chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse effects reported; was given ZOSTAVAX instead of VARIVAX second dose on 3/28/2019 inadvertently; This spontaneous report was received from a registered nurse referring to a patient of unknown age. The patient's medical history, concurrent conditions and concomitant therapies were not provided.     On 28-MAR-2019, the patient was inadvertently vaccinated with a dose of zoster vaccine live(ZOSTAVAX) (lot# reported as N028855 expiration date 13-JAN-2019 (also reported as 13-JAN-2020); route was not provided) instead of the second dose of varicella virus vaccine live (Oka/Merck)(VARIVAX); for prohylaxis. However, the reporting nurse stated that there was no product confusion. No adverse effects were reported.
Sex: U
Vaccine: MMR, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: multiple unspecified patients received improperly stored vaccines.; No adverse effects reported.; Information has been received from a medical assistant referring to multiple unspecified patients of unknown ages and unknown genders. Information of concurrent condition, pertinent medical history, concomitant medication and drug reactions/allergies was not provided.  On multiple unspecified days, the patients received improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II)(lot# R010716 with expiration date 11-APR-2020; therapy type rHA (recombinant Human albumin); strength, route and dose detail were not reported) and rotavirus vaccine, live, oral, pentavalent(ROTATEQ)(lot # R028189 with expiration date 06-JUN-2020; strength, route and dose detail were not reported) for prophylaxis (product storage error). Measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) was reconstituted with properly stored sterile diluent (unknown lot number & expiration date). The vaccines were exposed to temperature excursion of above 47 fahrenheit degree(also reported as 49.1 fahrenheit degree) for 1 hour and 23 minutes. Previous temperature excursion was above 47 fahrenheit degree(also reported as 49.8 fahrenheit degree) for 1 hour and 21 minutes. No adverse effects reported. Data logger was involved.  This case was determined to be non-valid as no patient identifier.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effects reported; vaccinated with improperly stored Proquad; This spontaneous report was received from a nurse and refers to a patient of unknown age. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 22-JAN-2019 the patient was vaccinated with improperly stored dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (recombinant human albumin) (PROQUAD) injection, 1 dose, lot # R020678 expiration date: 15-JAN-2020, (frequency and route of administration were not reported).  The suspect vaccine was reconstituted with properly stored sterile diluent (STERILE DILUENT) (lot # N035970, expiration date 30-APR-2020). No adverse effects was reported.  The vaccine was stored in 16.5 Fahrenheit degrees for 1 hour and 44 minutes. There was no previous temperature excursion. Digital data logger was involved. This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1904USA003435: US-009507513-1904USA003434: US-009507513-1904USA003436:
Sex: U
Vaccine: HPV9
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 21-JUL-2015, the patient was vaccinated with the first dose of GARDASIL (dose, route of administration, anatomical location, lot number and expiry date were not provided) for prophylaxis. On 04-APR-2019, the patient came to the office for administration of GARDASIL 9 as a second dose (dose, route of administration, anatomical location, lot number and expiry date were not provided) for prophylaxis. No adverse effects were reported.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effects reported; vaccinated with improperly stored Proquad; This spontaneous report was received from a nurse and refers to a patient of unknown age. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 29-JAN-2019 the patient was vaccinated with improperly stored dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (recombinant human albumin) (PROQUAD) injection, lot # R020678 expiration date: 15-JAN-2020, (dose, frequency and route of administration were not reported).  The suspect vaccine was reconstituted with properly stored sterile diluent (STERILE DILUENT) (lot # N035970, expiration date 30-APR-2020). No adverse effects was reported. The vaccine was stored in 16.5 Fahrenheit degrees for 1 hour and 44 minutes. There was no previous temperature excursion.. Digital data logger was involved. This is one of four reports received from the same reporter.; Sender's Comments:  US-009507513-1904USA003435: US-009507513-1904USA003436: US-009507513-1904USA002106:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effects reported; vaccinated with improperly stored Proquad; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 14-JAN-2019, the patient was vaccinated with improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) injection, lot # R010468 expiration date: 10-APR-2020, (dose, frequency and route of administration were not reported) for prophylaxis. The suspect vaccine was reconstituted with properly stored sterile diluent (STERILE DILUENT) (lot # N035970, expiration date 30-APR-2020). No adverse effects was reported. The vaccine was stored in 16.5 Fahrenheit degrees for 1 hour and 44 minutes. There was no previous temperature excursion.. Digital data logger was involved. This is one of four reports received from the same reporter.; Sender's Comments:  US-009507513-1904USA002106: US-009507513-1904USA003436: US-009507513-1904USA003434:
