chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: 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. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2011, 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. On or about 10-AUG-2015, the patient was treated at an urgent care center for a persistent and severe vesicular rash, which was diagnosed as shingles. She was prescribed valacyclovir for management of her painful symptoms and chronic pain. 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: 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 2013, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown), by a physician, 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 (by an unspecified healthcare professional) at a healthcare facility, 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.  The reporter considered the events to be related to ZOSTAVAX. The outcome of the events was unknown. 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 04-OCT-2010, the patient was inocculated with ZOSTAVAX, (lot# and route unknown), by the clinic (unspecified healthcare professional) 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 22-APR-2013, 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. The reporter considered the events to be related to ZOSTAVAX. The outcome of the events was unknown. 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 02-DEC-2014, the patient was inoculated with ZOSTAVAX, (lot# and route unknown), at a pharmacy, 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 2016, the patient was treated by a physician, at a surgical/medical healthcare facility, 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. The reporter considered the events to be related to ZOSTAVAX. The outcome of the events was unknown. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. In 2014, the patient was inoculated with ZOSTAVAX, (lot# and route unknown), at a healthcare facility (by an unspecified healthcare professional) 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 FEBRUARY 2016, the patient was treated by a physician, at a healthcare facility, 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.  The reporter considered the events to be related to ZOSTAVAX. The outcome of the events was unknown. 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 25-OCT-2012, the patient was inoculated with ZOSTAVAX, (lot# and route unknown), at a pharmacy, 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 by a physician, at a healthcare facility, 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.  The reporter considered the events to be related to ZOSTAVAX. The outcome of the events was unknown. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a patient (age and gender unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On or about 25-JUN-2013, the patient was inoculated with ZOSTAVAX, (lot# and route unknown), at a healthcare facility, 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 22-SEP-2015, the patient was treated (by an unspecified healthcare professional) at a healthcare facility, for a persistent and severe vesicular rash, which was diagnosed as 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. The reporter considered the events to be related to ZOSTAVAX. The outcome of the events was unknown. 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 2012, the patient was inoculated with ZOSTAVAX, (lot# and route unknown), at a clinic, 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 08-JAN-2016, the patient was treated by a physician assistant, at a clinic facility, for a persistent and severe vesicular rash, which was diagnosed as herpes zoster. The patient has been prescribed VALTREX 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. The reporter considered the events to be related to ZOSTAVAX. The outcome of the events was unknown. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: Information has been received on 06-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. In 2015, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route at a pharmacy 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 2016, 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 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: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: Information has been received on 06-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. In 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, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 01-FEB-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 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: Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information has been received on 06-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. On or about 31-MAY-2016, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route at a pharmacy 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 28-JUL-2016, the patient was treated by a physician at a primary care practice for a persistent and severe vesicular rash, which was diagnosed as herpes zoster or shingles. The patient has been prescribed valacyclovir for management of her painful symptoms. 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: Herpes zoster, Rash vesicular
Clinical narrative: Information has been received on 06-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. On or about 20-JAN-2014, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route at a pharmacy 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 June 2017, 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 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: Herpes zoster, Rash vesicular
Clinical narrative: Information has been received on 06-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. On or about 07-DEC-2014, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route at a hospital 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 01-OCT-2015, the patient was treated at a hospital emergency room for a persistent and severe vesicular rash, 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: M
Vaccine: VARZOS
Symptoms: 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. In 2014, the patient was inoculated 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 did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. In 2015, 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. The outcome is unknown. 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 of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. In 2014, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided), by a physician as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. Later in 2014, 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. The outcome is unknown. Additional information has been requested.
Sex: M
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 of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. In 2014, the patient was inoculated 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 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. The outcome is unknown. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a patient of unknown age and gender. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. In 2011, 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. The ZOSTAVAX 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. The outcome is unknown. 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 2013, the patient was inoculated with ZOSTAVAX at a pharmacy 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. In 2014, the patient was treated at a clinic 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: Herpes zoster, Pain, 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 07-MAY-2014, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided), at a pharmacy as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 14-NOV-2016, the patient was treated for a persistent and severe vesicular rash, which was diagnosed as shingles. The patient was prescribed valacyclovir and hydrocodone for management of his 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. The outcome is unknown. 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 of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 24-APR-2008, the patient was inoculated 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 did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 30-NOV-2014, the patient was treated by a nurse practitioner for a persistent and severe vesicular rash, which was diagnosed as shingles. The patient has been prescribed acyclovir 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. The outcome is unknown. 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 of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. In 2011, 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. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. In 2013, 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. The outcome is unknown. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, 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. In 2015, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided), by a physician as recommend for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 15-JUL-2015, the patient was treated by a physician for a persistent and severe vesicular rash, which was diagnosed as herpes zoster. The patient has been prescribed VALTREX and lidocaine for management of his 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. The outcome is unknown. Additional information has been requested.
