chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 60 year old female patient. On 17-JUL-2017, the patient was vaccinated with ZOSTAVAX, subcutaneous for prophylaxis. On 18-JUL-2017, 2 days after onset of therapy, the patient experienced injection site erythema, injection site induration, injection site warmth and injection site swelling. The outcome of injection site erythema, injection site induration, injection site warmth and injection site swelling was reported as not recovered/not resolved. Causality assessment was not provided. Additional information has been requested.
Age: 38.0
Sex: M
Vaccine: MMR
Symptoms: Measles antibody negative
Clinical narrative: This spontaneous report as received from a nurse concerning a 38 year old male patient with hypothyroidism. It was reported that the patient did not experienced drug reactions or allergies. The nurse reported that the patient who on an unknown date, started prednisone (manufacturer unknown) tablet, orally (strength, dose, frequency, route of administration, lot number and expiration date were not provided) an immunosuppressive therapy for asthma, on 20-JUN-2017, inadvertently received a first dose of M-M-R II, lot # M048368, expiration date: 08-DEC-2017, (strength, frequency, route of administration were not provided) for prophylaxis. Concomitant therapies included zolpidem, fluticasone propionate, ADVAIR and albuterol. According with the nurse the patient received the first dose of the vaccine, in this date. However there were records from childhood was received and it was also mentioned that the nurse stated prior to vaccination, patient had titers drawn (Measles antibody negative) and did not show immunity to Measles, Mumps, Rubella. Per nurse, patient experienced no adverse effects. No treatment was given for the adverse event. It was reported that the patient was doing fine. The patient did not seek the medical attention. There was no product quality complaint (PQC) involved.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, 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 2015, the patient was inoculated with the 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 01-DEC-2015, the patient was treated at a physicians office for a painful and blistering vesicular outbreak, 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, pain and suffering, and other damages. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Ophthalmic herpes zoster, Pain, Rash vesicular
Clinical narrative: Information was received on 25-JUL-2017 from a lawyer regarding a case in litigation concerning a male patient of unknown age.  Medical history, concurrent conditions, or concomitant medication was 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 11-APR-2012 at a pharmacy as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 16-DEC-2016 the patient was treated by a physician for blistering vesicular outbreak which had spread to the eyes and was then diagnosed as herpes zoster, or shingles with ophthalmic interference. The patient was treated again by the physician for ongoing and worsening symptoms of blisters forming on the eyes and forehead. The patient was prescribed acyclovir to help manage his recurrent 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: M
Vaccine: VARZOS
Symptoms: Vaccination failure
Clinical narrative: Information was received on 25-JUL-2017 from a lawyer regarding a case in litigation concerning a male patient of unknown age.  Medical history, concurrent conditions, or concomitant medication was 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 11-APR-2012 at a pharmacy as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 16-DEC-2016 the patient was treated by a physician for blistering vesicular outbreak which had spread to the eyes and was then diagnosed as herpes zoster, or shingles with ophthalmic interference. The patient was treated again by the physician for ongoing and worsening symptoms of blisters forming on the eyes and forehead. The patient was prescribed acyclovir to help manage his recurrent 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: U
Vaccine: HPVX
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. No concurrent conditions, medical history, allergy/drug reactions and concomitant medications were reported. On an unknown date in 2015, the patient was administered with the first dose of the unidentified Merck hpv vaccine GARDASIL 9 or GARDASIL (lot#, expiry date, dosing details not provided) for prophylaxis. On 25-JUL-2017, the patient was vaccinated the second dose of GARDASIL 9 or GARDASIL (inappropriate schedule of drug administration).  No adverse effects were reported. There were no product quality complaints (PQC) involved.
Age: 11.0
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a other health professional refers to a 11 year old patient.    On an unknown date the patient was vaccinated with GARDASIL 9 for prophylaxis. On 26-JUL-2017 the patient experienced inappropriate schedule of drug administration. On an unknown date the patient experienced no adverse event. The outcome of inappropriate schedule of drug administration and no adverse event is unknown. The reporter considered inappropriate schedule of drug administration and no adverse event to be not related to GARDASIL 9.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Peripheral swelling
Clinical narrative: Pt came in and her arm was swollen from shot site down to forearm.