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effects reported; vaccinated with improperly stored Proquad; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 29-JAN-2019, the patient was vaccinated with improperly stored dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (recombinant human albumin) (PROQUAD) injection, lot # R020678 with expiration date: 15-JAN-2020, (dose, frequency and route of administration were not reported). The suspect vaccine was reconstituted with properly stored sterile diluent (STERILE DILUENT) (lot # N035970, expiration date 30-APR-2020). No adverse effects was reported. The vaccine was stored in 16.5 Fahrenheit degrees for 1 hour and 44 minutes. There was no previous temperature excursion.. Digital data logger was involved. This is one of four reports received from the same reporter.; Sender's Comments:  US-009507513-1904USA003435: US-009507513-1904USA002106: US-009507513-1904USA003434:
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; improperly stored doses of VARIVAX and PROQUAD; This spontaneous report was received from an administrator referring to patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 28-MAR-2019 or 31-MAR-2019 or 02-APR-2019 or 03-APR-2019, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) with lot# R023736 with expiration date on 20-AUG-2020 or measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) lot numbers R008697 and R000551, for prophylaxis (dose and routes of administration). The administered doses of the vaccines experienced temperature excursion -12.85 degrees Celsius for 15 minutes. There was no adverse effect reported.  This call was because of a data logger and there was not previous temperature excursion.   No product quality complaint was involved.   Lot number R008697 and R000551 are invalid lot numbers for  measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) .  This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-1904USA004740: US-009507513-1904USA004744: US-009507513-1904USA004739: US-009507513-1904USA004741: US-009507513-1904USA004742: US-009507513-1904USA004743:
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Underdose
Clinical narrative: the patient was inadvertently administered an incomplete second dose of VAQTA; The nurse reported that no adverse effects were reported; This spontaneous report as received from a nurse, refers to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications, drug reactions or allergies.   On an unknown date, the patient was vaccinated with an incomplete(underdose) second dose of hepatitis a vaccine, inactivated (VAQTA) for prophylaxis (route of administration, lot number and expiration date were not reported). No adverse effects were reported.  At the moment of this report the outcome and the causal relationship between hepatitis a vaccine, inactivated (VAQTA) and underdose was unknown.
Sex: M
Vaccine: VARZOS
Symptoms: Patient isolation, Pyrexia, Rash generalised, Secondary transmission, Varicella
Clinical narrative: Secondary transmission; I gave the chicken pox to my partner who has suffered greatly with fever, and rash all over his body; Information has been received regarding a case in litigation for zoster vaccine live (ZOSTAVAX) (MARRS # 1810USA013278) from a factsheet and physician medical record, concerning a male patient who was vaccinated with zoster vaccine live (ZOSTAVAX) on 19-MAY-2015.  The male reported that "I gave the chicken pox to my partner who has suffered greatly with fever, and rash all over his body."  The male partner (of unknown age) was "Put into quarantine for 1.5 weeks."  The male partner was diagnosed on 09-NOV2016.  This was considered to be a secondary transmission. The outcome of the chickenpox, fever and rash was not reported.  The medical record 24-OCT-2016 reported the male was in a mutually monogamous relationship.  All available medical records will be provided upon request. Additional information is not expected.; Sender's Comments:  US-009507513-1810USA013278:
Age: 43.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site swelling, Pain in extremity
Clinical narrative: Information has been received from a 43 year old female patient (no pregnant), referring to herself. Concurrent condition included menstrual migraines. The patient was allergic to sulfa drugs. Concomitant therapy included MAXALT. On 27-MAR-2019, the patient was vaccinated with GARDASIL 9 (first dose of 3; strength, lot # and expiration date were unknown) intramuscularly for cervical cancer protection. On 03-APR-2019, the patient experienced arm soreness and a bump where the vaccine was injected. The patient did not receive the treatment for the events. The patient had not sought medical attention. There was no lab diagnostics or studies performed. Therapy with GARDASIL 9 was continued. The outcome of the events was reported as recovered. The causality assessment was not provided by the reporter.