Sex: F
Vaccine: HPV9
Symptoms: Drug administered to patient of inappropriate age, Off label use
Clinical narrative: This spontaneous report was received from a pharmacist via poison control center(PC) referring to a 30 year old female patient. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 29-MAR-2018 the patient was vaccinated with GARDASIL 9 for unknown indication (dosing details, lot/batch# and expiry date not reported). The patient was falling outside of the Food and Drug Administration (FDA) approved age-group for GARDASIL 9 administration, so this was an off-label use of the vaccination. It was unknown if the patient had experienced an adverse reaction from the vaccination. Outcome of the event was unknown.
Age: 0.17
Sex: M
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a public health nurse and refers to a currently 3 month old male patient. There was no information about patient's concurrent conditions, medical history or concomitant medications. Two instances of a temperature excursion took place. The first excursion occurred on an unspecified date in March 2018. Following which, it was reported that approval was provided from the manufacturer for the effected vaccinations to be administered. On 08-MAY-2018, the patient, at an approximated age of 2 months, was vaccinated with improperly stored ROTATEQ orally, lot # N012757 with expiration date of 27-JAN-2019 for prophylaxis. Dosing details were not reported. The first temperature excursion occurred in a range at or above 32 Fahrenheit (°F) degrees to 35°F for 19 hours and 30 minutes. The second excursion occurred on 15-MAY-2018; the details of which were not reported. Following the second temperature excursion, no doses of the ROTATEQ were administered. No adverse effects were reported. A previous temperature excursion was reported to have occurred on an unknown date in a range at or above 32°F to 35°F for 4 hours. A digital data logger was involved. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1806USA004704: US-009507513-1803USA011860.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Post herpetic neuralgia, 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-JUN-2011, 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 15-NOV-2015, the patient was treated by a physician for a persistent and severe vesicular rash, which was diagnosed as shingles and post-herpetic polyneuropathy, a chronic condition of nerve damage and ongoing pain. The patient has been prescribed acetaminophen-codeine, gabapentin and valacyclovir 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. Upon internal review post-herpetic polyneuropathy was considered a medically significant event. Additional information has been requested.
Age: 59.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report as received from a 59 year old female patient reporting on herself. The patient's historical drugs were not reported. The patient's medical history included parathyroid surgery and flu (reported as "within the last 12 months"). The patient did not have any drug allergy/reaction. The patient's concurrent condition included asthma. Concomitant therapies included ZANTAC and unspecified medication for asthma treatment. On 06-JUN-2018, the patient was vaccinated with PNEUMOVAX 23 intramuscularly, dose and frequency reported as "one injection", for prevention of pneumonia (strength, lot# and expiration date were not reported). On 07-JUN-2018, the patient experienced redness, pain, swelling, and a warm sensation in her upper left arm after getting PNEUMOVAX 23 vaccination (erythema, feeling hot, peripheral swelling and pain in extremity). The patient sought medical attention and contacted an unknown pharmacist for treatment because her nurse practitioner's office was closed. Diagnostic laboratories were not performed. At the time of reporting, the outcome of erythema, feeling hot, peripheral swelling and pain in extremity was not recovered (reported as "present status: yes"). Additionally, the causality assessment between aforementioned events and PNEUMOVAX 23 was not provided.
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Pain, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in a female patient who received SHINGRIX for prophylaxis. On 4th June 2018, the patient received the 1st dose of SHINGRIX. On 5th June 2018, 1 days after receiving SHINGRIX, the patient experienced pain, tiredness and fever. On an unknown date, the outcome of the pain, tiredness and fever were not recovered/not resolved. The reporter considered the pain, tiredness and fever to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not provided. The patient was vaccinated on 4th June 2018 and was experiencing pain, tiredness and fever the next day on 5th June 2018.
Sex: M
Vaccine: VARZOS
Symptoms: Hyperhidrosis, Nausea, Pyrexia
Clinical narrative: This case was reported by a pharmacist via sales rep and described the occurrence of sweating in a male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced sweating, fever and nausea. On an unknown date, the outcome of the sweating, fever and nausea were unknown. It was unknown if the reporter considered the sweating, fever and nausea to be related to SHINGRIX. Additional details were provided as follows: This case was not reported to anyone previously. The age at vaccination was not reported. The call was taken by vaccines inside the sales department. The reporter did not have further details.
