chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Electrocardiogram normal, Exposure during pregnancy, Prenatal screening test
Clinical narrative: This serious clinical study case, received from other health professional on 31-May-2018, concerning a female infant subject whose mother (age: 29, body weight: 202 lbs, height: 62.2 inches, body mass index: 36.7) enrolled in study. The patient's mother had no history of pregnancies and family history had no congenital malformations. The patient's mother had no habit of tobacco, alcohol or illicit drug use. The history of the patient's mother included hypertension and concomitant medications included VITAFOL ONE for healthy pregnancy. The last menstrual period (LMP) of the patient's mother was reported as 20-Jul-2017. On 17-Oct-2017, the patient's mother was administered with Influenza vaccine (batch number: 00644623A, dose, route of administration, anatomical location and expiry date: not reported), at 12th week of pregnancy. On 17-Oct-2017, electrocardiogram (EKG) was performed and the result was normal (no major congenital malformations noted). On 24-Oct-2017, after 8 days of vaccination, the patient's mother was diagnosed with chronic hypertension. The patient's mother was treated with Labetalol (200 mg, twice daily via oral route since 08-Sep-2017) for chronic hypertension. On 24-Oct-2017, cystic fibrosis mutation analysis of the patient's mother was performed, the result was found to be normal (no major congenital malformations noted). On 25-Oct-2017, 1st trimester screen of the patient's mother was performed, the result was found to be normal (no major congenital malformations noted). The nature of pregnancy was reported as singleton. On 05-Dec-2017, the patient's mother had given the informed consent. On 20-Mar-2018, prenatal test of the patient's mother (Group B streptococcus agalactiae) was done which showed the result was normal (no major congenital malformation was noted). The estimated date of delivery (EDD) of the patient was 26-Apr-2018. In 2018, at 39.1 gestational age, the patient's mother gave birth to female infant (patient) of weight 2410 g (reported as low birth weight), length: 43.2 cm and head circumference was 34.0. Type of pregnancy was reported as caesarean. The APGAR (appearance, pulse, grimace, activity, and respiration) score at 1 minute was 7 and 5 minutes was 9. The patient had no pregnancy complications. This case was cross-linked to case 201703634 (mother case).
Age: 79.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Skin warm
Clinical narrative: Patient has redness/swelling/itching covering half of her left arm, from shoulder to elbow. Patient's arm was very feverish to the touch. She woke up with this reaction the morning following her vaccination.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Nausea
Clinical narrative: Nausea, chills.
Age: 51.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Blister, Burning sensation, Erythema, Headache, Herpes zoster
Clinical narrative: In 24 hours, the patient had a headache in the left forehead and anterior left scalp area, and skin felt prickly in the same area -- headache felt like a piercing sensation. By 48 hours after the vaccination, she broke out in the typical herpes zoster rash (shingles) in the left first branch distribution of the trigeminal (5th) cranial nerve, with swelling and blistering in the same distribution.
Age: 51.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Ophthalmological examination, Paraesthesia
Clinical narrative: In 24 hours, the patient had a headache in the left forehead and anterior left scalp area, and skin felt prickly in the same area -- headache felt like a piercing sensation. By 48 hours after the vaccination, she broke out in the typical herpes zoster rash (shingles) in the left first branch distribution of the trigeminal (5th) cranial nerve, with swelling and blistering in the same distribution.
Age: 51.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Blister, Headache, Herpes zoster, Paraesthesia, Rash
Clinical narrative: In 24 hours, the patient had a headache in the left forehead and anterior left scalp area, and skin felt prickly in the same area -- headache felt like a piercing sensation. By 48 hours after the vaccination, she broke out in the typical herpes zoster rash (shingles) in the left first branch distribution of the trigeminal (5th) cranial nerve, with swelling and blistering in the same distribution.
Age: 51.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Swelling
Clinical narrative: In 24 hours, the patient had a headache in the left forehead and anterior left scalp area, and skin felt prickly in the same area -- headache felt like a piercing sensation. By 48 hours after the vaccination, she broke out in the typical herpes zoster rash (shingles) in the left first branch distribution of the trigeminal (5th) cranial nerve, with swelling and blistering in the same distribution.