Sex: M
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist regarding to a male patient of unknown age. No information was provided regarding the patient's medical history, concurrent conditions, previous drug reactions or concomitant medications. On an unknown date, the patient was vaccinated with his second dose of GARDASIL 9 (lot # R024264, expiry date: 29-OCT-2019 (reported as 27-OCT-2019) dose 1, 0.5 milliliter for prophylaxis. It was reported that the patient was inadvertently administered his second dose of GARDASIL 9 at a 3 month interval rather than the two month interval in the prescribing information. There were no adverse effects.
Age: 12.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a nurse referring to a currently 12 years old patient of unknown gender. The patient's drug reactions/allergies, pertinent medical history and concomitant medication were not provided. On 20-MAR-2019, the patient was vaccinated with improperly stored GARDASIL 9 lot # 1581027, expiration date 03-JUN-2021 for prophylaxis (strength, dose, frequency and route were not provided). The outcome of improper storage of product in use was unknown. The storage temperatures of the GARDASIL 9 was reported as -11.9 degrees Celsius for a time frame of 1 hour and 45 minutes. There was no previous temperature excursion. The call was due to a data logger. No adverse effects reported. No product quality compliance provided. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1903USA010666: US-009507513-1904USA004569: US-009507513-1904USA004570: US-009507513-1904USA004571: US-009507513-1904USA004572.
Age: 12.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a nurse referring to a currently 12 years old patient of unknown gender. The patient's drug reactions/allergies, pertinent medical history and concomitant medication were not provided. On 20-MAR-2019, the patient was vaccinated with improperly stored GARDASIL 9 lot # 1581027, expiration date 03-JUN-2021 for prophylaxis (strength, dose, frequency and route were not provided). No adverse effects reported. The outcome of the events was unknown. The storage temperatures of the GARDASIL 9 was reported as -11.9 degrees Celsius for a time frame of 1 hour and 45 minutes. There was no previous temperature excursion. The call was due to a data logger. No product quality compliance provided. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1903USA010666: US-009507513-1904USA004568: US-009507513-1904USA004570: US-009507513-1904USA004571: US-009507513-1904USA004572.
Age: 12.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a nurse referring to a 12 years old patient of unknown gender. The patient's drug reactions/allergies, pertinent medical history and concomitant medication were not provided. On 20-MAR-2019, the patient was vaccinated with improperly stored GARDASIL 9 lot # 1581027, expiration date 03-JUN-2019 for prophylaxis (strength, dose, frequency and route were not provided). No adverse effects reported. The outcome of the events was unknown. The storage temperature of the GARDASIL 9 was reported as -11.9 degrees Celsius for a time frame of 1 hour and 45 minutes. There was no previous temperature excursion. The call was due to a data logger. No product quality compliance. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1903USA010666: US-009507513-1904USA004568: US-009507513-1904USA004569: US-009507513-1904USA004571: US-009507513-1904USA004572.
