chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: FORGOT TO TAKE THE LAST DOSE ON TIME; This spontaneous case (PVX2019-2249) was received from a consumer on 03-Sep-2019. It described a male consumer who "forgot to take the last dose on time" (PT: Inappropriate schedule of product administration), while being on Vivotif for an unknown indication.  Case report: The consumer did not take the last dose of Vivotif on time. The doses were taken on 26-Aug-2019, 28-Aug-2019, 30-Aug-2019, and 02-Sep-2019, respectively.  Action taken with Vivotif with respect to the event was not applicable.  The clinical outcome of the reported event was unknown.  Company's Comment: The causality of the event "forgot to take the last dose on time" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "forgot to take the last dose on time" was considered as not applicable.
Sex: M
Vaccine: TYP
Symptoms: Product dose omission
Clinical narrative: MISSED SECOND DOSE; This spontaneous case (PVX2019-2260) was received from a consumer on 04-Sep-2019. It described a 67-year-old elderly male consumer who "missed second dose" (PT: Product dose omission), while being on Vivotif for an unknown indication.  Case report: The consumer took the first dose of Vivotif on 01-Sep-2019 and missed to take the second dose on 03-Sep-2019. The consumer planned to take it on 04-Sep-2019.  Action taken with Vivotif with respect to the event was not applicable.  The clinical outcome of the reported event was unknown.  Company's Comment: The causality of the event "missed the second dose" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "missed the second dose" was considered as not applicable.
Sex: M
Vaccine: TYP
Symptoms: Product administration error
Clinical narrative: TOOK THREE DOSES INCORRECTLY; This spontaneous case (PVX2019-2272) was received form a physician on 05-Sep-2019. It described a 25-years-old male consumer who "took three doses incorrectly" (PT: Product administration error), while being on Vivotif for typhoid prophylaxis.  Case report: The consumer took three doses of Vivotif incorrectly. The first dose was taken with alcohol on 30-Aug-2019, the second dose with food, and the third dose with a hot drink. The fourth dose was scheduled for today (05-Sep-2019) and he had not taken it yet.   Action taken with Vivotif with respect to the event was not applicable.  The clinical outcome of the reported event was unknown.  Company's Comment: The causality of the event "took three doses incorrectly" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took three doses incorrectly" was considered as not applicable.
Sex: F
Vaccine: TYP
Symptoms: Product dose omission
Clinical narrative: MISSED TO TAKE LAST DOSE OF VIVOTIF ON TIME; This spontaneous case (PVX2019-2275) was received form a nurse on 05-Sep-2019. It described a female consumer who "missed to take last dose of Vivotif on time" (PT: Product dose omission), while being on oral Vivotif for typhoid fever prophylaxis.  Case report: The consumer took three doses of Vivotif every other day but missed to take fourth dose on time. She had not taken the fourth dose till the time of the report.  Action taken with Vivotif with respect to the event was not applicable.  The clinical outcome of the reported event was unknown.  Company's Comment: The causality of the event "missed to take last dose of Vivotif on time" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "missed to take last dose of Vivotif on time" was considered as not applicable.
Sex: M
Vaccine: TYP
Symptoms: Product storage error
Clinical narrative: TOOK TWO UNREFRIGERATED DOSES; A spontaneous case report was received from a pharmacist on 06-Sep-2019 for two consumers.  Based on the information obtained from the pharmacist, two individual case safety reports PVX201909-000723 (PVX2019-2277; husband) and PVX201909-000724 (PVX2019-2278; wife) were created and cross-linked in the database.  This spontaneous case (PVX2019-2277) described a male consumer who "took two unrefrigerated doses" (PT: Product storage error), while being on oral Vivotif (one dose every other day) for typhoid fever prophylaxis.  Case report: The consumer took two doses of Vivotif, which were unrefrigerated for 2 weeks.   Action taken with Vivotif with respect to the event was not applicable.  The clinical outcome of the reported event was unknown.  Company's Comment: The causality of the event "took two unrefrigerated doses" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took two unrefrigerated doses" was considered as not applicable. US-PaxVax Berna GmbH-PVX201909-000724:
Sex: F
Vaccine: TYP
Symptoms: Product storage error
Clinical narrative: TOOK TWO UNREFRIGERATED DOSES; A spontaneous case report was received from a pharmacist on 06-Sep-2019 for two consumers.  Based on the information obtained from the pharmacist, two individual case safety reports PVX201909-000723 (PVX2019-2277; husband) and PVX201909-000724 (PVX2019-2278; wife) were created and cross-linked in the database.  This spontaneous case (PVX2019-2278) described a female consumer who "took two unrefrigerated doses" (PT: Product storage error), while being on oral Vivotif for typhoid fever prophylaxis.  Case report: The consumer took two doses of Vivotif, which were unrefrigerated for 2 weeks.   Action taken with Vivotif with respect to the event was not applicable.  The clinical outcome of the reported event was unknown.  Company's Comment: The causality of the event "took two unrefrigerated doses" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took two unrefrigerated doses" was considered as not applicable. US-PaxVax Berna GmbH-PVX201909-000723:
Sex: F
Vaccine: TYP
Symptoms: Product storage error
Clinical narrative: TOOK UNREFRIGERATED DOSES; This spontaneous case report (PVX2019-2304) was received from a consumer on 09-Sep-2019. It described a 60-years-old female consumer who "took unrefrigerated doses" (PT: Product storage error), while being on Vivotif for an unknown indication.  Case report: The consumer left Vivotif doses unrefrigerated overnight at 79 to 80-degree Fahrenheit and it were no longer good to use. She took all the doses from 26-Aug-2019 to 01-Sep-2019.  Action taken with Vivotif was not applicable.  The clinical outcome with respect to the event was unknown.  Company's Comment: The causality of the event "took unrefrigerated doses" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took unrefrigerated doses" was considered as not applicable.