Age: 51.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Blister, Eyelid oedema, Headache, Herpes zoster, Injection site pain
Clinical narrative: In 24 hours, the patient had a headache in the left forehead and anterior left scalp area, and skin felt prickly in the same area -- headache felt like a piercing sensation. By 48 hours after the vaccination, she broke out in the typical herpes zoster rash (shingles) in the left first branch distribution of the trigeminal (5th) cranial nerve, with swelling and blistering in the same distribution.
Age: 51.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Pain of skin, Rash
Clinical narrative: In 24 hours, the patient had a headache in the left forehead and anterior left scalp area, and skin felt prickly in the same area -- headache felt like a piercing sensation. By 48 hours after the vaccination, she broke out in the typical herpes zoster rash (shingles) in the left first branch distribution of the trigeminal (5th) cranial nerve, with swelling and blistering in the same distribution.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Myalgia, Pain in extremity, Pyrexia
Clinical narrative: Sore Arm, Muscles and Headache, Fever of 102.01
Age: 18.0
Sex: M
Vaccine: ANTH, JEV1, SMALL, TYP
Symptoms: Chest discomfort, Echocardiogram normal, Electrocardiogram ST segment normal, Electrocardiogram T wave normal, Electrocardiogram normal
Clinical narrative: Seen in ED for a 1-2 day history of chest tightness and syncopal event. Found to have elevated troponin I concerning for myocarditis at 0.178 ng/mL. ECG unremarkable without concerning features for pericarditis. No ST segment elevations/depressions or T wave inversions. Bedside limited echocardiogram without evidence of pericardial effusion. Hospitalized to be pulled from employee training and undergo inpatient echocardiography.
Age: 18.0
Sex: M
Vaccine: ANTH, JEV1, SMALL, TYP
Symptoms: Syncope, Troponin I increased
Clinical narrative: Seen in ED for a 1-2 day history of chest tightness and syncopal event. Found to have elevated troponin I concerning for myocarditis at 0.178 ng/mL. ECG unremarkable without concerning features for pericarditis. No ST segment elevations/depressions or T wave inversions. Bedside limited echocardiogram without evidence of pericardial effusion. Hospitalized to be pulled from employee training and undergo inpatient echocardiography.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills
Clinical narrative: I woke up about 3 AM with uncontrollable shivering which lasted for about 10 minutes. It went away after I turned the thermostat up and bundled up. I have never had this happen before.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain, Chills, Headache, Myalgia, Pyrexia
Clinical narrative: Had a fever, shivering, abdominal pain, myalgia, and headache the night after 2nd dose.
Sex: F
Vaccine: HPV9
Symptoms: Loss of consciousness
Clinical narrative: This spontaneous report was received from a medical assistant, via a company representative, reporting on two female patients of approximately 11 years of age, reported as "around 11 years old". On an separate unspecified dates, in approximately May 2018, reported as "separate unspecified date "within last month""), the patients were vaccinated with GARDASIL 9 for prevention of Human papillomaviruses (HPV) related cancer and diseases (dose, route of administration, lot number and expiration date were not reported), and both patients "passed out after receiving GARDASIL 9". Both patients visited the physician's office as a consequence of the event; there was no need for the patients' hospitalization. The event was not life threatening and there was no overdose involved. No further clarifying information was provided. It was also reported by the medical assistant that both patients were "doing fine" at the time of the report (recovered). The reporter did not provide a causal assessment between the therapy with GARDASIL 9 and the syncope.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to an unspecified patient of unknown age and gender. Information regarding the patient's medical history, concurrent conditions and concomitant medications was not provided. The nurse reported that on 30-MAY-2018, the patient was inadvertently vaccinated with an expired dose of VAQTA, (lot # N005274, expiry date 03-APR-2018) (strength, dose and route of administration were not reported). No adverse effects were reported.
Sex: U
Vaccine: HEPA
Symptoms: Exposure via skin contact, No adverse event, Syringe issue, Underdose
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not provided. On 03-JUN-2018, the patient was vaccinated with a dose of VAQTA (dose, frequency and route were unknown) lot # N031940 for prophylaxis. However, due to syringe malfunction, the vaccine leaked onto patient's skin and the patient did not receive 1/4 of the dose (underdose). It was specified that the VAQTA did not come from a prefilled syringe. No adverse effects were reported.
