chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
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 23-MAY-2014 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 29-JUN-2015, the patient was treated at a medical center for a vesicular outbreak that was diagnosed as severe shingles. The patient was prescribed famciclovir (FAMVIR) 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: U
Vaccine: RV5
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 ROTATEQ lot number reported as "M040367" with expiration date on 14-MAY-2018, administered orally (strength, dose and anatomical location 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-009507513-1706USA007354:
Sex: U
Vaccine: PPV
Symptoms: Hypersensitivity
Clinical narrative: This spontaneous report was received from a pharmacist via Pfizer regarding 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 PNEUMOVAX 23 (dose, frequency, route and lot number were not reported) for prophylaxis. On an unknown date the patient experienced allergic reaction (hypersensitivity). The pharmacist enquired of the patient can be vaccinated with Prevnar 13.  The outcome of hypersensitivity was unknown. The causality was not reported. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse practitioner and refers 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, the patients were vaccinated with improperly stored doses of GARDASIL 9 lot # L011846, expiration date 16-JUN-2017; lot L024993, expiration date 17-OCT-2017 (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursions of 33.6 degrees Fahrenheit for 49.5 hours and 34.8 degrees Fahrenheit for 7 hours. There was no product quality complaint involved. Data logger was involved. This is one of several reports received from the same reporter. Additional information is not expected because there was no consent to contact physician. Sender's Comments: US-009507513-1610USA010976.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse practitioner and refers 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, the patients were vaccinated with improperly stored doses of VAQTA lot # K012457, expiration date 04-JUN-2017; lot M011116, expiration date 17-JUN-2017 (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursions of 33.6 degrees Fahrenheit for 49.5 hours and 34.8 degrees Fahrenheit for 7 hours. There was no product quality complaint involved. Data logger was involved. This is one of several reports received from the same reporter. Additional information is not expected because there was no consent to contact physician.; Sender's Comments: US-009507513-1610USA010976:
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse practitioner and refers 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, the patients were vaccinated with improperly stored doses of PNEUMOVAX 23 lot # M018766, expiration date 15-OCT-2017 (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursions of 33.6 degrees Fahrenheit for 49.5 hours and 34.8 degrees Fahrenheit for 7 hours. There was no product quality complaint involved. Data logger was involved. This is one of several reports received from the same reporter. Additional information is not expected because there was no consent to contact physician.; Sender's Comments:  US-009507513-1610USA010976:
Sex: F
Vaccine: PNC13
Symptoms: Adverse reaction, Pain in extremity, Peripheral swelling, Rheumatoid arthritis, Skin warm
Clinical narrative: This is a spontaneous report from a non-contactable consumer. A female patient of an unspecified age and race received PREVNAR13, (NDC number: 0005-1971-01, lot S15227, exp.date Feb2018) for immunization at 0.5ml single dose on unknown date. Relevant medical history and concomitant medications were not reported. On unknown date the patient experienced rheumatoid arthritis, and a reaction in her arm where it's hot and swollen and painful. The outcome of the events were unknown. No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: PNC13
Symptoms: Contusion, Swelling
Clinical narrative: This is a spontaneous report from a contactable pharmacist via Pfizer sales representative. A patient of an unspecified age, race and gender received PREVNAR 13 for immunization at single dose via an unspecified route on unknown date. Relevant medical history and concomitant medications were unknown. On unknown date the patient experienced swelling and bruising. The outcome of the events were unknown.
Age: 0.42
Sex: M
Vaccine: PNC13
Symptoms: Contusion, Gingival bleeding, Immune thrombocytopenic purpura, Immunoglobulin therapy, Injection site bruising
Clinical narrative: On 6/14 my son received PREVNAR 13 vaccination, his body temp at the time was 99.4 was indicated as normal by primary pediatric and okay to administrator vaccine. On 6/16 my wife and I noticed small red spots under my son's chin, but didn't think anything of it. My mom who is a nurse we saw on 6/17 identified it as petechia, she told us to watch it if it continues. On 6/18/17 my wife and I noticed that petechia increased to all extremities, body, including feet, hands, ears, head, rectal, and groin areas. We went to urgent care and doctor mentioned it was something that ER needed to see. We went to hospital and blood work was done identifying low platelet counts of 7,000 normal range is 150k-450k. We were admitted, doctor also noticed bruising in the leg areas and low back which did not appear until we were in the ER. Additionally, my son had bleeding on his gums we thought was related to teething or him putting his hands in his mouth, but believe now related to diagnosis of ITP. He is being treated now with IVIG and bloodwork will be completed at 12pm, at the time of my writing this is 9am, infusion was started at 3:45AM. My son was completely healthly prior to his vaccination of PREVNAR 13. We have been staggering the vaccinations and have completed ROTO, DTAP, HEP-B and just now started the PREVNAR 13. I believe PREVNAR 13 caused this issue and was directly responsible for entry into the ER.
