.6 degrees Fahrenheit for 120 hours (from 10-MAR-2017 to 12-MAR-2017), 53.4 degrees Fahrenheit for 48 hours (from 14-MAR-2017 to 15-MAR-2017) and 53.4 degrees Fahrenheit for 48 hours (from 20-MAR-2017 to 21-MAR-2017). There was no previous temperature excursion reported. No adverse events were reported. No digital data logger was involved. Follow up information has been received from the reporting office manager via telephone call on 18-MAY-2017. The reporter stated that she would run a report and fax the patient identifiers and dates of vaccination. This is one of several reports received from the same reporter (linked with MARRS# 1704USA005744, 1706USA007378 and 1706USA007379). Additional information has been requested.; Sender's Comments:  US-009507513-1706USA007379: US-009507513-1706USA007378: US-009507513-1704USA005744:
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from an office manager refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' pertinent medical history, concomitant medications and drug reactions or allergies was provided. On unknown dates starting on or after 11-JAN-2017, the patients were vaccinated with improperly stored doses of ROTATEQ lot number M017558, expiration date: 27-FEB-2018 or lot number M040271, expiration date: 30-APR-2018, orally, (dose and dose number were not provided) for prophylaxis. The reporter also stated that in February 2017, the patients were administered improperly stored doses of ROTATEQ lot number M032636, expiration date: 06-APR-2018 and in March 2017, the unspecified patients received improperly stored doses of ROTATEQ lot number M038846, expiration date: 26-APR-2018, orally, (dose and dose number were not provided) for prophylaxis. According to the reporting office manager, the first two vaccines underwent a temperature excursion of 47 degrees Fahrenheit to 77 degrees Fahrenheit for 839 hours, while the third vaccine was exposed to the excursion conditions of 52.3 degrees Fahrenheit for 168 hours (from 20-JAN-2017 to 26-JAN-2017), 46.9 degrees Fahrenheit for 336 hours (from 07-FEB-2017 to 21-FEB-2017) and 46.4 degrees Fahrenheit for 8 hours (from 27-FEB-2017 to 28-FEB-2017). The last vaccine with lot number M038846 was exposed to the excursion conditions of 49.5 degrees Fahrenheit for 144 hours (from 16-FEB-2017 to 21-FEB-2017), 46.4 degrees Fahrenheit for 8 hours (from 27-FEB-2017 to 28-FEB-2017), 46.6 degrees Fahrenheit for 120 hours (from 10-MAR-2017 to 12-MAR-2017), 53.4 degrees Fahrenheit for 48 hours (from 14-MAR-2017 to 15-MAR-2017) and 53.4 degrees Fahrenheit for 48 hours (from 20-MAR-2017 to 21-MAR-2017). There was no previous temperature excursion reported. No adverse events were reported. No digital data logger was involved. Follow up information has been received from the reporting office manager via telephone call on 18-MAY-2017. The reporter stated that she would run a report and fax the patient identifiers and dates of vaccination. This is one of several reports received from the same reporter (linked with MARRS# 1704USA005744, 1706USA007377 and 1706USA007379). Additional information has been requested.; Sender's Comments:  US-009507513-1706USA007379: US-009507513-1706USA007377: US-009507513-1704USA005744:
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from an office manager refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' pertinent medical history, concomitant medications and drug reactions or allergies was provided. On unknown dates starting on or after 11-JAN-2017, the patients were vaccinated with improperly stored doses of VAQTA injection, lot number N003194, expiration date: 28-OCT-2018, (dose, dose number, route of administration and injection site were not provided) for prophylaxis. The reporter stated that in February 2017, the patients were also administered improperly stored doses of VAQTA injection, lot number M038572, expiration date: 11-MAR-2018 and in March 2017, the unspecified patients received improperly stored doses of VAQTA injection, lot number M047658, expiration date: 28-OCT-2017, (dose, dose number, route of administration and injection site were not provided) for prophylaxis. According to the reporting office manager, the first vaccine underwent a temperature excursion of 47 degrees Fahrenheit to 77 degrees Fahrenheit for 839 hours, while the second vaccine was exposed to the excursion conditions of 52.3 degrees Fahrenheit for 168 hours (from 20-JAN-2017 to 26-JAN-2017), 46.9 degrees Fahrenheit for 336 hours (from 26-JAN-2017 to 07-FEB-2017) and 46.4 degrees Fahrenheit for 8 hours (from 27-FEB-2017 to 28-FEB-2017). The last VAQTA with lot number M047658 was exposed to the excursion conditions of 49.5 degrees Fahrenheit for 144 hours (from 16-FEB-2017 to 21-FEB-2017), 46.4 degrees Fahrenheit for 8 hours (from 27-FEB-2017 to 28-FEB-2017), 46.6 degrees Fahrenheit for 120 hours (from 10-MAR-2017 to 12-MAR-2017), 53.4 degrees Fahrenheit for 48 hours (from 14-MAR-2017 to 15-MAR-2017) and 53.4 degrees Fahrenheit for 48 hours (from 20-MAR-2017 to 21-MAR-2017). There was no previous temperature excursion reported. No adverse events were reported. No digital data logger was involved. Follow up information has been received from the reporting office manager via telephone call on 18-MAY-2017. The reporter stated that she would run a report and fax the patient identifiers and dates of vaccination. This is one of several reports received from the same reporter (linked with MARRS# 1704USA005744, 1706USA007377 and 1706USA007378). Additional information has been requested.; Sender's Comments: US-009507513-1704USA005744: US-009507513-1706USA007377:  US-009507513-1706USA007378:
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information was received on 14-JUN-2017 from a lawyer regarding a case in litigation concerning a female patient of unknown age. It was reported that the patient was inoculated with a dose of ZOSTAVAX (lot, expiration not reported) vaccine on or about 19-SEP-2014 at  a pharmacy as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster or shingles. On or about 08-SEP-2016, the patient broke out with a blistering vesicular rash accompanied by weakened immune symptoms and was treated by a physician's assistant at which time the patient's condition was diagnosed as severe herpes zoster shingles. The patient has been prescribed valacyclovir (VALTREX) for management of her painful symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information has been received on 14-JUN-2017 regarding a case in litigation from a lawyer and a female patient of unknown age. The patient's concurrent conditions, medical history and concomitant medications were not reported. The patient was inoculated with  ZOSTAVAX vaccine (lot #, expiration and dose not reported) subcutaneous on or about 21-OCT-2013 at a pharmacy as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 05-NOV-2013, the patient was treated at a hospital for a vesicular outbreak that was diagnosed as herpes zoster. The shingles quickly spread throughout the patient's body. The patient was prescribed cortisone injection and prednisone for management of her painful symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Discomfort, Emotional distress, Herpes zoster, Pain
Clinical narrative: Information was received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication The patient was inoculated with ZOSTAVAX (lot number, dosage, and route of administration not provided) on or about 16-AUG-2012, administered by a physician, as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingle as intended, but rather caused the patient to contract a persistent and chronic strain of herpes zoster. On or about 01-AUG-2016, the patient  was treated by the physician for blistering vesicular lesions accompanied by weakened immune symptoms and severe discomfort and distress, which was diagnosed as herpes zoster. The patient  has been prescribed valacyclovir (VALTREX) for management of her painful symptoms and outbreaks. As a direct and proximate result of these malfunctions, the patient has  suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient  has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Rash vesicular
Clinical narrative: Information was received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication The patient was inoculated with ZOSTAVAX (lot number, dosage, and route of administration not provided) on or about 16-AUG-2012, administered by a physician, as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingle as intended, but rather caused the patient to contract a persistent and chronic strain of herpes zoster. On or about 01-AUG-2016, the patient  was treated by the physician for blistering vesicular lesions accompanied by weakened immune symptoms and severe discomfort and distress, which was diagnosed as herpes zoster. The patient  has been prescribed valacyclovir (VALTREX) for management of her painful symptoms and outbreaks. As a direct and proximate result of these malfunctions, the patient has  suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient  has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Nerve injury, Pain, Post herpetic neuralgia
Clinical narrative: Information had been received on 14-JUN-2017 from a lawyer regarding a case in litigation. It was alleged in litigation that a male patient (age unknown) was inoculated with ZOSTAVAX on or about 12-NOV-2014 at a pharmacy, as recommended for routine adult health maintenance for the prevention of shingles (dosage and lot#/expiration not reported). The vaccine did not prevent shingles as intended but rather caused the patient to contract a persistent strain of herpes zoster. On or about 12-MAY-2016, patient was treated at a healthcare facility for a blistering vesicular outbreak, which was diagnosed as herpes zoster. On or about 28-MAY-2016, patient was treated at the same facility for ongoing and worsening symptoms, at which time the patient was diagnosed with post-herpetic neuralgia, a chronic condition of nerve damage and residual pain secondary to shingles. Patient was prescribed gabapentin, amitriptyline (ELAVIL), acetaminophen/hydrocodone (NORCO), fentanyl patches and amitriptyline for management of his excruciating symptoms. As a direct and proximate result of these malfunctions, patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, patient has suffered and will continue to suffer significant medical expenses and pain and suffering and other damages. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Rash vesicular
Clinical narrative: Information had been received on 14-JUN-2017 from a lawyer regarding a case in litigation. It was alleged in litigation that a male patient (age unknown) was inoculated with ZOSTAVAX on or about 12-NOV-2014 at a pharmacy, as recommended for routine adult health maintenance for the prevention of shingles (dosage and lot#/expiration not reported). The vaccine did not prevent shingles as intended but rather caused the patient to contract a persistent strain of herpes zoster. On or about 12-MAY-2016, patient was treated at a healthcare facility for a blistering vesicular outbreak, which was diagnosed as herpes zoster. On or about 28-MAY-2016, patient was treated at the same facility for ongoing and worsening symptoms, at which time the patient was diagnosed with post-herpetic neuralgia, a chronic condition of nerve damage and residual pain secondary to shingles. Patient was prescribed gabapentin, amitriptyline (ELAVIL), acetaminophen/hydrocodone (NORCO), fentanyl patches and amitriptyline for management of his excruciating symptoms. As a direct and proximate result of these malfunctions, patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, patient has suffered and will continue to suffer significant medical expenses and pain and suffering and other damages. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Deafness, Herpes zoster, Herpes zoster oticus, Pain, Rash vesicular