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: This spontaneous report was received from a nurse regarding an unknown age patient of unknown gender. The patient's medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not reported. On 14-MAY-2018, the patient was vaccinated with an improperly stored Oka-Merck PROQUAD for prophylaxis (dose, strength, frequency, lot#, expiration date and route of administration were not reported). The temperature excursion was reported from 6°F to 14°F, and the time frame was reported as 1 hour and 30 minutes. Previous temperature excursion was reported from -9°C to 9°C (-6.4°C) for a time frame of 3 hours. Data logger was reported. Merck sterile diluent was used to reconstitute the vaccine. No product quality complain was present. This is one of several reports received from the same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: 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 11-OCT-2012, the patient was inoculated with the ZOSTAVAX vaccine as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 24-JUN-2016, the patient was treated by a physician for a persistent and severe vesicular rash, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving for long-term prevention of shingles. 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: Herpes zoster, Pain, 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 25-FEB-2016, the patient was inoculated with the ZOSTAVAX vaccine as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 16-MAY-2016, the patient was treated by a physician for the onset of a vesicular rash, which was diagnosed as herpes zoster, or shingles. The patient has been prescribed gabapentin for management of her painful symptoms and chronic pain. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, 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: 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 01-JUN-2016, the patient was inoculated with the ZOSTAVAX vaccine as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 15-JUN-2016, the patient was treated at a medical facility for the onset of a vesicular rash, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, 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: 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. In 2010, the patient was inoculated with the ZOSTAVAX vaccine as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. In 2014, the patient was treated for a persistent and severe vesicular rash, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX, for long-term prevention of shingles, 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: Herpes zoster, Pain, 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. In 2010, the patient was inoculated with the ZOSTAVAX vaccine as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 06-MAR-2013, the patient was treated at a medical facility for a persistent and severe vesicular rash, which was diagnosed as shingles. The patient was prescribed VALTREX for management of her painful symptoms. As a direct and proximate result of the VALTREX vaccine, and/or despite receiving VALTREX for long-term prevention of shingles, 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: 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. In 2006, the patient was inoculated with the ZOSTAVAX vaccine as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 31-MAY-2013, the patient was treated by a physician for a persistent and severe vesicular rash, which was diagnosed as a herpes zoster, shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, 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: 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. In 2014, the patient was inoculated with the ZOSTAVAX vaccine as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. In 2015, the patient was treated at a medical center for a persistent and severe vesicular rash, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, 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: 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. In 2014, the patient was inoculated with the ZOSTAVAX vaccine as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. In 2015, the patient was treated at a hospital, for a persistent and severe vesicular rash, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, 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: 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. In 2014, the patient was inoculated with the ZOSTAVAX vaccine as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. In 2015, the patient was treated by a physician for a persistent and severe vesicular rash, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, 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: 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. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2009, the patient was inoculated with ZOSTAVAX by a physician as recommended for routine adult health maintenance and for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. Later in 2009, the patient was treated by a physician for a persistent and severe vesicular rash, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, 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. Causality assessment was related. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 20-JAN-2016, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) at a pharmacy, for routine adult health maintenance and the intended purpose for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended. The patient subsequently contracted a persistent strain of herpes zoster. On or about 21-APR-2016 the patient was treated by a physician for a blistering vesicular outbreak, which was diagnosed as herpes zoster or shingles. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, 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: Blister, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 13-NOV-2014, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided), at a pharmacy, for routine adult health maintenance and the intended purpose for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended. The patient subsequently contracted a persistent strain of herpes zoster. On an unknown date during 2015, the patient was treated by a physician for a blistering vesicular outbreak, which was diagnosed as shingles. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, 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: Blister, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received on 11-JUN-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 2013, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route by a physician as recommended for routine adult health maintenance and for the intended purpose for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, the very virus ZOSTAVAX is intended to prevent. During 2016, the patient was treated by a physician for a blistering vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX and/or despite receiving ZOSTAVAX or long-term prevention of shingles, the patient has suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received on 11-JUN-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 01-APR-2008, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route by a physician as recommended for routine adult health maintenance and for the intended purpose for the prevention of shingles. The vaccine did not prevent shingles as intended. The patient subsequently contracted a persistent strain of herpes zoster, the very virus ZOSTAVAX is intended to prevent. During July 2016, the patient was treated in a clinic for a blistering vesicular eruption, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient has suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, 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 has been received regarding the patient's past medical history, concurrent conditions, or concomitant medication. In 2015, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided),by the pharmacy, for routine adult health maintenance and the intended purpose for the prevention of shingles. The vaccine did not prevent shingles as intended. The patient subsequently contracted a persistent strain of herpes zoster, the very virus the ZOSTAVAX vaccine is intended to prevent. In 2016, the patient was treated (by an unspecified healthcare professional) at a healthcare facility/family medicine center, for a blistering vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX, and or despite receiving ZOSTAVAX for long-term prevention of shingles, 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 reporter considered the events to be related to ZOSTAVAX. The outcome of the events is unknown. Additional information has been requested.