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Injection site erythema, Pain, Pain in extremity, Tenderness
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 53-year-old male patient who received SHINGRIX (batch number LT533, expiry date 11th October 2020) for prophylaxis. On 1st June 2018, the patient received the 1st dose of SHINGRIX .5 ml. On 1st June 2018, several hours after receiving SHINGRIX, the patient experienced pain in arm, injection site erythema and tenderness. On 2nd June 2018, the patient experienced general body pain and chills. On an unknown date, the outcome of the pain in arm was not recovered/not resolved and the outcome of the general body pain, chills and tenderness were recovered/resolved and the outcome of the injection site erythema was recovering/resolving. The reporter considered the pain in arm, general body pain, chills and injection site erythema to be related to SHINGRIX. It was unknown if the reporter considered the tenderness to be related to SHINGRIX. Additional details were provided as follows: The patient experienced redness close to the injection site after receiving the SHINGRIX vaccine on left deltoid at 2:00 to 2:30 in the afternoon that was larger than a quarter, approximately the size of a baseball. The patient also had soreness that hurts when touching. The redness peaked yesterday and seems to get worse when he was moving at work. On Saturday he experienced chills and a body ache.
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Influenza like illness, Injection site erythema, Nausea, Pain
Clinical narrative: This case was reported by a consumer and described the occurrence of injection site erythema in a male patient who received SHINGRIX for prophylaxis. On 4th June 2018 17:30, the patient received SHINGRIX. In June 2018, 15 hrs after receiving SHINGRIX, the patient experienced injection site erythema, tiredness, general body pain, nausea and influenza like illness. On an unknown date, the outcome of the injection site erythema, tiredness, general body pain, nausea and influenza like illness were unknown. It was unknown if the reporter considered the injection site erythema, tiredness, general body pain, nausea and influenza like illness to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. On 5th June 2018, at 8:30, the patient experienced redness at shot site, tiredness, body aches, little nauseated and the side effect feel flu like. The patient was able to function at work.
Sex: M
Vaccine: VARZOS
Symptoms: Paraesthesia
Clinical narrative: This case was reported by a consumer and described the occurrence of injection site erythema in a male patient who received SHINGRIX for prophylaxis. On 4th June 2018 17:30, the patient received SHINGRIX. In June 2018, 15 hrs after receiving SHINGRIX, the patient experienced injection site erythema, tiredness, general body pain, nausea and influenza like illness. On an unknown date, the outcome of the injection site erythema, tiredness, general body pain, nausea and influenza like illness were unknown. It was unknown if the reporter considered the injection site erythema, tiredness, general body pain, nausea and influenza like illness to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. On 5th June 2018, at 8:30, the patient experienced redness at shot site, tiredness, body aches, little nauseated and the side effect feel flu like. The patient was able to function at work.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, PNC13, RV1
Symptoms: Diarrhoea, Frequent bowel movements, Stool analysis, Vomiting
Clinical narrative: Extreme diarrhea and vomiting, having bowel movements 10+ times per day for 5+ days now. Started the evening of the vaccinations.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site discolouration, Injection site erythema, Injection site pruritus, Injection site rash, Injection site warmth
Clinical narrative: Patient had redness and warmth on day after immune. 5-24-18 patient was seen in office for rash of Lt thigh with itching and color change. Patient was started on BENADRYL , BACTRIM, and prednisone at the 5-24-18 office visit. Patient returned to office on 6-4-18. Patient was seen for vomiting and fever and hives of bilateral arms and trunk of body. Redness warmth continued at site of injections and has now radiated around to the back of the leg. Patient was started on ZYRTEC.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Pyrexia, Urticaria, Vomiting
Clinical narrative: Patient had redness and warmth on day after immune. 5-24-18 patient was seen in office for rash of Lt thigh with itching and color change. Patient was started on BENADRYL , BACTRIM, and prednisone at the 5-24-18 office visit. Patient returned to office on 6-4-18. Patient was seen for vomiting and fever and hives of bilateral arms and trunk of body. Redness warmth continued at site of injections and has now radiated around to the back of the leg. Patient was started on ZYRTEC.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Blister, Fatigue, Headache, Injection site erythema
Clinical narrative: Fever 101 degrees/ Headache/ joint aches (hips, arms, legs, neck)/ fatigue/  hives - 2 raised spots on right hand, 1 cluster of raised blister like on left ankle, 1 cluster of raised blisters on bottom of right foot arch area/ redness, soreness and pain at injection site/ mild nausea off and on. All side effects were present at the same time with the exception of the "hives". Hives appeared during the late afternoon of 6/12/2018.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Nausea, Pyrexia, Urticaria
