chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 35.0
Sex: F
Vaccine: TYP
Symptoms: Exposure via skin contact, Syringe issue, Underdose
Clinical narrative: part of the dose went down the patients arm and they did not get the complete dosage; the syringe leaked or was an issue with Huber Lok/ syringe multifunctioned; part of the dose went down the patients arm and they did not get the complete dosage; Initial information received on 23-Apr-2019 regarding an unsolicited valid non-serious case received from a nurse by phone.  This case involves a 35 years old female patient who was vaccinated with 0.5 ml dose of TYPHOID VI POLYSACCHARIDE VACCINE [TYPHIM VI] (Batch number: NG10 and expiry date: 30-Jun-2019) via intramuscular route in the right deltoid.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS A VACCINE (HEPATITIS A VACCINE) and DIPHTHERIA VACCINE TOXOID, TETANUS VACCINE TOXOID (DIPHTHERIA AND TETANUS TOXOIDS) on an unknown date.  It was a case of actual medication error due to vaccine underdose. and Exposure via skin contact  It was also a case of syringe issue.  It was reported that usually pulls off the cap to put needle on but she is not sure why it is designed this way. It is sealed baggage and she was not sure why the rubber tip is there and said this was not normal course for nurses. She said it took her a while to figure this syringe out but now she know. But the person who did this injection may not have known. She said she is not sure what is the purpose of that rubber cap, if any. Caller said this poor woman has a lot of things going wrong for her.  It was unknown if any adverse event occurred or not following the vaccination.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.   Documents held by the sender: none.
Sex: F
Vaccine: DTAPIPV, FLU4
Symptoms: Urticaria
Clinical narrative: urticaria reaction; Initial information received on 23-Apr-2019 regarding an unsolicited valid non-serious case received from a physician.  This case involves female patient of unknown age who experienced urticaria reaction, while she received vaccines DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [Quadracel] and INFLUENZA QUADRIVAL A-B VACCINE [Fluzone Quadrivalent].  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.   On an unknown date, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot U1847AB, expiry date: 30-Jun-2018 via unknown route. On an unknown date, the patient received a dose of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE lot C5248AA, expiry date: 21-Aug-2018  via unknown route in unknown administration site.  On 20-Mar-2018, unknown latency after receiving of  INFLUENZA QUADRIVAL A-B VACCINE and DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE, the patient developed a non-serious urticaria reaction (urticaria).  Lab data was not reported.  Final diagnosis was Mild urticaria reaction.   It was not reported if the patient received a corrective treatment.  The outcome of event was not reported.  List of documents held by sender: none.
Sex: F
Vaccine: FLU3
Symptoms: Expired product administered, No adverse event
Clinical narrative: administered expired fluzone hd/ no side effects reported; Initial information received on 23-Apr-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 71 years old female patient who administered expired INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [Fluzone High Dose].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient had no concomitant medication.   On 23-Apr-2019, the patient received a 0.5 ml  single-dose, prefilled syringe, without needle of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot number not reported expiry date: 09-Apr-2019 via unknown route in the left deltoid.  It was an actual medication error due to expired vaccine used. No side effects reported  This suspected adverse reaction report was submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none
Age: 1.25
Sex: U
Vaccine: DTAP
Symptoms: Expired product administered
Clinical narrative: patient was given an expired daptacel vaccine; Initial information received on 23-Apr-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 15 months old patient of unknown gender who was received an expired DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [Daptacel].  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.  On 22-Apr-2019, the patient received a 0.5 ml dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE lot number not reported (expired 16 days ago) via unknown route in unknown administration site.  It was an actual medication error due to expired vaccine used. It was reported that nurse did not have the lot number and expiration date of the Daptacel, but had been told that the Daptacel vaccine had expired 16 days ago, and that probably meant 16 days prior to the date of administration yesterday.   t was not reported whether the patient had any adverse event or not.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Age: 37.0
Sex: F
Vaccine: TDAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: inadvertently administering expired dose of Adacel to a patient/ No AE; Initial information received on 23-Apr-2019 regarding an unsolicited valid non-serious case received from a nurse by phone.  This case involves a 37 years old female patient who was vaccinated with an expired 0.5 ml once dose of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (Batch number: U5603AA and expiry date: 11-Apr-2019) via intramuscular route in the left deltoid on 23-Apr-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications were not reported.    It was a case of actual medication error due to expired vaccine used.  No adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.   Documents held by the sender: none.