Age: 0.5
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; patient were vaccinated with improperly stored ROTATEQ; Information has been received from a nurse referring to a 6 months old patient of unknown gender. The patient's drug reactions/allergies, pertinent medical history and concomitant medication were not provided.  On 20-MAR-2019, the patient was vaccinated with improperly stored rotavirus vaccine, live, oral, pentavalent(ROTATEQ) lot # R021650, expiration date 27-MAY-2020 for prophylaxis (strength, dose, frequency and route were not provided). No adverse effects reported. The outcome of the events was unknown. The storage temperature of the rotavirus vaccine, live, oral, pentavalent(ROTATEQ) was reported as -11.9 degrees Celcius for a time frame of 1 hour and 45 minutes. There was no previous temperature excursion. The call was due to a data logger. No product quality compliance provided.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1903USA010666: US-009507513-1904USA004568: US-009507513-1904USA004569: US-009507513-1904USA004570: US-009507513-1904USA004572:
Age: 0.5
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; patient were vaccinated with improperly stored ROTATEQ; Information has been received from a nurse referring to a 6 months old patient of unknown gender. The patient's drug reactions/allergies, pertinent medical history and concomitant medication were not provided.  On 20-MAR-2019, the patient was vaccinated with improperly stored rotavirus vaccine, live, oral, pentavalent(ROTATEQ) lot # R021650, expiration date 27-MAY-2019 for prophylaxis (strength, dose, frequency and route were not provided). No adverse effects reported. The outcome of the events was unknown. The storage temperature of rotavirus vaccine, live, oral, pentavalent(ROTATEQ) was reported as -11.9 degrees Celcius for a time frame of 1 hour and 45 minutes. There was no previous temperature excursion. The call was due to a data logger. No product quality compliance provided.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1903USA010666: US-009507513-1904USA004568: US-009507513-1904USA004569: US-009507513-1904USA004570: US-009507513-1904USA004571:
Sex: U
Vaccine: PNC13, PPV
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse effects were reported; Patient received a dose of PREVNAR 13 on 11-FEB-2019 and also received a dose of PENUMOVAX 23 on 08-APR-2019; This spontaneous report was received from a registered nurse concerning a patient of unknown age and gender. The patient's medical history included a splenectomy. There was no information about the patient's drug reactions, allergies, concurrent conditions or concomitant medications to be reported.  It was reported that on 11-FEB-2019, the patient received a dose of pneumococcal 13v conj vaccine (CRM197) (PREVNAR 13) (strength, dose, route, lot number and expiration date not reported) and on 08-APR-2019, received 1 dose of Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) (strength and route not reported), lot number: R033079 (expiration date: 06-JUN-2020) (interchange of vaccine products). No adverse effects were reported. There was no product quality complaint (PQC) reported.
Sex: U
Vaccine: HIBV, MMR, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: An unknown number of improperly stored vaccines were administered; No adverse effect reported; This spontaneous report was received from a nurse an unknown number of patients of unknown age or gender. There was no information about the patients' medical history, drug reactions, allergies, concurrent conditions or concomitant medications to be reported.  It was reported that on unknown dates, the patient received improperly stored vaccines of Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (PEDVAXHIB), lot numbers: R000877 (expiration date: 24-SEP-2020) and R001086 (expiration date: 25-SEP-2020); Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) lot number: N025894 (expiration date: 19-SEP-2019) and Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) lot numbers: R013288 (expiration date: 01-DEC-2019), R007152 (expiration date: 25-OCT-2019) and R002517 (expiration date: 19-SEP-2019) (strength, doses and routed not reported) all administered for prophylaxis (product storage error).  The vaccines were stored above 9 degrees Celsius (°C) for a timeframe of 39 minutes. There was no previous temperature excursion. The digital data logger was involved in recording the temperature excursion. No adverse effects were reported. There was no product quality complaint (PQC) reported.  This case is considered non-valid due to the lack of patient identifiers.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; improperly stored doses of VARIVAX and PROQUAD; This spontaneous report was received from an administrator referring to patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 28-MAR-2019 or 31-MAR-2019 or 02-APR-2019 or 03-APR-2019, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) with lot# R023736 with expiration date on 20-AUG-2020 or measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) lot numbers R008697 and R000551, for prophylaxis (dose and routes of administration). The administered doses of the vaccines experienced temperature excursion -12.85 degrees Celsius for 15 minutes. There was no adverse effect reported.  This call was because of a data logger and there was not previous temperature excursion.   No product quality complaint was involved.   Lot number R008697 and R000551 are invalid lot numbers for  measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) .  This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-1904USA004741:Original Case : 1904USA003556 US-009507513-1904USA004742:Original Case : 1904USA003556 US-009507513-1904USA004743:Original Case : 1904USA003556 US-009507513-1904USA004744:Original Case : 1904USA003556 US-009507513-1904USA003556:Original Case : 1904USA003556 US-009507513-1904USA004740:Original Case : 1904USA003556