Age: 50.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site pain, Muscle fatigue, Swelling
Clinical narrative: Got the shot from a nurse, which hurt a fair amount, but didn't think much of it. Shot site sore as expected initially, but then got increasingly worse that evening, to the point of severe pain which kept me awake all night, and had difficulty moving and lifting arm (literally hard to move, not only because it hurt). Also, there has been swelling in the upper right arm muscle, which is causing the muscle to not function properly. Although the swelling improved a little bit (helped by massage from an OT 10 days after injection), it continued even three weeks later and caused pain in other areas of the shoulder and arm due to having to compensate. Now it is a month later and it is more improved in terms of swelling, but not 100% because muscle still tired sometimes (while filling this in!).
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Mobility decreased, Pain in extremity, Skin warm
Clinical narrative: About 4:30 Lt arm sore. By 5 difficulty raising arm. 6PM could not move arm from shoulder to elbow; arm extremely painful to the touch and warm. Started taking Tylenol 500mg max.dose. Have had gastric bypass so no NSAIDS. Warm wet compress & heating pad. Could not lie on Lt side. Arm painful to the touch. These symptoms lasted 48 hrs. Wed about 5 pm i could move my arm 4-5 inches from my body. By 9 pm i could l lift over head with pain and much effort. Continued with Tylenol reduced dose for 3 more days. Arm sore until Monday 7 days after injection. I was in contact with my PCP and my daughter is an NP so did not go in to be seen I'm an RN, PHN, retired after 42+ years and have never had a reaction to any vaccine like this.
Age: 26.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Ear discomfort, Injection site erythema, Lymphadenopathy, Throat tightness, Urticaria
Clinical narrative: 07/26/2017 9:00 pm client reports, felt ears begin to stop up and throat began to feel tight. Noted lymph nodes to throat area were swollen. She noted few raised red whlelps at the vaccine site to the left arm. Reports, had chicken pox as a child at age 7. 07/27/2017 09:15 am client phone clinic and instructed to come to clinic and VAERS would be completed.
Age: 26.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Vaccination site reaction
Clinical narrative: 07/26/2017 9:00 pm client reports, felt ears begin to stop up and throat began to feel tight. Noted lymph nodes to throat area were swollen. She noted few raised red whlelps at the vaccine site to the left arm. Reports, had chicken pox as a child at age 7. 07/27/2017 09:15 am client phone clinic and instructed to come to clinic and VAERS would be completed.
Age: 44.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Peripheral swelling, Pyrexia
Clinical narrative: Left arm became red, swollen, and developed a high fever.
Age: 18.0
Sex: M
Vaccine: HPV9, MENB
Symptoms: Dizziness, Headache, Loss of consciousness, Neck pain
Clinical narrative: PATIENT PASSED OUT EVEN AFTER SITTING IN THE EXAM ROOM FOR 10 MINS AFTER IMMUNIZATION HAD TO BE TAKEN TO THE ER BY AMBULANCE , STILL AFTER A HALF HOUR COMPLAINING OF DIZZINESS AND HEAD/NECK PAIN.
Sex: M
Vaccine: DTAP
Symptoms: Pertussis, Vaccination failure
Clinical narrative: This case was  reported by a other health professional via sales rep and described the occurrence of vaccination failure in a 3-year-old male patient who received INFANRIX. Co-suspect products included INFANRIX, INFANRIX and INFANRIX. On an unknown date, the patient received the 1st dose of INFANRIX, the 2nd dose of INFANRIX, the 3rd dose of INFANRIX and the 4th dose of INFANRIX. In July 2017, unknown after receiving INFANRIX, INFANRIX, INFANRIX and INFANRIX, the patient experienced vaccination failure (serious criteria GSK medically significant) and pertussis (serious criteria GSK medically significant). On an unknown date, the outcome of the vaccination failure and pertussis were unknown. It was unknown if the reporter considered the vaccination failure and pertussis to be related to INFANRIX, INFANRIX, INFANRIX and INFANRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient was diagnosed with pertussis two and a half weeks ago after being administered an INFANRIX vaccine at his 15 month old visit. The exact diagnosis written by the physician was bordetella parapertussis. The patient was fully vaccinated at County Health prior to coming to this office to receive his 4th scheduled dose of INFANRIX. The field representative also noted that the office manager said they had seen 4 cases of pertussis. Two were from unvaccinated children. This case was linked to case US2017113119, reported by the same reporter.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Peripheral swelling, Pruritus, Rash
Clinical narrative: Pt came to ER with complaints of rash on right deltoid, hands itching, swollen rt arm. Pt had received 3 vaccinations at clinic on 7/24/17--HPV, meningococcal, and tetanus. I don't know any more details about the names of the vaccines that what is listed here. Clinic should have this information, as well is it should be listed in the vaccines database, which I do not have access to.
