chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: no other AEs reported; concomitant administration of PROQUAD and VARlVAX; Information has been received from a nurse referring to a patient of unknown age or gender. Information about pertinent medical history, concurrent conditions, concomitant medications and drug reactions/allergies was not provided.   On 08-JUN-2021, the patient had concomitant administration of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (1 injection, lot #: T036735, expiration date: 28-APR-2022, therapy type: recombinant Human albumin (RHA)) and varicella virus vaccine live (Oka/Merck) (VARIVAX) (1 injection, lot #: S032357, expiration date: 14-OCT-2021) (both vaccines' strength and route were not reported) for prophylaxis (inappropriate schedule of product administration). The patient was not exhibiting any side effects. No other adverse events (AEs) reported.
Age: 64.0
Sex: M
Vaccine: PPV
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Adverse Reaction or Side Effects Experienced: None; date of vaccination: 06-OCT-2009 and 15-DEC-2013; This spontaneous report has been received from a lawyer, via a Plaintiff Fact Sheet from a case in litigation for zoster vaccine live (ZOSTAVAX) (MARRS # 2008USA002320), concerning to a 69-year-old male patient.  On 06-OCT-2009 and 15-DEC-2013, the patient was vaccinated with Pneumococcal Vaccine, Polyvalent (23-valent) (manufacture unknown) (strength, dose, route, lot number and expiration date were unknown) for prophylaxis respectively (Inappropriate schedule of vaccine administered). No adverse reaction or side effects experienced.; Sender's Comments:  US-009507513-2008USA002320:
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; M-M-R II has been administered to a patient since the excursion occured; This spontaneous report was received from a nurse referring to a patient of unknown age. Information about concurrent condition, concomitant medication and medical history was not provided.     On 09-JUN-2021, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (albumin status of recombinant human albumin (rHA)) (M-M-R II) (strength, dose, route were unknown, lot # T007235, expiration date 27-FEB-2022) for prophylaxis since the excursion occurred. The temperature was 53 Fahrenheit degree for 1 hour and 15 minutes. There was no previous temperature excursion. The call was because of a data logger. No additional adverse event or product quality complaint was reported.
Sex: U
Vaccine: MMRV
Symptoms: Product temperature excursion issue
Clinical narrative: no other AE; a dose of PROQUAD was administered after experiencing a temperature excursion.; This spontaneous report was received from a nurse, referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant medication were not provided.   On 06-APR-2021, a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant Human albumin (rHA) (PROQUAD) (lot # t005404 was evaluated and changed to T005404 based interval rules, expiration date was reported as 24-MAR-2022, but upon internal validation established as 12-AUG-2021; strength and route were unknown) was administered for prophylaxis after experiencing a temperature excursion at 37.2 degrees Fahrenheit for 3 hours (product storage error). There was no previous temperature excursion. The call was due to digital data logger. No other AE occurred. No PQC.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Inappropriate schedule of vaccine administered; This spontaneous report has been received from a lawyer, via a Fact Sheet from a case in litigation for zoster vaccine live (ZOSTAVAX) (MARRS # 2008USA003287), concerning to a 67-year-old female patient.  In October 2016, October 2017, October 2018, October 2019, and October 2020, the patient was vaccinated with Pneumococcal Vaccine, Polyvalent (23-valent) (manufacture unknown) (strength, dose, route, lot number and expiration date were unknown) for prophylaxis respectively (Inappropriate schedule of vaccine administered).; Sender's Comments:  US-009507513-2008USA003287:
Sex: U
Vaccine: MMRV
Symptoms: Product temperature excursion issue
Clinical narrative: Confirmed with customer that no other AE occurred; PROQUAD was administered after experiencing a temperature excursion; Information has been received from a nurse concerning a patient of unknown age or gender. Information of concurrent condition, medical history and concomitant therapy was not provided.    On 27-APR-2021, the patient was vaccinated with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) (recombinant human albumin (rHA)) (strength, route, lot# T005404 and expiration date expiration date reported as 24-MAR-2022, but upon internal validation established as 12-AUG-2021) for prophylaxis. This vaccine experienced a temperature excursion (incorrect product storage). The vaccine was stored in 37.2 Fahrenheit degrees (F) for 3 hours. There was no previous temperature excursion reported. Digital data logger was involved. The reporter confirmed no other adverse event (AE) occurred.