Age: 0.42
Sex: M
Vaccine: PNC13
Symptoms: Petechiae, Platelet count decreased, Rash erythematous
Clinical narrative: On 6/14 my son received PREVNAR 13 vaccination, his body temp at the time was 99.4 was indicated as normal by primary pediatric and okay to administrator vaccine. On 6/16 my wife and I noticed small red spots under my son's chin, but didn't think anything of it. My mom who is a nurse we saw on 6/17 identified it as petechia, she told us to watch it if it continues. On 6/18/17 my wife and I noticed that petechia increased to all extremities, body, including feet, hands, ears, head, rectal, and groin areas. We went to urgent care and doctor mentioned it was something that ER needed to see. We went to hospital and blood work was done identifying low platelet counts of 7,000 normal range is 150k-450k. We were admitted, doctor also noticed bruising in the leg areas and low back which did not appear until we were in the ER. Additionally, my son had bleeding on his gums we thought was related to teething or him putting his hands in his mouth, but believe now related to diagnosis of ITP. He is being treated now with IVIG and bloodwork will be completed at 12pm, at the time of my writing this is 9am, infusion was started at 3:45AM. My son was completely healthly prior to his vaccination of PREVNAR 13. We have been staggering the vaccinations and have completed ROTO, DTAP, HEP-B and just now started the PREVNAR 13. I believe PREVNAR 13 caused this issue and was directly responsible for entry into the ER.
Sex: F
Vaccine: TDAP
Symptoms: White matter lesion
Clinical narrative: This case was reported in a literature article and described the occurrence of acute disseminated encephalomyelitis in a 56-year-old female patient who received dTpa vaccine. The patient's past medical history included pituitary adenoma (asymptomatic pituitary adenoma). On an unknown date, the patient received dTpa vaccine at an unknown dose. On an unknown date, 21 days after receiving dTpa vaccine, the patient experienced acute disseminated encephalomyelitis (serious criteria GSK medically significant), myelopathy (serious criteria GSK medically significant), brain stem dysfunction (serious criteria GSK medically significant), cerebellar disorder, pleocytosis and white matter hyperintensities. On an unknown date, the outcome of the acute disseminated encephalomyelitis, myelopathy, brain stem dysfunction, cerebellar disorder, pleocytosis and white matter hyperintensities were unknown. The reporter considered the acute disseminated encephalomyelitis, myelopathy, brain stem dysfunction, cerebellar disorder, pleocytosis and white matter hyperintensities to be possibly related to dTpa vaccine. Additional information was provided. This case was reported in a literature article and described the occurrence of acute disseminated encephalomyelitis in a 56-year-old female patient who was vaccinated with unspecified Tdap vaccine (manufacturer unknown). The patient had a history of asymptomatic pituitary adenoma. No information on patient's family history or concomitant medication was provided. On an unspecified date, the patient received unspecified Tdap vaccine (administration route and site unspecified; dosages unknown; batch number not provided). The age of vaccination was not provided. On an unspecified date between July and October 2016, 3 weeks after vaccination, the patient presented with subacute progressive multifocal neurological symptoms including myelopathic, brainstem, and cerebellar deficits. Repeated magnetic resonance imaging (MRIs) demonstrated multifocal and progressive T2/FLAIR hyperintensities of the cauda equina, long spinal cord segments, supratentorial and infratentorial brain white matter, with scattered associated contrast enhancement. Cerebrospinal fluid, clear (CSF) was notable for lymphocytic pleocytosis with 128 White blood cells (WBCs) (normal range not provided) and elevated protein (value and normal range not provided). Extensive infectious, neoplastic/paraneoplastic, and autoimmune workup was unrevealing. Subsequently, the clinical diagnosis of acute disseminated encephalomyelitis thought to be secondary to Tdap vaccination was made. Treatment was unknown. The outcome of the event was not reported. The authors considered the event of acute disseminated encephalomyelitis possibly associated to unspecified Tdap vaccine. The author concluded, "This two patient case series provides further evidence for a possible association between Tdap vaccination and acute demyelinating events." This is 1 of 2 valid cases in the same literature article.
