chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
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. The patient's healthcare providers recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 09-DEC-2015, a healthcare provider administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On or about 09-DEC-2015, the patient was treated by a healthcare provider for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
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. The patient's healthcare providers recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. In 2013, a healthcare provider administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On or about 14-APR-2017, the patient was treated by a healthcare at an Emergency room provider for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
Age: 11.0
Sex: U
Vaccine: HPV9, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This non-valid, spontaneous report was received from a registered nurse, referring to an unspecified number of patients of unknown age and gender. No information was provided regarding the patients' medical history, previous drug reactions, allergies, concurrent medical conditions or concomitant medications. On unknown dates, the patients were vaccinated with improperly stored doses of LIQUID PEDVAXHIB, lot number N034005 (expiration date 31-JAN-2020) and lot number reported as "N021920" (expiration date 07-FEB-2020) for prophylaxis (doses, routes and anatomical locations of administration were not reported). Additionally, the patients were vaccinated with ROTATEQ by oral route, lot number N005078 (expiration dates 22-NOV-2018 and 04-OCT-2018) for prophylaxis (doses were unknown), GARDASIL 9, lot number N020352 (expiration date 10-APR-2020) for prophylaxis (doses, routes and anatomical locations of administration were not provided) and M-M-R II for prophylaxis (dose numbers, routes and anatomical locations of administration were not provided; lot numbers N010496 [expiration date 31-MAR-2019], N014485 [expiration date 10-MAY-2019], and N023149 [expiration date 24-AUG-2019]). The vaccines were reconstituted with sterile diluent which was reported to be properly stored. The doses of all vaccines were exposed to a temperature excursion below 32 degrees Fahrenheit (F) (also reported as 31F) during a time frame of 15 days, which was detected by the Digital Data Logger. There was no previous temperature excursion and no adverse effects were reported. Follow-up information was received from the nurse on 17-DEC-2018. The reporter provided patients' demographics which made the case valid. This report refers to a 11-year-old patient of unknown gender. On 20-MAR-2018, the patient was vaccinated with an improperly stored doses of GARDASIL 9, lot number N020352 (expiration date 10-APR-2020) and VARIVAX, lot number N027002, expiration date: 28-SEP-2018 (exact dose, site and route of administration and frequency were not reported) for prophylaxis. This is one of multiple reports received from the same reporter. Sender's Comments: US-009507513-1807USA011661.
Age: 0.33
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This non-valid, spontaneous report was received from a registered nurse, referring to an unspecified number of patients of unknown age and gender. No information was provided regarding the patients' medical history, previous drug reactions, allergies, concurrent medical conditions or concomitant medications. On unknown dates, the patients were vaccinated with improperly stored doses of LIQUID PEDVAXHIB lot number N034005 (expiration date 31-JAN-2020) and lot number reported as "N021920" (expiration date 07-FEB-2020) for prophylaxis (doses, routes and anatomical locations of administration were not reported). Additionally, the patients were vaccinated with ROTATEQ by oral route, lot number N005078 (expiration dates 22-NOV-2018 and 04-OCT-2018) for prophylaxis (doses were unknown), GARDASIL 9 lot number N020352 (expiration date 10-APR-2020) for prophylaxis (doses, routes and anatomical locations of administration were not provided) and M-M-R II for prophylaxis (dose numbers, routes and anatomical locations of administration were not provided; lot numbers N010496 [expiration date 31-MAR-2019], N014485 [expiration date 10-MAY-2019], and N023149 [expiration date 24-AUG-2019]). The vaccines were reconstituted with sterile diluent which was reported to be properly stored. The doses of all vaccines were exposed to a temperature excursion below 32 degrees Fahrenheit (F) (also reported as 31F) during a time frame of 15 days, which was detected by the Digital Data Logger. There was no prior temperature excursion and no adverse effects were reported. Follow-up information was received from the nurse on 17-DEC-2018. The reporter provided patients' demographics which made the case valid. This report refers to a 4-month-old patient of unknown gender. On 11-JUN-2018, the patient was vaccinated with an improperly stored dose of LIQUID PEDVAXHIB lot number N031492 (expiration date 02-MAY-2020). This is one of multiple reports received from the same reporter. Sender's Comments: US-009507513-1807USA011661.