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; improperly stored doses of VARIVAX and PROQUAD; This spontaneous report was received from an administrator referring to patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 28-MAR-2019 or 31-MAR-2019 or 02-APR-2019 or 03-APR-2019, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) with lot# R023736 with expiration date on 20-AUG-2020 or measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) lot numbers R008697 and R000551, for prophylaxis (dose and routes of administration). The administered doses of the vaccines experienced temperature excursion -12.85 degrees Celsius for 15 minutes. There was no adverse effect reported.  This call was because of a data logger and there was not previous temperature excursion.   No product quality complaint was involved.   Lot number R008697 and R000551 are invalid lot numbers for  measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) .  This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-1904USA004742:Original Case : 1904USA003556 US-009507513-1904USA004743:Original Case : 1904USA003556 US-009507513-1904USA004744:Original Case : 1904USA003556 US-009507513-1904USA004739:Original Case : 1904USA003556
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; improperly stored doses of VARIVAX and PROQUAD; This spontaneous report was received from an administrator referring to patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 28-MAR-2019 or 31-MAR-2019 or 02-APR-2019 or 03-APR-2019, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) with lot# R023736 with expiration date on 20-AUG-2020 or measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) lot numbers R008697 and R000551, for prophylaxis (dose and routes of administration). The administered doses of the vaccines experienced temperature excursion -12.85 degrees Celsius for 15 minutes. There was no adverse effect reported.  This call was because of a data logger and there was not previous temperature excursion.   No product quality complaint was involved.   Lot number R008697 and R000551 are invalid lot numbers for  measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) .  This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-1904USA004743:Original Case : 1904USA003556 US-009507513-1904USA004744:Original Case : 1904USA003556 US-009507513-1904USA004739:Original Case : 1904USA003556 US-009507513-1904USA004740:Original Case : 1904USA003556
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; improperly stored doses of VARIVAX and PROQUAD; This spontaneous report was received from an administrator referring to patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 28-MAR-2019 or 31-MAR-2019 or 02-APR-2019 or 03-APR-2019, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) with lot# R023736 with expiration date on 20-AUG-2020 or measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) lot numbers R008697 and R000551, for prophylaxis (dose and routes of administration). The administered doses of the vaccines experienced temperature excursion -12.85 degrees Celsius for 15 minutes. There was no adverse effect reported.  This call was because of a data logger and there was not previous temperature excursion.   No product quality complaint was involved.   Lot number R008697 and R000551 are invalid lot numbers for  measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) .  This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-1904USA004741:Original Case : 1904USA003556 US-009507513-1904USA004742:Original Case : 1904USA003556 US-009507513-1904USA003556:Original Case : 1904USA003556 US-009507513-1904USA004744:Original Case : 1904USA003556 US-009507513-1904USA004739:Original Case : 1904USA003556 US-009507513-1904USA004740:Original Case : 1904USA003556
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; improperly stored doses of VARIVAX and PROQUAD; This spontaneous report was received from an administrator referring to patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 28-MAR-2019 or 31-MAR-2019 or 02-APR-2019 or 03-APR-2019, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) with lot# R023736 with expiration date on 20-AUG-2020 or measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) lot numbers R008697 and R000551, for prophylaxis (dose and routes of administration). The administered doses of the vaccines experienced temperature excursion -12.85 degrees Celsius for 15 minutes. There was no adverse effect reported.  This call was because of a data logger and there was not previous temperature excursion.   No product quality complaint was involved.   Lot number R008697 and R000551 are invalid lot numbers for  measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) .  This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-1904USA004741:Original Case : 1904USA003556 US-009507513-1904USA004742:Original Case : 1904USA003556 US-009507513-1904USA004743:Original Case : 1904USA003556 US-009507513-1904USA003556:Original Case : 1904USA003556 US-009507513-1904USA004739:Original Case : 1904USA003556 US-009507513-1904USA004740:Original Case : 1904USA003556
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Unknown number of patients have received improperly stored doses of VARIVAX.; no reported adverse events; This spontaneous report as received from a Medical Assistant referring to an unspecified number of patients of unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported.  On unknown dates, the patients were vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) (Strength, route, dose, frequency, and anatomical location were unknown) with lot # R017642 and expiration date 20-JUN-2020. The administered doses of the vaccine experienced the temperature excursion of 25.5 F  degrees Fahrenheit  for 1hour and 30 minutes. There was a digital data logger invloved, but there was no previous temperature excursion.  Follow-up information was received from the medical assistant on 09-APR-2019, regarding a female patient who is reported to be under 10 years of age. There were no reported adverse events following the administration of varicella virus vaccine live (oka/merck)(VARIVAX) (No adverse event).  This is one of two reports received from the same reporter.
