chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
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 was provided regarding the patient's past medical history, concurrent conditions, or concomitant medication. In 2009, the patient was inoculated with  ZOSTAVAX (lot number, dosage and route of administration not provided) at a pharmacy, as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. Later in 2009, the patient was treated at a healthcare facility (by an unspecified healthcare professional) for a blistering vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and or despite receiving ZOSTAVAX for the 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, Ophthalmic herpes zoster, Rash vesicular
Clinical narrative: Information has been received on 11-SEP-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 07-SEP-2012, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route at a physician's office as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster. On or about 01-JUL-2014, the patient was treated by a physician at an eye center for a blistering vesicular outbreak, which was diagnosed as herpes zoster iridocyclitis. As a direct and proximate result of the ZOSTAVAX and/or despite receiving the 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, herpes zoster iridocyclitis was considered to be medically significant. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: This initial spontaneous report was received on 11-SEP-2018 from a lawyer regarding a case in litigation and refers to a male patient of unknown age. Information regarding medical history, concurrent conditions and concomitant medications was not provided. In 2012, the patient was inoculated with ZOSTAVAX 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. Later in 2012, the patient was treated at a doctor's office for a vesicular outbreak, 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: Blister, 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 2016, the patient was inoculated with ZOSTAVAX at a pharmacy as recommended for routine adult health maintenance 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 2016, the patient was treated by a Nurse Practitioner for a blistering vesicular outbreak 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 of the events was unknown. Causality assessment was related. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, 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 2014, the patient was inoculated with ZOSTAVAX at a pharmacy as recommended for routine adult health maintenance 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 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 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: Blister, 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 2014 the patient was inoculated with ZOSTAVAX at a pharmacy as recommended for routine adult health maintenance 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 2010, the patient was treated at a family medical center for a blistering vesicular outbreak 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 of the events was unknown. Causality assessment was related. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, 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. On or about 02-OCT-2007, the patient was inoculated with ZOSTAVAX at a pharmacy as recommended for routine adult health maintenance 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 condition of herpes zoster. On or about 29-JUN-2011, the patient was treated at a clinic for a blistering vesicular outbreak which was diagnosed as herpes zoster or shingles. She was 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 of the events was unknown. Causality assessment was related. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, 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 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 condition of herpes zoster. In 2016, the patient was treated at a health center for a blistering vesicular outbreak 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 of the events was unknown. Causality assessment was related. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, 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. On or about 10-OCT-2012, the patient was inoculated with ZOSTAVAX bat a pharmacy as recommended for routine adult health maintenance 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 condition of herpes zoster. On or about 07-JAN-2015, the patient was treated at a family health care facility for a blistering vesicular outbreak 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 of the events was unknown. Causality assessment was related. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, 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 2007, the patient was inoculated with ZOSTAVAX at a medical center as recommended for routine adult health maintenance 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 condition of herpes zoster.  In 2010, 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 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: Blister, 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 2014, the patient was inoculated with ZOSTAVAX at a pharmacy as recommended for routine adult health maintenance 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 condition of herpes zoster. Later in 2014, 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 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: Eyelid ptosis, Facial paralysis, Hypoaesthesia, Mastication disorder
Clinical narrative: Information has been received on 11-SEP-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 or around 10-APR-2017, the patient received the ZOSTAVAX (lot number and expiration unknown) unknown for its intended purpose of the prevention of shingles. Shortly thereafter, the patient suffered facial numbness, dropping of the eyelid and corner of the mouth and began to have difficulty chewing. In or around December of 2017, the patient presented to his physician for this injury and was diagnosed with Bell's palsy. As a direct and proximate result of the ZOSTAVAX, the patient's symptoms have resulted in physical limitations not present prior to using the ZOSTAVAX. The patient also experiences mental and emotional distress due to resulting physical limitations and seriousness of his condition. As a result of ZOSTAVAX, the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of ZOSTAVAX, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, low of enjoyment of life, physical impairment and injury. The patient has incurred and will continue to incur medical expenses and other economic harm as a direct result of use of ZOSTAVAX. Bell's palsy was considered to be disabling. Upon internal review, Bell's palsy was considered to be medically significant. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Injection site reaction
Clinical narrative: This spontaneous report was received from a physician referring to an unspecified patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were unknown by reporter. On an unknown date, the patient was vaccinated with M-M-R II as scheduled immunization (strength, dose, route, anatomical location, lot # and expiration date were not reported) which was diluted with a sterile diluent (MERCK STERILE DILUENT) as scheduled immunization (strength, dose, route, anatomical location, lot # and expiration date were not reported). On an unknown date, after receiving M-M-R II, the patient experienced an unspecified injection site reaction. The patient was seen in an office but it was unknown if any treatment was given for the reaction or if any laboratory study was performed. At the reporting time, the outcome of injection site reaction was unknown. The causality assessment between the aforementioned adverse event and M-M-R II with sterile diluent (MERCK STERILE DILUENT) was not provided. This is a non-valid case due to lack of patient identifier.
