chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On or about 21-MAR-2014, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. The same day of being inoculated with ZOSTAVAX, the patient experienced pain, redness and swelling at the injection site. On or about 21-MAR-2014, the patient was diagnosed with shingles at an urgent care facility. 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: M
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received on 09-MAR-2018 regarding a case in litigation from a lawyer and a male consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. On or about 11-OCT-2012, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route, 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 07-MAR-2016, the patient was treated by a physician for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses and pain and suffering and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 15-JUL-2008, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided) administered by a physician, as recommended for routine adult health maintenance and for the prevention of shingles. ZOSTAVAX did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 22-MAR-2016, the patient was treated by a physician for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles. The patient was prescribed tramadol, acyclovir and prednisone for management of her painful symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expense, and pain and suffering, and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received on 09-MAR-2018 regarding a case in litigation from a lawyer and a female consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. On or about 25-OCT-2013, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route, 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 17-MAR-2016, the patient was treated for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses and pain and suffering and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. Information regarding medical history, concurrent conditions and concomitant medications was not provided. On or about 15-MAR-2015, the patient was inoculated with ZOSTAVAX at a pharmacy for routine 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 2016, the patient was treated by a family physician for a persistent and severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcomes of the events were unknown at the time of reporting. Causality assessment was related. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history, drug reactions and allergies were not reported. The patient's concomitant medication included sterile diluent (DILUENT MRK INJ) which was used for the reconstitution of PROQUAD (unknown lot# and expiration date). On an unknown date the patient was vaccinated with improperly stored PROQUAD (dose, units and frequency not reported) (lot # N020620 and expiration date: 22-JAN-2019) subcutaneously at a temperature from -14 degree Celsius ( °C) to -10 °C for 13 hours (product storage error). It was unknown whether previous temperature excursion was occurred for the PROQUAD or not. No data logger was involved. No adverse effects and no additional information was provided. No product quality complaint was involved.; Sender's Comments: US-009507513-1803USA004759: US-009507513-1803USA004761: US-009507513-1803USA004758: US-009507513-1803USA004757: US-009507513-1803USA004760:
Sex: F
Vaccine: HPV9
Symptoms: Face and mouth X-ray, Fall, Headache, Immediate post-injection reaction, Laboratory test
Clinical narrative: This spontaneous report was received from a physician via a company representative referring to a female patient of unknown age. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported. In an unspecified date in 2017 (also reported as "about 1 year ago"), the patient was vaccinated with GARDASIL 9, intramuscularly, for prophylaxis (dose, lot # and expiration date were not reported). It was stated that immediately after received the vaccine the patient experienced syncope. Additionally, the patient fell forward off the examination table at the time of the syncope. On an unspecified date, the patient went to her physician office and a facial x-ray and another unspecified test were performed and they were normal. On an unknown date, the patient experienced headaches. At the time of reporting, the outcome of syncope and fall were unknown. The outcome of headaches was reported as not recovered. The causality assessment between the events and GARDASIL 9 was not provided.
Sex: F
Vaccine: HPV9
Symptoms: Syncope
Clinical narrative: This spontaneous report was received from a physician via a company representative referring to a female patient of unknown age. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported. In an unspecified date in 2017 (also reported as "about 1 year ago"), the patient was vaccinated with GARDASIL 9, intramuscularly, for prophylaxis (dose, lot # and expiration date were not reported). It was stated that immediately after received the vaccine the patient experienced syncope. Additionally, the patient fell forward off the examination table at the time of the syncope. On an unspecified date, the patient went to her physician office and a facial x-ray and another unspecified test were performed and they were normal. On an unknown date, the patient experienced headaches. At the time of reporting, the outcome of syncope and fall were unknown. The outcome of headaches was reported as not recovered. The causality assessment between the events and GARDASIL 9 was not provided.