Age: 1.5
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Underdose
Clinical narrative: No adverse effects.; an 18 month old child was inadvertently administered a partial dose of VAQTA; Information has been received from a nurse referring to a unknown gender 18 month old child. Information about concomitant medications, pertinent medical history and drug reactions/allergies was not reported.  On 09-APR-2019, the patient was inadvertently administered a partial dose of hepatitis a vaccine, inactivated(VAQTA)(lot # R034340, expiration date: 23-NOV-2019, dose, frequency and route were not reported) for prophylaxis (incorrect dose administered). No adverse effects. Information about treatment given for the event, lab diagnostics/studies and medical attention was not provided.
Age: 70.0
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shingles in a 70-year-old patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included rheumatoid arthritis. Concomitant products included Biologics (Medication Unknown). In March 2019, the patient received the 1st dose of SHINGRIX. On an unknown date, 10 days after receiving SHINGRIX, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional case details were provided as follows: The age at vaccination was not reported. The patient received the dose of SHINGRIX and 10 days later came down with a severe case of shingles. The patient want to know that does this vaccine gave shingles. No contact details were provided for further follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of fever in a male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX .5 ml. On an unknown date, 1 day after receiving SHINGRIX, the patient experienced fever and pain. On an unknown date, the outcome of the fever and pain were unknown. It was unknown if the reporter considered the fever and pain to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. This case was reported by the personal assistant. The patient presented with aches and fever 24 hours after the vaccine was administered at the pharmacy. The reporter agreed to be followed up.
Sex: U
Vaccine: VARZOS
Symptoms: Guillain-Barre syndrome
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of guillain barre syndrome in a adult patient who received SHINGRIX for prophylaxis. In March 2019, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced guillain barre syndrome (serious criteria hospitalization and GSK medically significant). On an unknown date, the outcome of the guillain barre syndrome was unknown.  It was unknown if the reporter considered the guillain barre syndrome to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the clinician, who was just contacted by another physician's friend. The age at vaccination was not reported. The age group was not reported, but was selected as adult as per vaccine indication. A week prior to the reporting, the patient received a dose of SHINGRIX. Few days before the time of reporting, the patient was hospitalized. The reported inquired about specific data related to this condition if it was seen as a complication in the clinical trials related to SHINGRIX. The reporter wanted to know, it was possible even from a vaccine mechanism point of view or had there been any patients reported in the literature with this complication as an association. The reporter wanted to speak to someone medical.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Extensive swelling of vaccinated limb, Injection site erythema, Injection site pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 53-year-old female patient who received SHINGRIX for prophylaxis. On 30th March 2019, the patient received the 1st dose of SHINGRIX (intramuscular). On 30th March 2019, less than a day after receiving SHINGRIX, the patient experienced injection site pain. On 31st March 2019, the patient experienced extensive swelling of vaccinated limb and injection site erythema. On an unknown date, the outcome of the extensive swelling of vaccinated limb and injection site erythema were not recovered/not resolved and the outcome of the injection site pain was unknown. It was unknown if the reporter considered the extensive swelling of vaccinated limb, injection site pain and injection site erythema to be related to SHINGRIX. Additional case details were reported as follows: The patient received vaccine in the right arm. In the evening on 30th March 2019, the patient had soreness and tenderness at the injection site. Yesterday (from the day of reporting) on 31st March 2019, 1 day after receiving SHINGRIX the patient noticed redness and swelling that was the size of a baseball and extended to the bone going to her neck bone. The patient stated it remains on the reporting date, patient called the pharmacist, who referred her to GlaxoSmithKline. The patient was encouraged to report to physician and treatment inquiry.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site itching in a 64-year-old male patient who received SHINGRIX (batch number 77PL3, expiry date 18th April 2021) for prophylaxis. On 24th November 2018, the patient received the 2nd dose of SHINGRIX (intramuscular). In February 2019, 91 days after receiving SHINGRIX, the patient experienced injection site itching and injection site erythema. On an unknown date, the outcome of the injection site itching and injection site erythema were recovering/resolving. It was unknown if the reporter considered the injection site itching and injection site erythema to be related to SHINGRIX. Additional case details were reported as follows: The pharmacist reported that about the end of February (or about 3 months after), patient started with redness and itching at the injection site. It had been a very delayed event. At the time of this report, the redness and itching at the injection site was still there. It was tolerable but it was there.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of shingles in a adult patient who received SHINGRIX for prophylaxis. On 1st April 2019, the patient received the 1st dose of SHINGRIX. On 3rd April 2019, 2 days after receiving SHINGRIX, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected as per the vaccine indication. The patient had no history of having shingles.