Sex: F
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: TOOK SECOND DOSE A DAY LATE; This spontaneous case (PVX2019-2309) was received from a consumer on 09-Sep-2019. It described a female consumer who "took second dose a day late" (PT: Inappropriate schedule of product administration), while being on oral Vivotif for typhoid fever prophylaxis.  Case report: The consumer did not take the Vivotif doses according to the schedule. The first two doses were taken on 05-Sep-2019 and 08-Sep-2019, respectively.  Action taken with Vivotif was not applicable.   The clinical outcome for the reported event was unknown.  Company's Comment: The causality of the event "took second dose a day late" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took second dose a day late" was considered as not applicable.
Sex: F
Vaccine: TYP
Symptoms: Product administration error
Clinical narrative: TOOK VIVOTIF RIGHT BEFORE A MEAL; This spontaneous case report (PVX2019-2313) was received from a physician on 10-Sep-2019. It described an adult female consumer who "took Vivotif right before a meal" (PT: Product administration error), while being on oral Vivotif capsule (one capsule every other day) for typhoid prophylaxis.  Case report: The consumer took all the doses of Vivotif on an empty stomach but ate breakfast right after each dose.  Action taken with Vivotif was not applicable.  The clinical outcome was unknown.  Company's Comment: The causality of the event "took Vivotif right before a meal" was considered as not applicable. ; Sender's Comments: Company's Comment: The causality of the event "took Vivotif right before a meal" was considered as not applicable.
Sex: M
Vaccine: TYP
Symptoms: Product storage error
Clinical narrative: TOOK ONE UNREFRIGERATED DOSE; This spontaneous case report (PVX2019-2341) was received from a pharmacist on 12-Sep-2019. It described a 46-years-old male consumer who "took one unrefrigerated dose" (PT: Product storage error), while being on oral Vivotif for typhoid fever prophylaxis.  Case report: The consumer took the first dose of Vivotif on 12-Sep-2019, which was unrefrigerated for one week at room temperature.  Action taken with Vivotif with respect to the event was not applicable.  The clinical outcome of the reported event was unknown.  Company's Comment: The causality of the event "took one unrefrigerated dose" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took one unrefrigerated dose" was considered as not applicable.
Sex: F
Vaccine: TYP
Symptoms: Labelled drug-drug interaction medication error
Clinical narrative: TOOK TWO DOSES OF VIVOTIF WITH CIPROFLOXACIN; This spontaneous case report (PVX2019-2541) was received from a nurse on 10-Oct-2019. It described a female consumer who "took two doses of Vivotif with ciprofloxacin" (PT: Labelled drug-drug interaction medication error), while being on oral Vivotif (company suspect) for typhoid fever prophylaxis and ciprofloxacin (non-company suspect) for urinary tract infection (UTI).  Case report: The consumer took two doses of Vivotif with ciprofloxacin. She had a UTI prior to starting of Vivotif and she was prescribed with ciprofloxacin.    The consumer's medical history included UTI.  Action taken with Vivotif and ciprofloxacin with respect to the event was not applicable.  The clinical outcome of the reported event was unknown.  Company's Comment: The causality of the event "took two doses of Vivotif with ciprofloxacin" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took two doses of Vivotif with ciprofloxacin" was considered as not applicable.
Sex: F
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: TOOK THE SECOND DOSE OF VIVOTIF A DAY LATE; This spontaneous case report (PVX2019-2545) was received from a consumer on 11-Oct-2019. It described a 69-year-old female consumer who "took the second dose of Vivotif a day late" (PT: Inappropriate schedule of product administration), while being on Vivotif for typhoid prophylaxis.  Case report: The consumer did not take the doses of Vivotif according to the schedule. The doses were taken on day 1, 4, and 6.   Action taken with respect to the event was not applicable.  The clinical outcome of the event was unknown.  Company's Comment: The causality of the event "took the second dose of Vivotif a day late" was considered as not applicable. .; Sender's Comments: Company's Comment: The causality of the event "took the second dose of Vivotif a day late" was considered as not applicable.
