chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 18.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Arthralgia, C-reactive protein normal, Decreased appetite, Epstein-Barr virus test negative, Eye swelling
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of fatigue in a 18-year-old female patient who received BEXSERO (batch number 165601A, expiry date 31st October 2018). On 31st July 2017 09:30, the patient received the 1st dose of BEXSERO .5 ml. On 31st July 2017 14:00, 4 hrs 30 min after receiving BEXSERO, the patient experienced fatigue, loss of energy, difficulty breathing and eating disorder. On an unknown date, the outcome of the fatigue, loss of energy, difficulty breathing and eating disorder were unknown. It was unknown if the reporter considered the fatigue, loss of energy, difficulty breathing and eating disorder to be related to BEXSERO. Additional details were provided as follows: The patient experienced, extreme fatigue, having to force herself to eat, lack of energy, and had to force air out to breathe. No emergency interventions were required. The healthcare professional would continue to monitor the patient.
Age: 18.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Fatigue, Full blood count normal, Headache, Metabolic function test normal, Mononucleosis heterophile test negative
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of fatigue in a 18-year-old female patient who received BEXSERO (batch number 165601A, expiry date 31st October 2018). On 31st July 2017 09:30, the patient received the 1st dose of BEXSERO .5 ml. On 31st July 2017 14:00, 4 hrs 30 min after receiving BEXSERO, the patient experienced fatigue, loss of energy, difficulty breathing and eating disorder. On an unknown date, the outcome of the fatigue, loss of energy, difficulty breathing and eating disorder were unknown. It was unknown if the reporter considered the fatigue, loss of energy, difficulty breathing and eating disorder to be related to BEXSERO. Additional details were provided as follows: The patient experienced, extreme fatigue, having to force herself to eat, lack of energy, and had to force air out to breathe. No emergency interventions were required. The healthcare professional would continue to monitor the patient.
Age: 18.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Oral mucosal blistering, Oropharyngeal pain
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of fatigue in a 18-year-old female patient who received BEXSERO (batch number 165601A, expiry date 31st October 2018). On 31st July 2017 09:30, the patient received the 1st dose of BEXSERO .5 ml. On 31st July 2017 14:00, 4 hrs 30 min after receiving BEXSERO, the patient experienced fatigue, loss of energy, difficulty breathing and eating disorder. On an unknown date, the outcome of the fatigue, loss of energy, difficulty breathing and eating disorder were unknown. It was unknown if the reporter considered the fatigue, loss of energy, difficulty breathing and eating disorder to be related to BEXSERO. Additional details were provided as follows: The patient experienced, extreme fatigue, having to force herself to eat, lack of energy, and had to force air out to breathe. No emergency interventions were required. The healthcare professional would continue to monitor the patient.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Decreased activity, Decreased appetite, Hypersomnia, Injection site swelling
Clinical narrative: Decreased appetite and activity. Sleeping more. Injection area on Left thigh slightly swollen.
Age: 76.0
Sex: M
Vaccine: FLUA3
Symptoms: Computerised tomogram, Fatigue, Nausea, Restlessness, Vomiting
Clinical narrative: Pt. had nausea and vomiting. He was fatigue and restless and had to call 911.
Age: 13.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: Patient upper right arm swollen, red and warm to touch. Patient reported swelling started a "little while 1-2 hours after vaccine". Patient and mom advised to apply ice/cold packs and to take CLARITIN. If symptoms worsen to return to clinic for further evaluation. Denies fever, temp taken 97.9 orally.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information was received on 08-AUG-2017 from a lawyer regarding a case in litigation concerning a female patient of unknown age. Medical history, concurrent conditions, and concomitant medications were not provided. It was reported that the patient was vaccinated with a dose of ZOSTAVAX (lot number, dosage, and route of administration not provided) on or about 02-DEC-2015 at a physician's office, 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 be treated by the physician for the onset of an ongoing vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles (date not reported). 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.