Age: 0.17
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This non-valid, spontaneous report was received from a registered nurse, referring to an unspecified number of patients of unknown age and gender. No information was provided regarding the patients' medical history, previous drug reactions, allergies, concurrent medical conditions or concomitant medications. On unknown dates, the patients were vaccinated with improperly stored doses of LIQUID PEDVAXHIB lot number N034005 (expiration date 31-JAN-2020) and lot number reported as "N021920" (expiration date 07-FEB-2020) for prophylaxis (doses, routes and anatomical locations of administration were not reported). Additionally, the patients were vaccinated with ROTATEQ by oral route, lot number N005078 (expiration dates 22-NOV-2018 and 04-OCT-2018) for prophylaxis (doses were unknown), GARDASIL 9 lot number N020352 (expiration date 10-APR-2020) for prophylaxis (doses, routes and anatomical locations of administration were not provided) and M-M-R II for prophylaxis (dose numbers, routes and anatomical locations of administration were not provided; lot numbers N010496 [expiration date 31-MAR-2019], N014485 [expiration date 10-MAY-2019], and N023149 [expiration date 24-AUG-2019]). The vaccines were reconstituted with sterile diluent which was reported to be properly stored. The doses of all vaccines were exposed to a temperature excursion below 32 degrees Fahrenheit (F) (also reported as 31F) during a time frame of 15 days, which was detected by the Digital Data Logger. There was no prior temperature excursion and no adverse effects were reported. Follow-up information was received from the nurse on 17-DEC-2018. The reporter provided patients' demographics which made the case valid. This report refers to a 11-week-old patient of unknown gender. On 12-JUN-2018, the patient was vaccinated with an improperly stored dose of LIQUID PEDVAXHIB lot number N031492 (expiration date 02-MAY-2020). This is one of multiple reports received from the same reporter. Sender's Comments: US-009507513-1807USA011661.
Age: 0.17
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This non-valid, spontaneous report was received from a registered nurse, referring to an unspecified number of patients of unknown age and gender. No information was provided regarding the patients' medical history, previous drug reactions, allergies, concurrent medical conditions or concomitant medications. On unknown dates, the patients were vaccinated with improperly stored doses of LIQUID PEDVAXHIB lot number N034005 (expiration date 31-JAN-2020) and lot number reported as "N021920" (expiration date 07-FEB-2020) for prophylaxis (doses, routes and anatomical locations of administration were not reported). Additionally, the patients were vaccinated with ROTATEQ by oral route, lot number N005078 (expiration dates 22-NOV-2018 and 04-OCT-2018) for prophylaxis (doses were unknown), GARDASIL 9 lot number N020352 (expiration date 10-APR-2020) for prophylaxis (doses, routes and anatomical locations of administration were not provided) and M-M-R II for prophylaxis (dose numbers, routes and anatomical locations of administration were not provided; lot numbers N010496 [expiration date 31-MAR-2019], N014485 [expiration date 10-MAY-2019], and N023149 [expiration date 24-AUG-2019]). The vaccines were reconstituted with sterile diluent which was reported to be properly stored. The doses of all vaccines were exposed to a temperature excursion below 32 degrees Fahrenheit (F) (also reported as 31F) during a time frame of 15 days, which was detected by the Digital Data Logger. There was no prior temperature excursion and no adverse effects were reported. Follow-up information was received from the nurse on 17-DEC-2018. The reporter provided patients' demographics which made the case valid. This report refers to a 8-week-old patient of unknown gender. On 15-JUN-2018, the patient was vaccinated with an improperly stored dose of LIQUID PEDVAXHIB lot number N031492 (expiration date 02-MAY-2020). This is one of multiple reports received from the same reporter. Sender's Comments: US-009507513-1807USA011661.