Age: 56.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Pain in extremity
Clinical narrative: Patient presented a few hours after administration with soreness in arm. Twenty-four hours later she presented with redness, swelling, warmness and pain in entire upper half of left arm.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to a patient of unknown age and gender. No information on the patient's concomitant medications, concurrent conditions, pertinent medical history, drug reactions or allergies was reported. On an unknown date, the patient received an improperly stored dose of PROQUAD (recombinant human albumin), lot # M036158, expiry date: 12-FEB-2018 (dose and route of administration were not provided) reconstituted with sterile diluent (STERILE DILUENT) (lot # and expiry date were not reported) (captured in linked report # 1706USA000951). The data logger detected that the products had been stored in temperature from -14 to -10 degrees Celsius for 70 minutes. No previous temperature excursion was reported. No adverse effects were reported. This is one of two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1706USA000951.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions or medical histories provided. On unknown dates from 19-MAY-2017 to 08-JUN-2017, the patients were vaccinated with improperly stored doses of ZOSTAVAX lot # M040146, expiration date 26-SEP-2018 (dose and route of administration were not reported) for prophylaxis. There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 15 to 46 degrees Fahrenheit for 1 hour 30 minutes. Concomitant therapies included sterile diluent (lot# M010689 with expiration date 11-MAR-2018) which was not improperly stored. Data logger was involved. There were no previous excursions reported. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Emotional distress, Herpes zoster, Nerve injury, Neuralgia
Clinical narrative: Information was received on 14-JUN-2017 regarding a case in litigation concerning a female (age not reported). Medical history, concurrent conditions and concomitant medications were not reported. On or about 08-APR-2014 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 26-NOV-2016 the patient was treated by a nurse practitioner for a vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster, or shingles. On or about 12-DEC-2016 she was treated further by another nurse practitioner for worsening symptoms. On or about 09-JAN-2017 the patient was treated by a physician assistant at a medical center, at which time she was diagnosed with post herpetic neuralgia, a chronic condition involving residual nerve pain and damage secondary to shingles.  The patient was prescribed gabapentin and trimethoprim (+) sulfamethoxazole (BACTRIM) for management of her ongoing 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: Post herpetic neuralgia, Rash vesicular
Clinical narrative: Information was received on 14-JUN-2017 regarding a case in litigation concerning a female (age not reported). Medical history, concurrent conditions and concomitant medications were not reported. On or about 08-APR-2014 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 26-NOV-2016 the patient was treated by a nurse practitioner for a vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster, or shingles. On or about 12-DEC-2016 she was treated further by another nurse practitioner for worsening symptoms. On or about 09-JAN-2017 the patient was treated by a physician assistant at a medical center, at which time she was diagnosed with post herpetic neuralgia, a chronic condition involving residual nerve pain and damage secondary to shingles.  The patient was prescribed gabapentin and trimethoprim (+) sulfamethoxazole (BACTRIM) for management of her ongoing 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: Blindness, Disability, Impaired work ability, Ophthalmic herpes zoster, Pain
Clinical narrative: Information was received on 14-JUN-2017 regarding a case in litigation concerning a female of unknown age. Medical history, concurrent conditions and concomitant medications were not reported. On or about 02-NOV-2014, the patient was inoculated with ZOSTAVAX (lot number, dosage, and route of administration not provided) at a pharmacy as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, but but rather caused the patient to contract a persistent strain of herpes zoster. On or about 11-JUN- 2015, the patient broke out with vesicular pustules on her face and in her eyes. On or about 15-JUN-2015, she  was treated by a physician for ongoing and worsening symptoms of this outbreak,  which was diagnosed as severe herpes zoster. The physician gave the patient a note precluding her from returning to work for a period of three weeks due to the severity of her condition. The shingles had spread to her eyes, and the patient was referred to ophthalmologic specialists; who diagnosed that herpes zoster had resulted in damage to the eye and have deemed the patient as clinically blind. The patient received ongoing treatment for her painful symptoms, and is permanently disabled by her blindness and severe facial scarring. The patient is unable to resume working due to her condition and has become largely homebound as a result. 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, she  has suffered and will continue to suffer significant medical expenses, and pain and suffering, lost wages, and other damages. Blindness and severe facial scarring were considered disabling. Upon internal review the event of shingles spread to her eyes, damage to the eyes and the patient as clinically blind was determined to be medically significant.