Age: 13.0
Sex: M
Vaccine: HPVX
Symptoms: Blister, Pruritus, Rash
Clinical narrative: Patient had a vaccine HPV or HPV9 I don't know. I would have to find out from the doctor. He woke up the next day with a few bumps on his forehead and by the evening he had bumps on his arms, neck, face. He was extremely itchy. I have him a BENADRYL and then called the doctor. It's day 2 and he woke up with a blister type on his earlobe. Still itchy. Still on BENADRYL and ZYRTEC and anti-itch cream. Item 21 doesn't not have a button to say I talked to the doctor and the nurse on the phone.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a physician concerning 200 unspecified patients. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On unknown dates between 2014 and 2015, improperly stored doses of PROQUAD (dose, route, lot# and expiration date were unknown) were administered to the patients for prophylaxis. The doses of PROQUAD were exposed to a temperature excursion of -14 to -10 Celsius degree (time frame unknown), which was detected by data logger. There was multiple temperature excursions (unspecified details). No adverse events were reported. This is one of two reports from the same reporter. As on 08-AUG-2017, all telephone attempts to obtain follow up information had been unsuccessful.; Sender's Comments: US-009507513-1706USA007775:
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report has been received from a physician referring to a patient of unknown age. The patient's medical history, concurrent condition and concomitant therapy were not reported. In 2015, the patient was vaccinated with two doses of GARDASIL series, (unknown if it was GARDASIL) (dose, route, lot# and expiration date was not reported) or GARDASIL 9 (dose, route, lot# and expiration date was not reported)). On 18-JUL-2017, the patient received the third dose of GARDASIL series with GARDASIL 9) (dose, route, lot# and expiration date was not reported) for prophylaxis (inappropriate schedule of drug administration and interchange of vaccine products). No adverse effects were reported.
Sex: U
Vaccine: HPVX
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report has been received from a physician via a field employee referring to a patient of unknown age and gender. On an unknown date, the patient was vaccinated with an expired dose of GARDASIL (dose, route, lot# and expiration date were not reported) (unspecified whether product involved was GARDASIL or GARDASIL 9 (dose, route, lot# and expiration date were not reported)) for prophylaxis. No adverse effects were reported.
Sex: U
Vaccine: HEP
Symptoms: Hepatitis B surface antibody negative, Therapy non-responder
Clinical narrative: This literature marketed report has been received from the authors of the literature article entitled as stated above concerning to 52 3-18 year old patients of unknown gender. The patients were under methotrexate (manufacturer unknown) for atopic dermatitis, psoriasis or morphea. On unknown dates, the patients were vaccinated with RECOMBIVAX HB (lot#, expiration date, dose and route were not reported) for prophylaxis. These patient were confirmed to have completed the recommended hepatitis B (HB) vaccination series. On unknown dates, the patients' anti-HBs titers were analyzed, showing the results of less than 10 milli international unit (mIU)/ml. These 52 patients had no anti-HBs protective levels and were considered as non-responders for RECOMBIVAX HB. The outcome of hepatitis b surface antibody negative and therapy non-responder was unknown. The reporter considered, in the patients with atopic dermatitis and psoriasis, these immunogenetic factors or excessive inflammation due to underlying disease might contribute to the increased rate of those without anti-HBs protective levels.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of unspecified patients. The patients' medical history, concurrent condition and concomitant therapy were not reported. On unspecified dates, an unspecified number of unspecified patients received a dose of improperly stored PROQUAD (Lot# reported as N002916, expiration date 24-JUL-2018 or Lot# N013268, expiration date 25-OCT-2018) (dose, frequency and route were not reported). The lot numbers and expiration dates of the sterile diluent (manufacturer unknown) used for reconstitution was unknown by reporter (dose, frequency and route were not reported). The sterile diluents did not undergo any temperature excursion. The vaccine was exposed to temperature excursion of 6 F to 14 F for 4 hours and the data logger was involved. There was no previous temperature excursion. No adverse effects reported. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1708USA000603:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of unspecified patients. The patients' medical history, concurrent condition and concomitant therapy were not reported. On unspecified dates, an unspecified number of unspecified patients received a dose of improperly stored VARIVAX (Lot# N012618, expiration date 21-APR-2019 or Lot # M043582, expiration date 28-OCT-2018) (dose, frequency and route were not reported). The lot numbers and expiration dates of the sterile diluent (manufacturer unknown) used for reconstitution was unknown by reporter (dose, frequency and route were not reported). The sterile diluents did not undergo any temperature excursion. The vaccine was exposed to temperature excursion of 6 F to 14 F for 4 hours and the data logger was involved. There was no previous temperature excursion. No adverse effects reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1708USA000600:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a registered nurse refers to a multiple unspecified patients of unknown age and gender. Since 20-JUL- 2017, the patients were vaccinated with improperly stored dose of ROTATEQ lot #s M041814, expiration date 27-JUN-2018; M041815, expiration date 28-JUN-2018 and M046008 expiration date 29-JUN-2018, oral for prophylaxis. The vaccine was exposed from 47 degree Fahrenheit (°F) to 77 degree Fahrenheit (°F) (52.7°F) for 2 hours and 15 minutes. There was no previous temperature excursion. The call was made because there was a "data logger". No side effects were reported. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1708USA004837: US-009507513-1708USA004838.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered
Clinical narrative: Information has been received from a licensed practical nurse referring to a patient of unknown age and gender. On 28-JUL-2017 the patient was vaccinated with ZOSTAVAX lot # L036454, expiration date 22-DEC-2016 for prophylaxis. Concomitant therapies included sterile diluent. On 28-JUL-2017, 1 day after onset of therapy the patient experienced expired product administered. The outcome of expired product administered is unknown. The reporter considered expired product administered to be not related to ZOSTAVAX.
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site rash, Pain, Pain in extremity
Clinical narrative: This spontaneous report as received from an office manager refers to a female patient of unknown age. On 03-AUG-2017, the patient was vaccinated with one dose of PNEUMOVAX 23 Lot # N011305 and expiration date on 20-JAN-2019, intramuscularly for prophylaxis. On an unknown date, the patient experienced injection site pain, pain in extremity, injection site erythema, pain, injection site pain, injection site rash and injection site erythema. The patient visited the physician but it was unknown if she received treatment for the adverse events. No any laboratory study was performed. The outcome of injection site pain, pain, injection site rash and injection site erythema was reported as not recovered/not resolved. This is one of several cases received from the same reporter.; Sender's Comments: US-009507513-1708USA004754: US-009507513-1708USA004753:
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant referring to multiple unspecified number of patients of unknown age and gender. On unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB, lot # L042846 with expiration date 15-SEP-2017, lot# N002922 with expiration date 30-SEP-2018, lot# N011851 with expiration date 19-DEC-2019, and lo# N002202 with expiration date 04-NOV-2019 for prophylaxis.  No adverse event was reported. The doses of RECOMBIVAX HB, were exposed to a temperature excursion of 47 degrees Fahrenheit (°F) to 77 °F during a time frame of 2 hours 45 minutes which was detected by the data logger. Previous temperature excursion was reported as 47 °F to 77 °F for 45 minutes. This is one of several reports from the same reporter; Sender's Comments: US-009507513-1708USA002992: US-009507513-1708USA002994: US-009507513-1708USA002995: US-009507513-1708USA002863:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant referring to multiple unspecified number of patients of unknown age and gender. On unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ, orally, lot # N003980 with expiration date 12-NOV-2018, lot# M043836 with expiration date 17-JUN-2018, for prophylaxis.  No adverse event was reported. The doses of ROTATEQ, were exposed to a temperature excursion of 47 degrees Fahrenheit (°F) to 77 °F during a time frame of 2 hours 45 minutes which was detected by the data logger. Previous temperature excursion was reported as 47 °F to 77 °F for 45 minutes. This is one of several reports from the same reporter; Sender's Comments: US-009507513-1708USA002992: US-009507513-1708USA002993: US-009507513-1708USA002995: US-009507513-1708USA002863:
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant referring to multiple unspecified number of patients of unknown age and gender. On unknown dates, the patients were vaccinated with improperly stored doses of PNEUMOVAX 23, lot # N010106 with expiration date 15-NOV-2018, lot# N011305 with expiration date 20-JAN-2019, for prophylaxis.  No adverse event was reported. The doses of PNEUMOVAX 23, were exposed to a temperature excursion of 47 degrees Fahrenheit (°F) to 77 °F during a time frame of 2 hours 45 minutes which was detected by the data logger. Previous temperature excursion was reported as 47 °F to 77 °F for 45 minutes. This is one of several reports from the same reporter; Sender's Comments: US-009507513-1708USA002992: US-009507513-1708USA002993: US-009507513-1708USA002994: US-009507513-1708USA002863:
Sex: U
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age, No adverse event, Product name confusion
Clinical narrative: This spontaneous report as received from a pharmacy student and refers to a patient of unknown age. Information on medical history, past drugs, concurrent conditions and concomitant medications were not provided. Pharmacy student reported that multiple unspecified adult patients received pediatric doses of VAQTA injection 25/0.5, (N014945, 31-AUG-2018), and multiple unspecified pediatric patients received adult doses of VAQTA, (N016805, 04-SEP-2018), (Captured in MARRS # 1708USA003849). All doses were administered on unspecified dates. Pharmacy student reported that product confusion was the cause of error (Product name confusion). No adverse effects were reported (No adverse event). All fields apply to all unspecified patients and all doses of VAQTA. No further information was provided. No product quality compliant (PQC) was present. Outcome of events was unknown. This is one of the several reports received from the same reporter.; Sender's Comments: US-009507513-1708USA003849:
Age: 1.0
Sex: U
Vaccine: HEPA, MMR, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse and refers to a 1 year-old White patient of unknown gender. There was no information about the patient's pertinent medical history, drug reactions or allergies provided. On 26-JUN-2017, the patient was vaccinated with improperly stored first dose of VARIVAX, one unspecified dose in the right thigh (lot # M047622 with the expiration date of 02-DEC-2018, route of administration was not reported), for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent (lot# and expiration date were not reported). No adverse effects were reported. The patient was concomitantly vaccinated with a dose of M-M-R II, and hepatitis a vaccine, inactivated (manufacturer: Merck Sharp & Dohme). The administered dose of vaccine experienced a temperature excursion between 9 and 25 Celsius degrees for 2 hours and 16 minutes. Digital data logger was involved. There were no previous temperature excursions reported. This was one of several reports received from the same reporter. Additional information is not expected as the reporter had no further information to provide.; Sender's Comments: US-009507513-1706USA009938:
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. Medical history, current conditions and concomitant medications were not reported. On an unknown date in JUL-2016, patient received one dose of ZOSTAVAX (unknown lot number) diluted with unspecified sterile diluent as prophylaxis (product preparation error). On 03-AUG-2017 the patient was vaccinated with dose 2 ZOSTAVAX (lot # M042850, expiry date 18-JAN-2018) reconstituted with sterile diluent (lot M019891 expiry date: 11-OCT-2018)  as prophylaxis (overdose). No adverse reactions were reported. The outcome of overdose and no adverse event was unknown.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Insomnia
Clinical narrative: This spontaneous report as received from a consumer refers to a 83 year old female patient. The patient's medical history included hypertension. On 2002 the patient was vaccinated with ZOSTAVAX for prophylaxis. Concomitant therapies included lavender oil (LAVENDER OIL) and witch hazel(WITCH HAZEL). On 2017 the patient experienced insomnia. On 24-JUL-2017 the patient experienced herpes zoster. The outcome of herpes zoster was reported as not recovered/not resolved. The outcome of insomnia is unknown.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a nurse practitioner referring to a female patient in her 60's. On approximately 2006 (reported as "about 11 years ago"), the patient was vaccinated with ZOSTAVAX for prophylaxis. Concomitant therapies included sterile diluent (STERILE DILUENT). On an unspecified date (also reported as 07-AUG-2017), the patient experienced shingles (herpes zoster). The outcome of herpes zoster was reported as not recovered/not resolved. The causality assessment between herpes zoster and ZOSTAVAX was not reported.