Age: 0.17
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This non-valid, spontaneous report was received from a registered nurse, referring to an unspecified number of patients of unknown age and gender. No information was provided regarding the patients' medical history, previous drug reactions, allergies, concurrent medical conditions or concomitant medications. On unknown dates, the patients were vaccinated with improperly stored doses of LIQUID PEDVAXHIB lot number N034005 (expiration date 31-JAN-2020) and lot number reported as "N021920" (expiration date 07-FEB-2020) for prophylaxis (doses, routes and anatomical locations of administration were not reported). Additionally, the patients were vaccinated with ROTATEQ by oral route, lot number N005078 (expiration dates 22-NOV-2018 and 04-OCT-2018) for prophylaxis (doses were unknown), GARDASIL 9 lot number N020352 (expiration date 10-APR-2020) for prophylaxis (doses, routes and anatomical locations of administration were not provided) and M-M-R II for prophylaxis (dose numbers, routes and anatomical locations of administration were not provided; lot numbers N010496 [expiration date 31-MAR-2019], N014485 [expiration date 10-MAY-2019], and N023149 [expiration date 24-AUG-2019]). The vaccines were reconstituted with sterile diluent which was reported to be properly stored. The doses of all vaccines were exposed to a temperature excursion below 32 degrees Fahrenheit (F) (also reported as 31F) during a time frame of 15 days, which was detected by the Digital Data Logger. There was no prior temperature excursion and no adverse effects were reported. Follow-up information was received from the nurse on 17-DEC-2018. The reporter provided patients' demographics which made the case valid. This report refers to a 9-week-old patient of unknown gender. On 30-JUN-2018, the patient was vaccinated with an improperly stored dose of LIQUID PEDVAXHIB lot number N031492 (expiration date 02-MAY-2020). This is one of multiple reports received from the same reporter. Sender's Comments: US-009507513-1807USA011661.
Age: 0.17
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This non-valid, spontaneous report was received from a registered nurse, referring to an unspecified number of patients of unknown age and gender. No information was provided regarding the patients' medical history, previous drug reactions, allergies, concurrent medical conditions or concomitant medications. On unknown dates, the patients were vaccinated with improperly stored doses of LIQUID PEDVAXHIB lot number N034005 (expiration date 31-JAN-2020) and lot number reported as "N021920" (expiration date 07-FEB-2020) for prophylaxis (doses, routes and anatomical locations of administration were not reported). Additionally, the patients were vaccinated with ROTATEQ by oral route, lot number N005078 (expiration dates 22-NOV-2018 and 04-OCT-2018) for prophylaxis (doses were unknown), GARDASIL 9 lot number N020352 (expiration date 10-APR-2020) for prophylaxis (doses, routes and anatomical locations of administration were not provided) and M-M-R II for prophylaxis (dose numbers, routes and anatomical locations of administration were not provided; lot numbers N010496 [expiration date 31-MAR-2019], N014485 [expiration date 10-MAY-2019], and N023149 [expiration date 24-AUG-2019]). The vaccines were reconstituted with sterile diluent which was reported to be properly stored. The doses of all vaccines were exposed to a temperature excursion below 32 degrees Fahrenheit (F) (also reported as 31F) during a time frame of 15 days, which was detected by the Digital Data Logger. There was no prior temperature excursion and no adverse effects were reported. Follow-up information was received from the nurse on 17-DEC-2018. The reporter provided patients' demographics which made the case valid. This report refers to a 8-week-old patient of unknown gender. On 02-JUL-2018, the patient was vaccinated with an improperly stored dose of LIQUID PEDVAXHIB lot number N031492 (expiration date 02-MAY-2020). This is one of multiple reports received from the same reporter. Sender's Comments: US-009507513-1807USA011661.
Age: 0.17
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This non-valid, spontaneous report was received from a registered nurse, referring to an unspecified number of patients of unknown age and gender. No information was provided regarding the patients' medical history, previous drug reactions, allergies, concurrent medical conditions or concomitant medications. On unknown dates, the patients were vaccinated with improperly stored doses of LIQUID PEDVAXHIB lot number N034005 (expiration date 31-JAN-2020) and lot number reported as "N021920" (expiration date 07-FEB-2020) for prophylaxis (doses, routes and anatomical locations of administration were not reported). Additionally, the patients were vaccinated with ROTATEQ by oral route, lot number N005078 (expiration dates 22-NOV-2018 and 04-OCT-2018) for prophylaxis (doses were unknown), GARDASIL 9 lot number N020352 (expiration date 10-APR-2020) for prophylaxis (doses, routes and anatomical locations of administration were not provided) and M-M-R II for prophylaxis (dose numbers, routes and anatomical locations of administration were not provided; lot numbers N010496 [expiration date 31-MAR-2019], N014485 [expiration date 10-MAY-2019], and N023149 [expiration date 24-AUG-2019]). The vaccines were reconstituted with sterile diluent which was reported to be properly stored. The doses of all vaccines were exposed to a temperature excursion below 32 degrees Fahrenheit (F) (also reported as 31F) during a time frame of 15 days, which was detected by the Digital Data Logger. There was no prior temperature excursion and no adverse effects were reported. Follow-up information was received from the nurse on 17-DEC-2018. The reporter provided patients' demographics which made the case valid. This report refers to a 8-week-old patient of unknown gender. On 03-JUL-2018, the patient was vaccinated with an improperly stored dose of LIQUID PEDVAXHIB lot number N031492 (expiration date 02-MAY-2020). This is one of multiple reports received from the same reporter. Sender's Comments: US-009507513-1807USA011661.