Sex: F
Vaccine: HPV9
Symptoms: Allergy to arthropod bite, Condition aggravated, Food allergy
Clinical narrative: This spontaneous report was received from a pharmacist, who was also the patient's father, referring to his daughter, a female patient of unknown age. The patient's pertinent medical history and concomitant medications were unknown by reporter. Concurrently, she was sensitive to mosquito bites and had food allergies. On an unknown date, the patient was vaccinated with GARDASIL 9 for prophylaxis (strength, dose, route of administration, lot # and expiration date were not reported). On unspecified dates, the patient experienced adverse events after vaccination with GARDASIL 9; she was more sensitive to mosquito bites and food allergies. It was unknown if the patient received treatment for the adverse experiences, if she sought medical attention or if any laboratory study was performed. At the reporting time, the outcome of allergy to arthropod bite and food allergy was unknown. The causality assessment between the aforementioned adverse events and GARDASIL 9 was not provided.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a Certified Medical Assistant (CMA), referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant therapies and drug or allergy reactions were not provided. On 13-JUN-2018, the patient was vaccinated with an expired dose of PNEUMOVAX 23 intramuscularly (strength, dose and dose number were not reported), lot number M037669, expiration date 09-MAY-2018, for prophylaxis. There were not known adverse effects.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On 12-JUN-2018, the patient was vaccinated with an improperly stored dose of Oka-Merck virus vaccine live PROQUAD (lot # N035171 exp date 09-JUN-2019) (dose and route not provided). The vaccine was reconstituted with properly stored sterile diluent. Data digital logger was reported. The vaccine was exposed to a temperature of 6 °F to 14 °F for a time frame of 30 minutes. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same source; Sender's Comments: US-009507513-1806USA006474: US-009507513-1806USA006475: US-009507513-1806USA006476: US-009507513-1806USA006477: US-009507513-1806USA006478: US-009507513-1806USA006479.
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: This spontaneous report was received from a nurse regarding an unknown age patient of unknown gender. The patient's medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not reported. On 02-MAR-2018, the patient was vaccinated with an improperly stored Oka-Merck PROQUAD for prophylaxis (dose, strength, frequency, lot#, expiration date and route of administration were not reported). The temperature excursion was reported from 6°F to 14°F, and the time frame was reported as 1 hour and 30 minutes. Previous temperature excursion was reported from -9°C to 9°C (-6.4°C) for a time frame of 3 hours. Data logger was reported. Merck sterile diluent was used to reconstitute the vaccine. No product quality complain was present. This is one of several reports received from the same reporter.