Sex: M
Vaccine: HPV9
Symptoms: Incomplete course of vaccination
Clinical narrative: has not received their second dose in the series; This spontaneous report was received from a pharmacist and refers to a 41 years old male patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 08-JUL-2020, the patient was the first dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (dose, route of administration, anatomical location, lot # and expiration date were not reported) for prophylaxis. But the patient had not received the second dose in the series (inappropriate schedule of vaccine administered).
Sex: M
Vaccine: MMR, MMRV, VARCEL
Symptoms: Wrong product administered
Clinical narrative: No additional adverse event or product quality concern; Patient received PROQUAD on 06/11/2021 and had received MMRII and VARIVAX in July of 2020; Information has been received from a nurse prescriber concerning a 5 years old male patient. Information of concurrent condition, medical history and concomitant therapy was not provided.   On ??-JUL-2020, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (dose, strength, route, lot# and expiration date were unknown) and varicella virus vaccine live (oka/merck)(VARIVAX) (dose, strength, route, lot# and expiration date were unknown) both for prophylaxis.      On 11-JUN-2021, because the nurse prescriber was unaware of he had received  measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) and varicella virus vaccine live (oka/merck) (VARIVAX), the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (strength, route, lot# and expiration date were unknown) 0.5 milliliter once for prophylaxis (wrong vaccine administered). No additional adverse event or product quality concern.
Age: 0.5
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: no additional AE information reported; a temperature excursion on ROT ATEQ and product administered; This spontaneous report was received from a medical assistant referring to a 6 months old patient of unknown gender. The patient's concomitant medication, pertinent medical history and drug allergies or reactions were not reported.   On 07-JUN-2021, the patient was vaccinated with singe dose of improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (strength was not reported, lot # T033812, expiration date 29-DEC-2021) orally for prophylaxis (product storage error).         It was reported that the suspect vaccine was exposed to a temperature of 47 Fahrenheit (F) for a time frame of 1 hour.  No digital data logger was reported. There were no previous temperature excursions. No additional adverse event (AE) information was provided.  This is one of the several reports reported by the same reporter.; Sender's Comments:  US-009507513-2106USA003944: US-009507513-2106USA004087: US-009507513-2106USA004106: US-009507513-2106USA003971:
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error, Product temperature excursion issue
Clinical narrative: Caller notes no symptoms were reported. No additional AE's/PQC's reported; a temperature excursion that occurred on 5/27/2021 and notes (1) patient was given VARlAX on 6/10/2021; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug allergies or reactions were not reported.   On 10-JUN-2021, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) (strength and route of administration were not reported, 1 dose, lot # T027299, expiration date was 12-AUG-2022) for prophylaxis (product storage error).   It was reported that the suspect vaccine was exposed to a temperature of minus 11.8 degree Celsius for a time frame of 30 minutes, as recorded by the digital data logger (on 27-MAY-2021). There were no previous temperature excursions. No additional adverse event reported.