Sex: F
Vaccine: RAB
Symptoms: Therapeutic response unexpected
Clinical narrative: after she received the rabies vaccine she never got trigeminal neuralgia again; Initial information received on 23-Apr-2019 regarding an unsolicited valid non-serious case received from a consumer.  This case involves a female patient who received the RABIES (HDC) VACCINE [IMOVAX RABIES vaccine and then she never got trigeminal neuralgia again.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect RABIES (HDC) VACCINE (formulation: Powder and solvent for suspension for injection) lot number and expiry date was not reported via unknown route in unknown administration site.  On an unknown date, the patient reported that after she received the rabies vaccine she never got trigeminal neuralgia again (therapeutic response unexpected) (Unknown latency) following the administration of RABIES (HDC) VACCINE.  (Other relevant tests included No lab data.)  List of document held by sender: none.
Sex: M
Vaccine: HIBV
Symptoms: No adverse event, Product preparation issue
Clinical narrative: lyophilized vaccine vial of Acthib reconstituted with Sterile water instead of single/no AE; Initial information received on 24-Apr-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 1 months old male patient who received lyophilized vaccine vial ofHIB (PRP/T) VACCINE [ACT-HIB] reconstituted with sterile water instead of single.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included MEASLES VACCINE LIVE (ENDERS-EDMONSTON), MUMPS VACCINE LIVE (JERYL LYNN), RUBELLA VACCINE LIVE (WISTAR RA 27/3) (MMRVAXPRO); and PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13).  On 22-Apr-2019, the patient received a dose of suspect HIB (PRP/T) VACCINE lot UI904AA via unknown route in the left thigh.  It was of actual medication error due to  Inappropriate reconstitution technique .  No adverse event was experienced..  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Sex: F
Vaccine: RAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: second Imovax dose approximately 23 hours early, on day 6 rather than day 7; Initial information received on 23-Apr-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 59 years old female patient who received vaccine RABIES (HDC) VACCINE [IMOVAX RABIES].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a first dose of suspect RABIES (HDC) VACCINE lot NIK302M, expiry date- 28-Oct-2019 via intramuscular route in unknown administration site and on an unknown date on day 6, she received second dose of RABIES (HDC) VACCINE (batch number, expiry date, route and site of administration were not reported).  It was a case of actual medication error due to Inappropriate schedule of vaccine administered.  It was unknown if any adverse event was occurred.   The patient was supposed to present to another Pharmacy for her second dose on Day 7, but instead presented on day 6 and received dose 2 of Imovax. The patient received her second Imovax dose approximately 23 hours early, on day 6 rather than day 7.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Documents held by sender: none.
Sex: F
Vaccine: DTAPIPV, HIBV, PPV
Symptoms: Product administered to patient of inappropriate age, Rash
Clinical narrative: rash up in leg; Quadracel was administered to a 14 months old patient; Initial information received on 23-Apr-2019 regarding an unsolicited valid non-serious case received from an other health care professional.  This case involves a 14 months old female patient who experienced rash up in leg while she received vaccine 0.5 ml fourth dose of DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] lot C5222AA, expiration date- 20-Jun-2019 via intramuscular route in the thigh nos on an unknown date.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HIB VACCINE (HIB) and PNEUMOCOCCAL VACCINE CONJ (PNEUMOCOCCAL CONJUGATE VACCINE).  On an unknown date, the patient experienced a non-serious rash up in leg (rash) (Unknown latency) following the administration of DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE.  It was an actual medication error due to inappropriate age at vaccine administration. Quadracel was administered to a 14 months old patient.   (Other relevant tests included no lab data.)  Final diagnosis was rash up in leg.   It was not reported if the patient received a corrective treatment.  The event outcome was not reported for rash up in leg.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation issue
Clinical narrative: 2 months old, received the DTaP-IPV portion only of the scheduled Pentacel vaccine as nurse forgot to reconstitute it prior administration, no adverse effects; Initial information received on 22-Apr-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a two months old patient who received only the DTaP-IPV portion of the scheduled DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] as nurse forgot to reconstitute the ActHIB portion prior to the administration (lot U6327AA and Exp. Date 19-Sep-2020) via unknown route in the right thigh, on 22-Apr-2019. This was the first Pentacel immunization in the series.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS B VACCINE (HEPATITIS B VACCINE) for Immunisation; PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) for Immunisation; and ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ) for Immunisation.  It was an actual medication error case due to inappropriate reconstitution technique.  No adverse effects reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Age: 0.17
