chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
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 13-NOV-2012, the patient was inoculated with the 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 an unknown date in 2014, the patient was treated by a physician for a persistent and severe vesicular rash, which was diagnosed as herpes zoster. The patient was prescribed acyclovir and oxycodone for management of her painful symptoms and chronic pain. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: 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 04-APR-2012, the patient was inoculated with the 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 02-OCT-2014, the patient was treated for a persistent and severe vesicular rash, which was diagnosed as shingles. The patient was prescribed VALTREX for management of her painful symptoms. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: 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 an unknown date in 2010, the patient was inoculated with the 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 an unknown date in 2011, the patient was treated for a persistent and severe vesicular rash, which was diagnosed as herpes zoster or shingles. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: 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 25-NOV-2015, 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-DEC-2015, the patient was treated by a Nurse Practitioner for a persistent and severe vesicular rash, which was diagnosed as herpes zoster. The patient has been prescribed Neurontin and 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 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. 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: 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. On an unknown date in 2008, the patient was inoculated with the 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 an unknown date late in 2008, the patient was treated by a physician for a persistent and severe vesicular rash, which was diagnosed as herpes zoster or shingles. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: 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 11-MAR-2011, the patient was inoculated with the 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 09-MAY-2014, the patient was treated at a hospital for a persistent and severe vesicular rash, which was diagnosed as herpes zoster or shingles. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: 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 an unknown date in 2013, the patient was inoculated with the 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 18-APR-2014, the patient was treated for a persistent and severe vesicular rash, which was diagnosed as shingles. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: 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 20-OCT-2015, the patient was inoculated with the 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 an unknown date in 2016, the patient was treated by a physician for a persistent and severe vesicular rash, which was diagnosed as herpes zoster or shingles. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: 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 19-AUG-2008, the patient was inoculated with the 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 17-APR-2013, the patient was treated by a physician for a persistent and severe vesicular rash, which was diagnosed as shingles. The patient was prescribed nortriptyline, prednisone, and hydrocodone for management of her painful symptoms and chronic pain. On or about 06-MAY-2016, the patient sought subsequent treatment by another physician. She was prescribed hydrocodone and gabapentin for management of her painful symptoms and chronic pain. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: 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 or about 19-APR-2012, the patient was inoculated with the 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-JAN-2016, the patient was treated by a physician for a persistent and severe vesicular rash, which was diagnosed as zoster. The patient was prescribed NEURONTIN to manage and ease his painful symptoms and chronic pain. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: 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 26-AUG-2010, the patient was inoculated with the 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. On an unknown date in 2015, the patient was treated by the physician for a persistent and severe vesicular rash, which was diagnosed as herpes zoster or shingles. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: 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 an unknown date in 2010, the patient was inoculated with the 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 an unknown date in 2011, the patient was treated for a persistent and severe vesicular rash, which was diagnosed as herpes zoster or shingles. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: 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 an unknown date in 2007, the patient was inoculated with the 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 an unknown date in 2011, the patient was treated for a persistent and severe vesicular rash, which was diagnosed as herpes zoster or shingles. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: 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 or about 30-AUG-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. On or about 07-MAY-2014, the patient was treated by physicians for a persistent and severe vesicular rash, which was diagnosed as herpes zoster. The patient was prescribed VALTREX for management of his painful symptoms and chronic pain. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: 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 an unknown date in 2012, 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. On an unknown date in 2014, the patient was treated by a physician for a persistent and severe vesicular rash, which was diagnosed as herpes zoster or shingles. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On an unknown date in 2012, 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 an unknown date later in 2012, the patient was treated for a persistent and severe vesicular rash, which was diagnosed as herpes zoster or shingles. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: 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 05-APR-2010, 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. On or about 01-AUG-2015, the patient was treated by a physician for a persistent and severe vesicular rash, which was diagnosed as herpes zoster or shingles. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On an unknown date in 2015, 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 an unknown date in 2016, the patient was treated by a physician for a persistent and severe vesicular rash, which was diagnosed as herpes zoster or shingles. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Age: 1.0
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant referring to multiple unspecified patients of unknown age and gender. The patient's concomitant therapies included sterile diluent. The patients' pertinent medical history, drug reactions/allergies and concurrent conditions were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of PROQUAD lot # N014634 with expiration date 07-NOV-2018 and/or improperly stored doses of M-M-R II lot # M045394 with expiration date 14-NOV-2018, both for prophylaxis (dose and route were not reported for the suspect therapies). No adverse effects were reported. It was stated that the temperature was -14 to -10 degrees Celsius with a duration of 33 hours and 46 minutes. A previous temperature excursion was reported with a temperature of -14 to -10 degrees Celsius for 16 hours and 53 minutes. A digital data logger was involved. Follow-up information has been received from Medical Assistant on 06-JUN-2018. A call was placed to the reporter. A request was made for patient identifiers and vaccination dates for the two lots involved. This is a non-valid report due to lack of patient identifiers. Upon receipt of follow-up information on 08-JUN-2018, it was determined that this case is now valid because patient identifier was received. On 27-SEP-2017, the patient was vaccinated with improperly stored M-M-R II reconstituted with properly stored sterile diluent. This is one of the reports received from the same reporter.
