chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 4.0
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), hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (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-year-old patient of unknown gender. On 26-APR-2018, the patient was vaccinated with an improperly stored dose of VARIVAX lot number N021720 (expiration date 10-AUG-2019). This is one of multiple reports received from the same reporter. Sender's Comments: US-009507513-1807USA011661.
Age: 4.0
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 4-year-old patient of unknown gender. On 26-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: 4.0
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 4-year-old patient of unknown gender. On 19-MAY-2018, the patient was vaccinated with an improperly stored dose of VARIVAX lot # N027002, expiration date 28-SEP-2019 (exact dose and route of administration were not reported) for prophylaxis. This is one of multiple reports received from the same reporter. Sender's Comments: US-009507513-1807USA011661.
Age: 4.0
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 4-year-old patient of unknown gender. On 19-MAY-2018, the patient was vaccinated with an improperly stored dose of VARIVAX lot # N0217202, expiration date 10-AUG-2019 (exact dose and route of administration were not reported) for prophylaxis. This is one of multiple reports received from the same reporter. Sender's Comments: US-009507513-1807USA011661.
Age: 4.0
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 4-year-old patient of unknown gender. On 05-JUN-2018, the patient was vaccinated with an improperly stored dose of VARIVAX lot # N021720, expiration date 10-AUG-2019 (exact dose and route of administration were not reported) for prophylaxis. This is one of multiple reports received from the same reporter. Sender's Comments: US-009507513-1807USA011661.
Age: 4.0
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 4-year-old patient of unknown gender. On 11-JUN-2018, the patient was vaccinated with an improperly stored dose of VARIVAX lot # N021720, expiration date 10-AUG-2019 (exact dose and route of administration were not reported) for prophylaxis. This is one of multiple reports received from the same reporter. Sender's Comments: US-009507513-1807USA011661.
Age: 4.0
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 4-year-old patient of unknown gender. On 18-JUN-2018, the patient was vaccinated with an improperly stored dose of VARIVAX lot # N021720, expiration date 10-AUG-2019 (exact dose and route of administration were not reported) for prophylaxis. This is one of multiple reports received from the same reporter. Sender's Comments: US-009507513-1807USA011661.
Age: 4.0
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 4-year-old patient of unknown gender. On 21-JUN-2018, the patient was vaccinated with an improperly stored dose of VARIVAX lot # N021720, expiration date 10-AUG-2019 (exact dose and route of administration were not reported) for prophylaxis. This is one of multiple reports received from the same reporter.; Sender's Comments: US-009507513-1807USA011661:
Age: 4.0
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 4-year-old patient of unknown gender. On 22-JUN-2018, the patient was vaccinated with an improperly stored dose of VARIVAX lot # N021720, expiration date 10-AUG-2019 (exact dose and route of administration were not reported) for prophylaxis. This is one of multiple reports received from the same reporter. Sender's Comments: US-009507513-1807USA011661.
Age: 4.0
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 4-year-old patient of unknown gender. On 06-JUL-2018, the patient was vaccinated with an improperly stored dose of VARIVAX lot # N034554, expiration date 05-DEC-2019 (exact dose and route of administration were not reported) for prophylaxis. This is one of multiple reports received from the same reporter. Sender's Comments: US-009507513-1807USA011661.
Age: 4.0
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 4-year-old patient of unknown gender. On 09-JUL-2018, the patient was vaccinated with an improperly stored dose of VARIVAX lot # N034554, expiration date 05-DEC-2019 (exact dose and route of administration were not reported) for prophylaxis. This is one of multiple reports received from the same reporter. Sender's Comments: US-009507513-1807USA011661.
Age: 4.0
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), hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (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-year-old patient of unknown gender. On 09-JUL-2018, the patient was vaccinated with an improperly stored dose of VARIVAX lot # N034554, expiration date 05-DEC-2019 (exact dose and route of administration were not reported) for prophylaxis. This is one of multiple reports received from the same reporter. Sender's Comments: US-009507513-1807USA011661.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Immediate post-injection reaction, Malaise, Pain in extremity, Peripheral swelling
Clinical narrative: This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a female patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. The patient's past medical history included fibromyalgia. Concurrent medical conditions included cold sores (in eye). Concomitant products included valaciclovir hydrochloride (Valtrex). In September 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, the patient received the 2nd dose of SHINGRIX. In September 2018, immediately after receiving SHINGRIX and not applicable after receiving SHINGRIX, the patient experienced pain in arm, swelling arm, sickness, fever and blister. On an unknown date, the patient experienced product supply issue. On an unknown date, the outcome of the pain in arm, swelling arm, sickness and product supply issue were unknown and the outcome of the fever and blister were recovered/resolved. It was unknown if the reporter considered the pain in arm, swelling arm, sickness, fever and blister to be related to SHINGRIX. Additional details were provided as follows: The patient had 2 previous bouts of cold sores in her eye and was getting over having cold sores when she got her SHINGRIX dose. She was taking Valtrex at the time of the vaccination. She has a preexisting condition of fibromyalgia. The age at vaccination was not reported. The patient's arm was extremely painful soon after getting the dose and it began to swell. That night, she was very sick (latency less than a day). She normally had a low body temperature, but she had a fever of 102 degrees F (latency less than a month) for 3 days. Her arm got worse and she got blisters on her arms (latency less than a month). The patient stated that, she could not get her 2nd dose of SHINGRIX due to shortage.