Age: 32.0
Sex: M
Vaccine: RAB
Symptoms: Anxiety, Arthralgia, Confusional state, Feeling abnormal, Headache
Clinical narrative: Went in for the rabies vaccine and when I came out I had the usual side effects: feeling nauseous, headache, pain, flu-like symptoms. However, starting the next day (12 July 2017), I began feeling worse with the flu-like symptoms - severe symptoms-severe muscle aches, severe headaches, severe confusion/unclear or foggy head/sight, etc. I take my last booster tomorrow, and right now my head is very foggy, I have a severe headache, all of my joints hurt bad, and I'm extremely anxious right now. This is one of the worst things I've dealt with medically in my life.
Age: 32.0
Sex: M
Vaccine: RAB
Symptoms: Influenza like illness, Myalgia, Nausea, Pain, Vision blurred
Clinical narrative: Went in for the rabies vaccine and when I came out I had the usual side effects: feeling nauseous, headache, pain, flu-like symptoms. However, starting the next day (12 July 2017), I began feeling worse with the flu-like symptoms - severe symptoms-severe muscle aches, severe headaches, severe confusion/unclear or foggy head/sight, etc. I take my last booster tomorrow, and right now my head is very foggy, I have a severe headache, all of my joints hurt bad, and I'm extremely anxious right now. This is one of the worst things I've dealt with medically in my life.
Age: 74.0
Sex: F
Vaccine: UNK
Symptoms: Erythema, Mobility decreased, Peripheral swelling, Skin warm
Clinical narrative: Pneumonia booster, arm swelled up, hot, could hardly move it.  In am the arm was even more swelled up and hot despite cold packs. Pain not quite as much but swelling moved into elbow and  arm looked red.
Age: 1.0
Sex: M
Vaccine: HIBV, MMR, PNC13, VARCEL
Symptoms: Rash, Scab, Skin lesion
Clinical narrative: Developed what was thought as rash on 7-14 early and lesions started at noon and became worse over next two days with crusted centers.
Age: 18.0
Sex: M
Vaccine: HPV9, MENB
Symptoms: Dizziness, Loss of consciousness
Clinical narrative: PATIENT GOT DIZZY AND PASSED OUT AFTER SITTING FOR 10 MINS.
Age: 1.25
Sex: M
Vaccine: MMR
Symptoms: Pyrexia, Rash
Clinical narrative: Fever and rash on chest, back and extremities.
Age: 0.5
Sex: F
Vaccine: RV1
Symptoms: Extra dose administered, No adverse event
Clinical narrative: A third dose of ROTARIX given at 6 month appt. Recommended is a 2 dose series. Patient asymptomatic currently.