Sex: F
Vaccine: HIBV, MNQ
Symptoms: No adverse event, Wrong product administered
Clinical narrative: 2 month female was accidentally injected with Menactra instead of ActHIB/ no AE; Initial information received on 24-Apr-2019 regarding an unsolicited valid non-serious case received from a Nurse via phone.  This case involves a two-months-old female patient who was vaccinated with 0.5 ml dose of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] instead of HIB (PRP/T) VACCINE [ACT-HIB] (lot number: U6153AA and expiry date: 20-Mar-2021) via intramuscular route in the left thigh on 03-Apr-2019.  Information on the batch number was requested for ACT-HIB.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant vaccinations included ROTAVIRUS VACCINE LIVE ORAL 1V (ROTARIX), PNEUMOCOCCAL VACCINE (PNEUMOCOCCAL VACCINE) and DIPHTHERIA VACCINE TOXOID, HEPATITIS B VACCINE RHBSAG (YEAST), PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, POLIO VACCINE INACT 3V (VERO), TETANUS VACCINE TOXOID (PEDIARIX) on an unknown date.  It was a case of actual medication error due to wrong vaccine administered. Patient was accidentally injected with Menactra instead of ActHIB.  No adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.   Documents held by the sender: none.
Age: 63.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: Approximately 1.5-2 months after second patient noticed shingles on center portion of back. Has gotten shingles in the past, but now is recurring every 3-4 weeks in a larger patch. Goes away after approximately a week. Patient takes Shingle Soothe when notices rash.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site reaction, Injection site warmth, Urticaria
Clinical narrative: NP. called and stated patient had welt on left arm approx. 5 in across and 7 in up and down left arm where shot was received, that was hot to the touch and fire red. The NP. stated that her harm was still looking like this on 4/25/19 when she called to make the health department aware.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Influenza like illness, Injection site pain, Pruritus, Rash vesicular
Clinical narrative: Pain near and at site of injection (left arm) for several days; flu-like symptoms for a few days; many chicken pox like sores all over body for three or four days following vaccination; hives along with itchy and burning sores for over two weeks since;  some hives and sores still developing despite steroid shot at Urgent Care on Friday, April 26.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin ulcer, Urticaria
Clinical narrative: Pain near and at site of injection (left arm) for several days; flu-like symptoms for a few days; many chicken pox like sores all over body for three or four days following vaccination; hives along with itchy and burning sores for over two weeks since;  some hives and sores still developing despite steroid shot at Urgent Care on Friday, April 26.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Blister, Injection site erythema, Injection site swelling
Clinical narrative: SWELLING AND REDNESS AT INJECTION SITE. MOM STATES HAD BLISTER.  WHEN CHECKED ON 4/20/19, SWELLING DECREASED AND NO BLISTER NOTED
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: improperly stored vaccine; No adverse effect; Information has been received from a medical assistant referring to a patient of unknown age and gender. Information about medical history, concurrent condition and concomitant medication was unknown.   On an unknown date the patient was vaccinated with one dose of improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) (lot # R030804 with expiration date of 22-APR-2020, rHA, 0.5 milliliter, subcutaneous) for prophylaxis. The sterile diluent used to reconstitute the measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) vaccine was stored in the correct temperature. No adverse effect was reported. The temperature excursion was 5.4 degree Fahrenheit with a time frame of 3 minutes. There was no previous temperature excursion. Data logger was involved. No product quality complaint was involved.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects were reported; Multiple unspecified patients were vaccinated with improperly stored PROQUAD and VARIVAX; This non-valid spontaneous report was received from the office manager and refers to multiple unspecified patients of unknown age and gender. There was no information about the patients' medical history, concurrent conditions or concomitant medications.   