Age: 19.0
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Underdose
Clinical narrative: This spontaneous report as received from a nurse refers to a 19 year old patient of unknown gender. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant therapy were not reported. On an unknown date, 19 year old patient was vaccinated with pediatric dose of RECOMBIVAX HB injection 2.5/0.5 (dose, frequency, lot number, expiration date and route were not reported) for prophylaxis. No adverse effects reported. No product quality complaint was involved.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: No adverse event, Wrong product administered
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to a identifiable patient of unknown age. The patient's medical history, concurrent condition and concomitant medications were not reported. On 12-SEP-2018 the patient was vaccinated with PROQUAD from lot N025718 by subcutaneous route instead of M-M-R II (product name confusion). Other suspect therapies included VARIVAX from lot R002056. Concomitant therapies included sterile diluent. No adverse events reported.
Sex: M
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: This spontaneous report was received from a pharmacist, concerning a 45 year old male patient. The patient's medical history, concurrent conditions, drug reactions, allergies and concomitant medications were not reported. On 14-JUN-2017, the patient was vaccinated with the first dose of GARDASIL 9 for prophylaxis (strength, dose, frequency, route of administration, lot number and expiration date were not reported). On 25-JUL-2017, the patient was vaccinated with the second dose of GARDASIL 9 for prophylaxis (strength, dose, frequency, route of administration, lot number and expiration date were not reported). On an unknown date, an unspecified physician wrote a prescription for the patient, it couldn't be determined if a third dose was necessary. No adverse effects were reported.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On 15-JAN-2018, the patient was vaccinated with the first dose of GARDASIL 9 and on 07-MAR-2018, was vaccinated with the second dose of GARDASIL 9 for prophylaxis (dose, route of administration, anatomical location, lot number and expiration date were not reported). No adverse effects reported.
Age: 68.0
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist concerning an unspecified number of patients of an unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not reported. On 02-JUN-2018, the unspecified patients were inadvertently vaccinated with an expired properly stored dose of PNEUMOVAX 23 injection, lot # M037669, expiry date: 09-MAY-2018 for prophylaxis (strength, dose, route, anatomical location and dosage schedule were not provided) (expired product administered). No adverse effects were reported. No product quality complaint was reported. Upon receipt of follow-up information received on 07-SEP-2018 it was determined that this case is now valid because the registered pharmacist confirmed that two patients received the vaccines on 02-JUN-2018 (MARRS: 1806USA002291). On 02-JUN-2018, a 68 year old patient was inadvertently vaccinated with an expired properly stored PNEUMOVAX 23. Sender's Comments: US-009507513-1806USA002291.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a Pharmacist concerning a patient of unknown age and gender. No pertinent medical history, drug reactions/ allergies or concurrent conditions were reported. On 03-AUG-2018, the patient was vaccinated with an improperly stored dose of GARDASIL 9 (lot # R004689; expiration date: 29-NOV-2020) or (lot # R006689; expiration date: 29-NOV-2020) (dose and route of administration were not reported) for prophylaxis, which had a temperature excursion of 47°F to 77°F (56F) for 15 days on unspecified dates. There were no previous temperature excursions and no digital data logger involved in recording the temperature excursion. No adverse effects were reported. This is one of several reports from the same source. Sender's Comments: US-009507513-1808USA012996: US-009507513-1809USA006252: US-009507513-1809USA006253: US-009507513-1809USA006254: US-009507513-1809USA006255: US-009507513-1809USA006256: US-009507513-1809USA006257: US-009507513-1809USA006258: US-009507513-1809USA006259: US-009507513-1809USA006260: US-009507513-1809USA006261: US-009507513-1809USA006262: US-009507513-1809USA006263.