Age: 1.08
Sex: M
Vaccine: VARCEL
Symptoms: Blister, Blood immunoglobulin A normal, Blood immunoglobulin E increased, Blood immunoglobulin G normal, Blood immunoglobulin M normal
Clinical narrative: This literature marketed report as received from a physician on a literature article refers to a 19 month old male patient. He had no personal history of varicella, no exposure to sick contacts with varicella, and no known exposure to the virus. The patient was otherwise completely healthy with no signs or symptoms of immunocompromise. The patient was up-to-date on his vaccinations. On an unknown date, at 13 months of age the patient received his first dose of vaccination with varicella virus vaccine live (oka/merck) (manufacturer unknown) (dose, route, lot/batch# were not reported) for prophylaxis. On an unknown date, 6 months after receiving vaccination he presented to the dermatology clinic with a rash that began 2 days prior on the right groin and spread to the right leg. The patient's mother denied that the child had been febrile and noted that the rash did not appear to bother him in any way. The physical examination revealed grouped vesicles on an erythematous base on the right thigh, right sacrum, and lower abdomen that did not cross the midline. There were no other pertinent physical examination findings. The eruption was most consistent with Herpes zoster (HZ) but concern remained for Herpes simplex virus (HSV) or impetigo. On an unknown date, a bacterial culture and polymerase chain reaction assay for Varicella zoster virus (VZV) and HSV from skin swabs was ordered. The patient was prescribed acyclovir (20 mg/kg every 6 hours) for 5 days. Laboratory testing revealed a positive result for VZV on polymerase chain reaction and a negative result for HSV. The majority of the patient's lesions had crusted after 2 days of treatment with acyclovir, and the rash had nearly resolved 1 week after presentation. Subsequent evaluation with a complete blood cell count with differential and basic metabolic profile was normal. Levels of IgG, IgA, and IgM also were normal however IgE was slightly elevated. The outcome of Herpes zoster was considered as recovering. The authors stated that the possibility for vaccine strain-induced HZ should be considered when HZ presents in a vaccinated immunocompetent child without a history of varicella infection or exposure.
Age: 1.08
Sex: M
Vaccine: VARCEL
Symptoms: Differential white blood cell count normal, Erythema, Full blood count normal, Herpes simplex test negative, Herpes zoster
Clinical narrative: This literature marketed report as received from a physician on a literature article refers to a 19 month old male patient. He had no personal history of varicella, no exposure to sick contacts with varicella, and no known exposure to the virus. The patient was otherwise completely healthy with no signs or symptoms of immunocompromise. The patient was up-to-date on his vaccinations. On an unknown date, at 13 months of age the patient received his first dose of vaccination with varicella virus vaccine live (oka/merck) (manufacturer unknown) (dose, route, lot/batch# were not reported) for prophylaxis. On an unknown date, 6 months after receiving vaccination he presented to the dermatology clinic with a rash that began 2 days prior on the right groin and spread to the right leg. The patient's mother denied that the child had been febrile and noted that the rash did not appear to bother him in any way. The physical examination revealed grouped vesicles on an erythematous base on the right thigh, right sacrum, and lower abdomen that did not cross the midline. There were no other pertinent physical examination findings. The eruption was most consistent with Herpes zoster (HZ) but concern remained for Herpes simplex virus (HSV) or impetigo. On an unknown date, a bacterial culture and polymerase chain reaction assay for Varicella zoster virus (VZV) and HSV from skin swabs was ordered. The patient was prescribed acyclovir (20 mg/kg every 6 hours) for 5 days. Laboratory testing revealed a positive result for VZV on polymerase chain reaction and a negative result for HSV. The majority of the patient's lesions had crusted after 2 days of treatment with acyclovir, and the rash had nearly resolved 1 week after presentation. Subsequent evaluation with a complete blood cell count with differential and basic metabolic profile was normal. Levels of IgG, IgA, and IgM also were normal however IgE was slightly elevated. The outcome of Herpes zoster was considered as recovering. The authors stated that the possibility for vaccine strain-induced HZ should be considered when HZ presents in a vaccinated immunocompetent child without a history of varicella infection or exposure.