On an multiple unspecified dates since September 2018, the patients were mostly vaccinated with doses of improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) (lot number N027000 with expiration date of 28-SEP-2019 or lot number N022979 with expiration date of 23-AUG-2019) or doses of improperly stored rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (rHA) (lot number R017628 with expiration date of 18-DEC-2019 or lot number N025929 with expiration date of 18-MAR-2019) (dose and route of administration) for prophylaxis. The vaccines were stored in the range of 6 Fahrenheit degrees to 14 Fahrenheit degrees (13.9 Fahrenheit degrees) for an unknown time frame. There were previous temperature excursions, however the details were unknown. It was reported that no doses of the and varicella (oka-merck) virus vaccine live(PROQUAD) (Lot number N025929 with expiration date 18-MAR-2019) were given after it expired; however doses were given after the first and subsequent temperature excursions, dating back to an unknown date in September 2018.  Digital data logger was involved.  Follow up information has been received from the office manager on 22-APR-2019. No dose of improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) was administered to the patient. Sterile diluent was properly stored. No adverse effects were reported. On 03-APR-2019, the patient was vaccinated with dose of improperly stored rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (rHA) (lot number R017628 with expiration date of 18-DEC-2019). The vaccine was stored in the range of 6 Fahrenheit degrees to 14 Fahrenheit degrees (13.9 Fahrenheit degrees) for 69 hours and 11 minutes (multiple excursions). No prior excursion was confirmed. Digital data logger was involved.  This case was previously considered non-valid but upon receipt of follow-up with patient identifiers, it was determined that the case is valid now.  This one of ten reports received from the same reporter.; Sender's Comments:  US-009507513-1904USA012652: US-009507513-1904USA012653: US-009507513-1904USA012654: US-009507513-1904USA012655: US-009507513-1904USA012656: US-009507513-1904USA012657: US-009507513-1904USA012658: US-009507513-1904USA012659: US-009507513-1904USA012660:
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects were reported; Multiple unspecified patients were vaccinated with improperly stored PROQUAD and VARIVAX; This non-valid spontaneous report was received from the office manager and refers to multiple unspecified patients of unknown age and gender. There was no information about the patients' medical history, concurrent conditions or concomitant medications.    On an multiple unspecified dates since September 2018, the patients were mostly vaccinated with doses of improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) (lot number N027000 with expiration date of 28-SEP-2019 or lot number N022979 with expiration date of  23-AUG-2019) or doses of improperly stored rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (rHA) (lot number R017628 with expiration date of 18-DEC-2019 or lot number N025929 with expiration date of 18-MAR-2019) (dose and route of administration) for prophylaxis. The vaccines were stored in the range of 6 Fahrenheit degrees to 14 Fahrenheit degrees (13.9 Fahrenheit degrees) for an unknown time frame. There were previous temperature excursions, however the details were unknown. It was reported that no doses of the and varicella (oka-merck) virus vaccine live(PROQUAD) (Lot number N025929 with expiration date 18-MAR-2019) were given after it expired; however doses were given after the first and subsequent temperature excursions, dating back to an unknown date in September 2018.   Digital data logger was involved.  Follow up information has been received from the office manager on 22-APR-2019. No dose of improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) was administered to the patient. Sterile diluent was properly stored. No adverse effects were reported. On 05-SEP-2018, the patient was vaccinated with dose of improperly stored rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (rHA) (lot number N025929 with expiration date of 18-MAR-2019). The vaccine was stored in the range of 6 Fahrenheit degrees to 14 Fahrenheit degrees (13.9 Fahrenheit degrees) for 69 hours and 11 minutes (multiple excursions). No prior excursion was confirmed. Digital data logger was involved.  This case was previously considered non-valid but upon receipt of follow-up with patient identifiers, it was determined that the case is valid now.  This one of ten reports received from the same reporter.; Sender's Comments:  US-009507513-1904USA009929: US-009507513-1904USA012658: US-009507513-1904USA012653: US-009507513-1904USA012656: US-009507513-1904USA012659: US-009507513-1904USA012657: US-009507513-1904USA012654: US-009507513-1904USA012655: US-009507513-1904USA012660:
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects were reported; Multiple unspecified patients were vaccinated with improperly stored PROQUAD and VARIVAX; This non-valid spontaneous report was received from the office manager and refers to multiple unspecified patients of unknown age and gender. There was no information about the patients' medical history, concurrent conditions or concomitant medications.    On an multiple unspecified dates since September 2018, the patients were mostly vaccinated with doses of improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) (lot number N027000 with expiration date of 28-SEP-2019 or lot number N022979 with expiration date of  23-AUG-2019) or doses of improperly stored rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (rHA) (lot number R017628 with expiration date of 18-DEC-2019 or lot number N025929 with expiration date of 18-MAR-2019) (dose and route of administration) for prophylaxis. The vaccines were stored in the range of 6 Fahrenheit degrees to 14 Fahrenheit degrees (13.9 Fahrenheit degrees) for an unknown time frame. There were previous temperature excursions, however the details were unknown. It was reported that no doses of the and varicella (oka-merck) virus vaccine live(PROQUAD) (Lot number N025929 with expiration date 18-MAR-2019) were given after it expired; however doses were given after the first and subsequent temperature excursions, dating back to an unknown date in September 2018.   Digital data logger was involved.  Follow up information has been received from the office manager on 22-APR-2019. No dose of improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) was administered to the patient. Sterile diluent was properly stored. No adverse effects were reported. On 17-SEP-2018, the patient was vaccinated with dose of improperly stored rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (rHA) (lot number N025929 with expiration date of 18-MAR-2019). The vaccine was stored in the range of 6 Fahrenheit degrees to 14 Fahrenheit degrees (13.9 Fahrenheit degrees) for 69 hours and 11 minutes (multiple excursions). No prior excursion was confirmed. Digital data logger was involved.  This case was previously considered non-valid but upon receipt of follow-up with patient identifiers, it was determined that the case is valid now.  This one of ten reports received from the same reporter.; Sender's Comments:  US-009507513-1904USA012655: US-009507513-1904USA012656: US-009507513-1904USA012657: US-009507513-1904USA012658: US-009507513-1904USA012659: US-009507513-1904USA012660: US-009507513-1904USA009929: US-009507513-1904USA012654: US-009507513-1904USA012652:
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects were reported; Multiple unspecified patients were vaccinated with improperly stored PROQUAD and VARIVAX; This non-valid spontaneous report was received from the office manager and refers to multiple unspecified patients of unknown age and gender. There was no information about the patients' medical history, concurrent conditions or concomitant medications.    On an multiple unspecified dates since September 2018, the patients were mostly vaccinated with doses of improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) (lot number N027000 with expiration date of 28-SEP-2019 or lot number N022979 with expiration date of  23-AUG-2019) or doses of improperly stored rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (rHA) (lot number R017628 with expiration date of 18-DEC-2019 or lot number N025929 with expiration date of 18-MAR-2019) (dose and route of administration) for prophylaxis. The vaccines were stored in the range of 6 Fahrenheit degrees to 14 Fahrenheit degrees (13.9 Fahrenheit degrees) for an unknown time frame. There were previous temperature excursions, however the details were unknown. It was reported that no doses of the and varicella (oka-merck) virus vaccine live(PROQUAD) (Lot number N025929 with expiration date 18-MAR-2019) were given after it expired; however doses were given after the first and subsequent temperature excursions, dating back to an unknown date in September 2018.   Digital data logger was involved.  Follow up information has been received from the office manager on 22-APR-2019. No dose of improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) was administered to the patient. Sterile diluent was properly stored. No adverse effects were reported. On 25-SEP-2018, the patient was vaccinated with dose of improperly stored rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (rHA) (lot number N025929 with expiration date of 18-MAR-2019). The vaccine was stored in the range of 6 Fahrenheit degrees to 14 Fahrenheit degrees (13.9 Fahrenheit degrees) for 69 hours and 11 minutes (multiple excursions). No prior excursion was confirmed. Digital data logger was involved.  This case was previously considered non-valid but upon receipt of follow-up with patient identifiers, it was determined that the case is valid now.  This one of ten reports received from the same reporter.; Sender's Comments:  US-009507513-1904USA012655: US-009507513-1904USA012656: US-009507513-1904USA012657: US-009507513-1904USA012658: US-009507513-1904USA012659: US-009507513-1904USA012660: US-009507513-1904USA012653: US-009507513-1904USA009929: US-009507513-1904USA012652:
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects were reported; Multiple unspecified patients were vaccinated with improperly stored PROQUAD and VARIVAX; This non-valid spontaneous report was received from the office manager and refers to multiple unspecified patients of unknown age and gender. There was no information about the patients' medical history, concurrent conditions or concomitant medications.    On an multiple unspecified dates since September 2018, the patients were mostly vaccinated with doses of improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) (lot number N027000 with expiration date of 28-SEP-2019 or lot number N022979 with expiration date of  23-AUG-2019) or doses of improperly stored rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (rHA) (lot number R017628 with expiration date of 18-DEC-2019 or lot number N025929 with expiration date of 18-MAR-2019) (dose and route of administration) for prophylaxis. The vaccines were stored in the range of 6 Fahrenheit degrees to 14 Fahrenheit degrees (13.9 Fahrenheit degrees) for an unknown time frame. There were previous temperature excursions, however the details were unknown. It was reported that no doses of the and varicella (oka-merck) virus vaccine live(PROQUAD) (Lot number N025929 with expiration date 18-MAR-2019) were given after it expired; however doses were given after the first and subsequent temperature excursions, dating back to an unknown date in September 2018.   Digital data logger was involved.  Follow up information has been received from the office manager on 22-APR-2019. No dose of improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) was administered to the patient. Sterile diluent was properly stored. No adverse effects were reported. On 26-SEP-2018, the patient was vaccinated with dose of improperly stored rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (rHA) (lot number N025929 with expiration date of 18-MAR-2019). The vaccine was stored in the range of 6 Fahrenheit degrees to 14 Fahrenheit degrees (13.9 Fahrenheit degrees) for 69 hours and 11 minutes (multiple excursions). No prior excursion was confirmed. Digital data logger was involved.  This case was previously considered non-valid but upon receipt of follow-up with patient identifiers, it was determined that the case is valid now.  This one of ten reports received from the same reporter.; Sender's Comments:  US-009507513-1904USA009929: US-009507513-1904USA012656: US-009507513-1904USA012657: US-009507513-1904USA012658: US-009507513-1904USA012659: US-009507513-1904USA012660: US-009507513-1904USA012653: US-009507513-1904USA012652: US-009507513-1904USA012654:
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects were reported; Multiple unspecified patients were vaccinated with improperly stored PROQUAD and VARIVAX; This non-valid spontaneous report was received from the office manager and refers to multiple unspecified patients of unknown age and gender. There was no information about the patients' medical history, concurrent conditions or concomitant medications.    On an multiple unspecified dates since September 2018, the patients were mostly vaccinated with doses of improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) (lot number N027000 with expiration date of 28-SEP-2019 or lot number N022979 with expiration date of  23-AUG-2019) or doses of improperly stored rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (rHA) (lot number R017628 with expiration date of 18-DEC-2019 or lot number N025929 with expiration date of 18-MAR-2019) (dose and route of administration) for prophylaxis. The vaccines were stored in the range of 6 Fahrenheit degrees to 14 Fahrenheit degrees (13.9 Fahrenheit degrees) for an unknown time frame. There were previous temperature excursions, however the details were unknown. It was reported that no doses of the and varicella (oka-merck) virus vaccine live(PROQUAD) (Lot number N025929 with expiration date 18-MAR-2019) were given after it expired; however doses were given after the first and subsequent temperature excursions, dating back to an unknown date in September 2018.   Digital data logger was involved.  Follow up information has been received from the office manager on 22-APR-2019. No dose of improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) was administered to the patient. Sterile diluent was properly stored. No adverse effects were reported. On 25-OCT-2018, the patient was vaccinated with dose of improperly stored rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (rHA) (lot number N025929 with expiration date of 18-MAR-2019). The vaccine was stored in the range of 6 Fahrenheit degrees to 14 Fahrenheit degrees (13.9 Fahrenheit degrees) for 69 hours and 11 minutes (multiple excursions). No prior excursion was confirmed. Digital data logger was involved.  This case was previously considered non-valid but upon receipt of follow-up with patient identifiers, it was determined that the case is valid now.  This one of ten reports received from the same reporter.; Sender's Comments:  US-009507513-1904USA012655: US-009507513-1904USA012656: US-009507513-1904USA012657: US-009507513-1904USA009929: US-009507513-1904USA012659: US-009507513-1904USA012660: US-009507513-1904USA012653: US-009507513-1904USA012654: US-009507513-1904USA012652:
Age: 17.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Diarrhoea, Pain, Pain in extremity, Weight bearing difficulty
Clinical narrative: Child developed pain in her left leg at 10pm 4/29/19. She was unable t bear weight and ay 3am developed achiness all over and diarrhea.