Sex: F
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. Information regarding medical history, concurrent conditions and concomitant medications was not provided. On or about 10-FEB-2008, the patient was inoculated with ZOSTAVAX at a medical center for routine 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 2016, the patient was treated at the same medical center for a persistent and severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcomes of the events were unknown at the time of reporting. Causality assessment was related. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Pain, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. Information regarding medical history, concurrent conditions and concomitant medications was not provided. On or about 24-SEP-2017, the patient was inoculated with ZOSTAVAX at a family physician's office for routine 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 29-NOV-"2012" (note this is prior to vaccination date), the patient was treated by a dermatologist for a persistent and severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles. She was prescribed VALTREX, gabapentin, and TYLENOL for management of her painful symptoms. On or about 06-DEC-2012, the patient sought subsequent treatment by another Dermatologist for a persistent and severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster.  She was prescribed VALTREX and gabapentin. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment.  As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcomes of the events were unknown at the time of reporting. Causality assessment was related. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history, drug reactions and allergies were not reported. The patient's concomitant medication included sterile diluent (Diluent Mrk Inj) which was used for the reconstitution of PROQUAD (unknown lot# and expiration date). On an unknown date the patient was vaccinated with improperly stored PROQUAD (dose, units and frequency not reported) (lot # N020620 and expiration date: 22-JAN-2019) subcutaneously at a temperature from -14 degree Celsius ( °C) to -10 °C for 13 hours (product storage error). It was unknown whether previous temperature excursion was occurred for the PROQUAD or not. No data logger was involved. No adverse effects and no additional information was provided. No product quality complaint was involved. This is one of the 6 reports received from the same reporter. Sender's Comments: US-009507513-1803USA004613; US-009507513-1803USA004758; US-009507513-1803USA004759; US-009507513-1803USA004760; US-009507513-1803USA004761.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history, drug reactions and allergies were not reported. The patient's concomitant medication included sterile diluent (DILUENT MRK INJ) which was used for the reconstitution of PROQUAD (unknown lot# and expiration date). On an unknown date the patient was vaccinated with improperly stored PROQUAD (dose, units and frequency not reported) (lot # N020620 and expiration date: 22-JAN-2019) subcutaneously at a temperature from -14 degree Celsius ( °C) to -10 °C for 13 hours (product storage error). It was unknown whether previous temperature excursion was occurred for the measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) or not. No data logger was involved. No adverse effects and no additional information was provided. No product quality complaint was involved. This is one of the 6 reports received from the same reporter.; Sender's Comments: US-009507513-1803USA004757: US-009507513-1803USA004613: US-009507513-1803USA004759: US-009507513-1803USA004761: US-009507513-1803USA004760:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history, drug reactions and allergies were not reported. The patient's concomitant medication included sterile diluent (Diluent Mrk Inj) which was used for the reconstitution of VARIVAX (unknown lot# and expiration date). On an unknown date the patient was vaccinated with improperly stored VARIVAX (dose, units and frequency not reported) (lot # N022981 and expiration date: 23-AUG-2019) subcutaneously at a temperature from -14 degree Celsius (°C) to -10 °C for 10 hours (product storage error). The vaccine VARIVAX also had previous temperature excursion at a temperature from -14 degree Celsius (°C) to -10 °C for 11 hours and 30 minutes. No data logger was involved. No adverse effects and no additional information was provided. No product quality complaint was involved. This is one of the 6 reports received from the same reporter. Sender's Comments: US-009507513-1803USA004613; US-009507513-1803USA004757; US-009507513-1803USA004758; US-009507513-1803USA004760; US-009507513-1803USA004761.