Sex: F
Vaccine: HPV4, HPV9
Symptoms: Colposcopy normal, Papilloma viral infection, Smear cervix abnormal
Clinical narrative: The PAP test came back positive for HPV Type 16; she was not sure if the vaccine involved was GARD ASIL or GARD ASIL 9; This spontaneous report was received from a nurse via a vaccine representative referring to a female patient of unknown age. The patient was not pregnant. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were unknown by reporter.  On unknown dates (reported as in patient's late 20s to early 30s), the patient received the 3 dose series of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) or hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot#, expiration date, anatomical location and route of administration were unknown) for prophylaxis (reported as HPV prevention). It was reported that the patient was not sure if the vaccine involved was quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL) or hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (product name confusion).   On an unknown date (reported as recently), the patient had a papanicolaou (PAP) smear test performed. The PAP test came back positive for HPV Type 16. A colposcopy was performed on patient, which came back negative for HPV Type 16. The reporter was not aware of any error at the lab but was going to further investigate the discrepancy of results. It was reported that the patient had never been sexually active. No treatment was given for the event. The outcome of HPV test positive was unknown. The causality assessment between the event and suspect vaccine was not reported.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs; improperly stored administered GARDASIL 9; This spontaneous report was received from a physician assistant referring to a patient of unknown age and gender. Information about medical history, concurrent conditions and concomitant therapies was not provided.     On 29-APR-2021, the patient was vaccinated with improperly stored hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (lot # 1691180, expiration date 15-NOV-2022, 0.5 milliliter) for prophylaxis (product storage error).  Temperature excursion was 28.8 Fahrenheit degree for 2 hours and 35 minutes and 31.4 Fahrenheit degree for 0 hours and 15 minutes. There was no previous temperature excursion. Digital data logger was not involved. No adverse event was reported.  This is one of three reports received from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: 1691180; expirationdate: 15-NOV-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability; Sender's Comments:  US-009507513-2106USA004138: US-009507513-2106USA003990  :
Age: 0.5
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE information reported.; temperature excursion; This spontaneous report was received from a medical assistant, referring to a 6-month-old patient of unknown gender. The patient's pertinent medical history, current conditions, previous drug reactions or allergies and concomitant medications were not reported.  On 05-JUN-2021, the patient was vaccinated with improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (single dose unspecified, lot # T033812, expiration date: 29-DEC-2021) orally for prophylaxis. The administered dose of vaccine experienced the temperature excursion of 47 degrees Fahrenheit for 1 hour (product storage error). No previous temperature excursion was reported. No additional adverse event information reported.
Sex: F
Vaccine: HPV4
Symptoms: Nervous system disorder
Clinical narrative: some neurological issues; This spontaneous report was received from a nurse practitioner concerning a female patient, who was her daughter's friend. No concurrent condition, medical history or concomitant therapy was reported.   On an unknown date (reported as when the patient was younger), the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL) (dose, route and lot# were not reported) as prophylaxis.         On an unknown date, the patient had some neurological issues (preferred term: nervous system disorder). The reporter believed the patient had fully recovered. However, the patient had to have one on one care. Action taken with quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) was not applicable.   The causality between the event of some neurological issues and quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) was not reported.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse effect reported; vaccine that underwent a temperature excursion was administered; This spontaneous report was received from a certified medical assistant (C.M.A.) referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies, concurrent condition and concomitant medication were not provided.  On 11-JUN-2021, the patient was vaccinated with incorrectly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) orally for prophylaxis (lot# was 1707457 or 1707460: lot# 1707457 has been verified to be a valid lot number, expiration date reported as 22-FEB-2022, but upon internal validation established as 23-FEB-2022; lot# 1707460 has been verified to be a valid lot number, expiration date reported as 13-MAR-2022, but upon internal validation established as 14-MAR-2022) (strength and dose were not reported) (incorrect product storage). The vaccine underwent a temperature excursion as it was stored at 47.2 Fahrenheit (F) (above 46 F) for 52 minutes, recorded by digital data logger. There was no previous temperature excursion. No additional adverse effect was reported.