Sex: M
Vaccine: MMR
Symptoms: Rubella antibody negative
Clinical narrative: This spontaneous report as received from a pharmacist refers to a male patient of unknown age. On an unknown date the patient was vaccinated with M-M-R II for prophylaxis. On an unknown date the patient experienced rubella antibody negative. The outcome of rubella antibody negative is unknown.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age. Concomitant therapies included sterile diluent (MRK). On 29-JUN-2017 the patient was vaccinated with an improperly stored dose of M-M-R II (lot number M010426 expiration date: 01-MAR-2018, lot number: M032157 expiration date: 01-JUL-2018, lot number: M039913 expiration date: 26-SEP-2018) for prophylaxis (digital data logger). No adverse effects reported. This is one of several reports received from the same source. Sender's Comments: US-009507513-1708USA002800.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a physician concerning 200 unspecified patients. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On unknown dates between 2014 and 2015, improperly stored doses of VARIVAX (dose, route, lot# and expiry date were unknown) were administered to the patients for prophylaxis. The doses of measles, mumps, rubella and VARIVAX were exposed to a temperature excursion of -14 to -10 Celsius degree (time frame unknown), which was detected by data logger. There was multiple temperature excursions (unspecified details). No adverse events were reported. All telephone attempts to obtain follow up information had been unsuccessful. This is one of two reports from the same reporter.; Sender's Comments:  US-009507513-1706USA007775:
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a other health professional refers to an unspecified number of patients of unknown age and gender. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 lot # M018810 with expiration date of 28-JUN-2019, and lot# M018810 with expiration date of 28-MAY-2018, for prophylaxis. On an unknown date the patient experienced incorrect product storage and no adverse event. The outcome of incorrect product storage is unknown. No adverse effects reported. It was stated that the vaccines underwent a temperature excursion of 36-45 degrees Fahrenheit  (35.7F) for 15 Hours (worst case). Previous temperature excursion was reported as 47 - 77 degrees Fahrenheit (54.2F) for 3 Hours. The call was because of a "data logger". The reporter considered incorrect product storage and no adverse event to be not related to GARDASIL 9. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from an Office Manager and refers to an unspecified number of patients of unknown age and gender. No information regarding the patient's medical history or concurrent conditions was provided. On 08-AUG-2017, the patients were vaccinated with improperly stored doses of M-M-R II injection with lot number: M036543 and expiry date: 15-AUG-2018 (exact dose, route of administration, were not reported) for prophylaxis. The vaccine was reconstituted with sterile diluent (lot number and expiration date not reported). There were no concomitant therapies reported. The administered doses of the vaccine were exposed to a temperature between 47 degrees Fahrenheit to 77 degrees Fahrenheit on an unspecified date, for a time frame of 16 hours. A digital data logger was not involved. There were no previous temperature excursions recorded. No adverse experiences were reported. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1708USA005224: US-009507513-1708USA005225.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a physician refers to multiple patients of unknown age and gender. On unknown dates, the patients were vaccinated with doses of improperly stored VAQTA lot# N022924 with expiration date of 31-AUG-2018, lot# M039202 and lot# N005274 (expiration dates were not reported) (dose, route of administration and anatomical location were not reported) for prophylaxis. From an unknown date in October 2016, the vaccines underwent multiple temperature excursions (details to be determined) which were detected by a digital data logger. No adverse effects were reported. This is one of several reports form the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1708USA003935: US-009507513-1708USA004395: US-009507513-1708USA004392: US-009507513-1708USA004393: US-009507513-1708USA004408: US-009507513-1708USA004409.