Age: 6.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Urticaria
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of hives in a 5-year-old male patient who received KINRIX. Concomitant products included MMR (MMR vaccine) and Varicella (Varicella vaccine). On an unknown date, the patient received KINRIX. On an unknown date, less than a day after receiving KINRIX, the patient experienced hives. The patient was treated with benadryl (nos) (Benadryl), epinephrine (Epi Pen) and steroids nos (Steroid (Not Specified)). On an unknown date, the outcome of the hives was recovering/resolving. It was unknown if the reporter considered the hives to be related to KINRIX. Additional details were provided as follows: The patient just moved from other country and was behind on his shots. The patient was given three at the time of his visit. The physician reported that the patient experienced hives in the night after receiving the vaccines. The patient was given Benadryl but it did not help. The patient was taken to urgent care and given an Epi pen and steroid. The next day the hives were worse and he was treated at the emergency room with a steroid. The patient was seen by the physician the following day and the hives were resolving. The patient had not returned to the office since. There were no dates provided. Follow up information received from the physician on 1st June 2018: The reporter details were updated. The patient demographic details were updated. On 6th April 2018, the patient received 0.5 ml dose of KINRIX intramuscularly as a 5th dose of DTaP and 4th dose of IPV (batch number and expiry date was updated). On 6th April 2018, the patient experienced hives. The VAERS details were updated.; Sender's Comments: US2018068884: Previous VAERS submission in paper format
Age: 45.0
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Injury associated with device, Laceration, Product quality issue
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of laceration of finger in a 45-year-old female patient who received SHINGRIX (batch number B9739, expiry date 22nd November 2020) for prophylaxis. This case was associated with a product complaint. On 23rd May 2018, the patient received SHINGRIX. On 23rd May 2018, immediately after receiving SHINGRIX, the patient experienced laceration of finger and injury associated with device. On an unknown date, the patient experienced pharmaceutical product complaint. On an unknown date, the outcome of the laceration of finger, injury associated with device and pharmaceutical product complaint were unknown. The reporter considered the laceration of finger and injury associated with device to be almost certainly related to SHINGRIX. Additional information was received as follows: This case was reported by certified medical assistant. The office ordered the product on 27th April 2018, and stored it in the vaccine refrigerator. There were no signs of damage or leakage. They used the first 9 vials with no issues. On Wednesday a technician reached to pick up the last vial of liquid adjuvant of SHINGRIX and she cut her finger and applied a bandage. The vial was broken on the front at the bottom of the vial and there was glass in the box but none in the vial itself and also there was no liquid in the vial and the dose was not administered. The office was sending a picture of the vial via email. The Global Response Center would arrange for replacement of 1 dose. Upon an internal review following changes were done on 8th June 2018: The event injury associated with device was removed since laceration occured due to broken vial and not due to a device.; Sender's Comments: US2018096040: Previous VAERS submission in paper format
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site rash, Injection site swelling
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 70-year-old female patient who received SHINGRIX (batch number 9779K, expiry date 11th October 2020) for prophylaxis. Concomitant products included atorvastatin calcium (Atorvastatin), methylphenidate hydrochloride (Concerta), methylphenidate hydrochloride (Ritalin), spironolactone and fluoxetine. On 30th May 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, less than a week after receiving Shingrix, the patient experienced injection site pain, injection site rash and injection site swelling. On an unknown date, the outcome of the injection site pain, injection site rash and injection site swelling were not recovered/not resolved. It was unknown if the reporter considered the injection site pain, injection site rash and injection site swelling to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in left lower forearm.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site discolouration, Injection site rash