Sex: U
Vaccine: RV5
Symptoms: Product temperature excursion issue
Clinical narrative: No additional adverse effect reported; vaccine that underwent a temperature excursion was administered; This spontaneous report was received from a medical assistant referring to a patient on unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  It was reported that rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot # 1707457, expiration date was reported as 22-FEB-2022 but upon internal validation established as 23-FEB-2022; lot # 1707460, expiration date was reported as 13-MAR-2022 but upon internal validation established as 14-MAR-2022) underwent a temperature excursion.  On 11-JUN-2021, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (strength and dose were not reported) orally for prophylaxis. Information for which lots were given to patient not provided. The vaccine was exposed the temperature excursion 47.2 Fahrenheit (F) (above 46 F) for 52 minutes (product storage error). The data logger was involved. There was no previous temperature excursion. No adverse effects were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2106USA004356:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse effect reported; vaccine that underwent a temperature excursion was administered; This spontaneous report was received from a medical assistant referring to a patient on unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  It was reported that rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot # 1707457, expiration date was reported as 22-FEB-2022 but upon internal validation established as 23-FEB-2022;  lot # 1707460, expiration date was reported as 13-MAR-2022 but upon internal validation established as 14-MAR-2022) underwent a temperature excursion.  On 10-JUN-2021, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (strength and dose were not reported) orally for prophylaxis. Information for which lots were given to patient not provided. The vaccine was exposed the temperature excursion 47.2 Fahrenheit (F) (above 46 F) for 52 minutes (product storage error). The data logger was involved. There was no previous temperature excursion. No adverse effects were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2106USA004356:
Sex: U
Vaccine: RV5
Symptoms: Product temperature excursion issue
Clinical narrative: No additional adverse effect reported; vaccine that underwent a temperature excursion was administered; This spontaneous report was received from a medical assistant referring to a patient on unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  It was reported that rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot # 1707457, expiration date was reported as 22-FEB-2022 but upon internal validation established as 23-FEB-2022;  lot # 1707460, expiration date was reported as 13-MAR-2022 but upon internal validation established as 14-MAR-2022) underwent a temperature excursion.  On 09-JUN-2021, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (strength and dose were not reported) orally for prophylaxis. Information for which lots were given to patient not provided. The vaccine was exposed the temperature excursion 47.2 Fahrenheit (F) (above 46 F) for 52 minutes (product storage error). The data logger was involved. There was no previous temperature excursion. No adverse effects were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2106USA004356:
Sex: U
Vaccine: RV5
Symptoms: Product temperature excursion issue
Clinical narrative: No additional adverse effect reported; vaccine that underwent a temperature excursion was administered; This spontaneous report was received from a medical assistant referring to a patient on unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  It was reported that rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot # 1707457, expiration date was reported as 22-FEB-2022 but upon internal validation established as 23-FEB-2022; lot # 1707460, expiration date was reported as 13-MAR-2022 but upon internal validation established as 14-MAR-2022) underwent a temperature excursion.  On 08-JUN-2021, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (strength and dose were not reported) orally for prophylaxis. Information for which lots were given to patient not provided. The vaccine was exposed the temperature excursion 47.2 Fahrenheit (F) (above 46 F) for 52 minutes (product storage error). The data logger was involved. There was no previous temperature excursion. No adverse effects were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2106USA004356:
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse effect reported; vaccine that underwent a temperature excursion was administered; This spontaneous report was received from a medical assistant referring to a patient on unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  It was reported that Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (lot # T005400, expiration date was reported as 11-AUG-2021 but upon internal validation established as 12-AUG-2021; lot # T028138, expiration date was reported as 14-FEB-2022 but upon internal validation established as 15-FEB-2022; lot # T025509, expiration date was reported as 22-JAN-2022 but upon internal validation established as 23-JAN-2022; lot # T025510, expiration date was reported as 22-JAN-2022 but upon internal validation established as 23-JAN-2022) underwent a temperature excursion.  11-JUN-2021, the patient was vaccinated with an improperly stored dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (dose and route were not reported) for prophylaxis. Information for which lots were given to patient not provided. The vaccine was exposed the temperature excursion above 7.3 Fahrenheit degrees (F) (6 F to 14 F) for 10 minutes (product storage error). The data logger was involved. There was no previous temperature excursion. No adverse effects were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2106USA004356:
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse effect reported; vaccine that underwent a temperature excursion was administered; This spontaneous report was received from a medical assistant referring to a patient on unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  It was reported that measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (lot # T003384, expiration date was reported as 27-JAN-2022 but upon internal validation established as 28-JAN-2022; lot # T007231, expiration date was reported as 26-FEB-2022 but upon internal validation established as 27-FEB-2022; lot # S023656, expiration date was reported as 29-JUL-2021 but upon internal validation established as 30-JUL-2021; lot # S039313, expiration date was reported as 03-DEC-2021 but upon internal validation established as 04-DEC-2021) underwent a temperature excursion.  09-JUN-2021, the patient was vaccinated with an improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (dose and route were not reported) for prophylaxis. Information for which lots were given to patient not provided. The vaccine underwent a temperature excursion as it was stored at 47.2 Fahrenheit (F) (above 46 F) for 52 minutes, recorded by digital data logger. There was no previous temperature excursion. No additional adverse effect was reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2106USA004356:
Sex: U
Vaccine: HEPA, HEPA, HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse effect reported; vaccine that underwent a temperature excursion was administered; Information has been received from a medical assistant concerning a patient of unknown age and gender. There was no information regarding the patient's pertinent medical history, concomitant medications, or drug reactions/allergies.    It was reported that hepatitis a vaccine, inactivated (VAQTA) (lot # T013205, expiration date was reported as 02-DEC-2021 but upon internal validation established as 03-DEC-2021; lot # T023913, expiration date was reported as 30-MAR-2022 but upon internal validation established as 31-MAR-2022; lot # T018229, expiration date was reported as 13-DEC-2021 but upon internal validation established as 14-DEC-2021) underwent a temperature excursion. On 11-JUN-2021, the patient was vaccinated with an improperly stored dose of hepatitis a vaccine, inactivated (VAQTA) (dose and route were not reported) for prophylaxis. Information for which lots were given to patient not provided. The vaccine was exposed the temperature excursion above 46 Fahrenheit degrees (47.2 Fahrenheit degrees) for 52 minutes (product storage error). The data logger was involved. There was no previous temperature excursion. No adverse effects were reported.  This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T013205; expirationdate: 03-DEC-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability; Sender's Comments:  US-009507513-2106USA004356:
Sex: U
Vaccine: HEPA, HEPA, HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse effect reported; vaccine that underwent a temperature excursion was administered; Information has been received from a medical assistant concerning a patient of unknown age and gender. There was no information regarding the patient's pertinent medical history, concomitant medications, or drug reactions/allergies.    It was reported that hepatitis a vaccine, inactivated (VAQTA) (lot # T013205, expiration date was reported as 02-DEC-2021 but upon internal validation established as 03-DEC-2021; lot # T023913, expiration date was reported as 30-MAR-2022 but upon internal validation established as 31-MAR-2022; lot # T018229, expiration date was reported as 13-DEC-2021 but upon internal validation established as 14-DEC-2021) underwent a temperature excursion. On 09-JUN-2021, the patient was vaccinated with an improperly stored dose of hepatitis a vaccine, inactivated (VAQTA) (dose and route were not reported) for prophylaxis. Information for which lots were given to patient not provided. The vaccine was exposed the temperature excursion above 46 Fahrenheit degrees (47.2 Fahrenheit degrees) for 52 minutes (product storage error). The data logger was involved. There was no previous temperature excursion. No adverse effects were reported.  This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T013205; expirationdate: 03-DEC-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability; Sender's Comments:  US-009507513-2106USA004356:
Sex: U