Sex: F
Vaccine: VARZOS
Symptoms: Product supply issue, Pyrexia
Clinical narrative: This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a female patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. The patient's past medical history included fibromyalgia. Concurrent medical conditions included cold sores (in eye). Concomitant products included valaciclovir hydrochloride (Valtrex). In September 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, the patient received the 2nd dose of SHINGRIX. In September 2018, immediately after receiving SHINGRIX and not applicable after receiving SHINGRIX, the patient experienced pain in arm, swelling arm, sickness, fever and blister. On an unknown date, the patient experienced product supply issue. On an unknown date, the outcome of the pain in arm, swelling arm, sickness and product supply issue were unknown and the outcome of the fever and blister were recovered/resolved. It was unknown if the reporter considered the pain in arm, swelling arm, sickness, fever and blister to be related to SHINGRIX. Additional details were provided as follows: The patient had 2 previous bouts of cold sores in her eye and was getting over having cold sores when she got her SHINGRIX dose. She was taking Valtrex at the time of the vaccination. She has a preexisting condition of fibromyalgia. The age at vaccination was not reported. The patient's arm was extremely painful soon after getting the dose and it began to swell. That night, she was very sick (latency less than a day). She normally had a low body temperature, but she had a fever of 102 degrees F (latency less than a month) for 3 days. Her arm got worse and she got blisters on her arms (latency less than a month). The patient stated that, she could not get her 2nd dose of SHINGRIX due to shortage.
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Headache, Injection site pain, Pain
Clinical narrative: This case was reported by a consumer and described the occurrence of injection site pain in a patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX (refer case US2018GSK230780). On 11th December 2018, the patient received the 2nd dose of SHINGRIX. On 12th December 2018, 1 days after receiving SHINGRIX, the patient experienced injection site pain, general body pain, headache and shivering. On an unknown date, the outcome of the injection site pain, general body pain, headache and shivering were unknown. It was unknown if the reporter considered the injection site pain, general body pain, headache and shivering to be related to SHINGRIX. Additional details were received as follows: The age at vaccination was not reported. After vaccination, the patient presented with injection site pain, body aches, headache, and shivering. The patient was asking, how long the side effects will last.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Nasopharyngitis, Pyrexia, Sluggishness
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fever in a 59-year-old female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced fever, sluggishness, cold and shivers. On an unknown date, the outcome of the fever, sluggishness, cold and shivers were unknown. It was unknown if the reporter considered the fever, sluggishness, cold and shivers to be related to SHINGRIX. Additional details were provided as follows: The patient experienced a low grade fever, felt a little sluggish, shivery and a little cold. For tolerance to the 2nd dose of SHINGRIX refer case US2018GSK230529, reported for same patient.
Sex: F
Vaccine: VARZOS
Symptoms: Heart rate increased, Pyrexia, Tremor
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of tremor in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, unknown after receiving SHINGRIX, the patient experienced tremor, heartbeats increased and fever. On an unknown date, the outcome of the tremor, heartbeats increased and fever were unknown. It was unknown if the reporter considered the tremor, heartbeats increased and fever to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced severe effects of the SHINGRIX included tremors, rapid heartbeat and slight fever.
Sex: F
Vaccine: FLU4
Symptoms: Fibromyalgia, Influenza like illness, Malaise
Clinical narrative: This case was reported by a consumer and described the occurrence of influenza-like symptoms in a female patient who received Influenza vaccine Quadrivalent unspecified season for prophylaxis. On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season at an unknown dose. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced influenza-like symptoms, fibromyalgia and sickness. On an unknown date, the outcome of the influenza-like symptoms and fibromyalgia were unknown and the outcome of the sickness was not recovered/not resolved. It was unknown if the reporter considered the influenza-like symptoms, fibromyalgia and sickness to be related to Influenza vaccine Quadrivalent unspecified season. Additional details were provided as follows: This case was reported by the patient's daughter. The age at the vaccination was not reported. The reporter stated that the people were getting flu like symptoms from the flu shot. Sometimes these symptoms were much worse. The reported stated that her mother (patient) got sick with flu like symptoms, all at the same time, after they got their shots. At the time of reporting, the patient had been diagnosed with fibromyalgia. The reporter stated that Flu shots were not properly tested and well known not to be effective and these flu like symptoms were contagious. The patient was sick the longest and never fully recovered. The reporter did not believe this was a coincidence. This case is 1 of the 3 linked cases reported by the same reporter.