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history, drug reactions and allergies were not reported. The patient's concomitant medication included sterile diluent (DILUENT MRK INJ) which was used for the reconstitution of VARIVAX (unknown lot# and expiration date). On an unknown date the patient was vaccinated with improperly stored VARIVAX (dose, units and frequency not reported) (lot # N022981 and expiration date: 23-AUG-2019) subcutaneously at a temperature from -14 degree Celsius ( °C) to -10 °C for 10 hours (product storage error). The vaccine VARIVAX also had previous temperature excursion at a temperature from -14 degree Celsius (°C) to -10 °C for 11 hours and 30 minutes. No data logger was involved. No adverse effects and no additional information was provided. No product quality complaint was involved. This one of 6 reports received from the same reporter.; Sender's Comments: US-009507513-1803USA004759: US-009507513-1803USA004613: US-009507513-1803USA004757: US-009507513-1803USA004758: US-009507513-1803USA004761:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history, drug reactions and allergies were not reported. The patient's concomitant medication included sterile diluent (Diluent Mrk Inj) which was used for the reconstitution of VARIVAX (unknown lot# and expiration date). On an unknown date the patient was vaccinated with improperly stored VARIVAX (dose, units and frequency not reported) (lot # N022981 and expiration date: 23-AUG-2019) subcutaneously at a temperature from -14 degree Celsius (°C) to -10 °C for 10 hours (product storage error). The vaccine VARIVAX also had previous temperature excursion at a temperature from -14 degree Celsius (°C) to -10 °C for 11 hours and 30 minutes. No data logger was involved. No adverse effects and no additional information was provided. No product quality complaint was involved. This is one of 6 reports received from the same reporter. Sender's Comments: US-009507513-1803USA004613; US-009507513-1803USA004760; US-009507513-1803USA004757; US-009507513-1803USA004759; US-009507513-1803USA004758.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Decreased immune responsiveness, Herpes zoster, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. Information regarding medical history, concurrent conditions and concomitant medications was not provided. During 2103, the patient was inoculated with ZOSTAVAX at a 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. During 2016, the patient was treated at a hospital for a blistering vesicular outbreak and decreased immune symptoms which was then diagnosed as herpes zoster, or shingles. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcomes of the events were unknown at the time of reporting. Causality assessment was related. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history, drug reactions and allergies was unknown. Concomitant therapy included sterile diluent. On an unknown date the patient was vaccinated with improperly stored VARIVAX (dose, units and frequency were unknown) (Lot# N021317 and expiration date 07-AUG-2019) at a temperature excursion from 14"C to -10"C (-13.5"C) for 1 hour 5 minutes. There was no previous temperature excursion. The call was because of a data logger. No adverse effects were reported. There was no product quality compliant reported. No further details were provided.
Age: 58.0
Sex: F
Vaccine: TDAP
Symptoms: Agitation, Mouth swelling, Pharyngeal oedema, Swollen tongue
Clinical narrative: Initial unsolicited report received from consumer in the United States on 27-Feb-2018. This case involves 57-year-old female patient who was vaccinated with 0.5 ml dose (once) of ADACEL (Batch number: C4365AA, expiration date, dose and site of administration was not reported) via intramuscular route on 01 May 2013. The patient's medical history was not reported. Concomitant medications included short term steroids for poison ivy a few days before receiving the vaccine. On 02 May 2013, one day post vaccination, the patient started with tongue swelling, mouth swelling, agitated and had throat swelling down to her pelvic floor and she feels it's the vaccine that caused her injury (a doctor who saw her told her so). It was reported that, this is ongoing admits to seeing providers that asked for Biopsy of tongue but, unclear if she ever had it done. It was also states that "they only want to poke and prod me without any results". Lab data was not reported. Patient was advised that she would have to continue with medical provider treatment. The patient was not recovered from the events. List of documents held by sender: none.
