chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation issue
Clinical narrative: Patient received a Diluent of the DTap/IPV and not the Hib of the Pentacel.; Initial information received on 16-Dec-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 6 months old female patient who was vaccinated with 0.5 ml diluent of the dtap/ipv and not the hib of the vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] via intramuscular route in the left thigh on 13-Dec-2019. The lot number U6218AA, UJ015AAA and UJ015AAA and expiry date: 26-Oct-2020.  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13); INFLUENZA VACCINE INACT SPLIT VIRION 4V (FLUZONE QUADRIVALENT); and ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ).  It was actual medication error due to inappropriate reconstitution technique.  At the time of report 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.
Sex: U
Vaccine: FLU3, PPV
Symptoms: Extra dose administered, No adverse event, Wrong product administered
Clinical narrative: Patient received two doses of Fluzone HD in one year, No AE; Fluzone High dose instead of giving pneumonia vaccine, No AE; Initial information received on 17-Dec-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves patient who was vaccinated with a dose of vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE]  this year and also received another dose of same in 2019 instead of PNEUMOCOCCAL VACCINE.  It was a actual medication error due to extra dose administered and wrong vaccine administered.  At the time of report 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 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.  Information on the batch number was requested.
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation error
Clinical narrative: patient was only given the Hib portion of the Pentacel vaccination that was reconstituted with sterile water; Initial information received on 17-Dec-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves female patient of unknown age who received only HIB portion of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] vaccine that was reconstituted with sterile water (Product preparation error) [lot number and other dosing details were not reported] via unknown route in unknown administration site on an unknown date.  Medical history, medical treatment, vaccination and family history were not provided.  Concomitant vaccination included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) [PREVNAR] and RODA vaccine.  It was a case of actual medication error due to product preparation error.  At the time of report 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 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.  Information on the batch number was requested.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Aphonia, Cough, Ear pain, Expired product administered, Eye pain
Clinical narrative: lost her voice; achy ears; achy eyes; patient received expired product; coughing a lot; 99 F fever; lethargy; felt sick; Initial information received on 18-Dec-2019 regarding an unsolicited valid non-serious case received from a consumer.  This case involves Elderly female (age at the of vaccination was 66 years) patient who experienced lost her voice (aphonia), coughing a lot (cough), 99 f fever (pyrexia), lethargy (lethargy), achy ears (ear pain), felt sick (malaise) and achy eyes (eye pain), while she received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  Medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 05-Nov-2019, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE (lot number not reported and expiry date: 30-Jun-2019) via intramuscular route in the left arm.  On an unknown date, the patient experienced a non-serious lost her voice (aphonia), coughing a lot (cough), 99 f fever (pyrexia), lethargy (lethargy), achy ears (ear pain), felt sick (malaise) and achy eyes (eye pain), (Unknown latency), following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE.  This is also a case actual medication error due to expired vaccine used.   Relevant laboratory test results included: Body temperature - On an unknown date: 99 F  Final diagnosis was aphonia, ear pain, eye pain, lethargy, malaise, cough and pyrexia.  It was not reported if the patient received a corrective treatment.  The patient outcome was reported as unknown for events aphonia, ear pain, eye pain, lethargy, malaise, cough and pyrexia.  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 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.  Information on the batch number was requested.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Lethargy, Malaise, Pyrexia
Clinical narrative: lost her voice; achy ears; achy eyes; patient received expired product; coughing a lot; 99 F fever; lethargy; felt sick; Initial information received on 18-Dec-2019 regarding an unsolicited valid non-serious case received from a consumer.  This case involves Elderly female (age at the of vaccination was 66 years) patient who experienced lost her voice (aphonia), coughing a lot (cough), 99 f fever (pyrexia), lethargy (lethargy), achy ears (ear pain), felt sick (malaise) and achy eyes (eye pain), while she received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  Medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 05-Nov-2019, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE (lot number not reported and expiry date: 30-Jun-2019) via intramuscular route in the left arm.  On an unknown date, the patient experienced a non-serious lost her voice (aphonia), coughing a lot (cough), 99 f fever (pyrexia), lethargy (lethargy), achy ears (ear pain), felt sick (malaise) and achy eyes (eye pain), (Unknown latency), following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE.  This is also a case actual medication error due to expired vaccine used.   Relevant laboratory test results included: Body temperature - On an unknown date: 99 F  Final diagnosis was aphonia, ear pain, eye pain, lethargy, malaise, cough and pyrexia.  It was not reported if the patient received a corrective treatment.  The patient outcome was reported as unknown for events aphonia, ear pain, eye pain, lethargy, malaise, cough and pyrexia.  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 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.  Information on the batch number was requested.