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: On 13-AUG-2018, the patient was vaccinated with an improperly stored dose of GARDASIL 9 (lot # R004689; expiration date: 29-NOV-2020) or (lot# R006689; expiration date: 29-NOV-2020) (dose and route of administration were not reported) for prophylaxis, which had a temperature excursion of 47°F to 77°F (56F) for 15 days on unspecified dates. There were no previous temperature excursions and no digital data logger involved in recording the temperature excursion. No adverse effects were reported. This is one of several reports from the same source. Sender's Comments: US-009507513-1808USA012996: US-009507513-1809USA006251: US-009507513-1809USA006253: US-009507513-1809USA006254: US-009507513-1809USA006255: US-009507513-1809USA006256: US-009507513-1809USA006257: US-009507513-1809USA006258: US-009507513-1809USA006259: US-009507513-1809USA006260: US-009507513-1809USA006261: US-009507513-1809USA006262: US-009507513-1809USA006263.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: On 14-AUG-2018, the patient was vaccinated with an improperly stored dose of GARDASIL 9 (lot # R004689; expiration date: 29-NOV-2020) or (lot # R006689; expiration date: 29-NOV-2020) (dose and route of administration were not reported) for prophylaxis, which had a temperature excursion of 47 degrees F to 77 degrees F (56F) for 15 days on unspecified dates. There were no previous temperature excursions and no digital data logger involved in recording the temperature excursion. No adverse effects were reported. This is one of several reports from the same source. Sender's Comments: US-009507513-1808USA012996: US-009507513-1809USA006252: US-009507513-1809USA006254: US-009507513-1809USA006255: US-009507513-1809USA006256: US-009507513-1809USA006257: US-009507513-1809USA006258: US-009507513-1809USA006259: US-009507513-1809USA006260: US-009507513-1809USA006261: US-009507513-1809USA006262: US-009507513-1809USA006263: GB-009507513-2011SP027616.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: On 16-AUG-2018, the patient was vaccinated with an improperly stored dose of GARDASIL 9 (lot # R004689; expiration date: 29-NOV-2020) or (lot # R006689; expiration date: 29-NOV-2020) (dose and route of administration were not reported) for prophylaxis, which had a temperature excursion of 47°F to 77°F (56F) for 15 days on unspecified dates. There were no previous temperature excursions and no digital data logger involved in recording the temperature excursion. No adverse effects were reported. This is one of several reports from the same source. Sender's Comments: US-009507513-1808USA012996: US-009507513-1809USA006252: US-009507513-1809USA006253: US-009507513-1809USA006255: US-009507513-1809USA006256: US-009507513-1809USA006257: US-009507513-1809USA006258: US-009507513-1809USA006259: US-009507513-1809USA006260: US-009507513-1809USA006261: US-009507513-1809USA006262: DE-009507513- 1805DEU013376: US-009507513-1809USA006251.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: On 17-AUG-2018, the patient was vaccinated with an improperly stored dose of GARDASIL 9 (lot # R004689; expiration date: 29-NOV-2020) or (lot # R006689; expiration date: 29-NOV-2020) (dose and route of administration were not reported) for prophylaxis, which had a temperature excursion of 47 degrees F to 77 degrees F (56F) for 15 days on unspecified dates. There were no previous temperature excursions and no digital data logger involved in recording the temperature excursion. No adverse effects were reported. This is one of several reports from the same source; Sender's Comments: US-009507513-1808USA012996: US-009507513-1809USA006251: US-009507513-1809USA006252: US-009507513-1809USA006253: US-009507513-1809USA006254: US-009507513-1809USA006256: US-009507513-1809USA006257: US-009507513-1809USA006258: US-009507513-1809USA006259: US-009507513-1809USA006260: US-009507513-1809USA006261: US-009507513-1809USA006262: US-009507513-1809USA006263.