Sex: F
Vaccine: VARZOS
Symptoms: Rash pustular, Scar
Clinical narrative: Information was received on 14-JUN-2017 regarding a case in litigation concerning a female of unknown age. Medical history, concurrent conditions and concomitant medications were not reported. On or about 02-NOV-2014, the patient was inoculated with ZOSTAVAX (lot number, dosage, and route of administration not provided) at a pharmacy as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, but but rather caused the patient to contract a persistent strain of herpes zoster. On or about 11-JUN- 2015, the patient broke out with vesicular pustules on her face and in her eyes. On or about 15-JUN-2015, she  was treated by a physician for ongoing and worsening symptoms of this outbreak,  which was diagnosed as severe herpes zoster. The physician gave the patient a note precluding her from returning to work for a period of three weeks due to the severity of her condition. The shingles had spread to her eyes, and the patient was referred to ophthalmologic specialists; who diagnosed that herpes zoster had resulted in damage to the eye and have deemed the patient as clinically blind. The patient received ongoing treatment for her painful symptoms, and is permanently disabled by her blindness and severe facial scarring. The patient is unable to resume working due to her condition and has become largely homebound as a result. 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, she  has suffered and will continue to suffer significant medical expenses, and pain and suffering, lost wages, and other damages. Blindness and severe facial scarring were considered disabling. Upon internal review the event of shingles spread to her eyes, damage to the eyes and the patient as clinically blind was determined to be medically significant.
Age: 62.0
Sex: M
Vaccine: FLUC3
Symptoms: Abasia, Decreased appetite, Dysgeusia, Dysgraphia, Hypoacusis
Clinical narrative: Darkening of vision, loss of appetite, bad taste in mouth, weakness in arms and legs, unable to walk or write name, diminished hearing, loss 70 pounds.
Age: 62.0
Sex: M
Vaccine: FLUC3
Symptoms: Laboratory test, Muscular weakness, Visual impairment, Weight decreased
Clinical narrative: Darkening of vision, loss of appetite, bad taste in mouth, weakness in arms and legs, unable to walk or write name, diminished hearing, loss 70 pounds.
Age: 18.0
Sex: F
Vaccine: HEPA, HPV9, MENB, MNQ
Symptoms: Asthenia, Dizziness, Feeling abnormal, Feeling hot, Nausea
Clinical narrative: Client reported of pain in left arm shooting down arm on 6/14/2017. On 6/15/2017 client reported of feeling weak, dizzy, foggy, nauseous, hot and stinging inside of her body but skin is warm to touch.
Age: 18.0
Sex: F
Vaccine: HEPA, HPV9, MENB, MNQ
Symptoms: Pain, Pain in extremity, Skin warm
Clinical narrative: Client reported of pain in left arm shooting down arm on 6/14/2017. On 6/15/2017 client reported of feeling weak, dizzy, foggy, nauseous, hot and stinging inside of her body but skin is warm to touch.
Age: 25.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site nodule, Injection site swelling
Clinical narrative: Bulging knot on injection area about 2"x2".