Age: 1.08
Sex: M
Vaccine: VARCEL
Symptoms: Metabolic function test normal, Polymerase chain reaction positive, Scab, Skin lesion, Varicella virus test positive
Clinical narrative: This literature marketed report as received from a physician on a literature article refers to a 19 month old male patient. He had no personal history of varicella, no exposure to sick contacts with varicella, and no known exposure to the virus. The patient was otherwise completely healthy with no signs or symptoms of immunocompromise. The patient was up-to-date on his vaccinations. On an unknown date, at 13 months of age the patient received his first dose of vaccination with varicella virus vaccine live (oka/merck) (manufacturer unknown) (dose, route, lot/batch# were not reported) for prophylaxis. On an unknown date, 6 months after receiving vaccination he presented to the dermatology clinic with a rash that began 2 days prior on the right groin and spread to the right leg. The patient's mother denied that the child had been febrile and noted that the rash did not appear to bother him in any way. The physical examination revealed grouped vesicles on an erythematous base on the right thigh, right sacrum, and lower abdomen that did not cross the midline. There were no other pertinent physical examination findings. The eruption was most consistent with Herpes zoster (HZ) but concern remained for Herpes simplex virus (HSV) or impetigo. On an unknown date, a bacterial culture and polymerase chain reaction assay for Varicella zoster virus (VZV) and HSV from skin swabs was ordered. The patient was prescribed acyclovir (20 mg/kg every 6 hours) for 5 days. Laboratory testing revealed a positive result for VZV on polymerase chain reaction and a negative result for HSV. The majority of the patient's lesions had crusted after 2 days of treatment with acyclovir, and the rash had nearly resolved 1 week after presentation. Subsequent evaluation with a complete blood cell count with differential and basic metabolic profile was normal. Levels of IgG, IgA, and IgM also were normal however IgE was slightly elevated. The outcome of Herpes zoster was considered as recovering. The authors stated that the possibility for vaccine strain-induced HZ should be considered when HZ presents in a vaccinated immunocompetent child without a history of varicella infection or exposure.
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received on 10-JUL-2017 from a pharmacist and refers to 38-year-old unspecified patient of unknown gender. No information about the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant therapies was provided. The pharmacist reported that an unspecified patient received the first dose of RECOMBIVAX HB (Dose, route of administration, site of administration, Lot number and expiration date were not reported) on 13-MAY-2016 and second dose of RECOMBIVAX HB (Dose, route of administration, site of administration, Lot number and expiration date were not reported) on 13-JUL-2016. No side effects reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a consumer refers to a patient of unknown age with prophylaxis. On 12-JUL-2017 the patient was vaccinated with ZOSTAVAX for prophylaxis. Other suspect therapies included sterile diluent. On 12-JUL-2017 the patient experienced vaccination error. On an unknown date the patient experienced no adverse event. The outcome of vaccination error and no adverse event is unknown. The reporter considered no adverse event to be not related to ZOSTAVAX and sterile diluent. The reporter considered vaccination error to be not related to sterile diluent and ZOSTAVAX.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age. On 25-JUL-2017 the patient was vaccinated with ZOSTAVAX lot # M024700, expiry date 18-JUL-2017 0.65 ml, subcutaneous for prophylaxis. On 25-JUL-2017, 1 day after onset of therapy the patient experienced expired product administered. On an unknown date the patient experienced no adverse event. The outcome of expired product administered and no adverse event is unknown. The reporter considered expired product administered and no adverse event to be not related to ZOSTAVAX.
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Pain, Post herpetic neuralgia, Rash
Clinical narrative: Information has been received on 24-JUL-2017 regarding a case in litigation from a lawyer and a male patient of unknown age. The patient's concurrent conditions, medical history and concomitant medications were not reported. On or about 13-MAR-2015, the patient was inoculated with ZOSTAVAX (lot number and expiration were not reported) subcutaneous, 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 23-NOV-2015, the patient was treated by two physicians at a hospital for a painful and blistering vesicular outbreak, which was diagnosed as herpes zoster, or shingles. The patient was treated by another physician at the hospital for ongoing and worsening symptoms, which was then diagnosed at herpetic neuralgia, a chronic condition involving residual nerve pain and damage secondary to shingles. The patient has been prescribed NORCO and TYLENOL WITH CODEINE #3 for management of his painful symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Rash vesicular