Sex: M
Vaccine: FLU4
Symptoms: Influenza like illness, Malaise
Clinical narrative: This case was reported by a consumer and described the occurrence of influenza-like symptoms in a male patient who received Influenza vaccine Quadrivalent (unspecified season) for prophylaxis. On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season at an unknown dose. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced influenza-like symptoms and sickness. On an unknown date, the outcome of the influenza-like symptoms and sickness were unknown. It was unknown if the reporter considered the influenza-like symptoms and sickness to be related to Influenza vaccine Quadrivalent unspecified season. Additional details were provided as follows: This case was reported by the patient's daughter. The age at the vaccination was not reported. The reporter stated that the people were getting flu like symptoms from the flu shot all at the same time, after they got their shots. Sometimes these symptoms were much worse. The reporter's father (patient) got sick with flu like symptoms. The reporter stated that that Flu shots were not properly tested and well known not to be effective and these flu like symptoms were contagious. This case is 1 of the 3 linked cases reported by the same reporter.
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness, Injection site pain, Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a male patient who received SHINGRIX for prophylaxis. On 10th December 2018, the patient received the 2nd dose of Shingles vaccine. On 10th December 2018, less than a day after receiving Shingles vaccine, the patient experienced injection site pain. On 11th December 2018, the patient experienced generalized aching. In December 2018, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the injection site pain, generalized aching and influenza-like symptoms were unknown. It was unknown if the reporter considered the injection site pain, generalized aching and influenza-like symptoms to be related to Shingles vaccine. Additional details were reported as follows: The patient had a question about the Shingles vaccine. The patient received the 2nd dose the day before reporting. The patient had pain at the site. The patient asked was it possible to have generalized aches which started on the day of reporting in the morning in his legs and were radiating to his back. The patient felt like flu symptoms which he was praying was not the case.
Sex: F
Vaccine: FLUX, PPV
Symptoms: Asthenia, Asthma, Fatigue, Malaise, Pharyngitis streptococcal
Clinical narrative: This case was reported by a consumer via interactive digital media and described the occurrence of pneumonia in a female patient who received Flu unspecified (Influenza vaccine) for prophylaxis. Co-suspect products included PNEUMONIA VACCINE for prophylaxis. On an unknown date, the patient received Influenza vaccine at an unknown dose and PNEUMONIA VACCINE at an unknown dose. On an unknown date, unknown after receiving Influenza vaccine, the patient experienced pneumonia (serious criteria GSK medically significant), asthmatic attack, streptococcal sore throat, sickness, tiredness and weakness. On an unknown date, the outcome of the pneumonia, asthmatic attack, streptococcal sore throat, sickness, tiredness and weakness were recovered/resolved. It was unknown if the reporter considered the pneumonia, asthmatic attack, streptococcal sore throat, sickness, tiredness and weakness to be related to Influenza vaccine. Additional details were received as follows: The patient's aunt was 86 year old had never been vaccinated for any vaccine, not even with polio vaccine. As per the reporter, her aunt was the healthiest person and she rarely got a cold. The age at vaccination was not reported. In 1998, the patient received a flu shot and 1st pneumonia shot (unspecified). Within 2 weeks, the patient was sick with strep throat. The patient went to severe asthma attack, which the patient never had before. The patient was severely ill for 8 months and physician never knew what was wrong. The patient started with treatment, went to naturopath because she was tired and heard could get vitamin injections. The neuropath said, she was too weak and vitamin injection could kill her. The physician suggested peroxide drips given intravenously 3 times a week, several weeks. The patient got better, but only about half what she used to be. Then the patient did not received any vaccinations, never have had flu but she got pneumonia. The patient wished that she never got those first vaccinations. It was unknown if the reporter considered the pneumonia, asthmatic attack, streptococcal sore throat, sickness, tiredness and weakness to be related to Pneumonia vaccine.