Sex: U
Vaccine: RAB
Symptoms: Incomplete course of vaccination, No adverse event, Product dose omission
Clinical narrative: patient not returned for the 2nd and 3rd dose for Preexposure prophylaxis.; Initial information received on 18-Dec-2019 regarding an unsolicited valid non-serious case received from a physician.  This case involves a patient who was vaccinated with a first dose of RABIES (HDC) VACCINE [IMOVAX RABIES] on 15-Nov-2019 via unknown route and site of administration (The lot number and expiry date not reported) and patient did not return for the 2nd and 3rd dose for preexposure prophylaxis (missed dose).  Patient's medical history, vaccinations, treatments and concomitant therapies were not reported.  It was actual medication error due to Missed dose.  At the time of report 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 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.  Information on the batch number was requested.
Sex: M
Vaccine: MNQ
Symptoms: No adverse event, Product distribution issue, Product storage error
Clinical narrative: temperature excursion caused because the Menactra was delivered 1 day late/longer than it was supposed, a nurse administered the vaccine before they learned that it was not a good vaccine/no AE; temperature excursion caused because the Menactra was delivered 1 day late/longer than it was supposed, a nurse administered the vaccine before they learned that it was not a good vaccine/no AE; Initial information received on 19-Dec-2019 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional (office staff).  This case involves a 16 years old male patient who received a 0.5 ml dose vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (lot U6576AA and expiry date: 04-Apr-2021)  via intramuscular route in the right arm, on 12-Dec-2019.  The patient's past medical history, medical treatment(s), treatment(s) and family history were not provided.  Concomitant vaccinations included INFLUENZA VACCINE (FLU VACCINE VII) for Immunisation; and MENINGOCOCCAL VACCINE B RFHBP/NADA/NHBA OMV (BEXSERO) for Immunisation.  It was of actual medication error case due Incorrect product storage and product shipment delay. It was reported that temperature excursion caused because the Menactra was delivered 1 day late/longer than it was supposed to be. A patient administered the vaccine on 12-12-19 to a patient before they learned that it was not a good vaccine and they were told it needed to be discarded.  At the time of reporting, 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.
Sex: F
Vaccine: FLUX
Symptoms: Urticaria
Clinical narrative: broke out in hives; Initial information received on 27-Nov-2019 regarding an unsolicited valid non-serious case received from a consumer.  This case is linked to 2019SA333485.  This case involves a 34 years old female patient who broke out in hives (urticaria), while she received vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history and concomitant therapies were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and Expiry date unknown) via unknown route in unknown administration site.  On an unknown date, the patient developed a non-serious event broke out in hives (urticaria) 1 week following the administration of INFLUENZA VACCINE.  (Other relevant tests included no laboratory data.)  Final diagnosis was hives.   It was not reported if the patient received a corrective treatment.  The event outcome is reported as Unknown for hives.  Information on the batch number was requested.
Sex: U
Vaccine: UNK
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: vaccine administrated to patient subcutaneously instead of intramuscular/No AE; Initial information received on 26-Dec-2019 regarding an unsolicited valid non-serious case received from other health professional.  This case involves patient who received DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE [DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE] subcutaneously instead of intramuscular (incorrect route of product administration).  Medical history, medical treatment, vaccination and family history were not provided.  On an unknown date, the patient received a dose of suspect DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE (produced by unknown manufacturer) [lot number and other dosing details were not reported] via subcutaneous route in unknown administration site.  It was a case of actual medication error due to incorrect route of product administration.  At the time of report 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 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.  Information on the batch number was requested.
Sex: F
Vaccine: DTAP, TDAP
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: inadvertently administered Adacel instead of Daptacel for 4th dose in DTaP series.; inadvertently administered Adacel instead of Daptacel for 4th dose in DTaP series.; Initial information received on 30-Dec-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 15 months old female patient who inadvertently administered DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] instead of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] for 4th dose in DTAP series (wrong product administered and product administered to patient of inappropriate age).  Medical history, medical treatment, vaccination and family history were not provided.  Concomitant medications included HIB VACCINE CONJ (TET TOX) (ACT-HIB), [PNEUMOCOCCAL VACCINE] PNEUMONIA VACCINE.  It was a case of actual medication error due to wrong product administered and product administered to patient of inappropriate age as 15month old female was inadvertently administered Adacel instead of Daptacel for 4th dose in DTaP series.  At the time of report 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 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.