Sex: M
Vaccine: TDAP
Symptoms: Anaphylactoid reaction
Clinical narrative: Initial unsolicited report received from physician on 26 Feb 2018. This case involves male patient (Age not reported) who was vaccinated with dose of DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE (TDAP) (batch number, expiry date, route and site of administration were not reported) on an unspecified date. The patient's medical history and concomitant medication were not reported. On an unspecified date, following the vaccination, patient had anaphylactoid response. Physician saw this as an allergist and learned of reaction. Laboratory investigation and corrective treatment were not reported. Outcome of event was not reported. Upon internal review the case was considered as serious because of important medical event: anaphylactoid response. List of documents held by sender: none.; Sender's Comments: The patient experienced anaphylactoid response post-vaccination with TDaP vaccine (unknown manufacturer). Time to onset is unknown. Additional information including vaccination details, dechallenge outcome, patient's demography, allergic history, concomitant vaccination details, past vaccination history and tolerance, lab test to confirm cause would be needed to assess causal relationship with the vaccine. Based on limited information available, the role of vaccine cannot be evaluated.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site haemorrhage
Clinical narrative: 4 x 3 area of blanching erythema with central 1 cm area of ecchymosis is R deltoid area.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Hyperhidrosis, Injection site reaction, Pain, Pyrexia, Rash erythematous
Clinical narrative: The patient received the vaccine on Wednesday 3/7/2018. On Friday morning 3/9/2018 the patient felt soreness, was febrile (up to a temp of 102F degrees). He also experienced a red "soft ball" sized rash at the injection site. It persisted thru Sunday 3/11/2018 which he also perspired for most of the day. Throughout this episode he self-medicated with additional ibuprofen and stayed hydrated with Pedialyte. Today 3/12/2018 he states that the soreness and rash are gone. The patient was told to follow up with his PCP.
Age: 1.0
Sex: F
Vaccine: HEPA
Symptoms: Body temperature increased
Clinical narrative: Temp 103 X 3 days per mom.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injection site rash, Pain in extremity
Clinical narrative: I wanted to pass along symptoms I had from the recent Shingles vaccination (dose one). We had the shot on Wednesday, March 7. Thursday I was fine, other than my arm was a little sore. Thursday night I had a severe case of shivers but did not check my temperature. Friday I felt fine other than a sore arm, but found that I also had a rash at the site of the shot. Do we expect similar results with the second dose scheduled for May?
Age: 10.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Fall, Head injury, Syncope
Clinical narrative: Patient fainted in the elevator on his way out of the office and hit his head on the handrail as he fell in the elevator, as reported.
Age: 59.0
Sex: F
Vaccine: JEV1
Symptoms: Computerised tomogram normal, Electromyogram normal, Feeling abnormal, Hypoaesthesia, Impaired work ability
Clinical narrative: Client experiencing tingling and numbness that started in her lower extremities and progressed to her upper extremities. Complains of feeling "in a fog". Unable to work due to tingling and numbness. On short term disability. As of time of report, symptoms continue.
Age: 59.0
Sex: F
Vaccine: JEV1
Symptoms: Laboratory test normal, Lumbar puncture normal, Nuclear magnetic resonance imaging normal, Paraesthesia
Clinical narrative: Client experiencing tingling and numbness that started in her lower extremities and progressed to her upper extremities. Complains of feeling "in a fog". Unable to work due to tingling and numbness. On short term disability. As of time of report, symptoms continue.
Age: 51.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Muscular weakness, Pain
Clinical narrative: Severe pain, weakness to bilateral arms, ongoing for months.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Feeling abnormal, Injection site rash, Injection site swelling
Clinical narrative: I had a bit of a reaction, swelling and rash near injection (the rash is still faint and it has been 5 days).  I had the shot Wednesday morning and Thursday night I had chills and was just overall miserable.
Age: 17.0
Sex: F
Vaccine: HEPA
Symptoms: Abdominal pain upper, Alanine aminotransferase increased, Aspartate aminotransferase increased, Blood alkaline phosphatase increased, Blood immunoglobulin M increased
Clinical narrative: Patient developed all symptoms of Hepatitis A, beginning on Feb. 11,2018, 11 days after receiving the vaccine. She had stomach pain, gray stool, jaundice, dark urine and extreme tiredness.