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: On 17-AUG-2018, the patient was vaccinated with an improperly stored dose of GARDASIL 9 lot # R004689; expiration date: 29-NOV-2020 or lot # R006689; expiration date: 29-NOV-2020 (dose and route of administration were not reported) for prophylaxis, which had a temperature excursion of 47 degrees F to 77 degrees F (56F) for 15 days on unspecified dates. There were no previous temperature excursions and no digital data logger involved in recording the temperature excursion. No adverse effects were reported. This is one of several reports from the same source; Sender's Comments: US-009507513-1808USA012996: US-009507513-1809USA006251: US-009507513-1809USA006252: US-009507513-1809USA006253: US-009507513-1809USA006254: US-009507513-1809USA006255: US-009507513-1809USA006257: US-009507513-1809USA006258: US-009507513-1809USA006259: US-009507513-1809USA006260: US-009507513-1809USA006261: US-009507513-1809USA006262: US-009507513-1809USA006263.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: On 17-AUG-2018, the patient was vaccinated with an improperly stored dose of GARDASIL 9 (lot # R004689; expiration date: 29-NOV-2020 or lot # R006689; expiration date: 29-NOV-2020) (dose and route of administration were not reported) for prophylaxis, which had a temperature excursion of 47 degrees F to 77 degrees F (56F) for 15 days on unspecified dates. There were no previous temperature excursions and no digital data logger involved in recording the temperature excursion. No adverse effects were reported. This is one of several reports from the same source. Sender's Comments: US-009507513-1808USA012996; US-009507513-1809USA006251; US-009507513-1809USA006252; US-009507513-1809USA006253; US-009507513-1809USA006254; US-009507513-1809USA006255; US-009507513-1809USA006256; US-009507513-1809USA006258; US-009507513-1809USA006259; US-009507513-1809USA006260; US-009507513-1809USA006261; US-009507513-1809USA006262; US-009507513-1809USA006263.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a Pharmacist concerning a patient of unknown age and gender. No pertinent medical history, drug reactions/ allergies or concurrent conditions were reported. On 06-AUG-2018, the patient was vaccinated with an improperly stored dose of (Wistar RA 27-3) M-M-R II lot # N027781; expiration date: 08-AUG-2019 (dose and route of administration were not reported) for prophylaxis, which had a temperature excursion of 47°F to 77°F (56F) for 15 days on unspecified dates. There were no previous temperature excursions and no digital data logger involved in recording the temperature excursion. No adverse effects were reported. This is one of several reports from the same source. Sender's Comments: US-009507513-1808USA012996: US-009507513-1809USA006251: US-009507513-1809USA006252: US-009507513-1809USA006253: US-009507513-1809USA006254: US-009507513-1809USA006255: US-009507513-1809USA006256: US-009507513-1809USA006257: US-009507513-1809USA006259: US-009507513-1809USA006260: US-009507513-1809USA006261: US-009507513-1809USA006262: US-009507513-1809USA006263.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a Pharmacist concerning a patient of unknown age and gender. No pertinent medical history, drug reactions/ allergies or concurrent conditions were reported. On 17-AUG-2018, the patient was vaccinated with an improperly stored dose of M-M-R II lot# N027781; expiration date: 08-AUG-2019 (dose and route of administration were not reported) for prophylaxis, which had a temperature excursion of 47°F to 77°F (56F) for 15 days on unspecified dates. There were no previous temperature excursions and no digital data logger involved in recording the temperature excursion. No adverse effects were reported. This is one of several reports from the same source. Sender's Comments: US-009507513-1808USA012996: US-009507513-1809USA006251: US-009507513-1809USA006252: US-009507513-1809USA006253: US-009507513-1809USA006254: US-009507513-1809USA006255: US-009507513-1809USA006256: US-009507513-1809USA006257: US-009507513-1809USA006258: US-009507513-1809USA006260: US-009507513-1809USA006261: US-009507513-1809USA006262: US-009507513-1809USA006263.