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: This spontaneous report was received from a nurse regarding an unknown age patient of unknown gender. The patient's medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not reported. On 20-FEB-2018, the patient was vaccinated with an improperly stored Oka-Merck PROQUAD for prophylaxis (dose, strength, frequency, lot#, expiration date and route of administration were not reported). The temperature excursion was reported from 6°F to 14°F, and the time frame was reported as 1 hour and 30 minutes. Previous temperature excursion was reported from -9°C to 8°C (-6.4°C) for a time frame of 3 hours. Data logger was reported. Merck sterile diluent was used to reconstitute the vaccine. No product quality complain was present. This is one of several reports received from the same reporter.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On 13-JUN-2018, the patient was vaccinated with an improperly stored dose of PROQUAD (lot # N035171 exp date 09-JUN-2019) (dose and route not provided). The vaccine was reconstituted with properly stored sterile diluent. Data digital logger was reported. The vaccine was exposed to a temperature of 6 °F to 14 °F for a time frame of 30 minutes. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same source. Sender's Comments: US-009507513-1806USA006475: US-009507513-1806USA006476: US-009507513-1806USA006477: US-009507513-1806USA006478: US-009507513-1806USA006479: US-009507513-1806USA006387.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On 13-JUN-2018, the patient was vaccinated with an improperly stored dose of PROQUAD (lot # N035171 exp date 09-JUN-2019) (dose and route not provided). The vaccine was reconstituted with properly stored sterile diluent. Data digital logger was reported. The vaccine was exposed to a temperature of 6 °F to 14 °F for a time frame of 30 minutes. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same source.; Sender's Comments: US-009507513-1806USA006387: US-009507513-1806USA006474: US-009507513-1806USA006476: US-009507513-1806USA006477: US-009507513-1806USA006478: US-009507513-1806USA006479.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On 12-JUN-2018, the patient was vaccinated with an improperly stored dose of GARDASIL 9 (lot # N025428 exp date 19-JUN-2020) (dose and route not provided). Data digital logger was reported. The vaccine was exposed to a temperature of 47 °F to 77 °F for a time frame of 30 minutes. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same source. Sender's Comments: US-009507513-1806USA006387: US-009507513-1806USA006474: US-009507513-1806USA006475: US-009507513-1806USA006477: US-009507513-1806USA006478: US-009507513-1806USA006479.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On 12-JUN-2018, the patient was vaccinated with an improperly stored dose of GARDASIL 9 (lot # N025428 exp date 19-JUN-2020) (dose and route not provided). Data digital logger was reported. The vaccine was exposed to a temperature of 47 °F to 77 °F for a time frame of 30 minutes. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same source. Sender's Comments: US-009507513-1806USA006387: US-009507513-1806USA006474: US-009507513-1806USA006475: US-009507513-1806USA006476: US-009507513-1806USA006478. US-009507513-1806USA006479:
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On 13-JUN-2018, the patient was vaccinated with an improperly stored dose of GARDASIL 9 (lot # N025428 exp date 19-JUN-2020) (dose and route not provided). Data digital logger was reported. The vaccine was exposed to a temperature of 47 °F to 77 °F for a time frame of 30 minutes. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same source. Sender's Comments: US-009507513-1806USA006387: US-009507513-1806USA006474: US-009507513-1806USA006475: US-009507513-1806USA006476: US-009507513-1806USA006477: US-009507513-1806USA006479.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On 13-JUN-2018, the patient was vaccinated with an improperly stored dose of GARDASIL 9 (lot # N025428 exp date 19-JUN-2020) (dose and route not provided). Data digital logger was reported. The vaccine was exposed to a temperature of 47 °F to 77 °F for a time frame of 30 minutes. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same source.; Sender's Comments: US-009507513-1806USA006387: US-009507513-1806USA006474: US-009507513-1806USA006475: US-009507513-1806USA006476: US-009507513-1806USA006477: US-009507513-1806USA006478:
Age: 54.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Fatigue, Headache, Rash pruritic, Scab
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of headache in a 54-year-old female patient who received SHINGRIX for prophylaxis. Co-suspect products included DIPHTHERIA TOXOID + PERTUSSIS TOXOID ACELLULAR + TETANUS TOXOID (TDAP VACCINE) for prophylaxis. Concomitant products included acetylsalicylic acid (Aspirin), cetirizine hydrochloride (Zyrtec) and hydrochlorothiazide + valsartan (Valsartan-Hctz). On 24th May 2018, the patient received the 1st dose of SHINGRIX (intramuscular) and TDAP VACCINE. On 25th May 2018, 1 days after receiving SHINGRIX, the patient experienced headache and fatigue. On 29th May 2018, the patient experienced pruritus and rash. On an unknown date, the patient experienced crust. On an unknown date, the outcome of the headache and fatigue were recovered/resolved and the outcome of the pruritus and rash were unchanged and the outcome