Clinical narrative: Fever 101 degrees/ Headache/ joint aches (hips, arms, legs, neck)/ fatigue/  hives - 2 raised spots on right hand, 1 cluster of raised blister like on left ankle, 1 cluster of raised blisters on bottom of right foot arch area/ redness, soreness and pain at injection site/ mild nausea off and on. All side effects were present at the same time with the exception of the "hives". Hives appeared during the late afternoon of 6/12/2018.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Rash pruritic, Skin irritation, Swelling
Clinical narrative: Swelling (hot dog sized area) then transitioned to itchy rash over a palm of hand sized area on 6/7/18 that remained irritated for 5 days.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Discomfort, Injection site pain, Lymphadenopathy
Clinical narrative: Developed swelling in glands under tongue. Still persistent some 8 days after onset. Did not notice any swelling when I went to bed and then woke up at 5 am with extreme swelling. Swelling reduced some over the next 24 hours but is still present and causes discomfort. Especially when eating. Had quite a bit of pain at injection site for 3-4 days.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Headache, Injection site pain
Clinical narrative: Soreness at injection site. Joint aches and pains, slight headache. Chills.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Patient given second dose of SHINGRIX series on 6/12/18 at 1 pm. Patient reports waking up at 5 am on 6/13/18 feeling feverish, and recorded an oral temperature of 101 degrees F. Patient took one 500 mg Tylenol at 5 am. Patient then recorded an oral temperature of 100 degrees F at 7:30 am. Patient took another 500 mg Tylenol at 7:30 am. Patient then recorded a normal oral temperature of 98.5 degrees F at 10:15 am.
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 an unknown age and gender. The patient's medical history, concurrent condition and drug reactions or allergies were not reported. On an unknown date, the patient was vaccinated with improperly stored dose of Oka-Merck PROQUAD lot# N034561, expiration date: 03-JUN-2019 or lot# N025926, expiration date: 18-MAR-2019 (dose and route of administration were not reported) reconstituted with properly stored MERCK STERILE DILUENT for prophylaxis. Administered dose of vaccine experienced the temperature excursion between -14 degrees Celsius to -10 degrees Celsius (also reported as -10.4 degrees Celsius) for 1 hour and 3 minutes. There was no previous temperature excursion. Digital data logger was involved. No adverse events were reported. This is one of four reports received from the same reporter. Sender's Comments: US-009507513-1806USA004463: US-009507513-1806USA004464: US-009507513-1806USA004465.
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 of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 30-OCT-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. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. In 2014, the patient was treated at a clinic 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. The outcome is unknown. Additional information has been requested.
Age: 0.58
Sex: M
Vaccine: DTAPIPVHIB, FLUX, HEP, PNC13, RV5
Symptoms: Pyrexia, Seizure
Clinical narrative: This is a spontaneous report from a contactable physician received via Pfizer sales representative. This physician reported that a consumer (patient's mother) referred that a 7-month-old male patient received PREVNAR 13 (lot S58703, expiry date 31Oct2019), PENTACEL, hepatitis B vaccine (unknown Manufacturer), influenza vaccine (unknown Manufacturer) and ROTATEQ, all on an unknown date, at single dose, for immunization. Medical history and concomitant medications were not reported. On vaccination evening the patient developed a fever and had a seizure. Patient's mother called 2 days later to report to office and that she did not seek medical attention for the patient. The patient had only one seizure and recovered on an unspecified date. The outcome of fever was unknown. Sender's Comments: Based on the information currently available, a contributory role of PREVNAR 13 towards the occurrence of "seizure" cannot be fully excluded considering the known adverse event profile of PREVNAR 13.
Age: 72.0
Sex: F
Vaccine: PNC13
Symptoms: Chills, Decreased appetite, Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: This is a spontaneous report received from a contactable physician (patient's husband). A 72-year-old female patient received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13), intramuscular in the left deltoid on 05Jun2018 at single dose to prevent pneumonia. There were no medical history and concomitant medications reported. On 05Jun2018, it was reported that the patient had a side reaction on her left deltoid which despite a BENADRYL and steroid ointment on it, it was spreading. It was described as like the diameter of half a tennis ball and about half of the half of a tennis ball size that was quiet raised, tender and very red. The husband was asking for treatment that the patient can take for the rash that she was having. It was reported that the area of redness is not as red as it was but it is spreading upwards, all the way up above the shoulder and downwards towards the patient's elbow, around the back and all. The husband added that through the next few days it was less tender but itchy and firm only in one three or four centimeter area right around the injection site. On 05Jun2018, the patient also had nausea, lack of appetite and chills. The outcome of events 'quiet raised, tender and very red' (vaccination site erythema and pain) was recovering; events 'nausea' and 'chills' recovered on unspecified date; all other events was unknown.