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a Pharmacist concerning a patient of unknown age and gender. No pertinent medical history, drug reactions/ allergies or concurrent conditions were reported. On 06-AUG-2018, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 lot # R002084; expiration date: 02-OCT-2019 or lot # N024717; expiration date: 06-APR-2019 (dose and route of administration were not reported) for prophylaxis, which had a temperature excursion of 47°F to 77°F (56F) for 15 days on unspecified dates. There were no previous temperature excursions and no digital data logger involved in recording the temperature excursion. No adverse effects were reported. This is one of several reports from the same source. Sender's Comments: US-009507513-1808USA012996: US-009507513-1809USA006251: US-009507513-1809USA006252: US-009507513-1809USA006253: US-009507513-1809USA006254: US-009507513-1809USA006255: US-009507513-1809USA006256: US-009507513-1809USA006257: US-009507513-1809USA006258: US-009507513-1809USA006259: US-009507513-1809USA006261: US-009507513-1809USA006262: US-009507513-1809USA006263.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a Pharmacist concerning a patient of unknown age and gender. No pertinent medical history, drug reactions/ allergies or concurrent conditions were reported. On 15-AUG-2018, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 lot # R002084; expiration date: 02-OCT-2019 or lot # N024717; expiration date: 06-APR-2019 (dose and route of administration were not reported) for prophylaxis, which had a temperature excursion of 47°F to 77°F (56F) for 15 days on unspecified dates. There were no previous temperature excursions and no digital data logger involved in recording the temperature excursion. No adverse effects were reported. This is one of several reports from the same source. Sender's Comments: US-009507513-1808USA012996: US-009507513-1809USA006251: US-009507513-1809USA006252: US-009507513-1809USA006253: US-009507513-1809USA006254: US-009507513-1809USA006255: US-009507513-1809USA006256: US-009507513-1809USA006257: US-009507513-1809USA006258: US-009507513-1809USA006259: US-009507513-1809USA006260: US-009507513-1809USA006262: US-009507513-1809USA006263.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a Pharmacist concerning a patient of unknown age and gender. No pertinent medical history, drug reactions/ allergies or concurrent conditions were reported. On 13-AUG-2018, the patient was vaccinated with an improperly stored dose of ROTATEQ (lot# N013992); expiration date 27-JAN-2019 orally (dose not reported) for prophylaxis, which had a temperature excursion of 47 degrees F to 77 degrees F (56F) for 15 days on unspecified dates. There were no previous temperature excursions and no digital data logger involved in recording the temperature excursion. No adverse effects were reported. This is one of several reports from the same source. Sender's Comments: US-009507513-1808USA012996; US-009507513-1809USA006251; US-009507513-1809USA006252; US-009507513-1809USA006253; US-009507513-1809USA006254; US-009507513-1809USA006255; US-009507513-1809USA006256; US-009507513-1809USA006257; US-009507513-1809USA006258; US-009507513-1809USA006259; US-009507513-1809USA006260; US-009507513-1809USA006261; US-009507513-1809USA006263.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a Pharmacist concerning a patient of unknown age and gender. No pertinent medical history, drug reactions/ allergies or concurrent conditions were reported. On 13-AUG-2018, the patient was vaccinated with an improperly stored dose of ROTATEQ lot# N013992; expiration date 27-JAN-2019 orally (dose not reported) for prophylaxis, which had a temperature excursion of 47°F to 77°F (56F) for 15 days on unspecified dates. There were no previous temperature excursions and no digital data logger involved in recording the temperature excursion. No adverse effects were reported. This is one of several reports from the same source. Sender's Comments: US-009507513-1808USA012996: US-009507513-1809USA006251: US-009507513-1809USA006252: US-009507513-1809USA006253: US-009507513-1809USA006254: US-009507513-1809USA006255: US-009507513-1809USA006256: US-009507513-1809USA006257: US-009507513-1809USA006258: US-009507513-1809USA006259: US-009507513-1809USA006260: US-009507513-1809USA006261: US-009507513-1809USA006262.