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site rash in a 70-year-old female patient who received SHINGRIX for prophylaxis. On 17th May 2018, the patient received the 2nd dose of SHINGRIX. On 18th May 2018, 1 days after receiving SHINGRIX, the patient experienced injection site rash. On an unknown date, the patient experienced injection site discoloration. On an unknown date, the outcome of the injection site rash and injection site discoloration were not recovered/not resolved. The reporter considered the injection site rash to be related to SHINGRIX. It was unknown if the reporter considered the injection site discoloration to be related to SHINGRIX. Additional details were provided as follows: The patient did not received any other vaccine. The patient reported that, she had a bad rash that was 3 inches across and two inches wide the day after she had the SHINGRIX vaccine. It was been 2 weeks and she still sees the mark (injection site discoloration latency less than a month) where she had the rash. The patient had denied permission to contact their physician.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 73-year-old male patient who received SHINGRIX for prophylaxis. On 17th May 2018, the patient received SHINGRIX. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved. The reporter considered the pain in arm to be related to SHINGRIX. Additional details were provided as follows: The reporter is the spouse of the patient. The age at vaccination was not reported. The patient arm got hurts after vaccination. It was the arm where the patient got the injection. The patient had denied permission to contact their physician.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 66-year-old female patient who received SHINGRIX (batch number B334Y, expiry date 17th October 2020) for prophylaxis. Concurrent medical conditions included arthritis.  On 27th March 2018 14:15, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 27th March 2018, several hours after receiving SHINGRIX, the patient experienced injection site pain and injection site erythema. On an unknown date, the outcome of the injection site pain and injection site erythema were recovered/resolved. The reporter considered the injection site pain and injection site erythema to be probably related to SHINGRIX. Additional details were provided as follows: The health care professional reported that the patient received the SHINGRIX vaccine about 2 months before the date of reporting in left arm. The health care professional called the patient to remind them that it was time for their booster dose and the patient told the health care professional that when they received the vaccine, that it was the most pain they ever experienced from a vaccine. They had pain and redness at the injection site which started hours later that day and lasted for about 4 to 5 days. The patient called the pharmacy on 31st March 2018 and spoke to the pharmacist on duty (this was a different health care professional than the reporter spoke to) and the pharmacist just advised the patient on how to manage the injection site reaction. The patient experienced a constant, dull, aching pain at the injection site which started after the initial pain went away (about 4 to 5 days after vaccination) and they are still experiencing this constant, dull, aching pain 2 months later. The patient compared this pain to a toothache. The patient reported that they also have arthritis but this pain was completely different.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash papular
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of papular rash in a 65-year-old female patient who received SHINGRIX for prophylaxis. The patient had a Family History of sulfonamide allergy and allergic reaction to antibiotics (family history of Sulfa and Erythromycin allergy, caused red from head to toe and hard to breath). Previously administered products included ZOSTAVAX (received about 5 years ago). On 31st May 2018 16:30, the patient received the 1st dose of SHINGRIX. On 31st May 2018 19:30, 3 hrs after receiving SHINGRIX, the patient experienced papular rash. On an unknown date, the outcome of the papular rash was not recovered/not resolved. It was unknown if the reporter considered the papular rash to be related to SHINGRIX. Additional details were provided as follows: The patient did not receive any concomitant medications. The patient received SHINGRIX in the left arm at the physician office. At around 19:30 hours, the patient experienced 6 bumps in an arch pattern from the left side of her neck downward to the right side of her. The patient did not reported this to her physician, but she was encouraged to do so.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Lymphadenopathy, Musculoskeletal pain, Tenderness