Sex: F
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information was received from a lawyer 08-AUG-2017 regarding a case in litigation concerning a female plaintiff of unspecified age. It was claimed the plaintiff was inoculated with ZOSTAVAX in 2013 at the office of a physician, as recommended for routine adult health maintenance and for the prevention of shingles. It was claimed the vaccine did not prevent shingles as intended, but rather caused her to contract a persistent strain of herpes zoster. On or about 24-FEB-2015, the plaintiff was treated by a Nurse Practitioner for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles. She had been prescribed mupirocin topical ointment and valacyclovir (VALTREX) 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, the plaintiff has suffered and will continue to suffer significant medical expenses, pain and suffering and other damages. Additional information was requested.
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema
Clinical narrative: This spontaneous report as received from a other refers to a 70 year old male patient. On 08-AUG-2017 the patient was vaccinated with PNEUMOVAX 23 lot # N010109, intramuscular for prophylaxis. On 08-AUG-2017, 1 day after onset of therapy the patient experienced injection site erythema. The outcome of injection site erythema was reported as not recovered/not resolved. The reporter did not assess the causality between the events and PNEUMOVAX 23.
Sex: F
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Disability, Emotional distress, Herpes zoster, Loss of personal independence in daily activities
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 medical history, concurrent conditions or concomitant medications. On or about 24-JUL-2009, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration unknown), as recommended for routine adult health maintenance and the prevention of shingles. It was reported that the vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 11-MAR-2011, the patient was treated by a physician for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles. The patient has experienced significant pain and complication from her shingles infections, rendering her homebound since 2013. She had been prescribed valacyclovir hydrochloride (VALTREX) and acetaminophen hydrocodone bitartrate (VICODIN) 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. The events shingles, immune system disorder, and vaccination failure were considered disabling as they rendered the patient homebound. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Rash vesicular, Vaccination failure
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 medical history, concurrent conditions or concomitant medications. On or about 24-JUL-2009, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration unknown), as recommended for routine adult health maintenance and the prevention of shingles. It was reported that the vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 11-MAR-2011, the patient was treated by a physician for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles. The patient has experienced significant pain and complication from her shingles infections, rendering her homebound since 2013. She had been prescribed valacyclovir hydrochloride (VALTREX) and acetaminophen hydrocodone bitartrate (VICODIN) 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. The events shingles, immune system disorder, and vaccination failure were considered disabling as they rendered the patient homebound. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. On 2017 (reported as between the dates of 31-JUL-2017 through 04-AUG-2017), the patient was vaccinated with GARDASIL 9 for prophylaxis. On 2017 the patient experienced expired product administered. On an unknown date the patient experienced no adverse event.
Sex: F
Vaccine: VARZOS
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a pharmacist referring to a female patient of unknown age.  On 08-AUG-2017, the patient was vaccinated with ZOSTAVAX lot # M038864 and expiration date on 12-DEC-2017 for prophylaxis. The sterile diluent (MRK DILUENT) lot # M042852 and expiration date on 30-MAY-2019 used for reconstitution of the vaccine was properly stored. The doses of ZOSTAVAX were exposed to a temperature excursion of 15 degrees Fahrenheit (°F) to 46°F during a time frame of 1 hour and 45 minutes, which was detected by the data logger. there was not prior temperature excursion and no adverse events were reported.