Sex: U
Vaccine: HEPA
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: This spontaneous report was received from a medical assistant referring to an adult patient of unknown age and gender. The patient's medical history, concurrent conditions, drug allergies/reactions and concomitant medications were not reported. On 12-SEP-2018, the adult patient was vaccinated with a pediatric dose of VAQTA, intramuscular for prophylaxis. No product quality control issues was involved.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Back pain, Blood test normal, Erythema, Injection site erythema
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 71-year-old male patient who received SHINGRIX for prophylaxis. On 2nd August 2018, the patient received the 1st dose of SHINGRIX .5 ml. On 9th August 2018, 7 days after receiving SHINGRIX, the patient experienced neck discomfort. On 10th August 2018, the patient experienced shoulder pain. On 13th August 2018, the patient experienced back pain and tightness of back muscles. In August 2018, the patient experienced pain in arm, general body pain, lethargy, lipoma, myalgia, erythema of extremities and pain in hip. On an unknown date, the outcome of the pain in arm and shoulder pain were recovering/resolving and the outcome of the general body pain, lethargy, lipoma, myalgia, pain in hip and back pain were unknown and the outcome of the neck discomfort, erythema of extremities and tightness of back muscles were recovered/resolved. It was unknown if the reporter considered the pain in arm, general body pain, lethargy, lipoma, myalgia, neck discomfort, erythema of extremities, pain in hip, back pain, tightness of back muscles and shoulder pain to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX vaccine on left arm. The patient at first the only reaction experienced was soreness in the arm around the area it was administered and a red mark about an inch in diameter that went away after about a week. Since then the patient had experienced tremendous pain in the left side of his body including achiness and lethargy. Then his neck started to bother him about 7 to 8 days after the shot. On days 8, 9 and 10, the pain went down into his shoulder then on days 11,12, and 13 extended down into his arm, back and hip on the left side. The patient went to his physical therapist who said his back muscles were very tight but she worked her magic and the tightness had resolved. The patient's neck and shoulder was better.  The patient still had pain in his arm above the elbow, a little in the elbow and below the elbow. When the patient got up in the morning, he did yoga and the pain resolves but returns during the night.  Both physicians had diagnosed a lipoma above his elbow in his left arm. The patient's regular physician also felt as a result of the shot, the patient was suffering from myalgia. The patient took blood work and x-rays and all came back normal.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site reaction, Lethargy, Lipoma, Muscle tightness, Musculoskeletal discomfort
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 71-year-old male patient who received SHINGRIX for prophylaxis. On 2nd August 2018, the patient received the 1st dose of SHINGRIX .5 ml. On 9th August 2018, 7 days after receiving SHINGRIX, the patient experienced neck discomfort. On 10th August 2018, the patient experienced shoulder pain. On 13th August 2018, the patient experienced back pain and tightness of back muscles. In August 2018, the patient experienced pain in arm, general body pain, lethargy, lipoma, myalgia, erythema of extremities and pain in hip. On an unknown date, the outcome of the pain in arm and shoulder pain were recovering/resolving and the outcome of the general body pain, lethargy, lipoma, myalgia, pain in hip and back pain were unknown and the outcome of the neck discomfort, erythema of extremities and tightness of back muscles were recovered/resolved. It was unknown if the reporter considered the pain in arm, general body pain, lethargy, lipoma, myalgia, neck discomfort, erythema of extremities, pain in hip, back pain, tightness of back muscles and shoulder pain to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX vaccine on left arm. The patient at first the only reaction experienced was soreness in the arm around the area it was administered and a red mark about an inch in diameter that went away after about a week. Since then the patient had experienced tremendous pain in the left side of his body including achiness and lethargy. Then his neck started to bother him about 7 to 8 days after the shot. On days 8, 9 and 10, the pain went down into his shoulder then on days 11,12, and 13 extended down into his arm, back and hip on the left side. The patient went to his physical therapist who said his back muscles were very tight but she worked her magic and the tightness had resolved. The patient's neck and shoulder was better.  The patient still had pain in his arm above the elbow, a little in the elbow and below the elbow. When the patient got up in the morning, he did yoga and the pain resolves but returns during the night.  Both physicians had diagnosed a lipoma above his elbow in his left arm. The patient's regular physician also felt as a result of the shot, the patient was suffering from myalgia. The patient took blood work and x-rays and all came back normal.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Musculoskeletal pain, Myalgia, Pain, Pain in extremity, X-ray normal