Age: 0.25
Sex: M
Vaccine: DTAPIPV, HIBV, PNC13, RV5
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: None.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Stomatitis, Swollen tongue, Tongue erythema, Vaccination complication
Clinical narrative: Left side of tonugue felt like it was selling up on 06/05/2017. 06/06/2017 left underneath of tonugue had bright red sore patch on it & bed of mouth sore. So I called Dr. & made appt. He said it was an adverse reaction to varicella virus live vaccine. And prescribed two prescriptions. Magic Mouthwash & Fluocinonide Gel. After buying I found out this gel is for external use only. So was told not to use it. I used the Magic Mouthwash.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Gingival discomfort, Oral disorder, Pain, Rash vesicular, Tongue ulceration
Clinical narrative: Left side of tonugue felt like it was selling up on 06/05/2017. 06/06/2017 left underneath of tonugue had bright red sore patch on it & bed of mouth sore. So I called Dr. & made appt. He said it was an adverse reaction to varicella virus live vaccine. And prescribed two prescriptions. Magic Mouthwash & Fluocinonide Gel. After buying I found out this gel is for external use only. So was told not to use it. I used the Magic Mouthwash.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse and refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' pertinent medical histories, drug reactions or allergies and concomitant therapies was provided. On unknown dates from 25-APR-2017 to 24-MAY-2017, the patients were vaccinated with improperly stored doses of VAQTA lot # M038572, expiration date 11-MAR-2018 (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 47 degrees Fahrenheit to 77 degrees Fahrenheit for 30 minutes. Data logger was involved. There were no previous excursions reported. No product quality complaint was involved. 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 medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On 26-MAY-2017, around 09:45 AM, VARIVAX injection (dose, route and site of administration, lot number and expiration date were not reported) was reconstituted with properly stored MERCK STERILE DILUENT injection (dose, route and site of administration, lot number and expiration date were not reported). The reconstituted vaccine was stored in temperature of 36-46 degrees Fahrenheit for approximately 3 hours and 45 minutes, until it was administered to the patient on the same day, around 1:30 PM. No adverse effects were reported. There was no product quality complaint involved. 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 and refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' pertinent medical history, drug reactions or allergies and concomitant medications was provided. On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX injection (lot # M039317, expiration date: 20-SEP-2018; lot # M034583, expiration date: 27-JUL-2018; lot # M028546, expiration date: 07-JUN-2018); exact doses and route of administration were not reported). Concomitant therapy included well-stored sterile diluent (MERCK STERILE DILUENT) used to reconstitute doses of VARIVAX. The reporter stated that the administered doses of VARIVAX were stored at temperature between 15 to 46 degrees Fahrenheit (F) for 9 hours on unknown dates. Data logger was used to detect temperature excursions. There were no previous excursions reported. The physician stated that the sterile diluent (MERCK STERILE DILUENT) did not undergo a temperature excursion. No adverse effects were reported. No product quality complaint was involved. This is one of two reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1706USA004392:
Age: 17.0
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 25-year-old patient of unknown gender. No information regarding the patient's concurrent conditions, medical history and concomitant therapies was reported. On 05-APR-2010 and on 08-NOV-2010, the patient was vaccinated with the first and the second dose of GARDASIL (dose, route of administration, lot# and expiration date were not reported), respectively. On an unknown date in March 2017, instead of receiving the third dose of GARDASIL, the patient received a dose of GARDASIL 9 injection, lot# M035486, expiration date: 05-JUN-2019 (dose and route of administration were not reported). No adverse effects were reported. Additional information is not expected as there was no consent to contact the reporter.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to 2 unspecified patients of unknown age and gender. No information about the patients' pertinent medical history, concomitant medications, drug reactions or allergies was provided. On 05-MAY-2017, the patients were vaccinated with doses of improperly stored VARIVAX lot # M027344 with expiration date on 01-JUN-2018 (dose and route of administration were not reported). The vaccine underwent a temperature excursion of 13 degrees Fahrenheit for 9 hours. Digital data logger was used to record the excursion. The vaccine underwent previous temperature excursion of 7 degrees Fahrenheit for 17 hours and 30 minutes. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.; Sender's Comments: US-009507513-1706USA007148: US-009507513-1706USA007149: US-009507513-1706USA007150: US-009507513-1706USA007151: US-009507513-1706USA007152: US-009507513-1706USA007153: US-009507513-1706USA007154:
Sex: F
Vaccine: VARCEL
Symptoms: Cough, Pyrexia, Rash, Rash pustular, Respiratory tract congestion
Clinical narrative: This spontaneous report was received from a registered nurse reporting on a female patient of unknown age (the reporter's sister-in-law). No information was provided regarding the patient's pertinent medical history, concurrent conditions, concomitant medications, drug reactions or allergies. On 17-MAY-2017, the patient's daughter was vaccinated with VARIVAX injection (dose, frequency, lot number or expiration date were not reported), for prevention of chickenpox. The vaccine was reconstituted with the Merck (MRK) sterile diluent (lot # and expiration date were not reported). Over the following weekend, the patient's daughter developed "a bumpy, pox-like" rash across her body that could have actually been mosquito bites (captured in MARRS# 1705USA012785). On an unknown date in May 2017 (reported as "over the following weekend"), the patient developed a fever, rash (not described), cough and congestion, which was reported as either potential upper respiratory infection or secondary transmission of VARIVAX virus from the patient's daughter. The outcome of the events was not reported. The causality assessment between the events and VARIVAX was not provided. This is one of several reports received from the same reporter. Additional information is not expected as there was no consent for follow-up.; Sender's Comments: US-009507513-1705USA012785: US-009507513-1706USA004797:
Sex: U
Vaccine: HPV4
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a physician and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions, allergies and concomitant therapies was reported. On 09-JUN-2017, the patient was vaccinated with an expired dose of GARDASIL lot # M014929, expiration date: 27-MAY-2017 (dose and route of administration were not provided). No adverse effects were reported. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Eye pruritus, Pruritus generalised
Clinical narrative: This spontaneous report was received from a physician via company representative and refers to a male patient in his sixties. The patient's pertinent medical history, drug reactions or allergies, and concomitant therapies were unknown by the reporter. On an unknown date, the patient was vaccinated with ZOSTAVAX subcutaneously (strength, dose, lot number and expiration date were not reported) for prevention of shingles. Other suspect therapies included sterile diluent (strength, dose, frequency route, lot number, expiration date and indication were not reported). On an unknown date, the patient experienced "extreme itching in his eyes (eye pruritus) and all over his entire body (pruritus generalized)". The patient sought medical attention by contacting the physician's office and he received unspecified treatment for the events. At the time of reporting, the patient was 90% recovered. The causal assessment between the events and the suspect therapies ZOSTAVAX and sterile diluent was not provided. Additional information has been requested.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a licensed practical nurse concerning an unspecified patient (age and gender unknown). The nurse reported that on an unspecified date, an unspecified patient may have received one of the improperly stored lots, but she was not sure which of the vaccines the unspecified patient received. Names of vaccines involved: PROQUAD lot # M044720, expiration date 07-MAY-2018, (dosage and route of administration not provided) or VARIVAX lot #M017290, expiration date 07-APR-2018, (dosage and route of administration not provided). The vaccines were reconstituted with Merck sterile water diluent (lot number not provided) which was not improperly stored. Temperature: In the range 15°F to 46°F Time frame: 17 hours Previous temperature excursion: No Data logger involved: Yes. No adverse effects reported. No additional information was provided. 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 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 03-NOV-2014 (dosage, route 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 and chronic strain of herpes zoster.  On or about 07-JUN-2015, the plaintiff was treated by a physician for blistering vesicular lesions accompanied by weakened immune symptoms and severe discomfort and distress which was diagnosed as severe herpes zoster on the face.  The plaintiff has been prescribed hydrocodone and gabapentin for management of her painful and persistent 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: 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 03-NOV-2014 (dosage, route 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 and chronic strain of herpes zoster.  On or about 07-JUN-2015, the plaintiff was treated by a physician for blistering vesicular lesions accompanied by weakened immune symptoms and severe discomfort and distress which was diagnosed as severe herpes zoster on the face.  The plaintiff has been prescribed hydrocodone and gabapentin for management of her painful and persistent 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: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Post herpetic neuralgia, Rash vesicular
Clinical narrative: Information was received from a lawyer regarding a case in litigation concerning a male 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, administered by a physician, on or about 03-JUL-2012 (dosage, route 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 05-AUG-2015 the plaintiff was treated by a nurse practitioner for a vesicular outbreak that was diagnosed as severe shingles.  On or about 04-APR-2016 the patient was treated by the nurse practitioner at the offices of the physician who had administered ZOSTAVAX, for ongoing and worsening symptoms, which was then diagnosed as post-herpetic neuralgia.  The plaintiff was prescribed acyclovir (VALTREX), acyclovir, lidocaine, amitriptyline, gabapentin and tramadol for ongoing treatment of his unmanaged persistent 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: M
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Emotional distress, Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information has been received on 14-JUN-2017 from a lawyer and a male 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 28-SEP-2015 at a county health department 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 15-OCT-2015, the patient was treated by a physician for the onset of a vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster or shingles. The patient was prescribed famciclovir (FAMIR) 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, and pain and suffering and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Emotional distress, Herpes zoster, Post herpetic neuralgia, Rash, 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. The patient was inoculated  with a dose of ZOSTAVAX (lot and expiration not reported) vaccine on or about 13-FEB-2013 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 contract a persistent strain of herpes zoster and post herpetic neuralgia. On or about 12-AUG-2016,  the patient was treated by a physician for a blistering vesicular outbreak which was then diagnosed as severe herpes zoster, or shingles. On or about 17-AUG-2016, the patient sought additional treatment from another physician for worsening symptoms, and the diagnosis of shingles was affirmed. On or about 09-SEP-2016, the patient sought care from a third physician, who affirmed the diagnosis of herpes zoster and began a regiment of gabapentin (manufacturer unknown) to curb her symptoms. On or about 21-MAR-2017, the patient was treated at a hospital for a new painful outbreak that onset on or about 02-JAN-2017 and had continued to cause severe residual pain. At this encounter, the patient was diagnosed with post herpetic neuralgia; a chronic condition of nerve pain and permanent residual damage secondary to shingles. The patient continues to be prescribed gabapentin (manufacturer unknown) at increased dosages, in attempts to manage 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.