of the crust was unknown. It was unknown if the reporter considered the headache, fatigue, pruritus, rash and crust to be related to SHINGRIX. Additional information was reported as follows: The patient received Odactra as a concomitant medication. The patient called to inquire if SHINGRIX could cause chicken pox. The patient received two vaccines on the same day, the SHINGRIX vaccine on the right arm (vaccination time 15:00) and the Tdap vaccine on the left arm. The patient experienced headache and fatigue which lasted for about total of three days. She stated that on the fifth day post vaccination on May 29th she broke out in a rash accompanied with itching on her chest, neck, and to the edges of her face. The rash seemed to be crusting over and it was still spreading a little bit. The patient gave permission to contact the healthcare provider and provided contact details for the same.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Product quality issue
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 56-year-old female patient who received SHINGRIX (batch number 32GR4, expiry date 4th July 2020) and (batch number D3L5G, expiry date 29th November 2020) for prophylaxis. Previously administered products included SHINGRIX (1st dose received on an unknown date). Concomitant products included ADACEL. On 3rd June 2018, the patient received the 2nd dose of SHINGRIX. On an unknown date, the 2nd dose was an unknown dose. On 4th June 2018, 1 days after receiving SHINGRIX, the patient experienced injection site pain. On an unknown date, the patient experienced pharmaceutical product complaint. On an unknown date, the outcome of the injection site pain was recovered/resolved and the outcome of the pharmaceutical product complaint was unknown.  The reporter considered the injection site pain to be almost certainly related to SHINGIRX. Additional details were provided as follows: On 26th May 2018, the patient received 1st dose of ADACEL on the left arm. The patient received SHINGRIX on the left arm. The batch number of the adjuvant/liquid was D3L5G with an expiry of 11/29/2020. The pharmacist reported that he had been giving SHINGRIX injections since January 2018 and said that this last batch of SHINGRIX might be suspect. He reported that the patient experienced Adverse drug reactions (ADE's) unlike previous injections. The reporter did not have any product to return and was not seeking reimbursement. When asked, the pharmacist reported there was nothing unusual about the vials or the box. The side effect profile and percentages of ADEs experienced were reviewed. The pharmacist also reported via VAERS. This case is 1 of the 7 linked cases reported by the same reporter.
Sex: M
Vaccine: DTAP
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Initial information received on 04-Jun-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 10 years old male patient who had a cut in error, vaccinated with a dose of DAPTACEL (Batch number, expiry date, dose, dose in series, route and site of administration was not reported) on an unknown date. Patient's medical history and concomitant medications were not reported. It was a case of actual medication error due to Inappropriate age at vaccine administration. No adverse event was reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Expired product administered, No adverse event
Clinical narrative: Initial information received on 04-Jun-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 6 months old patient who experienced gave an expired dose to a 6 month old as the 3rd dose in the series/no adverse event, while he/she received vaccine PENTACEL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a dose 3 dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot C5375AA. It was a case of actual medication error due to expired vaccine used because gave an expired dose to a six month old as the third dose in the series. No adverse event was reported. The patient outcome is reported as Not Applicable for gave an expired dose to a 6 month old as the 3rd dose in the series/no adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation error
Clinical narrative: Initial unsolicited report received from a Nurse (LPN) on 04-Jun-2018. This case involves a child patient (age and gender was not reported) who was vaccinated with a dose of PENTACEL (Batch number, expiration date, dose, dose in series, route and site of administration were not reported) on an unspecified date. It was a case of actual medication error due to inappropriate reconstitution technique because only the dtap and ipv was given without hib from the suspect vaccine. No adverse event was reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none
Sex: U
Vaccine: TDAP
Symptoms: Extra dose administered, No adverse event, Wrong drug administered
Clinical narrative: Initial unsolicited case received from a nurse on 05 Jun 2018. This case involves an eleven years old patient (gender not reported) who was vaccinated with a dose of ADACEL and was given another dose yesterday in error instead of HPV VACCINE (Batch number, expiry date, dose, dose in series, route and site of administration was not reported) on an unspecified date. Patient's medical history and concomitant medications were not reported. It was of actual medication error due to Wrong vaccine administered and Extra dose administered. No adverse event was reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.