Age: 54.0
Sex: F
Vaccine: HEPA
Symptoms: Hypoaesthesia, Loss of personal independence in daily activities, Paraesthesia
Clinical narrative: Numbness of left hand / numbness left leg; tingling left hand / tingling left leg; struggling with tasks of daily living such as picking up objects or holding items between her fingers; This case was reported by a pharmacist via call center representative and described the occurrence of numbness of extremities in a 54-year-old female patient who received HAV (Havrix) (batch number F4EL2, expiry date 12th September 2021) for prophylaxis.   On 11th March 2019, the patient received Havrix. In March 2019, 7 days after receiving Havrix, the patient experienced numbness of extremities, tingling of extremity and activities of daily living impaired. On an unknown date, the outcome of the numbness of extremities, tingling of extremity and activities of daily living impaired were unknown.   It was unknown if the reporter considered the numbness of extremities, tingling of extremity and activities of daily living impaired to be related to Havrix.  Additional details were provided as follows: The patient received a dose of Havrix vaccine on the left arm. Aproximately one week after vaccination, the patient expereinced some tingling and numbness in the left hand and left leg. The patient stated that the symptoms had been getting worse and over the last few days increased in severity to the point that she was struggling with tasks of daily living such as picking up objects or holding items between her fingers. The reporter stated that, she requested the patient to attempt to make a fist and tried to assess the patient, patient was able to complete tasks but states it feels weird to do so because of the numbness and tingling. The reporter stated that the reporter knew that Guillian-Barre syndrome tends to be a bilateral process and tend to not believe this was the patient's issue. The reporter was wondering if the patient's current symptoms were possibly vaccine related (even if not GBS). The reporter asked for more information on this.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash, Vaccination failure
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of suspected vaccination failure in a female patient who received SHINGRIX for prophylaxis. In December 2018, the patient received SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and rash. On an unknown date, the outcome of the vaccination failure, shingles and rash were unknown.  It was unknown if the reporter considered the vaccination failure, shingles and rash to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received SHINGRIX and experienced active rash of shingles. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation were unknown at the time of reporting. Limited information was provided.