Vaccine: HEPA, HEPA, HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse effect reported; vaccine that underwent a temperature excursion was administered; Information has been received from a medical assistant concerning a patient of unknown age and gender. There was no information regarding the patient's pertinent medical history, concomitant medications, or drug reactions/allergies.    It was reported that hepatitis a vaccine, inactivated (VAQTA) (lot # T013205, expiration date was reported as 02-DEC-2021 but upon internal validation established as 03-DEC-2021; lot # T023913, expiration date was reported as 30-MAR-2022 but upon internal validation established as 31-MAR-2022; lot # T018229, expiration date was reported as 13-DEC-2021 but upon internal validation established as 14-DEC-2021) underwent a temperature excursion. On 08-JUN-2021, the patient was vaccinated with an improperly stored dose of hepatitis a vaccine, inactivated (VAQTA) (dose and route were not reported) for prophylaxis. Information for which lots were given to patient not provided. The vaccine was exposed the temperature excursion above 46 Fahrenheit degrees (47.2 Fahrenheit degrees) for 52 minutes (product storage error). The data logger was involved. There was no previous temperature excursion. No adverse effects were reported.  This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T013205; expirationdate: 03-DEC-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability; Sender's Comments:  US-009507513-2106USA004356:
Sex: U
Vaccine: HEPA, HEPA, HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse effect reported; vaccine that underwent a temperature excursion was administered; Information has been received from a medical assistant concerning a patient of unknown age and gender. There was no information regarding the patient's pertinent medical history, concomitant medications, or drug reactions/allergies.    It was reported that hepatitis a vaccine, inactivated (VAQTA) (lot # T013205, expiration date was reported as 02-DEC-2021 but upon internal validation established as 03-DEC-2021; lot # T023913, expiration date was reported as 30-MAR-2022 but upon internal validation established as 31-MAR-2022; lot # T018229, expiration date was reported as 13-DEC-2021 but upon internal validation established as 14-DEC-2021) underwent a temperature excursion. On 07-JUN-2021, the patient was vaccinated with an improperly stored dose of hepatitis a vaccine, inactivated (VAQTA) (dose and route were not reported) for prophylaxis. Information for which lots were given to patient not provided. The vaccine was exposed the temperature excursion above 46 Fahrenheit degrees (47.2 Fahrenheit degrees) for 52 minutes (product storage error). The data logger was involved. There was no previous temperature excursion. No adverse effects were reported.  This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. devicelotnumber: T013205; expirationdate: 03-DEC-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability; Sender's Comments:  US-009507513-2106USA004356:
Sex: U
Vaccine: HEPA, HEPA, HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse effect reported; vaccine that underwent a temperature excursion was administered; Information has been received from a medical assistant concerning a patient of unknown age and gender. There was no information regarding the patient's pertinent medical history, concomitant medications, or drug reactions/allergies.    It was reported that hepatitis a vaccine, inactivated (VAQTA) (lot # T013205, expiration date was reported as 02-DEC-2021 but upon internal validation established as 03-DEC-2021; lot # T023913, expiration date was reported as 30-MAR-2022 but upon internal validation established as 31-MAR-2022; lot # T018229, expiration date was reported as 13-DEC-2021 but upon internal validation established as 14-DEC-2021) underwent a temperature excursion. On 07-JUN-2021, the patient was vaccinated with an improperly stored dose of hepatitis a vaccine, inactivated (VAQTA) (dose and route were not reported) for prophylaxis. Information for which lots were given to patient not provided. The vaccine was exposed the temperature excursion above 46 Fahrenheit degrees (47.2 Fahrenheit degrees) for 52 minutes (product storage error). The data logger was involved. There was no previous temperature excursion. No adverse effects were reported.  This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T013205; expirationdate: 03-DEC-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability; Sender's Comments:  US-009507513-2106USA004356:
Age: 49.0
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: no additional AE; improperly stored dose was administered; Information has been received from a pharmacist referring to a 49 years old patient of unknown gender. Information of concomitant therapy, pertinent medical history and drug reactions/allergies was not reported.  On 16-JUN-2021, the patient was vaccinated with improperly stored of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) (lot # T034630, expiration date: 22-JUN-2022, strength, dose, frequency and route were unknown) for prophylaxis (incorrect product storage).  No adverse effects were reported.  The stored temperature was 31.5 Fahrenheit (F). The time frame was 15 hours and 33 minutes. There was no previous temperature excursion. The temperature excursion was detected by a data logger. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T034630; expirationdate: 22-JUN-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
Sex: U
Vaccine: HPV9
Symptoms: Incomplete course of vaccination
Clinical narrative: No additional AE; the patient only received the first dose and didn't complete the series; This spontaneous report was received from a pharmacy technician referring to a currently 46 years old patient of unknown gender. The patient's pertinent medical history, drug reactions/ allergies and concomitant medication were not reported.  On 07-NOV-2019, the patient was vaccinated with the first dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (dose, strength, route, lot# and expiration date unknown) for prophylaxis. The patient only received the first dose and didn't completed the series (Inappropriate schedule of product administration). No additional AE.