Clinical narrative: Information has been received on 24-JUL-2017 regarding a case in litigation from a lawyer and a male patient of unknown age. The patient's concurrent conditions, medical history and concomitant medications were not reported. On or about 13-MAR-2015, the patient was inoculated with ZOSTAVAX (lot number and expiration were not reported) subcutaneous, 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 23-NOV-2015, the patient was treated by two physicians at a hospital for a painful and blistering vesicular outbreak, which was diagnosed as herpes zoster, or shingles. The patient was treated by another physician at the hospital for ongoing and worsening symptoms, which was then diagnosed at herpetic neuralgia, a chronic condition involving residual nerve pain and damage secondary to shingles. The patient has been prescribed NORCO and TYLENOL WITH CODEINE #3 for management of his painful symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Neuralgia, Pain, Post herpetic neuralgia
Clinical narrative: Information was received on 25-JUL-2017 from a lawyer regarding a case in litigation concerning a male patient of unknown age.  Medical history, concurrent conditions, or concomitant medication was 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 24-SEP-2014 at a hospital 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 27-DEC-2014 the patient was treated at a clinic for a blistering vesicular outbreak, which was diagnosed as herpes zoster, or shingles. On or about 30-DEC-2014, the patient was treated in the emergency department of the hospital for ongoing and worsening symptoms of shingles accompanied by excruciating pain. The patient was diagnosed with post-herpatic neuralgia. On or about 13-JUL-2015 he was treated by a physician at a clinic for new or worsening outbreak symptoms and nerve pain, and the diagnoses of shingles and post-herpatic neuralgia was affirmed and all ongoing prescription regiments were doubled in strength. The patient was prescribed valacyclovir, gabapentin, and capsaicin cream for treatment of his painful symptoms.  As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result the patient has suffered and will continue to suffer significant medical expenses, pain and suffering and other damages. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Rash vesicular
Clinical narrative: Information was received on 25-JUL-2017 from a lawyer regarding a case in litigation concerning a male patient of unknown age.  Medical history, concurrent conditions, or concomitant medication was 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 24-SEP-2014 at a hospital 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 27-DEC-2014 the patient was treated at a clinic for a blistering vesicular outbreak, which was diagnosed as herpes zoster, or shingles. On or about 30-DEC-2014, the patient was treated in the emergency department of the hospital for ongoing and worsening symptoms of shingles accompanied by excruciating pain. The patient was diagnosed with post-herpatic neuralgia. On or about 13-JUL-2015 he was treated by a physician at a clinic for new or worsening outbreak symptoms and nerve pain, and the diagnoses of shingles and post-herpatic neuralgia was affirmed and all ongoing prescription regiments were doubled in strength. The patient was prescribed valacyclovir, gabapentin, and capsaicin cream for treatment of his painful symptoms.  As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result the patient has suffered and will continue to suffer significant medical expenses, pain and suffering and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information was received on 25-JUL-2017 from a lawyer regarding a case in litigation concerning a female patient of unknown age.  Medical history, concurrent conditions, or concomitant medication was 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 2012 by a physician 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. During 2013, the patient was treated by a physician for a vesicular eruption, 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, pain and suffering and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information was received on 25-JUL-2017 from a lawyer regarding a case in litigation concerning a female patient of unknown age.  Medical history, concurrent conditions, or concomitant medication was 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 06-APR-2014 at a pharmacy as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 22-JUL-2016, the patient was treated by a physician for blistering vesicular outbreaks, which were diagnosed as severe shingles. She was prescribed Acyclovir for management of her painful condition. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result the patient has suffered and will continue to suffer significant medical expenses, pain and suffering and other damages. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report received from a registered nurse refers to a patient of unknown age and gender. Information on pertinent medical history and concurrent condition was not provided. On an unknown date, the patient was vaccinated with improperly stored VARIVAX (Incorrect product storage) from lot # M038856 expiry date 14-SEP-2018 for prophylaxis. Lot M038856 was stored in the range of -14°C to-10°C for 483 hours and in the range of -9°C to 8°C for 28 hours. No previous temperature excursion was reported. The call was not because of a "data logger".  