Age: 4.0
Sex: F
Vaccine: DTAP, MMR
Symptoms: Epistaxis, Malaise, Pyrexia
Clinical narrative: fever, genera feeling of unwellness. That night had extreme nosebleed causing puddles of blood in her bed and then bathtub.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site inflammation
Clinical narrative: Patient received her first dose of Shingrix on 3/29/19, She was given her second dose of Shingrix too early on 4/27/19.  It shouldn't have been given earlier than 5/29.  Patient is experiencing more redness and inflammation at injection site than with first dose.  Most likely due to spacing between first and second shot.  Will continue to monitor patient.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood pressure increased, Extrasystoles, Influenza like illness, Pain in extremity
Clinical narrative: Beginning Friday 4/19/19 sore, arm flu like symptoms, blood pressure elevated to 178mmhg (systolic) 84mmhg (diastolic), heart rate was 96, patient felt like there was three dropped heart beats for every 5 normal heart beats, varying for 3 dropped heart beats for every 10 normal heart beats. This continued in an irregular fashion for all of 4/20. Then on 4/21 30 normal heart beats followed by a few dropped.  Blood pressure was 150 (systolic ) and heart rate was in the high 80s on sunday 4/21/19.  Patient felt all better by monday 4/22 and blood pressure had returned to baseline blood pressure (140/68) heart rate was in the low 70s upon rising prior to meds which is normal for patient.  Patient is a nurse and self monitored blood pressure and heart rate with devices at home.  She did take an extra lisinopril and asprin on saturday 4/20/19.
Age: 73.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Limb discomfort, Local reaction, Peripheral swelling
Clinical narrative: Fairly severe localized reaction w/swelling, redness, discomfort. Localized to Right upper arm from shoulder to elbow.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Cough, Pyrexia, Respiratory viral panel
Clinical narrative: Fever 101.9, cough
Age: 10.0
Sex: F
Vaccine: HPV9, HPV9, HPV9
Symptoms: Injection site pain, Pain
Clinical narrative: Prolonged Regional Pain Syndrome.  Pain to R deltoid since injection.
Age: 10.0
Sex: F
Vaccine: HPV9, HPV9, HPV9
Symptoms: Complex regional pain syndrome, Injection site pain
Clinical narrative: Prolonged Regional Pain Syndrome.  Pain to R deltoid since injection.
Age: 10.0
Sex: F
Vaccine: HPV9, HPV9, HPV9
Symptoms: Injection site pain
Clinical narrative: Prolonged Regional Pain Syndrome.  Pain to R deltoid since injection.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Myalgia, Nausea
Clinical narrative: Mild symptoms night of receiving vaccine injection. Followed by 3 days in bed due to EXTREME muscle pain and shivering. Also suffered frequent nausea and headaches. No registered fever.
Age: 59.0
Sex: M
Vaccine: PNC13
Symptoms: Joint range of motion decreased, Pain, Tenderness
Clinical narrative: Sharp stabbing pain 1/28/19; Seen in clinic 1/31/19 and referred to PT therapy.  Prescribed Mobic 15mog po daily.  Limited range of motion initially due to pain.  Tender at acromion.
Age: 1.5
Sex: F
Vaccine: MMR
Symptoms: Eye movement disorder, Gait disturbance, Lethargy, Rash, Speech disorder
Clinical narrative: On 4/13/19: child had rash on torso lasted 2-3 days; then revolved. On 4/20/19: In am, child with eye rolling, unable to speak, lethargic, gait issues, child went to sleep after 1 hr symptoms resolved
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: patient reported red area at injection site - warm to the touch - 1 to 1 1/2 inch around injection site
Age: 54.0
Sex: F
Vaccine: MMR
Symptoms: Blood pressure increased, Dizziness, Headache, Heart rate decreased, Hyperhidrosis
Clinical narrative: SYMPTOMS: Diaphoretic, Headache, Nausea, Dizziness, Elevated Blood pressure, low heart rate. Sent to ER, they initiated an IV and gave benadryl, pt was there for a number of hours.
Age: 54.0
Sex: F
Vaccine: MMR
Symptoms: Nausea
Clinical narrative: SYMPTOMS: Diaphoretic, Headache, Nausea, Dizziness, Elevated Blood pressure, low heart rate. Sent to ER, they initiated an IV and gave benadryl, pt was there for a number of hours.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Influenza like illness, Injection site bruising, Injection site erythema, Injection site swelling
Clinical narrative: bruising around injection site, red swelling from injection site to the elbow crease.  Patient also had flu-like symptoms and fever.  started shortly after vaccination
Age: 1.08
Sex: F
Vaccine: DTAP, HEP, MMR, VARCEL
Symptoms: Rash erythematous
Clinical narrative: Rash consisting of small, faint red bumps have formed on her chest, abdomin, and back. There does not appear to be any itching or pain associated with the bumps.