Sex: F
Vaccine: PPV, TD
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: This spontaneous report as received from an office manager refers to a female patient of unknown age. On 01-AUG-2017, the patient was vaccinated with PNEUMOVAX 23 Lot # N011305 and expiration date on 20-JAN-2019, 1 DF, intramuscularly for prophylaxis. In August 2017, the patient experienced injection site erythema and injection site pain. The patient visited the physician but it was unknown if she received any treatment for the adverse events. No any laboratory study was performed. The outcome of injection site erythema and injection site pain was reported as not recovered/not resolved.  This is one of several cases received from the same reporter.; Sender's Comments:  US-009507513-1708USA004754: US-009507513-1708USA002956:
Age: 78.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Pain in extremity
Clinical narrative: This spontaneous report as received from an office manager refers to a male patient of unknown age.   On 02-AUG-2017, the patient was vaccinated with PNEUMOVAX 23 lot # N011305 and expiration date on 20-JAN-2019, 1 DF, intramuscularly for prophylaxis. In August 2017, the patient experienced injection site erythema and pain in extremity. The patient visited the physician but it was unknown if he received any treatment for the adverse events. No any laboratory study was performed. The outcome of injection site erythema and pain in extremity was reported as not recovered/not resolved. This is one of several cases received from the same reporter.; Sender's Comments: US-009507513-1708USA002956: US-009507513-1708USA004753:
Sex: F
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Pain, 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 medical history, concurrent conditions or concomitant medications. In 2008, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration unknown), as recommended for routine adult health maintenance and for the prevention of shingles. It was reported that the vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 03-FEB-2016, the patient was treated by a Nurse Practitioner at an Urgent Care facility for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles. She has been prescribed MEDROL and valacyclovir for management of her 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 signification medical expenses, pain and suffering, and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medications were not provided. On or about 11-JAN-2013, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown), 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. On or about 03-MAR-2016 the patient was treated by a physician for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles. 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: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age. On an unknown date the patient was vaccinated with GARDASIL 9 lot # M024261, expiration date: 30-JUL-2018; and lot # N013695, expiration date: 21-MAR-19 for prophylaxis. On an unknown date the patient experienced incorrect product storage and no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage and no adverse event to be not related to GARDASIL 9. Sender's Comments: US-009507513-1708USA004836.
Sex: U
Vaccine: MMR
Symptoms: Pruritus, Urticaria
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age. On an unknown date the patient was vaccinated with M-M-R II for prophylaxis. Other suspect therapies included sterile diluent (MRK) for prophylaxis. On an unknown date, 6 days after onset of therapy the patient experienced urticaria and pruritus. The outcome of urticaria and pruritus was unknown.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age. On 23-JUN-2017 the patient was vaccinated with LIQUID PEDVAXHIB lot # N000238 for prophylaxis. On 23-JUN-2017, 1 day after onset of therapy the patient experienced incorrect product storage. On an unknown date the patient experienced no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage and no adverse event to be not related to LIQUID PEDVAXHIB.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a other refers to a patient of unknown age. On an unknown date the patient was vaccinated with PNEUMOVAX 23 lot # N010105 for prophylaxis. On an unknown date the patient experienced incorrect product storage and no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage and no adverse event to be not related to PNEUMOVAX 23.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age. On an unknown date the patient was vaccinated with PNEUMOVAX 23 lot # N010105, expiration date: 15-NOV-2018, for prophylaxis. On an unknown date the patient experienced incorrect product storage and no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage and no adverse event to be not related to PNEUMOVAX 23.; Sender's Comments: US-009507513-1708USA004783:
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a registered nurse refers to a multiple unspecified patients of unknown age and gender. Since 20-JUL- 2017, the patients were vaccinated with improperly stored dose of LIQUID PEDVAXHIB, lot #s N003701, expiration date 01-NOV-2019 and N007750 expiration date 29-NOV-2019 (dose and routed were not reported). The vaccine was exposed from 47 degree Fahrenheit  (°F) to 77 degree Fahrenheit  (°F) (52.7°F) for 2 hours and 15 minutes. There was no previous temperature excursion. The call was made because there was a "data logger". No side effects were reported. This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-1708USA004838: US-009507513-1708USA001164:
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a registered nurse refers to a multiple unspecified patients of unknown age and gender. Since 20-JUL- 2017, the patients were vaccinated with improperly stored dose of VAQTA lot #s M047658, expiration date 28-OCT-2017 and N012324, expiration date 05-APR-2018 (dose and routed were not reported). The vaccine was exposed from 47 degree Fahrenheit  (°F) to 77 degree Fahrenheit  (°F) (52.7°F) for 2 hours and 15 minutes. There was no previous temperature excursion. The call was made because there was a "data logger". No side effects were reported. This is one of several reports from the same reporter.; Sender's Comments: US-009507513-1708USA001164: US-009507513-1708USA004837:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a other refers to a patient of unknown age. On an unknown date the patient was vaccinated with VARIVAX for prophylaxis. On 14-JUN-2017 the patient experienced incorrect product storage. On an unknown date the patient experienced no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage and no adverse event to be not related to VARIVAX.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The patient's medical history, current conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with improperly stored GARDASIL 9 (dose and route were not reported) lot # M024261 and expiry date: 30-JUL-2018 for prophylaxis. It was exposed to a temperature of 32 Fahrenheit to 35 Fahrenheit (33.1 Fahrenheit) for a time frame of 1 hour. There were no previous temperature excursions. No adverse effects were reported. No further information was provided.