Sex: F
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: TOOK TWO DOSE ON DAY 1 AND 2; This spontaneous case report (PVX2019-2536) was received from a consumer on 10-Oct-2019. It described a female consumer who "took two doses on days 1 and 2" (PT: Inappropriate schedule of product administration), while being on oral Vivotif for typhoid fever.  Case report: The consumer took two doses in a row. The doses were taken on 09-Oct-2019 and 10-Oct-2019, respectively.  Action taken with Vivotif with respect to the event was not applicable.  The clinical outcome of the reported event was unknown.  Company's Comment: The causality of the event "took two doses on days 1 and 2" was considered as not applicable. ; Sender's Comments: Company's Comment: The causality of the event "took two dose on days 1 and 2" was considered as not applicable.
Sex: F
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: TOOK VIVOTIF ON DAYS 1, 3, AND 4; This spontaneous case report (PVX2019-2565) was received from a nurse on 14-Oct-2019. It described a female consumer who "took Vivotif on days 1, 3, and 4" (PT: Inappropriate schedule of product administration). The consumer was receiving Vivotif for an unknown indication.  Case report: The consumer did not take Vivotif according to schedule. She took the third dose on day 4.  Action taken with Vivotif with respect to the event was not applicable.  The clinical outcome of the reported event was unknown.  Company's Comment: The causality of the event "took Vivotif on days 1, 3, and 4" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took Vivotif on days 1, 3, and 4" was considered as not applicable.
Sex: F
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: TOOK DOSES ON DAYS 1, 3, 4 AND 5; This spontaneous case report (PVX2019-2567) was received from a consumer on 14-Oct-2019. It described a female consumer who "took doses on days 1, 3, 4 and 5" (PT: Inappropriate schedule of product administration). The consumer was receiving Vivotif for an unknown indication.  Case report: The consumer did not take Vivotif doses according to schedule. The doses were taken on 10-Oct-2019, 12-Oct-2019, 13-Oct-2019, and 14-Oct-2019.  Action taken with Vivotif with respect to the event was not applicable.  The clinical outcome of the reported event was unknown.  Company's Comment: The causality of the event "took doses on days 1, 3, 4 and 5" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took doses on days 1, 3, 4 and 5" was considered as not applicable.
Sex: M
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: TOOK FOURTH DOSE ON DAY 6; This spontaneous case report (PVX2019-2537) was received from a consumer on 14-Oct-2019. It described an 18-year-old male consumer who "took fourth dose on day 6" (PT: Inappropriate schedule of product administration), while being on oral Vivotif for typhoid fever.  Case report: The consumer took first three doses of Vivotif according to schedule on day 1, 3, and 5 respectively however; he took the fourth dose one day 6.   Action taken with Vivotif with respect to reported event was not applicable.  The clinical outcome of the reported event was unknown.  Company's Comment: The causality of the event "took fourth dose on day 6" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took fourth dose on day 6" was considered as not applicable.
Sex: M
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: DID NOT COMPLETE IMMUNIZATION ONE WEEK PRIOR TO TRAVELING; This spontaneous case report (PVX2019-2586) was received from a consumer on 16-Oct-2019. It described a male consumer who "did not complete immunization one week prior to traveling" (PT: Inappropriate schedule of product administration). The consumer was receiving oral Vivotif for typhoid prophylaxis.  Case report: The consumer will not be completing his Vivotif course one week prior to traveling. He took first dose of Vivotif on 16-Oct-2019 and would be leaving for the endemic area on 22-Oct-2019.  Action taken with Vivotif with respect to event was not applicable.  The clinical outcome of the reported event was unknown.  Company's Comment: The causality of the event "did not complete immunization one week prior to traveling" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "did not complete immunization one week prior to traveling" was considered as not applicable.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Injected limb mobility decreased, Injection site pain, Pain in extremity
Clinical narrative: Immediate pain at the site of injection; Diminished ability to more his right arm; Soreness in his arm; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 74-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In October 2019, the patient received the 1st dose of Shingrix (intramuscular). In October 2019, immediately after receiving Shingrix, the patient experienced injection site pain, pain in arm and injected limb mobility decreased. On an unknown date, the outcome of the injection site pain, pain in arm and injected limb mobility decreased were recovered/resolved.   It was unknown if the reporter considered the injection site pain, pain in arm and injected limb mobility decreased to be related to Shingrix.  Additional details were provided as follows: Consumer reports receiving 1st Shingrix dose in middle or late October 2019 in his right arm. Consumer reports immediate pain at the site of injection followed by the onset of soreness in his arm 2 hours later that lasted for approximately 1 month. In addition to the soreness, consumer also reports a diminished ability to more his right arm starting 2 hours after vaccination lasting approximately 1.5 months. The patient reports being due to for 2nd dose within days but hesitant to receive it due to first dose reactions on top of being 75 years old while coronavirus was a threat. He mentioned he might not receive it at appropriate time as the recommended schedule.