Age: 1.58
Sex: F
Vaccine: DTAP, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Injection site nodule, Injection site swelling
Clinical narrative: Do not know the time or day that the symptoms first occurred. Patient was fine when she left after being vaccinated, other than that she jerked free from parents hold and kicked her leg when the injection was in her leg but I instructed them about a cool washcloth or covered ice pack if needed. Several days later, my supervisor informed me that the Grandmother (who was not at the visit) had called and spoke to the Health Department, and stated that the limb in which the Dtap was given (the left, which would have been the same leg she kicked during the injection) was entirely swollen and that there was a knot in both limbs. She took her to the Emergency room, where the physician said her lymph nodes were swollen, which happens when the vaccinations are working and building antibodies. My supervisor told me that patient has recovered. I do not know any other details as I was not the person contacted.
Age: 3.0
Sex: F
Vaccine: FLU4
Symptoms: Guillain-Barre syndrome, Paralysis
Clinical narrative: PARALYSIS OR G-B SYNDROME. PARALYSIS 10-31-2016. VACCINE 10-04-2016.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Chest pain, Erythema, Musculoskeletal pain, Pruritus, Pyrexia
Clinical narrative: Warm to touch, rash, and pain in upper shoulder and chest. Low grade fever.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Rash, Skin irritation, Skin warm
Clinical narrative: Warm to touch, rash, and pain in upper shoulder and chest. Low grade fever.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: 7cm x 7cm area to left deltoid redden, swollen, and hot to touch. No bruising noted. Discussed use of OTC pain relievers and warm compresses to site.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Death, Sudden infant death syndrome
Clinical narrative: SIDS. Patient died 6-15-17 in sleep.
Age: 40.0
Sex: F
Vaccine: PPV
Symptoms: Fatigue, Injection site pain, Injection site rash, Nausea, Pain
Clinical narrative: Pt. Presented with Nausea, body aches, fever 101F, rash and pain to injection site, general tiredness.
Age: 40.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: Pt. Presented with Nausea, body aches, fever 101F, rash and pain to injection site, general tiredness.
Age: 74.0
Sex: M
Vaccine: PPV
Symptoms: Injection site swelling, Injection site warmth, Peripheral swelling, Skin warm
Clinical narrative: Right arm swelling from shoulder to wrist, warm to touch, very swollen after receiving PNEUMOVAX 23 on 6/3/17 at Pharmacy.
Age: 16.0
Sex: F
Vaccine: TYP
Symptoms: Dizziness, Syncope
Clinical narrative: Dizziness and fainting; provider called the patient the next day and they were fine.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported. On 26-MAY-2017, the patient was vaccinated with an expired dose of ZOSTAVAX (dose and route of administration were not reported) lot # L039094, expiration date: 08-JAN-2017 for prophylaxis which was reconstituted with sterile water diluent (MERCK STERILE DILUENT) (lot number and expiration date were not provided).  No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse who referred to an unspecified patient of unknown demographics. The patient's pertinent medical history, concomitant therapies and drug reactions or allergies were not reported. On 18-MAY-2017, the patient was administered an expired dose of PNEUMOVAX 23 (lot# L031459 and expiration date: 30-APR-2017; dose, route of administration and anatomical location were not reported) as prophylaxis. No adverse effects were reported. No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a physician via a company representative and refers to two elderly (their ages were reported to be between 65 and 70) patients of unknown gender. No information regarding the patients' pertinent medical history, concomitant medications, drug reactions or allergies was provided. On unknown dates, the patients were vaccinated with ZOSTAVAX injection (dose, route of administration, lot number and expiration date were not reported) to prevent shingles. On unknown dates, a couple of years after vaccination, the patients developed shingles. There was no product quality complaint involved. The outcome of the shingles and the relatedness between shingles and ZOSTAVAX were not reported. Additional information is not expected as no consent to contact the physician was granted.