Age: 1.42
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This non-valid, spontaneous report was received from a registered nurse, referring to an unspecified number of patients of unknown age and gender. No information was provided regarding the patients' medical history, previous drug reactions, allergies, concurrent medical conditions or concomitant medications. On unknown dates, the patients were vaccinated with improperly stored doses of LIQUID PEDVAXHIB lot number N034005 (expiration date 31-JAN-2020) and lot number reported as "N021920" (expiration date 07-FEB-2020) for prophylaxis (doses, routes and anatomical locations of administration were not reported). Additionally, the patients were vaccinated with ROTATEQ by oral route, lot number N005078 (expiration dates 22-NOV-2018 and 04-OCT-2018) for prophylaxis (doses were unknown), GARDASIL 9 lot number N020352 (expiration date 10-APR-2020) for prophylaxis (doses, routes and anatomical locations of administration were not provided) and M-M-R II for prophylaxis (dose numbers, routes and anatomical locations of administration were not provided; lot numbers N010496 [expiration date 31-MAR-2019], N014485 [expiration date 10-MAY-2019], and N023149 [expiration date 24-AUG-2019]). The vaccines were reconstituted with sterile diluent which was reported to be properly stored. The doses of all vaccines were exposed to a temperature excursion below 32 degrees Fahrenheit (F) (also reported as 31F) during a time frame of 15 days, which was detected by the Digital Data Logger. There was no prior temperature excursion and no adverse effects were reported. Follow-up information was received from the nurse on 17-DEC-2018. The reporter provided patients' demographics which made the case valid. This report refers to a 17-month-old patient of unknown gender. On 10-APR-2018, the patient was vaccinated with an improperly stored dose of VARIVAX lot number N027002 (expiration date 28-SEP-2019). This is one of multiple reports received from the same reporter. Sender's Comments: US-009507513-1807USA011661.
Age: 1.25
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This non-valid, spontaneous report was received from a registered nurse, referring to an unspecified number of patients of unknown age and gender. No information was provided regarding the patients' medical history, previous drug reactions, allergies, concurrent medical conditions or concomitant medications. On unknown dates, the patients were vaccinated with improperly stored doses of LIQUID PEDVAXHIB lot number N034005 (expiration date 31-JAN-2020) and lot number reported as "N021920" (expiration date 07-FEB-2020) for prophylaxis (doses, routes and anatomical locations of administration were not reported). Additionally, the patients were vaccinated with ROTATEQ by oral route, lot number N005078 (expiration dates 22-NOV-2018 and 04-OCT-2018) for prophylaxis (doses were unknown), GARDASIL 9 lot number N020352 (expiration date 10-APR-2020) for prophylaxis (doses, routes and anatomical locations of administration were not provided) and M-M-R II for prophylaxis (dose numbers, routes and anatomical locations of administration were not provided; lot numbers N010496 [expiration date 31-MAR-2019], N014485 [expiration date 10-MAY-2019], and N023149 [expiration date 24-AUG-2019]). The vaccines were reconstituted with sterile diluent which was reported to be properly stored. The doses of all vaccines were exposed to a temperature excursion below 32 degrees Fahrenheit (F) (also reported as 31F) during a time frame of 15 days, which was detected by the Digital Data Logger. There was no prior temperature excursion and no adverse effects were reported. Follow-up information was received from the nurse on 17-DEC-2018. The reporter provided patients' demographics which made the case valid. This report refers to a 15-month-old patient of unknown gender. On 25-JUN-2018, the patient was vaccinated with an improperly stored dose of VARIVAX lot number N034554 (expiration date 05-DEC-2019). This is one of multiple reports received from the same reporter. Sender's Comments: US-009507513-1812USA010296.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Fatigue, Feeling cold, Headache
Clinical narrative: Nausea, very cold and shivering, headache, heavy heartbeat, leg thigh muscles hurt. Used lots of blankets to get warm and TYLENOL for headache and pain in legs. Was tired for few days and no energy. Slowly getting energy back.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Nausea, Pain in extremity, Palpitations
Clinical narrative: Nausea, very cold and shivering, headache, heavy heartbeat, leg thigh muscles hurt. Used lots of blankets to get warm and TYLENOL for headache and pain in legs. Was tired for few days and no energy. Slowly getting energy back.