Age: 17.0
Sex: F
Vaccine: HEPA
Symptoms: Chromaturia, Cytomegalovirus test positive, Faeces discoloured, Fatigue, Hepatitis A
Clinical narrative: Patient developed all symptoms of Hepatitis A, beginning on Feb. 11,2018, 11 days after receiving the vaccine. She had stomach pain, gray stool, jaundice, dark urine and extreme tiredness.
Age: 17.0
Sex: F
Vaccine: HEPA
Symptoms: Hepatitis A virus test positive, Jaundice, Polymerase chain reaction positive, Protein total abnormal, White blood cell disorder
Clinical narrative: Patient developed all symptoms of Hepatitis A, beginning on Feb. 11,2018, 11 days after receiving the vaccine. She had stomach pain, gray stool, jaundice, dark urine and extreme tiredness.
Sex: M
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Rash vesicular
Clinical narrative: Information was received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received concerning the patient's past medical history, concurrent conditions, or concomitant medication. On or about 07-OCT-2013, the patient was vaccinated at a pharmacy with ZOSTAVAX (lot number, dosage, and route of administration not provided), as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 23-MAR-2016, the patient was treated at a hospital for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On or about 18-NOV-2014, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 26-APR- 2016, the patient was treated by a physician for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On or about 09-MAY-2013, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 13-MAR-2016, the patient was treated at a clinic for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster, or shingles. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 18-MAR-2013, 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 and for the prevention of shingles. ZOSTAVAX did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 10-MAR-2016, the patient was treated at a medical center for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster, or shingles. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. Medical history, concurrent conditions, and concomitant medications were not provided. On or about 19-JUL-2013, the patient was inoculated (by an unspecified person) with ZOSTAVAX at a pharmacy, as recommended for routine adult health maintenance and for the prevention of shingles (dose, route of administration, site of administration and lot # were not provided). 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-APR-2016, she was treated (by an unspecified healthcare professional) at a community physicians group for a persistent and severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. The lawyer felt the events were related to ZOSTAVAX. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received on 09-MAR-2018 regarding a case in litigation from a lawyer and a female consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. During 2014, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route, 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 11-JUL-2016, the patient was treated for a persistent and severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses and pain and suffering and other damages. Additional information has been requested
Sex: F
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received on 09-MAR-2018 regarding a case in litigation from a lawyer and a female consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. On or about 03-JAN-2011, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route, 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 2016, the patient was treated at a medical center for a persistent and severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses and pain and suffering and other damages. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. Medical history, concurrent conditions, and concomitant medications were not provided. On or about 26-JUL-2012, the patient was inoculated (by an unspecified person) with ZOSTAVAX at a medical clinic, as recommended for routine adult health maintenance and for the prevention of shingles (dose, route of administration, site of administration and lot # were not provided). The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. During 2016, the patient was treated (by an unspecified healthcare professional) at a medical clinic for a persistent and severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. The lawyer felt the events were related to ZOSTAVAX. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. Medical history, concurrent conditions, and concomitant medications were not provided. During 2014, the patient was inoculated with ZOSTAVAX, as administered by the physician (MD), as recommended for routine adult health maintenance and for the prevention of shingles (dose, route of administration, site of administration and lot # were not provided). The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. During 2016, he was treated at the office of the physician (who administered the vaccine) for a persistent and severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. The lawyer felt the events were related to ZOSTAVAX. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Pain, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. Information regarding medical history, concurrent conditions and concomitant medications was not provided. During 2016, the patient was inoculated with ZOSTAVAX at a pharmacy 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-APR-2016, the patient was treated by an internal medicine physician for a blistering vesicular outbreak and decreased immune symptoms, which was diagnosed as herpes zoster, or shingles. The patient was prescribed acyclovir and prednisone for management of her painful symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcomes of the events were unknown at the time of reporting. Causality assessment was related. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Decreased immune responsiveness, Herpes zoster, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. Information regarding medical history, concurrent conditions and concomitant medications was not provided. During 2015, the patient was inoculated with ZOSTAVAX at a pharmacy 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 2016, the patient was treated by a physician for a blistering vesicular outbreak and decreased immune symptoms which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcomes of the events were unknown at the time of reporting. Causality assessment was related. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Decreased immune responsiveness, Herpes zoster, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. Information regarding medical history, concurrent conditions and concomitant medications was not provided. During 2014, the patient was inoculated with ZOSTAVAX by a physician 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 2016, the patient was treated by the same physician for a blistering vesicular outbreak and decreased immune symptoms which was then diagnosed as herpes zoster, or shingles. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages.  The outcomes of the events were unknown at the time of reporting. Causality assessment was related. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Decreased immune responsiveness, Herpes zoster, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. Information regarding medical history, concurrent conditions and concomitant medications was not provided. During 2013, the patient was inoculated with ZOSTAVAX at a pharmacy 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 2015, the patient was treated by a family medicine physician for a blistering vesicular outbreak and decreased immune symptoms which was then diagnosed as herpes zoster, or shingles. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcomes of the events were unknown at the time of reporting. Causality assessment was related. Additional information has been requested.