Sex: F
Vaccine: FLUX, PPV
Symptoms: Pneumonia
Clinical narrative: This case was reported by a consumer via interactive digital media and described the occurrence of pneumonia in a female patient who received Flu unspecified (Influenza vaccine) for prophylaxis. Co-suspect products included PNEUMONIA VACCINE for prophylaxis. On an unknown date, the patient received Influenza vaccine at an unknown dose and PNEUMONIA VACCINE at an unknown dose. On an unknown date, unknown after receiving Influenza vaccine, the patient experienced pneumonia (serious criteria GSK medically significant), asthmatic attack, streptococcal sore throat, sickness, tiredness and weakness. On an unknown date, the outcome of the pneumonia, asthmatic attack, streptococcal sore throat, sickness, tiredness and weakness were recovered/resolved. It was unknown if the reporter considered the pneumonia, asthmatic attack, streptococcal sore throat, sickness, tiredness and weakness to be related to Influenza vaccine. Additional details were received as follows: The patient's aunt was 86 year old had never been vaccinated for any vaccine, not even with polio vaccine. As per the reporter, her aunt was the healthiest person and she rarely got a cold. The age at vaccination was not reported. In 1998, the patient received a flu shot and 1st pneumonia shot (unspecified). Within 2 weeks, the patient was sick with strep throat. The patient went to severe asthma attack, which the patient never had before. The patient was severely ill for 8 months and physician never knew what was wrong. The patient started with treatment, went to naturopath because she was tired and heard could get vitamin injections. The neuropath said, she was too weak and vitamin injection could kill her. The physician suggested peroxide drips given intravenously 3 times a week, several weeks. The patient got better, but only about half what she used to be. Then the patient did not received any vaccinations, never have had flu but she got pneumonia. The patient wished that she never got those first vaccinations. It was unknown if the reporter considered the pneumonia, asthmatic attack, streptococcal sore throat, sickness, tiredness and weakness to be related to Pneumonia vaccine.
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Influenza like illness, Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 61-year-old female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On 11th December 2018, unknown after receiving SHINGRIX, the patient experienced influenza-like symptoms, pain and shivers. On an unknown date, the outcome of the influenza-like symptoms, pain and shivers were not recovered/not resolved. It was unknown if the reporter considered the influenza-like symptoms, pain and shivers to be related to SHINGRIX. Additional details were provided as follows: The age at the vaccination was not reported but it could be 60 or 61 years. The patient had a shot of SHINGRIX vaccine and had no issues but on the day of reporting the patient felt horrible with flu like symptoms. The patient experienced flu like side effects as aches, pain and shivers. The reporter asked that how long do the flu like side effects would lasts.
Sex: M
Vaccine: FLUX
Symptoms: Influenza like illness, Malaise
Clinical narrative: This case was reported by a consumer and described the occurrence of influenza-like symptoms in an unspecified number of male patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis. On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season at an unknown dose. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced influenza-like symptoms and sickness. On an unknown date, the outcome of the influenza-like symptoms and sickness were unknown. It was unknown if the reporter considered the influenza-like symptoms and sickness to be related to Influenza vaccine Quadrivalent unspecified season. Additional details were provided as follows: The age at the vaccination was not applicable. The reporter stated that the people were getting flu like symptoms from the flu shot all at the same time, after they got their shots. Sometimes these symptoms were much worse. The reporter's father all group home boys got sick with flu like symptoms. The reporter stated that that Flu shots were not properly tested and well known not to be effective and these flu like symptoms were contagious. This case is 1 of the 3 linked cases reported by the same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Fatigue, Injection site pain
Clinical narrative: This case was reported by a consumer and described the occurrence of injection site pain in a 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 injection site pain and tiredness. On an unknown date, the outcome of the injection site pain and tiredness were unknown. It was unknown if the reporter considered the injection site pain and tiredness to be related to SHINGRIX. Additional details were received as follows: The age at vaccination was not reported. After vaccination with SHINGRIX, the patient was tired and had injection site pain. For tolerance to 2nd dose refer US2018GSK226545.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Malaise, Pyrexia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of fever in a 51-year-old female patient who received SHINGRIX (batch number 3Z53C, expiry date 13th March 2021) for prophylaxis. On 7th December 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a week after receiving SHINGRIX, the patient experienced fever, chills and malaise. On 11th December 2018, the outcome of the fever, chills and malaise were recovered/resolved. It was unknown if the reporter considered the fever, chills and malaise to be related to SHINGRIX. Additional details were provided as follows: The patient developed fever, chills and malaise. All the symptoms had resolved by the morning on the date of reporting. No further details were reported regarding the event. The reporter gave consent to follow up.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of influenza-like symptoms in a 66-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included malaria. Concurrent medical conditions included cancer. On 6th July 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, several days after receiving SHINGRIX, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was recovered/resolved.  It was unknown if the reporter considered the influenza-like symptoms to be related to SHINGRIX. Additional details were reported as follows: This case was reported by a licensed clinical social worker, who was also the patient. The patient received SHINGRIX on the left arm. The patient stated that, a couple of days after receiving SHINGRIX, she experienced flu-like symptoms. The reporter did not consent to follow up.