Age: 17.0
Sex: F
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration, Incorrect dose administered, Pain in extremity, Product administered to patient of inappropriate age
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of pain in arm in a 17-year-old female patient who received ENGERIX B (batch number 3G535, expiry date 24th January 2021) for prophylaxis. On 7th November 2018, the patient received ENGERIX B 1 ml. On 7th November 2018, unknown after receiving ENGERIX B, the patient experienced accidental overdose and adult product administered to child. On an unknown date, the outcome of the accidental overdose and adult product administered to child were unknown. Additional details were provided as follows: The patient's date of birth was unknown. The batch number of ENGERIX-B was unknown. A 17 year old patient inadvertently received 1 ml dose of ENGERIX-B, which led to accidental overdose and adult product administered to child. The reporter provided consent to follow up. Follow up information were received from other health professional on 13th December 2018: The reporter spoke to patient's mother. The patient's demographic details were updated. The batch number for suspect vaccine has been updated. The patient received 1st dose of ENGERIX-B at birth. On 7th November 2018, the patient received the 2nd dose of ENGERIX B by intramuscularly, which led to lengthening of vaccination schedule. In 2018, less than a year after receiving ENGERIX B the patient experienced pain in arm. The outcome of the pain in arm was unknown. It was unknown if the reporter considered the pain in arm to be related to ENGERIX B. This was medication error associated with adverse event. The VAERS details were updated.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Blister, Burning sensation, Chills, Injection site pain
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of chickenpox in a 52-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of injection site pain (1st dose received on 12th September 2018, please refer the case US2018GSK227916.). On 30th November 2018, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. On 5th December 2018, 5 days after receiving SHINGRIX, the patient experienced chickenpox and itchy legs. On 6th December 2018, the patient experienced burning sensation, vesicles, leg pain and buttock pain. On an unknown date, the patient experienced injection site pain, fever, chills, joint pain and general body pain. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the chickenpox, itchy legs, burning sensation, vesicles, leg pain and buttock pain were unknown and the outcome of the injection site pain, fever, chills, joint pain and general body pain were recovered/resolved. It was unknown if the reporter considered the chickenpox, injection site pain, fever, chills, joint pain, general body pain, itchy legs, burning sensation, vesicles, leg pain and buttock pain to be related to SHINGRIX. Additional details were provided as follows: The pharmacist was the caller and the reported for herself. The patient received 2nd dose of SHINGRIX vaccine in left arm. She experienced the exact same symptoms with the second dose of the vaccine and had recovered. On 5th December 2018, 5 days after receiving the vaccine, she started noticing itching on her thigh area. On 6th December 2018, 6 days after receiving the vaccine, while at work she experienced soreness and burning sensation around the buttock area, back of the legs and thighs. She also noticed small vesicles with white head. On 7th December 2018, she noticed vesicles with fluid on the waist area, on the back, side of her body, under arm, armpit area, under the breast and closer to belly button area. She sent pictures to her pediatrician and she thinks she might had chicken pox. She had an appointment with her physician later on the day of reporting. She wanted to know if she could develop chicken pox from SHINGRIX. The reporter gave consent to follow up. No further details were provided. Transferred call to medical information vaccines for further information.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Musculoskeletal pain, Pain, Pain in extremity, Pruritus, Pyrexia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of chickenpox in a 52-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of injection site pain (1st dose received on 12th September 2018, please refer the case US2018GSK227916.). On 30th November 2018, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. On 5th December 2018, 5 days after receiving SHINGRIX, the patient experienced chickenpox and itchy legs. On 6th December 2018, the patient experienced burning sensation, vesicles, leg pain and buttock pain. On an unknown date, the patient experienced injection site pain, fever, chills, joint pain and general body pain. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the chickenpox, itchy legs, burning sensation, vesicles, leg pain and buttock pain were unknown and the outcome of the injection site pain, fever, chills, joint pain and general body pain were recovered/resolved. It was unknown if the reporter considered the chickenpox, injection site pain, fever, chills, joint pain, general body pain, itchy legs, burning sensation, vesicles, leg pain and buttock pain to be related to SHINGRIX. Additional details were provided as follows: The pharmacist was the caller and the reported for herself. The patient received 2nd dose of SHINGRIX vaccine in left arm. She experienced the exact same symptoms with the second dose of the vaccine and had recovered. On 5th December 2018, 5 days after receiving the vaccine, she started noticing itching on her thigh area. On 6th December 2018, 6 days after receiving the vaccine, while at work she experienced soreness and burning sensation around the buttock area, back of the legs and thighs. She also noticed small vesicles with white head. On 7th December 2018, she noticed vesicles with fluid on the waist area, on the back, side of her body, under arm, armpit area, under the breast and closer to belly button area. She sent pictures to her pediatrician and she thinks she might had chicken pox. She had an appointment with her physician later on the day of reporting. She wanted to know if she could develop chicken pox from SHINGRIX. The reporter gave consent to follow up. No further details were provided. Transferred call to medical information vaccines for further information.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Vaccine positive rechallenge, Varicella
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of chickenpox in a 52-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of injection site pain (1st dose received on 12th September 2018, please refer the case US2018GSK227916.). On 30th November 2018, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. On 5th December 2018, 5 days after receiving SHINGRIX, the patient experienced chickenpox and itchy legs. On 6th December 2018, the patient experienced burning sensation, vesicles, leg pain and buttock pain. On an unknown date, the patient experienced injection site pain, fever, chills, joint pain and general body pain. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the chickenpox, itchy legs, burning sensation, vesicles, leg pain and buttock pain were unknown and the outcome of the injection site pain, fever, chills, joint pain and general body pain were recovered/resolved. It was unknown if the reporter considered the chickenpox, injection site pain, fever, chills, joint pain, general body pain, itchy legs, burning sensation, vesicles, leg pain and buttock pain to be related to SHINGRIX. Additional details were provided as follows: The pharmacist was the caller and the reported for herself. The patient received 2nd dose of SHINGRIX vaccine in left arm. She experienced the exact same symptoms with the second dose of the vaccine and had recovered. On 5th December 2018, 5 days after receiving the vaccine, she started noticing itching on her thigh area. On 6th December 2018, 6 days after receiving the vaccine, while at work she experienced soreness and burning sensation around the buttock area, back of the legs and thighs. She also noticed small vesicles with white head. On 7th December 2018, she noticed vesicles with fluid on the waist area, on the back, side of her body, under arm, armpit area, under the breast and closer to belly button area. She sent pictures to her pediatrician and she thinks she might had chicken pox. She had an appointment with her physician later on the day of reporting. She wanted to know if she could develop chicken pox from SHINGRIX. The reporter gave consent to follow up. No further details were provided. Transferred call to medical information vaccines for further information.
Age: 66.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site mass
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site lump in a 66-year-old female patient who received BOOSTRIX for prophylaxis. On 7th December 2018, the patient received BOOSTRIX. On 8th December 2018, 1 days after receiving BOOSTRIX, the patient experienced injection site lump. On an unknown date, the outcome of the injection site lump was unknown. It was unknown if the reporter considered the injection site lump to be related to BOOSTRIX. Additional details were reported as follows: The next day after receiving BOOSTRIX, the patient noticed a small knot beneath the surface of the skin at the injection site.  Per the patient, the knot had decreased in size and the healthcare professional (HCP) it to resemble a small bead. The patient had experienced no muscle pain, redness or swelling. The reporting pharmacist did not administer the vaccine and was waiting for a response from the administering pharmacist to confirm the route of administration. The reporter did consent to follow up.