Age: 15.0
Sex: M
Vaccine: UNK, UNK
Symptoms: Chills, Pain
Clinical narrative: Arrived at clinic c/o chills and body aches. Temp taken=103.6. Unable to contact guardian by phone, msg. left. Uncle was called--said he would try to contact guardian to inform of student's condition.   ~15 mins. later, temp retaken= 105.3. Ice packs applied to back and cold towel to forehead.  10:55, still no contact from guardian, 911 was called. EMTS arrived at 11:05. Took temp=104.  Child was transported to ER, treated with antipyretic, Discharged from ER.
Sex: F
Vaccine: HEP
Symptoms: Vaccination failure
Clinical narrative: Initial vaccination failure in inflammatory bowel disease patients; 149 patients with inadequate baseline titers; Overall, 58.4% (n = 87/149) of patients received 1 or 2 sequential HBV revaccination doses within a 6- month time period, and 41.6% (n = 62/149) of patients received 3 sequential revaccination doses during a 12-month time period; Information was received from the authors in a published literature article titled as stated below. The aim of this article was to analyze the association between additional vaccination doses and HBsAb seroconversion in infIammatory bowel disease (IBD) patients. This case concerns 149 unspecified patients of unknown genders and age. This retrospective cohort study of patients seen in a large tertiary care facility from 2000-2014. Inclusion criteria: age >=18, diagnosis of Crohn's disease (CD) / ulcerative colitis (UC), prior vaccination history/presence of >= 1 +HBsAb level <10 IU/l, follow up HBsAb level after re vaccination. Patients were separated into study arms based on the number of additional vaccine doses received: 1 and 2 (within 6 months) or 3 (within 12months). Follow-up serum HBsAb, demographic info and IBD medications received in the 6 months prior to titer measurements were reported. Seroprotection was defined as HBsAb >= 10 IU/l.   On unknown dates, the patients were vaccinated with hepatitis b vaccine (manufacturer unknown), lot number, expiration date, dose and route were not reported, for prophylaxis. On unknown date, the patients showed inadequate baseline titers (vacination failure): 63 then received 1 dose, 25 received 2 doses, 61 received 3 doses. Following 1, 2 and 3 doses, average follow-up titers were 122.8, 55.1 and 263.8 IU/l, respectively. Following 1, 2 and 3 doses, 41.3, 40 and 62.3%, respectively, developed HBsAb 10 . Patients exposed to immunosuppressive therapy within 6 months of titer measurement were significantly less likely to seroconvert after any number of additional vaccinations.  A copy of the published article is attached as further documentation of the patient's experience.  Follow up information was received on 25-APR-2019 to this previously non-valid case, from the authors in a published literature article titled as stated below, regarding 81 female patients from 149 patients in study cohort.  It was also reported that unspecified number of women (of a total of 87 out of 149 patients) received 1 or 2 sequential HBV revaccination doses within a 6-month time period (previously reported as 88), and unspecified number of women (of a total of 62 out of 149 patients) received 3 sequential revaccination doses during a 12-month time period (previously reported as 61).  A copy of the published article is attached as further documentation of the patient's experience.  This is one of several reports received from the same reporter.
Sex: U
Vaccine: MMR, MMRV, UNK
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No advers effect reported; either administered a third dose of M-M-R II or a dose of Proquad at over 12 years of age; either administered a third dose of M-M-R II or a dose of Proquad at over 12 years of age; This spontaneous report was received from healthcare professional and refers to a patient of unknown age (reported by the medical assistant as of being currently "college age"). The patient's concurrent conditions, medical history or concomitant drugs were not reported.  On 30-APR-2013, the patient received a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) subcutaneously (strength, dose, lot # and expiration date not reported) and a dose of varicella virus vaccine live (Oka/Merck)(VARIVAX). Later, on 30-MAY-2013, the patient received a second dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) subcutaneously (strength, dose, lot # and expiration date not reported) and a second dose of varicella virus vaccine live (Oka/Merck)(VARIVAX). The medical assistant stated that for college entry, on 30-MAY-2018, the patient received either a third dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) subcutaneously (strength, dose, lot # and expiration date not reported) or a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) subctuaneously (strength, dose, lot # and expiration date not reported). Merck Sterile diluent was used as diluent for the administered vaccines. All vaccines were administered for prophylaxis. No adverse effects were reported.