Sex: F
Vaccine: UNK
Symptoms: Exposure during pregnancy
Clinical narrative: pregnant woman who received INFLUENZA TRIVALENT RECOMBINANT VACCINE/NO AE; Upon internal review information received on 13-Apr-2020, a significant amendment was performed on 15-Apr-2020, to correct report type from " Solicited Non-Sponsored" to " Unsolicited Non Literature".  Upon second medical examination of the case during internal review, a significant amendment was performed on 04 January 2019, to correct study drug from "Quadrivalent Recombinant Influenza Vaccine" to "Trivalent Recombinant Influenza Vaccine".  This is a pregnancy report for a sponsored study.This initial report of a Pregnancy, received on 27Oct2015.  This case involves a 23 year old female patient who received INFLUENZA TRIVALENT RECOMBINANT VACCINE, while he was pregnant.  Data regarding this pregnancy were received prospectively.  The date of last menstrual period was not reported.  The estimated due date is 02-May-2016.  No information on previous pregnancy history was provided.  The patient received first and second dose of suspect INFLUENZA TRIVALENT RECOMBINANT VACCINE lot number not reported via intramuscular route in the arm NOS on 30-Jul-2015 and 20-Aug-2015 for prophylactic vaccination, while she was pregnant.  It was a case of vaccine exposure during pregnancy.  At time of reporting, the outcome of the pregnancy is unknown. Company Assessment: Based on the information received the patient received vaccine Intramuscular on 30Jul2015 and 20Aug2015. The company assessment of causality between the reported event of pregnancy and the vaccine (Flublok Trivalent or Fluarix) is assessed as not related.  Addendum: 04 January 2019, upon second medical examination of case, at time of internal review, a significant amendment was performed to correct study drug from "Quadrivalent Recombinant Influenza Vaccine" to "Trivalent Recombinant Influenza Vaccine".  Addendum: information received on 13-Apr-2020, a significant amendment was performed on 15-Apr-2020, to correct report type from " Solicited Non-Sponsored" to " Unsolicited Non Literature".  Study ID, study type deleted from field and narrative was updated accordingly.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Nausea, Pyrexia
Clinical narrative: PATIENT SAID HE HAD A ROUGH 36 HOURS AFTER THE SHOT. HE HAD FEVER, CHILLS, NAUSEA AND FATIGUE.
Age: 0.33
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: no additional adverse event; the patinet received the first dose of MMR II at age 5 months; This spontaneous report as received from a other health professional refers to a 4 month (also reported as 5 month) old patient.    On 16-JUN-2009 the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) dose 1 for prophylaxis.    Concomitant therapies included sterile diluent(STERILE DILUENT).   On 16-JUN-2009, 1 day after onset of therapy the patient experienced product administered to patient of inappropriate age.  On an unknown date the patient experienced no adverse event.      This report was voided incorrectly as case # 2003USA004717. The root cause for the error was misunderstood of guidelines. The vaccine measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) cannot be administered to 4-month-old patient.
Age: 43.0
Sex: F
Vaccine: HEP, MMR, VARCEL
Symptoms: Cellulitis, Erythema
Clinical narrative: Patient contacted me on 04/15/2020 at approx. 3:00pm.  Patient said"I have cellulitis in my right arm. I have had this before. What should I do?" I advised her to call her family DR. and to have this taken care of ASAP. I called Patient @9:56 am of 04/16/20 to check on her. She said"the redness is getting better. I thought I would just keep an eye on it. I have not called my Dr. yet." I encouraged her to call her family Dr.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site rash
Clinical narrative: Red, patchy rash on Right thigh. Hard lump developed on 4/13/20. 2 inches in length, less than an inch in diameter
Age: 39.0
Sex: F
Vaccine: VARCEL
Symptoms: Exposure during pregnancy, Pregnancy test positive, Ultrasound antenatal screen
Clinical narrative: she was pregnant when the vaccine was administered.   she had a negative pregnancy in our office on 3/3/20, we administered the vaccine (varicella).  she had a positive home pregnancy test on 3/26/20.  ultrasound on 4/15/20 dates the pregnancy to be 8 weeks.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Differential white blood cell count normal, Full blood count normal, Laboratory test normal, Magnetic resonance imaging, Seizure
Clinical narrative: Seizure lasting 10 minutes.  Did not break when Diastat was given at 5 minutes
Age: 1.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse effects reported; one patient was administered improperly stored proquad; This spontaneous report was received from a registered nurse referring to a 12 month old infant patient of unknown gender. Information regarding the patient's pertinent medical history or drug allergies was not provided. Concomitant medications included sterile diluent (MERCK STERILE DILUENT). On 31-MAR-2020, the patient was vaccinated with an improperly stored dose measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin) (PROQUAD), for prophylaxis (dose, route of administration, vaccination scheme frequency and anatomical location were not reported (valid lot number: S022917; expiration date: 19-JAN-2021). The administered dose of the vaccine experienced a temperature excursion -14.1 degrees Celsius for 26 minutes, as recorded by a data logger. There was no adverse effect reported.  This is one of several reports received from the same reporter.