Sex: U
Vaccine: HPV4
Symptoms: Expired product administered
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. The patient medical history was not reported. On 07-AUG-2017, the GARDASIL vaccine was dispensed to the patient. On 08-AUG-2017,  the patient was vaccinated with an expired dose of GARDASIL (Strength, dose, frequency, anatomical location and route were not reported) of lot # M014929 with an expiry date of 27-MAY-2017 for prophylaxis in a physician's office. There were no concomitant therapies reported. The pharmacist was not able to provide excursion details for the product. There was no product quality complaint involved.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant and refers to approximately 4 patients of unknown demographics. On an unknown date(s), the patients were vaccinated with improperly stored PROQUAD lot # M042497, expiry: 17-APR-2018 for prophylaxis (incorrect product storage). The sterile diluent used to reconstitute the PROQUAD was properly stored. No symptoms reported. Temperature excursion details were as follows: Temperature: -13 degree Centigrade Time frame: 3 hours and 20 minutes (cumulative total). The call was due to a data logger. There were no previous temperature excursions. No Product Quality Complaint (PQC) was involved.
Sex: M
Vaccine: HPV4
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report was received from a physician regarding a 12 year old male patient. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date in 2012 (5 years ago, as reported), the patient was vaccinated with second dose of GARDASIL (lot #, expiration date, dose and route were not reported), for prophylaxis. On an unknown date in 2012 (5 years ago, as reported), the patient experienced severe injection site reaction consisting of severe redness and swelling. On 09-AUG-2017, the patient went to physician to receive a dose of GARDASIL 9 as his third dose in the HPV series, but physician decided not to administer the dose. The outcome of injection site erythema and infusion site swelling was unknown. Causality assessment was not provided by the reporter. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: This spontaneous report as received from a consumer refers to a female patient of unknown age. The patient's medical history included arthritis and systemic lupus erythematosus. No drug allergies.  Approximately 2-3 years ago, the patient was vaccinated with ZOSTAVAX, intravenous for shingles prevention. Concomitant therapies included acyclovir (ACYCLOVIR). On 18-JUL-2017, the patient experienced herpes zoster although she received ZOSTAVAX (vaccination failure). She reached out to her health care professional (HCP) and pharmacist, and they prescribed antibiotics. No laboratory diagnostics/studies performed. The outcome of herpes zoster and vaccination failure is unknown. Causality was unknown. No Product Quality Complaint (PQC) was involved.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a pharmacist refers to an unspecified number of patients of unknown demographics. Patient's pertinent medical history, concurrent condition, concomitant medication and previous drug reactions/ allergies were not reported. On an unknown date, these patients were vaccinated with improperly stored doses of ZOSTAVAX lot # M037015, expiry date 22-NOV-2017, for prophylaxis (strength, dosing details and anatomical location were unknown). No adverse symptoms were reported. The vaccines were exposed to the temperature of 29.8 F. The vaccines had previous temperature excursions. No data logger was involved. Additional information has been requested.