Sex: F
Vaccine: VARZOS
Symptoms: Mobility decreased, Nerve injury
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of nerve damage 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 nerve damage and mobility decreased. On an unknown date, the outcome of the nerve damage and mobility decreased were unknown. It was unknown if the reporter considered the nerve damage and mobility decreased to be related to SHINGRIX. Additional details were provided as follows: The reporter knew the patient and reported on behalf of her. Age at vaccination was not reported. After a SHINGRIX shot, the patient experienced nerve damage and she could not move her arm. This was mentioned during passing. The reporter was angry so unable to probe for more information. The consent to follow-up was not given.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Flushing, Headache, Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 62-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included ZOSTAVAX (on an unknown date) and SHINGRIX (1st dose received on 6th November 2018). Concurrent medical conditions included shingles. On 1st April 2019, the patient received SHINGRIX (intramuscular). On 1st April 2019, less than a day after receiving SHINGRIX, the patient experienced pain in arm, headache, tiredness, generalized aching, chills and flushing. In April 2019, the outcome of the pain in arm and headache were recovered/resolved. On an unknown date, the outcome of the tiredness, generalized aching, chills and flushing were unknown. It was unknown if the reporter considered the pain in arm, headache, tiredness, generalized aching, chills and flushing to be related to SHINGRIX. Additional details were provided as follows: The case was reported by the patient for herself. The patient experienced sore arm, headache, tiredness, felt achy all over, chills, developed red flushing on front and back of her torso and her face. The reporter provided the consent to follow up.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 62-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included ZOSTAVAX (on an unknown date) and SHINGRIX (1st dose received on 6th November 2018). Concurrent medical conditions included shingles. On 1st April 2019, the patient received SHINGRIX (intramuscular). On 1st April 2019, less than a day after receiving SHINGRIX, the patient experienced pain in arm, headache, tiredness, generalized aching, chills and flushing. In April 2019, the outcome of the pain in arm and headache were recovered/resolved. On an unknown date, the outcome of the tiredness, generalized aching, chills and flushing were unknown. It was unknown if the reporter considered the pain in arm, headache, tiredness, generalized aching, chills and flushing to be related to SHINGRIX. Additional details were provided as follows: The case was reported by the patient for herself. The patient experienced sore arm, headache, tiredness, felt achy all over, chills, developed red flushing on front and back of her torso and her face. The reporter provided the consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Inflammation, Pain in extremity
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. In November 2018, unknown after receiving SHINGRIX, the patient experienced inflammation localized. On an unknown date, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm and inflammation localized were unknown. It was unknown if the reporter considered the pain in arm and inflammation localized to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. After receiving 1st dose of SHINGRIX, the patient experienced pain in arm and it was still inflamed since November of last year. On 4th April 2019, the patient received the 2nd dose of SHINGRIX.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Malaise, Pain in extremity, Product preparation issue
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 70-year-old female patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. On 4th December 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 4th April 2019, the patient received the 2nd dose of SHINGRIX. On 4th December 2018, unknown after receiving SHINGRIX and not applicable after receiving SHINGRIX, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On 4th April 2019, the patient experienced pain in arm. On 5th April 2019, the patient experienced malaise and shivering. On an unknown date, the outcome of the pain in arm, malaise and shivering were not recovered/not resolved and the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown. It was unknown if the reporter considered the pain in arm, malaise and shivering to be related to SHINGRIX. Additional details were provided as follows: The patient reported that she possibly only received the adjuvant for her 1st dose because the pharmacist withdrew the medication out of a vial with a red metal collar into the syringe, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The patient reported after receiving the 2nd SHINGRIX dose, she experienced arm pain, and next day she experienced malaise and shivering. The patient reported that for the 2nd dose, the vaccine was withdrawn from a vial with a green metal collar into the syringe. The patient had planned to follow up with her pharmacy and physician on an unknown date. The patient provided the consent to follow up.
Age: 17.0
Sex: F
Vaccine: HPV9
Symptoms: Eczema, Malaise, Pain, Pyrexia
Clinical narrative: Following the injection, I (the patient) left the office feeling fine. This was not my first GARDASIL shot, but I am unsure of whether it was my 2nd or 3rd in the series. Within 4 hours of the shot, I began to feel sick and achy. I had a low-grade fever of 102 for the next two days. This is the same reaction I had had following the first GARDASIL shot. In addition to fever, I developed painful eczema within weeks of starting the GARDASIL series. I did not know at the time that eczema can be attributed to vaccines, but now I do. I still have mild eczema.
Age: 16.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Chills, Dizziness, Fatigue, Myalgia, Pain in extremity
Clinical narrative: Right arm pain, fatigue, lightheaded for several hours following vaccine. Also muscle pain, chills that night. Symptoms lasted a week (see below). Still with arm pain as of 6-26-18. All symptoms resolved by 5 days.
Age: 16.0
Sex: F
Vaccine: HPV9
Symptoms: Abdominal pain upper, Dysmenorrhoea, Headache, Immediate post-injection reaction, Menstruation irregular
Clinical narrative: Immediate headaches, stomach pains, developed ovarian cysts, irregular and painful periods.
Age: 16.0
Sex: F
Vaccine: HPV9
Symptoms: Ovarian cyst
Clinical narrative: Immediate headaches, stomach pains, developed ovarian cysts, irregular and painful periods.