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 71-year-old male patient who received SHINGRIX for prophylaxis. On 2nd August 2018, the patient received the 1st dose of SHINGRIX .5 ml. On 9th August 2018, 7 days after receiving SHINGRIX, the patient experienced neck discomfort. On 10th August 2018, the patient experienced shoulder pain. On 13th August 2018, the patient experienced back pain and tightness of back muscles. In August 2018, the patient experienced pain in arm, general body pain, lethargy, lipoma, myalgia, erythema of extremities and pain in hip. On an unknown date, the outcome of the pain in arm and shoulder pain were recovering/resolving and the outcome of the general body pain, lethargy, lipoma, myalgia, pain in hip and back pain were unknown and the outcome of the neck discomfort, erythema of extremities and tightness of back muscles were recovered/resolved. It was unknown if the reporter considered the pain in arm, general body pain, lethargy, lipoma, myalgia, neck discomfort, erythema of extremities, pain in hip, back pain, tightness of back muscles and shoulder pain to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX vaccine on left arm. The patient at first the only reaction experienced was soreness in the arm around the area it was administered and a red mark about an inch in diameter that went away after about a week. Since then the patient had experienced tremendous pain in the left side of his body including achiness and lethargy. Then his neck started to bother him about 7 to 8 days after the shot. On days 8, 9 and 10, the pain went down into his shoulder then on days 11,12, and 13 extended down into his arm, back and hip on the left side. The patient went to his physical therapist who said his back muscles were very tight but she worked her magic and the tightness had resolved. The patient's neck and shoulder was better.  The patient still had pain in his arm above the elbow, a little in the elbow and below the elbow. When the patient got up in the morning, he did yoga and the pain resolves but returns during the night.  Both physicians had diagnosed a lipoma above his elbow in his left arm. The patient's regular physician also felt as a result of the shot, the patient was suffering from myalgia. The patient took blood work and x-rays and all came back normal.
Age: 76.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Flushing, Pain, Pain in extremity, Peripheral swelling
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of chills in a 76-year-old female patient who received SHINGRIX for prophylaxis. On 3rd September 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In September 2018, 12 hrs after receiving SHINGRIX, the patient experienced chills, pain in arm, pain, facial flushing and swelling of feet. In September 2018, the outcome of the chills was recovered/resolved. On an unknown date, the outcome of the pain in arm was unknown and the outcome of the pain, facial flushing and swelling of feet were recovering/resolving. It was unknown if the reporter considered the chills, pain in arm, pain, facial flushing and swelling of feet to be related to SHINGRIX. Additional details were reported as follows: The reporting nurse was the patient who received a dose of SHINGRIX in right arm. The patient reported that about 12 hours after the vaccination with SHINGRIX, she awoke with shaking chills which lasted about 10 minutes. The patient did not have a fever. On 5th September 2018, after 60 hours, the patient noted right axillary area tenderness. The next evening, the patient noted that her upper arm was tender to the touch. The events subsequently progressed to her lower arm being tender. The patient also began experiencing achiness, flushing of her face, and puffy feet. The axillary and arm tenderness lasted for approximately three days and it was resolving. The symptoms related to the achiness, flushing, and puffy feet were unchanged. The patient called back and stated that she changed her mind and did not want her physician to be contacted.
Age: 76.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Tenderness, Tremor
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of chills in a 76-year-old female patient who received SHINGRIX for prophylaxis. On 3rd September 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In September 2018, 12 hrs after receiving SHINGRIX, the patient experienced chills, pain in arm, pain, facial flushing and swelling of feet. In September 2018, the outcome of the chills was recovered/resolved. On an unknown date, the outcome of the pain in arm was unknown and the outcome of the pain, facial flushing and swelling of feet were recovering/resolving. It was unknown if the reporter considered the chills, pain in arm, pain, facial flushing and swelling of feet to be related to SHINGRIX. Additional details were reported as follows: The reporting nurse was the patient who received a dose of SHINGRIX in right arm. The patient reported that about 12 hours after the vaccination with SHINGRIX, she awoke with shaking chills which lasted about 10 minutes. The patient did not have a fever. On 5th September 2018, after 60 hours, the patient noted right axillary area tenderness. The next evening, the patient noted that her upper arm was tender to the touch. The events subsequently progressed to her lower arm being tender. The patient also began experiencing achiness, flushing of her face, and puffy feet. The axillary and arm tenderness lasted for approximately three days and it was resolving. The symptoms related to the achiness, flushing, and puffy feet were unchanged. The patient called back and stated that she changed her mind and did not want her physician to be contacted.