The reporter was unable to provide the lot number and expiration date for the properly stored sterile diluent that were used to reconstitute the vaccines. No adverse effects reported. No PQC has been filed. No additional information is available. This is one of the several reports reported from same source. Additional information has been requested.; Sender's Comments: US-009507513-1707USA010912: US-009507513-1707USA010913: US-009507513-1707USA010914: US-009507513-1707USA010915: US-009507513-1707USA010916: US-009507513-1707USA010917: US-009507513-1707USA010918: US-009507513-1707USA010919: US-009507513-1707USA010920: US-009507513-1707USA010921: US-009507513-1707USA010922: US-009507513-1707USA010923: US-009507513-1707USA010927: US-009507513-1707USA010910:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from an other health professional refers to an unspecified number of patients of unknown demographics. On unknown dates, the patients were vaccinated with ROTATEQ lot # M025563 and lot# M040267, oral for prophylaxis. On unknown dates, the patients 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 to be not related to ROTATEQ. Additional information has been requested. Sender's Comments: US-009507513-1707USA007005: US-009507513-1707USA011012: US-009507513-1707USA011013: US-009507513-1707USA011015.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from an other health professional refers to an unspecified number of patients of unknown demographics. On unknown dates, the patients were vaccinated with PNEUMOVAX 23 (lot# reported as M003993) for prophylaxis. On unknown dates, the patients experienced incorrect product storage and no adverse event. The outcome of incorrect product storage is unknown. The reporter considered incorrect product storage and no adverse event to be not related to PNEUMOVAX 23. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1707USA007005: US-009507513-1707USA011012: US-009507513-1707USA011013: US-009507513-1707USA011014:
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age. On 25-JUL-2017 the patient was vaccinated with PNEUMOVAX 23 lot # L034335, expiration date 18-MAY-2017 for prophylaxis. On 25-JUL-2017, 1 day after onset of therapy the patient experienced expired product administered. On an unknown date the patient experienced no adverse event. The outcome of expired product administered and no adverse event is unknown. The reporter considered expired product administered and no adverse event to be not related to PNEUMOVAX 23.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a other health professional refers to an unknown number of patients of unknown age. On an unknown date, the patients were vaccinated with PROQUAD lot # M038229 (exp date 06-MAR-2018) and lot # N013865 (exp. date 31-OCT-2018) for prophylaxis. Concomitant therapies included sterile diluent. On an unknown date, the patients experienced incorrect product storage and no adverse event. Sender's Comments: US-009507513-1707USA007166.
Age: 5.0
Sex: F
Vaccine: MMRV
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth
Clinical narrative: Redness, warmth and edema at the site of injection. Started the morning following injection.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Approx 5 hours after immunization was given patient reported feeling soreness and pain at injection site. Also states that injection site was red and warm to the touch. The day after the vaccination was given patient stated that she could not lift her arm and/or open doors. States it was extremely painful. States two days after vaccination pain had improved but still had some pain.
Age: 84.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patients arm swelled up around the injection site, became red, and hot to the touch in the evening after given the shot at 3:13pm. By 11 am the next day her arm was not as swollen though still red and hot to the touch. Patient was told to monitor the swelling and if swelling was still occuring at day 7 to seek doctor attention.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Patient states that after receiving immunization her arm was painful and difficult to lift. States it is still painful 2 days after injection.
Age: 5.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Red and swollen left deltoid (site of Quadracel Injection). No fever, streaking or rash Mother instructed to watch the site and to follow up it the redness/swelling worsens.  Upon follow up by phone, mother states the site was iby the following day.
Age: 20.0
Sex: M
Vaccine: HEPA, MENB
Symptoms: Fall, Loss of consciousness
Clinical narrative: I instructed patient to wait 20 minutes in the office after vaccines are administered. He wanted to wait in the waiting area. He stopped at check out first before going to the waiting room at 4:50 p.m. He passed out while standing. He started falling and staff held him up and helped him sit down. We then laid him down in a room and observed him for 30 minutes and monitored his blood pressure and heart rate. He felt much better. Denied lightheadedness or dizziness.
Age: 4.0
Sex: M
Vaccine: HEPA
Symptoms: Extra dose administered, No adverse event
Clinical narrative: There were no S&S or treatment needed. Extra Hep. A was given, he was all ready complete with the series. Discussed with mom what happened and the rest of vaccines he was due for were given.
Age: 23.0
Sex: F
Vaccine: PPV
Symptoms: Impaired driving ability, Injected limb mobility decreased, Injection site erythema, Injection site pain, Injection site reaction
Clinical narrative: Given PNEUMOVAX right shoulder 7/24/17. Increasing right shoulder pain times past 3 days.  Pain is now intense and patient is unable to move her right arm. She has difficulty getting dressed and is unable to drive. Right shoulder is very warm to the touch. There are red raised blotches around the injection site. The injection site itself is not visible. The right deltoid/shoulder is diffusely swollen and extremely tender. Patient to take Ibuprofen, Hydrocodone as needed, Zyrtec, and apply ice to the area.