Age: 1.0
Sex: U
Vaccine: MMR, MMRV
Symptoms: Inappropriate schedule of product administration
Clinical narrative: PROQUAD and MMR-II were administered together to a one year old patient; Adverse Event filed with limited information reported, no additional information provided; This spontaneous report as received from a pharmacist on behalf of the nurse refers to a 1 year old patient. The patient's medical history, concurrent condition and concomitant medication were not reported.  On an unknown date, measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) (route, strength, dose, batch/lot # and expiration date were not reported) and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (route, strength, dose, batch/lot # and expiration date were not reported) were administered together to the patient for prophylaxis (Inappropriate schedule of vaccine administered). Per pharmacist, the parents of the patient called the nurse to report and inquired what should be done who in turn called the pharmacist to see what to do. Per caller/pharmacist, it was not given by the nurse that inquired nor was it given at their office but the parents called the nurse to see what to do. No additional information was provided.
Age: 11.0
Sex: M
Vaccine: DTAP
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: child received one dose of Infanrix when they should have received Boostrix; This case was reported by a physician via sales rep and described the occurrence of inappropriate age at vaccine administration in a 11-year-old male patient who received DTPa (Infanrix) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Infanrix and Infanrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The patient should have received Boostrix but received Infanrix at 11 years of age, which led to inappropriate age at vaccine administration. The patient did not experienced any adverse reaction to the Infanrix.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: got shingles after the first vac; This case was reported by a consumer via interactive digital media  and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, 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 Shingles vaccine.  Additional details were provided as follows: Age at vaccination was not reported. The patient received 1st dose of shingles vaccine and experienced shingles. No other information provided.
Sex: U
Vaccine: VARZOS
Symptoms: Back pain, Blister, Feeling abnormal, Herpes zoster, Musculoskeletal chest pain
Clinical narrative: sharp pain in my back; pain / along my right rib cage.; full blown case of shingles / from my center back to my center front / shingles rash / might be a side effect; blisters; shingles rash; last six weeks /have been totally miserable.; I continue to experience pain; This case was reported by a consumer and described the occurrence of back pain in a 76-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Zostavax with an associated reaction of no adverse event (Received 6-7 years before reporting date).   On 4th May 2021, the patient received the 1st dose of Shingrix. On 6th May 2021, 2 days after receiving Shingrix, the patient experienced back pain, rib pain, shingles, blister, vesicular rash, feeling miserable and pain. On an unknown date, the outcome of the back pain, rib pain, vesicular rash, feeling miserable and pain were unknown and the outcome of the shingles and blister were recovered/resolved.   It was unknown if the reporter considered the back pain, rib pain, shingles, blister, vesicular rash, feeling miserable and pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Zostavax 6-7 years before reporting date and did not have any reactions with it. The patient received the 1st dose Shingrix and 2 days after the vaccination patient experienced sharp pain in back along right rib cage.  On Saturday the patient had had a full blown case of shingles, running from center back to center front. It was stated that the patient also had shingles rash and blisters. The patient stated that he/she got late in getting doctor involved because patient didn't recognize what was happening, but patient had been taking medications for the past six weeks. The patient wanted to report that but patient was told that he/she could not et shingles from Shingrix because it was a dead vaccine. The patient did not believe that contracting shingles within 2 days of receiving the Shingrix vaccine was a coincidence and patient was truly afraid of taking the 2nd dose, because the last six weeks of patient's life had been totally miserable. It was stated that the shingles rash and blisters were healed but patient was continue to experience pain from the area involved. The patient stated that he/she was in excellent health, except for that outbreak of shingles. The patient believed that the manufacturers of Shingrix should include as a side effect possible cases of shingles as a result of taking the vaccine. The patient might have done a better job with early identification of his/her problem had patient know that shingles might be a side effect.