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of injection site pain in a 58-year-old male patient who received SHINGRIX for prophylaxis. Concomitant products included fexofenadine hydrochloride (Allegra (Fexofenadine Hydrochloride)) and atorvastatin calcium (Atorvastatin). In May 2018, the patient received the 1st dose of SHINGRIX (intramuscular). In May 2018, 1 day after receiving SHINGRIX, the patient experienced injection site pain and shoulder pain. On an unknown date, the patient experienced lymphadenopathy cervical. On an unknown date, the outcome of the injection site pain was recovering/resolving and the outcome of the shoulder pain was unknown and the outcome of the lymphadenopathy cervical was not recovered/not resolved. The reporter considered the injection site pain, shoulder pain and lymphadenopathy cervical to be probably related to SHINGRIX. Additional details were provided as follows: The reporter is an Infectious Disease physician and was also the patient. The reporter first said he received the vaccine 5 weeks before the reporting date further describing about 5 weeks before the reporting date sometime in May 2018. The patient received the vaccine in the left deltoid. The left upper arm pain started the day after he received the dose. The left upper arm pain was described to be at the injection site and also generally diffused in the shoulder girdle area. The tender left neck gland in the left lower neck region started about 2 weeks after receiving the first dose. He did not know the exact dosing details but thought it was the standard dose. The reporter indicated time constraints and said he needed to answer a page from the hospital. He was referred to his healthcare professional (HCP) before the call ended, and it was discussed that his HCP might contact the GSK Medical Information team to discuss his inquiry of whether or not he should have the second dose in the series and could his symptom be considered lymphadenitis or not. He described the symptoms as being bothersome but not disabling. It was unknown if he granted permission to be contacted, due to time constraints no further information beyond what was reported. He was not able to provide the specific pharmacy address or phone number. He provided his alternate cell phone number also. This reporter did not at first say he was an HCP. He called on behalf of himself as the patient. He said the address he had first provided was his office address. He did not provide a suite number and said there was no practice name.
Age: 64.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Fatigue, Hyperhidrosis, Laboratory test, Myalgia
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of shivering in a 64-year-old male patient who received SHINGRIX for prophylaxis. On 23rd May 2018, the patient received the 1st dose of SHINGRIX. On 24th May 2018, 1 days after receiving SHINGRIX, the patient experienced shivering, myalgia, sweating, fever and fatigue. On an unknown date, the outcome of the shivering, myalgia, sweating and fever were recovering/resolving and the outcome of the fatigue was not recovered/not resolved. It was unknown if the reporter considered the shivering, myalgia, sweating and fever to be related to SHINGRIX. The reporter considered the fatigue to be unrelated to SHINGRIX. Additional details were provided as follows: The reporting physician (who was the patient) reported that, he experienced reactions such as severe shivering, fever, severe fatigue, perspiration and myalgia and the symptoms were subsided as of on 1st June 2018. At the time of reporting the patient still felt "washed out" but did not think that was in relation to the vaccine. He had gotten lab work done in his office. Results were not back at the time of reporting. He did not go to the emergency room (ER) but during work hours his coworkers wanted to call the ambulance but he refused. The healthcare provider (HCP) was not sure to receive the 2nd dose of the SHINGRIX based on these reactions.
Age: 64.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Pyrexia
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of shivering in a 64-year-old male patient who received SHINGRIX for prophylaxis. On 23rd May 2018, the patient received the 1st dose of SHINGRIX. On 24th May 2018, 1 days after receiving SHINGRIX, the patient experienced shivering, myalgia, sweating, fever and fatigue. On an unknown date, the outcome of the shivering, myalgia, sweating and fever were recovering/resolving and the outcome of the fatigue was not recovered/not resolved. It was unknown if the reporter considered the shivering, myalgia, sweating and fever to be related to SHINGRIX. The reporter considered the fatigue to be unrelated to SHINGRIX. Additional details were provided as follows: The reporting physician (who was the patient) reported that, he experienced reactions such as severe shivering, fever, severe fatigue, perspiration and myalgia and the symptoms were subsided as of on 1st June 2018. At the time of reporting the patient still felt "washed out" but did not think that was in relation to the vaccine. He had gotten lab work done in his office. Results were not back at the time of reporting. He did not go to the emergency room (ER) but during work hours his coworkers wanted to call the ambulance but he refused. The healthcare provider (HCP) was not sure to receive the 2nd dose of the SHINGRIX based on these reactions.