Sex: M
Vaccine: PNC13
Symptoms: Bronchitis, Pneumonia bacterial
Clinical narrative: This is a spontaneous report from two contactable consumers, a consumer and another consumer (Patient). A currently 68-year-old male patient of an unspecified ethnicity received PREVNAR 13, via an unspecified route of administration at single dose in 2016 for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced acute bronchitis/bacterial pneumonia diagnosis on an unspecified date with outcome of unknown. The information on the lot number has been requested.
Age: 83.0
Sex: M
Vaccine: PPV
Symptoms: Burning sensation, Musculoskeletal pain, Musculoskeletal stiffness, Tenderness
Clinical narrative: Shoulder pain; shoulder stiffness; burning; painful when I lie on it. Ice pack relieves symptoms for short while.
Age: 0.58
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Apnoea, Erythema, Unresponsive to stimuli
Clinical narrative: Two day after the above vaccines, the baby is reported to have suffered a pause in breathing along with her face turning red and somewhat unresponsive. The event happened again today 5 days after the vaccine date of 03/07/2018. Brief resolved unexplained event (BRUE) in infant. She was evaluated at the hospital where infection/seizures were ruled out.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Chest pain
Clinical narrative: Patient was experiencing chest pain 30-40 mins after shot and we called 911 and his vitals were: BP: 91/60, HR: 78 and Oxygen:97. He was alert and was able to speak.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Cough, Hypersensitivity, Injection site erythema, Injection site induration, Injection site rash
Clinical narrative: On 03/07/2018 patient had a visible red rash in the form a large ring, the size of a palm, around the injection site (left thigh). It was hot to the touch and felt hard. I notified the Dr and they did advised to give benadryl. On 03/10/18, the redness increased and a new rash had developed on right ankle. While in Urgent care, small hives started showing up on his neck, chest, legs and arms. The Dr confirmed it was hives and an allergic reaction. The dr prescribed him prednisone. His symptoms persisted to large red spots covering head to toe, even his scalp area. It was itchy and hot to the touch, We did apply calamine lotion to soothe the itching. The redness did decrease but hive are still visible. Patient does not have any other symptoms except a minor cough along with the itchiness.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Injection site warmth, Pruritus, Rash erythematous, Rash generalised, Skin warm
Clinical narrative: On 03/07/2018 patient had a visible red rash in the form a large ring, the size of a palm, around the injection site (left thigh). It was hot to the touch and felt hard. I notified the Dr and they did advised to give benadryl. On 03/10/18, the redness increased and a new rash had developed on right ankle. While in Urgent care, small hives started showing up on his neck, chest, legs and arms. The Dr confirmed it was hives and an allergic reaction. The dr prescribed him prednisone. His symptoms persisted to large red spots covering head to toe, even his scalp area. It was itchy and hot to the touch, We did apply calamine lotion to soothe the itching. The redness did decrease but hive are still visible. Patient does not have any other symptoms except a minor cough along with the itchiness.