Age: 23.0
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling, Injection site warmth, Loss of personal independence in daily activities, Rash macular
Clinical narrative: Given PNEUMOVAX right shoulder 7/24/17. Increasing right shoulder pain times past 3 days.  Pain is now intense and patient is unable to move her right arm. She has difficulty getting dressed and is unable to drive. Right shoulder is very warm to the touch. There are red raised blotches around the injection site. The injection site itself is not visible. The right deltoid/shoulder is diffusely swollen and extremely tender. Patient to take Ibuprofen, Hydrocodone as needed, Zyrtec, and apply ice to the area.
Age: 1.25
Sex: F
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Febrile convulsion
Clinical narrative: Febrile Seizure.
Age: 0.58
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Dehydration, Dyskinesia, Haematochezia, Hypersomnia, Hypotonia
Clinical narrative: It started early morning with loud screaming and moving around. Very sleepy, didn't want to open eyes, slept for an unusual amount of time. He was very pale and lethargic. He vomited and was very limp and unresponsive. He also has bloody stool. We went to one emergency room and they turned us away saying it was too serious for their office and sent us to another ER. There we were told he was very dehydrated and so they started him on an IV. They took X-Rays sent us to a third hospital and took more xrays of his intestine came out to be Intussusception.
Age: 0.58
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Intussusception, Lethargy, Pallor, Screaming, Somnolence
Clinical narrative: It started early morning with loud screaming and moving around. Very sleepy, didn't want to open eyes, slept for an unusual amount of time. He was very pale and lethargic. He vomited and was very limp and unresponsive. He also has bloody stool. We went to one emergency room and they turned us away saying it was too serious for their office and sent us to another ER. There we were told he was very dehydrated and so they started him on an IV. They took X-Rays sent us to a third hospital and took more xrays of his intestine came out to be Intussusception.
Age: 0.58
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Unresponsive to stimuli, Vomiting, X-ray gastrointestinal tract abnormal
Clinical narrative: It started early morning with loud screaming and moving around. Very sleepy, didn't want to open eyes, slept for an unusual amount of time. He was very pale and lethargic. He vomited and was very limp and unresponsive. He also has bloody stool. We went to one emergency room and they turned us away saying it was too serious for their office and sent us to another ER. There we were told he was very dehydrated and so they started him on an IV. They took X-Rays sent us to a third hospital and took more xrays of his intestine came out to be Intussusception.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from  a healthcare professional refers to a patient of unknown age and gender. On 13-JUL-2017 the patient was vaccinated with an improperly storage ZOSTAVAX lot # M040623 for prophylaxis. The patient did not experience any adverse event. The outcome of incorrect product storage and no adverse event is unknown.
Age: 1.08
Sex: U
Vaccine: MMRV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received on 10-JUL-2017 from a registered nurse and refers to a 13-months and 17 days old patient of unknown gender. No information about the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant therapies was provided. The registered nurse reported that the patient, on 03-JUL-2017, received PROQUAD (Lot # M034692, expiration date 24-JAN-2018) (Dose, route of administration and site of administration were not reported) and inadvertently received PROQUAD (Lot # M034692, expiration date 24-JAN-2018) on 10-JUL-2017. Both, PROQUAD that were given came from same Lot. Both, PROQUAD were reconstituted with MERCK STERILE DILUENT (Lot number M026303 (as reported) with expiration date of 11-MAR-2017). No adverse effects reported. No further information provided. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a pharmacist refers to a multiple unspecified patients of unknown age and gender. On an unknown date, the patients were vaccinated with an improperly stored dose of VARIVAX. The VARIVAX was reconstituted with properly stored sterile diluent (MERCK). No adverse effects were reported with any patients. The digital data logger was involved in recording the excursion. This is one of two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1707USA010210.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Pain, Post herpetic neuralgia, Rash vesicular
Clinical narrative: Information has been received on 24-JUL-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 (lot number and expiration were not reported) subcutaneous on or about November of 2016 at a medical center, 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 01-DEC-2016, the patient was treated at an urgent care clinic for a painful and blistering vesicular outbreak, which was diagnosed as herpes zoster, or shingles. On or about 08-DEC-2016, the patient was treated by a physician at a medical clinic for ongoing and worsening symptoms, and was diagnosed with post-herpetic neuralgia. 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.