Sex: F
Vaccine: FLU4
Symptoms: Allergic reaction to excipient, Pruritus, Underdose, Urticaria
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of hives in a female patient who received FLULAVAL QUADRIVALENT for prophylaxis. Co-suspect products included FLULAVAL QUADRIVALENT for prophylaxis. Concurrent medical conditions included allergy to chemicals. On an unknown date, the patient received FluLaval Quadrivalent at an unknown dose and FLULAVAL QUADRIVALENT .25 ml. On an unknown date, less than a year after receiving FLULAVAL QUADRIVALENT and not applicable after receiving FLULAVAL QUADRIVALENT, the patient experienced hives, pruritus, allergic reaction to excipient and underdose. On an unknown date, the outcome of the hives and pruritus were recovered/resolved and the outcome of the allergic reaction to excipient and underdose were unknown. It was unknown if the reporter considered the hives, pruritus and allergic reaction to excipient to be related to FLULAVAL QUADRIVALENT. It was unknown if the reporter considered the allergic reaction to excipient to be related to FLULAVAL QUADRIVALENT. Additional details were provided as follows: Age at vaccination was not reported. The patient was employee at the health care professional office. The patient was allergic to the formaldehyde. The patient gets the Flu vaccine yearly. When the patient received the full dose of FLULAVAL QUADRIVALENT, she breaks out in hives which were itchy. From the current season, the patient gets the vaccine (FLULAVAL QUADRIVALENT) administered as half a dose at a time, which led to underdose. The reporter was not aware of the patient's having any reaction with the current administration.
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Bronchitis, Incomplete course of vaccination
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of bronchitis in a 51-year-old male patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. In January 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, the patient received the 2nd dose of SHINGRIX. In November 2018, less than a year after receiving SHINGRIX and not applicable after receiving SHINGRIX, the patient experienced bronchitis. On an unknown date, the patient experienced incomplete course of vaccination. The patient was treated with antibiotics, prednisone and Corticosteroids For Inhalation. On an unknown date, the outcome of the bronchitis and incomplete course of vaccination were unknown. It was unknown if the reporter considered the bronchitis to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported but it can be 50 or 51 years. The patient received SHINGRIX on left arm. The patient experienced bronchitis about 14 days before reporting. His pharmacy had the vaccine in stock, and he wants to know if it was safe for him to go ahead and get the vaccine. Till the time of reporting patient did not report the 2nd dose, which led to Incomplete course of vaccination. The reporter gave medical disclaimer referred to his HCP (healthcare professional). Emergency room visit Required. The reporter gave consent to follow up.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Discomfort, Herpes zoster, Rash
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shingles in a 72-year-old female patient who received SHINGRIX for prophylaxis. In August 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 16th November 2018, less than a year after receiving SHINGRIX, the patient experienced shingles, rash and discomfort. On an unknown date, the outcome of the shingles, rash and discomfort were not recovered/not resolved. It was unknown if the reporter considered the shingles, rash and discomfort to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on the left arm. The patient stated that she developed Shingles and shingles rash on the right side of her face and which wrapped around her right ear and underneath her right eye. The patient stated that, this was resolving, however, she still had some discomfort. The patient did not have any additional information. The reporter did not consent to follow-up. The patient did not want to provide her address and stated that any correspondence could be sent to her email.
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness, Injection site swelling, Pyrexia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of influenza-like symptoms in a male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced influenza-like symptoms, fever and injection site swelling. On an unknown date, the outcome of the influenza-like symptoms, fever and injection site swelling were unknown. It was unknown if the reporter considered the influenza-like symptoms, fever and injection site swelling to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient had flu like symptoms, fever (body temperature: 101 degree F) and swelling at the injection site. The reporter did not have any additional information as she did not speak to this specific patient. The pharmacy tech spoke with the patient. Lab Comments: On an unknown date, the patient's body temperature was 101 degree F.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Peripheral swelling
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of erythema of extremities in a female patient who received SHINGRIX for prophylaxis. On 11th December 2018, the patient received the 1st dose of SHINGRIX. On 11th December 2018, less than a day after receiving SHINGRIX, the patient experienced erythema of extremities and swelling arm. On an unknown date, the outcome of the erythema of extremities and swelling arm were unknown. It was unknown if the reporter considered the erythema of extremities and swelling arm to be related to SHINGRIX. Additional information received as follows: The age at vaccination was not reported. The healthcare professional was not able to provide lot number, expiry date and demographic details. The healthcare professional reported that the patient had swelling and redness following the dose of SHINGRIX that was wide spread across the vaccinated arm.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Burning sensation
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of burning sensation in joints in a 68-year-old female patient who received SHINGRIX (batch number 5544H, expiry date 15th May 2021) for prophylaxis. On 10th December 2018, the patient received the 2nd dose of SHINGRIX (intramuscular). On 12th December 2018, 2 days after receiving SHINGRIX, the patient experienced burning sensation in joints and extremities burning sensation of. On an unknown date, the outcome of the burning sensation in joints and extremities burning sensation of were unknown. It was unknown if the reporter considered the burning sensation in joints and extremities burning sensation of to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the left deltoid and called the pharmacy to report that she had a burning sensation on her knees and her hands.