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no additional adverse event; patient was administered a dose of improperly stored VARIVAX; This spontaneous report was received from a registered nurse concerning to a 12-year old patient of unknown gender. No information was provided regarding the patients' medical history, concurrent conditions or concomitant medications.  On 09-APR-2020, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) lot number S002393 with expiration date on 23-JAN-2021 (dosage schedule, route and anatomical location were not reported) for prophylaxis.  Administered dose of vaccine experienced temperature excursion of -9 to 8 degrees Celsius (C) (-6.8 C) for 6 hours. There was no previous temperature excursion. Digital data logger was involved. No adverse effects were reported.
Age: 22.0
Sex: M
Vaccine: MMR
Symptoms: Blister, Cough, Erythema, Livedo reticularis, Measles
Clinical narrative: positive measles infection; Information has been received from the authors of a published article, regarding a 22 year old male patient who was more than four years post-allogenic bone marrow transplant as management for Philadelphia-chromosome positive (Ph+) Pre B-cell Acute Lymphoblastic Leukemia (ALL) in complete remission.  In September 2019, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) (dose, dose number, anatomical location, lot number and expiration date were not provided), for prophylaxis.  On an unknown date in 2019 (reported as nine days after receiving the vaccine), the patient presented with a fever of 104 degrees Fahrenheit, itchy throat, and minimal cough. Physical examination showed mild scleral icterus, mild tightness on digits, skin mottling, and erythematous papules and vesicles on dorsal forearms, neck, face, and trunk. The Department of Public Health was contacted and confirmed positive measles infection via polymerase chain reaction (PCR)of urine and throat samples.  The authors stated that the patient, to their knowledge, was the first report of a major adverse reaction in the current era to the measles, mumps, and rubella vaccine post hematopoietic cell transplant.  At the time of reporting, the patient's outcome for measles was unknown. The authors considered the event to be related to measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown)  Upon internal review, measles was determined to be medically significant.
Age: 22.0
Sex: M
Vaccine: MMR
Symptoms: Morbillivirus test positive, Ocular icterus, Papule, Polymerase chain reaction positive, Pyrexia
Clinical narrative: positive measles infection; Information has been received from the authors of a published article, regarding a 22 year old male patient who was more than four years post-allogenic bone marrow transplant as management for Philadelphia-chromosome positive (Ph+) Pre B-cell Acute Lymphoblastic Leukemia (ALL) in complete remission.  In September 2019, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) (dose, dose number, anatomical location, lot number and expiration date were not provided), for prophylaxis.  On an unknown date in 2019 (reported as nine days after receiving the vaccine), the patient presented with a fever of 104 degrees Fahrenheit, itchy throat, and minimal cough. Physical examination showed mild scleral icterus, mild tightness on digits, skin mottling, and erythematous papules and vesicles on dorsal forearms, neck, face, and trunk. The Department of Public Health was contacted and confirmed positive measles infection via polymerase chain reaction (PCR)of urine and throat samples.  The authors stated that the patient, to their knowledge, was the first report of a major adverse reaction in the current era to the measles, mumps, and rubella vaccine post hematopoietic cell transplant.  At the time of reporting, the patient's outcome for measles was unknown. The authors considered the event to be related to measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown)  Upon internal review, measles was determined to be medically significant.
Age: 22.0
Sex: M
Vaccine: MMR
Symptoms: Skin tightness, Throat irritation, Urine analysis abnormal
Clinical narrative: positive measles infection; Information has been received from the authors of a published article, regarding a 22 year old male patient who was more than four years post-allogenic bone marrow transplant as management for Philadelphia-chromosome positive (Ph+) Pre B-cell Acute Lymphoblastic Leukemia (ALL) in complete remission.  In September 2019, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) (dose, dose number, anatomical location, lot number and expiration date were not provided), for prophylaxis.  On an unknown date in 2019 (reported as nine days after receiving the vaccine), the patient presented with a fever of 104 degrees Fahrenheit, itchy throat, and minimal cough. Physical examination showed mild scleral icterus, mild tightness on digits, skin mottling, and erythematous papules and vesicles on dorsal forearms, neck, face, and trunk. The Department of Public Health was contacted and confirmed positive measles infection via polymerase chain reaction (PCR)of urine and throat samples.  The authors stated that the patient, to their knowledge, was the first report of a major adverse reaction in the current era to the measles, mumps, and rubella vaccine post hematopoietic cell transplant.  At the time of reporting, the patient's outcome for measles was unknown. The authors considered the event to be related to measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown)  Upon internal review, measles was determined to be medically significant.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: No known adverse effects.; a patient received an expired dose of VATQA; This spontaneous report has been received from a medical assistant referring to a patient of unknown age and gender. Information about medical history, concurrent conditions, concomitant therapies and drug allergies was not provided.      On 08-APR-2020, the patient was vaccinated with an expired dose of hepatitis a vaccine, inactivated (VAQTA) (lot #: S001360, expiration date: 06-MAR-2020; route and dose details were unknown) for prophylaxis (expired product administered). No known adverse effects.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Cerebrovascular accident, Computerised tomogram, Death, Electroencephalogram, Laboratory test
Clinical narrative: Patient received the vaccine on 1/16/20 in the afternoon.  The following morning he had a massive heart attack and had to be resuscitated multiple times.  He was sent to Hospital where he received two stents.  There we were informed that he also had multiple strokes and passed away on 1/26/20.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Magnetic resonance imaging, Myocardial infarction, Resuscitation, Stent placement
Clinical narrative: Patient received the vaccine on 1/16/20 in the afternoon.  The following morning he had a massive heart attack and had to be resuscitated multiple times.  He was sent to Hospital where he received two stents.  There we were informed that he also had multiple strokes and passed away on 1/26/20.