Age: 64.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Bedridden, Chills, Pyrexia
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of shivering in a 64-year-old male patient who received SHINGRIX for prophylaxis. On 23rd May 2018, the patient received the 1st dose of SHINGRIX. On 24th May 2018, 1 days after receiving SHINGRIX, the patient experienced shivering, myalgia, sweating, fever and fatigue. On an unknown date, the outcome of the shivering, myalgia, sweating and fever were recovering/resolving and the outcome of the fatigue was not recovered/not resolved. It was unknown if the reporter considered the shivering, myalgia, sweating and fever to be related to SHINGRIX. The reporter considered the fatigue to be unrelated to SHINGRIX. Additional details were provided as follows: The reporting physician (who was the patient) reported that, he experienced reactions such as severe shivering, fever, severe fatigue, perspiration and myalgia and the symptoms were subsided as of on 1st June 2018. At the time of reporting the patient still felt "washed out" but did not think that was in relation to the vaccine. He had gotten lab work done in his office. Results were not back at the time of reporting. He did not go to the emergency room (ER) but during work hours his coworkers wanted to call the ambulance but he refused. The healthcare provider (HCP) was not sure to receive the 2nd dose of the SHINGRIX based on these reactions.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fever in a 60-year-old female patient who received SHINGRIX for prophylaxis. On 31st May 2018, the patient received the 2nd dose of SHINGRIX .5 ml. On an unknown date, less than a week after receiving SHINGRIX, the patient experienced fever and general body pain. On an unknown date, the outcome of the fever and general body pain were unknown. It was unknown if the reporter considered the fever and general body pain to be related to SHINGRIX. Additional details were provided as follows: The reporter had entered medical information chat by mistake. The adverse event was collected in chat and transferred to the GSK Response Center.  The reporter was patient's husband and and reported that his wife received SHINGRIX and developed a slight fever and body ache. The reporter did not have vaccine information. The reporter refused to provide full address.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Eye pain, Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of eye pain in a 72-year-old female patient who received SHINGRIX for prophylaxis. Concomitant products included thyroxine sodium (Levothyroxine), liothyronine sodium (Liothyronine), colestipol and oxybutynin. On 29th May 2018 14:30, the patient received the 1st dose of SHINGRIX. On 29th May 2018, several hours after receiving SHINGRIX, the patient experienced eye pain. On an unknown date, the outcome of the eye pain was unchanged. The reporter considered the eye pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that later on the evening of 29th May 2018, after vaccination with SHINGRIX in left arm, she developed eye pain that started in both eyes. The patient stated that the pain went away in the left eye by Wednesday morning, but the pain in the right eye was still present. The patient stated there was no pain in her eyes when she did not move her eyes. The patient stated that when she moved her eyes to look left and right, or up and down. She stated the pain was not excruciating. The patient had denied permission to contact their physician. The patient was referred to her physician for follow up. All questions were asked and no further details were provided.
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B antibody negative, Therapy non-responder
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of therapy non-responder in a female patient who received Hepatitis B vaccine for prophylaxis. On an unknown date, the patient received Hepatitis B vaccine at an unknown dose. On an unknown date, unknown after receiving Hepatitis B vaccine, the patient experienced therapy non-responder. On an unknown date, the outcome of the therapy non-responder was unknown. It was unknown if the reporter considered the therapy non-responder to be related to Hepatitis B vaccine. Additional details were provided as follows: The age at vaccination was not reported. The healthcare professional reported that after a primary hepatitis B series the patient did not seroconvert. The patient was transferred to the reporter's practice so they did not know what vaccine was given as the primary series, but she was going to look into it so might have more information later. Lab Comments: On an unknown date, the patient underwent serology test (for Hepatitis B antibody).