Sex: M
Vaccine: VARZOS
Symptoms: Nausea
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of nausea in an elderly male patient who received SHINGRIX (batch number 4492P, expiry date unknown) for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced nausea. On an unknown date, the outcome of the nausea was recovered/resolved. It was unknown if the reporter considered the nausea to be related to SHINGRIX. Additional details were provided as follows: The age at the vaccination was not reported. The reporter did not have expiration date of vaccine. The patient experienced nausea lasting 6 weeks after dose of SHINGRIX and did not intend on completing the series due to this adverse event. The reporter consented to follow up.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site swelling
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a 58-year-old male patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included mental disability and tremor. On 18th June 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 19th June 2018, 1 days after receiving SHINGRIX, the patient experienced injection site swelling. On an unknown date, the outcome of the injection site swelling was recovered/resolved. It was unknown if the reporter considered the injection site swelling to be related to SHINGRIX. Additional details were provided as follows: This case was reported by patient's brother. The next day after receiving SHINGRIX, the patient experienced swelling at the injection site. It was about 1.5 inch in diameter and bulged up like there was a ball under the skin and took 3 to 4 days to resolve.
Sex: F
Vaccine: VARZOS
Symptoms: Nodule, Swelling
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of local swelling in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced local swelling. On an unknown date, the outcome of the local swelling was recovered/resolved. It was unknown if the reporter considered the local swelling to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient experienced a knot in the arm after getting the SHINGRIX injection. The event lasted about a week or two. No further clarifications on the event were provided. This case has been linked to case US2018226058 and US2018226062, reported by same reporter.
Age: 85.0
Sex: F
Vaccine: VARZOS
Symptoms: Computerised tomogram normal, Headache
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of headache in a 85-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX (1st dose received on 20th August 2018). On 3rd December 2018, the patient received the 2nd dose of SHINGRIX. In December 2018, less than a month after receiving SHINGRIX, the patient experienced headache. On an unknown date, the outcome of the headache was not recovered/not resolved. It was unknown if the reporter considered the headache to be related to SHINGRIX. Additional details were provided as follows: The patient got their 1st dose of SHINGRIX and did not have a headache with the first dose. The pharmacist stated that a patient got their 2nd dose of Shingrix and had a severe headache since receiving SHINGRIX that was still ongoing at the time of reporting. The patient went to emergency room (ER) and they did a CAT Scan which was normal. The healthcare professional (HCP) did not know if the patient was given any medication to treat her. The severe headache started after the 2nd dose of SHINGRIX. The reporter consented to follow up.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 59-year-old female patient who received SHINGRIX (batch number HM3NC, expiry date 13th April 2021) for prophylaxis. On 10th December 2018, the patient received SHINGRIX (intramuscular). On 12th December 2018, 2 days after receiving SHINGRIX, the patient experienced shingles. On an unknown date, the outcome of the shingles was not recovered/not resolved. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional details were provided as follows: The patient developed a Shingles outbreak.
Age: 83.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Tenderness
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of erythema in a 83-year-old female patient who received SHINGRIX for prophylaxis. On 19th August 2018, the patient received the 1st dose of SHINGRIX (intramuscular) 50 µg. On 20th August 2018, 1 days after receiving SHINGRIX, the patient experienced erythema and tenderness. On an unknown date, the outcome of the erythema and tenderness were recovered/resolved. It was unknown if the reporter considered the erythema and tenderness to be related to SHINGRIX. Additional details were provided as follows: The patient received vaccine on right arm. After receiving SHINGRIX, the patient experienced red area on her arm which was about 6 to 7 inches long and 3 inches wide. Her arm was very tender for about 8 days. The reporter was consented to follow up. This case had been linked with case US2018GSK230650 for the same patient reported for the same reporter.