Sex: U
Vaccine: VARZOS
Symptoms: Pain, Rash vesicular
Clinical narrative: sharp pain in my back; pain / along my right rib cage.; full blown case of shingles / from my center back to my center front / shingles rash / might be a side effect; blisters; shingles rash; last six weeks /have been totally miserable.; I continue to experience pain; This case was reported by a consumer and described the occurrence of back pain in a 76-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Zostavax with an associated reaction of no adverse event (Received 6-7 years before reporting date).   On 4th May 2021, the patient received the 1st dose of Shingrix. On 6th May 2021, 2 days after receiving Shingrix, the patient experienced back pain, rib pain, shingles, blister, vesicular rash, feeling miserable and pain. On an unknown date, the outcome of the back pain, rib pain, vesicular rash, feeling miserable and pain were unknown and the outcome of the shingles and blister were recovered/resolved.   It was unknown if the reporter considered the back pain, rib pain, shingles, blister, vesicular rash, feeling miserable and pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Zostavax 6-7 years before reporting date and did not have any reactions with it. The patient received the 1st dose Shingrix and 2 days after the vaccination patient experienced sharp pain in back along right rib cage.  On Saturday the patient had had a full blown case of shingles, running from center back to center front. It was stated that the patient also had shingles rash and blisters. The patient stated that he/she got late in getting doctor involved because patient didn't recognize what was happening, but patient had been taking medications for the past six weeks. The patient wanted to report that but patient was told that he/she could not et shingles from Shingrix because it was a dead vaccine. The patient did not believe that contracting shingles within 2 days of receiving the Shingrix vaccine was a coincidence and patient was truly afraid of taking the 2nd dose, because the last six weeks of patient's life had been totally miserable. It was stated that the shingles rash and blisters were healed but patient was continue to experience pain from the area involved. The patient stated that he/she was in excellent health, except for that outbreak of shingles. The patient believed that the manufacturers of Shingrix should include as a side effect possible cases of shingles as a result of taking the vaccine. The patient might have done a better job with early identification of his/her problem had patient know that shingles might be a side effect.
Sex: M
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: temperature monitor log that the fridge temp went down to -6 Celsius/ Engerix-B that was in that fridge; This case was reported by a other health professional via sales rep and described the occurrence of incorrect storage of drug in a neonate male patient who received HBV (Engerix B) for prophylaxis.   On June 2021, the patient received Engerix B. On June 2021, unknown after receiving Engerix B, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.  Additional details were provided as follows: The newborn baby was administered Engerix-B, and since that time, reporter had seen on refrigerator temperature monitor log that the fridge temperature went down to minus 6 Celsius on 24th May 2021. Then it went right back up to normal temp it looks more like reporter system had an issue, not the fridge. The reporter temperatures are taken every 15 minute and it was just one time point that dipped down to the minus 6 degrees. The newborn baby got a dose of the Engerix-B that was in that fridge and he has not had any adverse reactions from the vaccine, which led to Incorrect storage of drug. The reporter consent to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: So sore and painful; This case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (had shingles before).   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain. On an unknown date, the outcome of the pain was unknown.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by the patient. The age at vaccination was not reported. The patient got the shot and experienced soreness and painful. No further information was provided.