Age: 37.0
Sex: F
Vaccine: UNK
Symptoms: Blister, Pruritus, Varicella post vaccine
Clinical narrative: Employee reported itchy blisters on her hands and torso, stating they started to appear 3 days ago.  Was seen by the Occupational Medicine physician on 4/16/2020 and diagnosed with a Varicella reaction. She was started on Valtrex and will be seen again on 4/22/2020.
Age: 72.0
Sex: F
Vaccine: TDAP
Symptoms: Fatigue, Influenza like illness
Clinical narrative: After getting shot in the morning was very tired by 9PM. went to bed.  Tues morn had flu-like symptoms and only got out of bed to go to the bathroom. Severe symptoms lasted 24 hours.  Took 7 days to get total strength back
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Respiratory failure, X-ray
Clinical narrative: At night on the day of vaccination, there was swelling, redness and pain at the site of injection, which continued for 10 days. On August 10, 2018 morning, when I woke up, I had a fever of 102.5 F which continued for 7 days. I took 2 tablets of Acetaminophen, 500 mg twice a day to control fever.  On December 1, 2018, while on a trip, I developed dry cough, fever and shortness of breath. I was given Acetaminophen to control fever, as needed, Azithromycin 500 mg for 5 days. On December 9, 2018, I was admitted to Emergency ward in the Hospital, with 73% oxygen saturation, fatigue, shortness of breath. X-ray showed severe damage to lungs and I was shifted to ICU where I was put on CPAP with 10 liters/minute oxygen. No bacterial infection or H1N1 flu were detected. However, I was given multiple antibiotics to treat for bacterial pneumonia and tamiflu to treat for pneumonia due to flu. None of these medicines improved my condition. Tests for malarial antigen, scrub typhus, leptospira, acid fast bacilli (tuberculosis), Pneumocystis carinii were negative. X-rays and CT scan taken during hospital stay showed sever damage to the lungs with fibrosis. A number of medicines were given with no benefit. I was started on 40 mg i/v methylprednisolone on December 13, 2018, increased to 1 g of methylprednisolone on December 17, 2018 for 3 days and bringing to 40 mg from December 20, 2018. Prednisolone continued until December 2019, when it was tapered down. On January 14, 2019, I was started with Azathioprine, 50 mg twice a day, which is still continuing. On February 1, 2019, I was discharged from the hospital with 24 hrs oxygen from a oxygen generator and taking prednisolone, 24 mg and Azathioprine 50 mg twice a day. On February 5, 2019, I cam back, was at the Hospital, on February 7, 2019 for 2 days due to shortness of breath. I consulted with a number of pulmonologists, including Dr who is currently treating me and pulmonologist.  I was diagnosed with Acute interstitial pneumonia leading to pulmonary fibrosis and type 1 respiratory failure at the hospital and Interstitial lung disease by the hospital, caused by a severe auto-immune reaction. I was enrolled for total lung transplant by the Hospital to which I refused due to personal reasons. I also consulted Rhematologist and Immunologist to rule out general autoimmune disease. None of the typical autoimmune factors came positive (ANA, dsDNA/ANCA all Negative). I believe that MPL and QS21 adjuvants present in Shingrix, produced high level of lipid A antibodies in my body after taking Shingrix Vaccine on August 9, 2018. MPL has been known to elicit antibodies against lipid A and presence of strong adjuvant QS 21 helped MPL to elicit very high levels of lipid A antibodies. There are a number of publications in 1990s that lipid A antibodies cross react with human muscles. These lipid A antibodies elicited a very strong inflammatory immune reactions in December 2018, about 4 months after taking the Shingrix vaccine and destroyed my lungs.  Due to the severe reactions, I did not take 2nd dose of Shingrix vaccine.
Age: 23.0
Sex: M
Vaccine: TDAP
Symptoms: Wrong product administered
Clinical narrative: Patient came into pharmacy requesting MMR vaccine. Prescription typed up as Boostrix, verified by RPh as Boostrix, and administered by Intern Pharmacist as Boostrix. Patient called pharmacy stating he was requesting MMR and not Boostrix. Reporting pharmacist explained to patient he had gotten Boostrix instead. Error report filed. Patient came back to pharmacy to get MMR.