Clinical narrative: Information was received on 14-JUN-2017 regarding a case in litigation concerning a male (age not reported). Medical history, concurrent conditions and concomitant medications were not reported. On or about 10-SEP-2010 the patient received a dose of ZOSTAVAX (lot # and dose not specified) as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 20-APR-2015 the patient was treated in a  clinic by a physician for a vesicular outbreak that was diagnosed as severe shingles. On or about 11-MAY-2015 he was treated again for worsening symptoms accompanied by hearing loss due to shingles spreading to the ear. The patient was prescribed valacyclovir (VALTREX) and hydrocodone for management of his painful symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages. Upon internal review the event of hearing loss due to shingles spreading to the ear was determined to be medically significant. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Vaccination failure
Clinical narrative: Information was received on 14-JUN-2017 regarding a case in litigation concerning a male (age not reported). Medical history, concurrent conditions and concomitant medications were not reported. On or about 10-SEP-2010 the patient received a dose of ZOSTAVAX (lot # and dose not specified) as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 20-APR-2015 the patient was treated in a  clinic by a physician for a vesicular outbreak that was diagnosed as severe shingles. On or about 11-MAY-2015 he was treated again for worsening symptoms accompanied by hearing loss due to shingles spreading to the ear. The patient was prescribed valacyclovir (VALTREX) and hydrocodone for management of his painful symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages. Upon internal review the event of hearing loss due to shingles spreading to the ear was determined to be medically significant. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Emotional distress, Herpes zoster, Nerve injury, Pain, Post herpetic neuralgia
Clinical narrative: Information was received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. It was reported that the patient was inoculated with a dose of ZOSTAVAX (lot number, dosage, and route of administration not provided) vaccine on or about 01-JUL-2014 at a pharmacy as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster and nerve damage. On or about 12-APR-2017, the patient was treated by a physician for a vesicular outbreak that had caused unbearable and persistent residual pain. The patient was diagnosed with post herpetic neuropathy, which the physician noted is a chronic and painful nervous system impediment that would be a lifelong condition.  As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result. the patient has suffered and will continue to suffer significant medical expenses, pain and suffering and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Rash vesicular
Clinical narrative: Information was received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. It was reported that the patient was inoculated with a dose of ZOSTAVAX (lot number, dosage, and route of administration not provided) vaccine on or about 01-JUL-2014 at a pharmacy as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster and nerve damage. On or about 12-APR-2017, the patient was treated by a physician for a vesicular outbreak that had caused unbearable and persistent residual pain. The patient was diagnosed with post herpetic neuropathy, which the physician noted is a chronic and painful nervous system impediment that would be a lifelong condition.  As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result. the patient has suffered and will continue to suffer significant medical expenses, pain and suffering and other damages. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Emotional distress, Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information was received on 14-JUN-2017 regarding a case in litigation concerning a male (age not reported). Medical history, concurrent conditions and concomitant medications were not reported. On or about 16-JUL-2015 the patient received a dose of ZOSTAVAX (lot # and dose not specified) as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 05-AUG-2015 the patient was treated at the clinic for a vesicular outbreak that was diagnosed as severe shingles. The patient was prescribed valacyclovir for management of his painful symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Emotional distress, Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information was received from a lawyer regarding a case in litigation concerning a female plaintiff of unspecified age. It was claimed this plaintiff suffered personal injuries and damages as a direct and proximate result of being inoculated with ZOSTAVAX. The plaintiff was inoculated with ZOSTAVAX on or about 10-AUG-2012 (dosage, route, lot # and site of administration unspecified) as recommended for routine adult health maintenance for the prevention of shingles.  It was claimed that the vaccine did not prevent shingles as intended, but rather caused the plaintiff to contract a persistent strain of herpes zoster. On or about 17-AUG-2012 the plaintiff was treated by a physician for a vesicular outbreak that was diagnosed as severe shingles. The plaintiff was prescribed acyclovir for management of her painful symptoms. As a direct and proximate result of these malfunctions, the plaintiff suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, plaintiff has suffered and will continue to suffer significant medical expenses, pain and suffering and other damages. Additional information was requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information has been received on 14-JUN-2017 from a lawyer and a female patient of unknown age regarding a case in litigation.  It is complained and alleged that the patient was inoculated with ZOSTAVAX (dose, route, lot number and expiration date were not reported) on or about 05-MAY-2012 at a pharmacy as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 10-JUL-2012, the patient was treated by a nurse practitioner at a hospital for a vesicular outbreak that was diagnosed as severe shingles. On or about 14-JUL-2014, the patient was treated by a nurse practitioner at a hospital for worsening symptoms, at which time the diagnosis of shingles was affirmed as being severe. The patient was prescribed hydrocodone-acetaminophen, valaciclovir and oxycodone-acetaminophen (PERCOCET) for management of her painful symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering and other damages. Additional information has been requested.