Age: 23.0
Sex: F
Vaccine: DTAP
Symptoms: Chest discomfort, Chills, Decreased appetite, Exposure during pregnancy, Influenza
Clinical narrative: First pregnancy (7 months pregnant)  Due/had baby in November of 2017 Baby birth weight was 8 lbs   Morning after shot, I had intense worse than flu like body aches. Felt like someone was sitting on my chest. Cold chills with uncontrollable shaking. Loss of appetite. Last for 12 hours. Almost went to the er because I could barely move
Age: 23.0
Sex: F
Vaccine: DTAP
Symptoms: Influenza like illness, Mobility decreased, Tremor
Clinical narrative: First pregnancy (7 months pregnant)  Due/had baby in November of 2017 Baby birth weight was 8 lbs   Morning after shot, I had intense worse than flu like body aches. Felt like someone was sitting on my chest. Cold chills with uncontrollable shaking. Loss of appetite. Last for 12 hours. Almost went to the er because I could barely move
Age: 56.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Acupuncture, Electromyogram abnormal, Fatigue, Hyperaesthesia, Hypersomnia
Clinical narrative: Sending online
Age: 56.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Hypoaesthesia, Immediate post-injection reaction, Impaired work ability, Inflammation, Injection site pain
Clinical narrative: Sending online
Age: 56.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Injection site swelling, Magnetic resonance imaging abnormal, Nerve injury, Neuralgic amyotrophy, Neuropathy peripheral
Clinical narrative: Sending online
Age: 56.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Pain in extremity, Paraesthesia, Peripheral swelling, Product administered at inappropriate site, Pyrexia
Clinical narrative: Sending online
Age: 56.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Rash, Rotator cuff syndrome, Sleep disorder, Swelling, Ultrasound scan abnormal
Clinical narrative: Sending online
Age: 56.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Unevaluable event
Clinical narrative: Sending online
Age: 1.5
Sex: F
Vaccine: DTAPIPVHIB, PNC
Symptoms: Cellulitis, Erythema
Clinical narrative: Cellulitis began 1 day after vaccines given, erythema doubled in size in 24' Temp 100.3 @ 24'. Treated with oral antibiotics
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: pt came in complaining of arm soreness she attributes from flu shot gotten Feb 2020. pt's MD recommended ibuprofen. pt states it did not all alleviate the pain,
Age: 86.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Death, Fall, Guillain-Barre syndrome, Pain in extremity
Clinical narrative: fell next day. great pain in arm, then as time went on great weakening downhill slide, showing general symptoms of GBS which was not properly recognized or diagnosed ortreated by medical professionals,they were looking for brain tumor or spine tumor or compression, etc.  then a  large Pulmonary embollism in December she was care flighted and then prevented from seeing neurologist to diagnose in timely manner which eventually led to death from GBS in April.  Charge Nurse at hosp in Feb 2018 told us this was a reaction to her flu shot and said she was going to report
Age: 86.0
Sex: F
Vaccine: FLU3
Symptoms: Pulmonary embolism, Vaccination complication
Clinical narrative: fell next day. great pain in arm, then as time went on great weakening downhill slide, showing general symptoms of GBS which was not properly recognized or diagnosed ortreated by medical professionals,they were looking for brain tumor or spine tumor or compression, etc.  then a  large Pulmonary embollism in December she was care flighted and then prevented from seeing neurologist to diagnose in timely manner which eventually led to death from GBS in April.  Charge Nurse at hosp in Feb 2018 told us this was a reaction to her flu shot and said she was going to report
Sex: M
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects; Improperly stored VARIVAX was inadvertently administered; This spontaneous report was received from a medical assistant referring to unspecified number of patients. The patients concomitant medication included sterile diluent. The patient's concurrent conditions, pertinent medical history, drug reactions/allergies were not reported. On  unknown dates, the patients were vaccinated with doses of varicella virus vaccine live (oka/merck) (VARIVAX) lot number S015459, expiration date 20-MAY-2021 (dose, strength, frequency, route of administration were not reported) for prophylaxis or measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) lot number S012536, expiration date 20-OCT-2020 (dose, strength, frequency, route of administration were not reported) for prophylaxis, that had been improperly stored (product storage error). All lots of varicella virus vaccine live (oka/merck) (VARIVAX) and measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) were reconstituted with properly stored sterile diluent. No adverse effects were reported. There was no product quality complaint present. Both of the lots of varicella virus vaccine live (oka/merck) (VARIVAX) and measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) went through temperature excursion of -11.5 Celsius degrees in the time frame of 47 minutes. There was no previous temperature excursion. The call was placed due to data logger.    This is a non-valid case as there are no identifiable patients (unspecified number of patients).  Follow up information was received from the medical assistant on 14-APR-2020. This case was previously considered non-valid, but upon receipt of follow-up it was determined that the case is now valid.   The report concerned to a 14 month old male patient. No medical history, concurrent conditions nor concomitant medications were reported. On 17-OCT-2019 the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) (Lot No. S015459, exp. date 20-MAY-2021) for prophylaxis. No adverse events reported.   This is one of several cases from the same reporter.; Sender's Comments:  US-009507513-2004USA004814: US-009507513-2004USA004815: US-009507513-2004USA004816: US-009507513-2004USA004817: US-009507513-2004USA004818: US-009507513-2004USA004819:
Age: 0.17
Sex: U
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Decreased appetite, Diarrhoea, Ear discomfort, Pyrexia, Rotavirus test positive
Clinical narrative: loose stool/patient still with diarrhea; ear pulling; low grade fever of 99.5 F; decreased appetite; This spontaneous report has been received from a nurse practitioner and a nurse via a company representative, referring to a currently 17 month old patient of unknown gender. The patient's concomitant medication and drug reactions or allergies were unknown by reporter. The patient had no pertinent medical history.  On 07-JAN-2019 and 13-MAR-2019, the patient had received two doses of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) as per the dosing schedule, orally, (dose/lot/expiration date: #1 lot# R013289 with expiration date reported as 03-OCT-2019,  but upon internal validation established as 10-MAR-2019, #2 lot#R017926 with expiration date: 30-APR-2020, strength was unknown) for prophylaxis (reported as normal childhood vaccine schedule), along with diphtheria toxoid, hepatitis b virus vaccine rhbsag (yeast), pertussis acellular 3-component vaccine, poliovirus vaccine inactivated (vero), tetanus toxoid (PEDIARIX) (dose, frequency, strength, route, lot# and expiration were unknown), haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (dose, frequency, strength, route, lot# and expiration were unknown) and pneumococcal 13v conj vaccine (crm197) (PREVNAR 13) (dose, frequency, strength, route, lot# and expiration were unknown).   On 14-MAY-2019 (reported as at 6 months of age), the patient received the third dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) as per the dosing schedule, orally, (lot# R022223 with expiration date: 24-MAY-2020; strength was unknown), along with diphtheria toxoid, hepatitis b virus vaccine rhbsag (yeast), pertussis acellular 3-component vaccine, poliovirus vaccine inactivated (vero), tetanus toxoid (PEDIARIX) and pneumococcal 13v conj vaccine (crm197)(PREVNAR 13) were given with rotavirus vaccine, live, oral, pentavalent (ROTATEQ).  On 01-APR-2020, the patient was seen on for loose stool, low grade fever of 99.5 degrees Fahrenheit (F) and ear pulling. No ear infection present. On the same day, a stool swab was done and was positive for rotavirus on 03-APR-2020. A follow up with the patient's parents on 03-APR-2020 found the patient still with diarrhea and decreased appetite and fully recovered on 07-APR-2020. Treatment was given for adverse events with oral hydration and ibuprofen. The patient had sought medical attention. The outcome of low grade fever of 99.5 F and ear pulling was unknown. The causality assessment between the events and the suspect therapies was not reported.  Upon internal review, the event diarrhea (positive for rotavirus) was determined to be medically significant.  This is one of 3 reports received from the same reporter.; Sender's Comments:  US-009507513-2004USA004637: US-009507513-2004USA004625:
Sex: M
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No additional adverse events reported; The caller stated that the patient(full demographics not provided) is due for his 3rd GARDASIL 9 shot today, 04/10/2020 and has not received it; This spontaneous report was received from a patient's wife referring to a male patient of unknown age.  The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not provided.     On unknown dates, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) dose 1 and dose 2 (dose detail, frequency, route, lot# and expiration date were not reported) for prophylaxis. On 10-APR-2020, the patient was due for his 3rd hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) shot and had not received it (inappropriate schedule of product administration). No additional adverse events were reported.
Sex: U
Vaccine: HEP, UNK
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: No additional adverse effects were reported; A second pediatric dose of RECOMBIVAX HB, on 4/14/2020; Nurse practitioner reported patient, 39 years of age, received a pediatric dose of RECOMBIVAX HB on 3/13/202; Information has been received from a nurse practitioner regarding a 39-years-old patient of unknown gender. The patient's medical history, drug allergies, previously drug reactions, concurrent conditions and concomitant medications were not reported.  On 13-MAR-2020, the patient was vaccinated with a pediatric dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) 0.5 ml as prophylaxis (lot number: R001530 with expiration date on 07-NOV-2020) (strength, frequency, route of administration and anatomical location were not provided) (incorrect dose administered). On 14-APR-2020, the patient received was vaccinated with a second pediatric dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) 0.5 ml as prophylaxis (lot number: R001530 with expiration date on 07-NOV-2020) (strength, frequency, route of administration and anatomical location were not provided) (incorrect dose administered).   No adverse effects reported.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: an unspecified patient was 8 months and 10 days old when they received "their third dose" of ROTATEQ.; No adverse event reported; This spontaneous report as received from a registered nurse refers to a 8 months 10 days (34 weeks approx.) old patient of an unspecified gender. Patient's medical history and concurrent conditions and concomitant therapies were not provided.     On unknown dates, the patient was vaccinated with the first and the second doses of rotavirus vaccine, live, oral, pentavalent(ROTATEQ) orally (dose, lot # and expiration date were not provided) for prophylaxis. It was stated that third dose was given when the patient was 8 months 10 days years old (Inappropriate age at vaccine administration). No adverse event was reported.