Age: 0.33
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation error
Clinical narrative: a four months old baby was vaccinated bynurse using a wrong diluent for Pentacel, no AE.; Initial information received on 31-Dec-2019 regarding an unsolicited valid non-serious case from a Nurse.  This case involves a four months old patient who was vaccinated using a wrong diluent for DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (lot number UJ020AA and expiration date 09-Oct-2020)(PT: product preparation error) via unknown route in unknown administration site on an unknown date.   The medical history and concomitant medications were not reported.  It was an actual medication error case due to product preparation error. It was reported that the nurse did not use the diluent for Pentacel and used the diluent for Merck live vaccine- as reported.   No adverse event reported at the time of reporting.  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.
Age: 0.75
Sex: M
Vaccine: FLU4
Symptoms: Ear infection, Extra dose administered, Irritability
Clinical narrative: ear infection; irritability; received 3 doses of Fluzone Quadrivalent 0.5mL; Initial information received on 31-Dec-2019 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional (patient's mother).  This case involves an 11 months old male patient who experienced irritability (irritability), ear infection (Ear infection) and reported extra dose administered (extra dose administered), while he received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT]. The patient received first dose at 9 months.  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS B VACCINE (HEPATITIS B VACCINE) for Immunisation; and IPOL for Immunisation.  On 17-Oct-2019, the patient received a dose of suspect 0.5 ml INFLUENZA QUADRIVAL A-B VACCINE lot number not reported via unknown route in unknown administration site. On 21-Nov-2019 he also received a dose of the same vaccine with an unknown batch number via unknown route in unknown administration site. On 30-Dec-2019 he also received a dose of the same vaccine with an unknown batch number via unknown route in the left thigh.  On an unknown date, the patient developed a non-serious irritability (irritability) and ear infection (ear infection) (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  The patient visited on 30-Dec-2019 for follow up for ear infection.  It was also a case of actual medication error due to extra dose administered.  Laboratory data was not reported.  Final diagnosis was irritability.  It was not reported if the patient received a corrective treatment.  The outcome of both the events was unknown at the time of reporting.  Information on the batch number was requested.  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
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product preparation error
Clinical narrative: one diluent was remaining in a box of ActHib and assumes the powder half of the dose had been given to a patient with sterile water instead, no adverse event; Initial information received on 02-Jan-2020 regarding an unsolicited valid non-serious case from a nurse.  This case is linked to cases 2020SA002810, 2020SA002811, 2020SA002812 and 2020SA002455 (same reporter).  This case involves an unknown demographic patient who was vaccinated with a dose of vaccine HIB (PRP/T) VACCINE [ACT-HIB] on an unknown date, (lot number UJ175AAA and expiration date 26-Nov-2020), other dosing details were not reported.  Medical history and concomitant medications were not reported.  It was an actual medication error case due to wrong solution used in drug reconstitution as Act-HIB was accidentally mixed with sterile water instead of the diluent that came with product and had been administered to the patient.  No adverse event was reported at the time of reporting.  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.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product preparation error
Clinical narrative: accidentally mixed ActHIB with sterile water instead of the diluent, No AE; Initial information was received on 02-Jan-2020 regarding an unsolicited valid non-serious case from a nurse.  This case is linked to cases 2020SA002810, 2020SA002455, 2020SA002812, 2020SA002456 and 2020SA004004 (same reporter).  This case involves a 6 month old patient who received HIB (PRP/T) VACCINE [ACT-HIB] which mixed with sterile water instead of the diluent.  Medical history, medical treatment, vaccination and family history were not provided.  On 19-Dec-2019, the patient received a dose of suspect HIB (PRP/T) VACCINE (lot UJ175AAA, expiry date- 26-11-2020) via unknown route in unknown administration site.  It was a case of actual medication error due to wrong solution used in drug reconstitution.  At the time of report, 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 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.
Sex: F
Vaccine: FLU4, TDAP
Symptoms: Exposure during pregnancy, No adverse event, Wrong product administered
Clinical narrative: a pregnant patient was given adacel was mistakenly administered instead of fluzone,no AE.; a pregnant patient was given adacel was mistakenly administered instead of fluzone,no AE.; Initial information received on 03-Jan-2020 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves female pregnant patient who was exposed to vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] mistakenly instead of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (lot number U6202BA, expiration 26 Feb 2021-reported for an unspecified vaccine) via unknown route of administration and unknown site on an unknown date of December 2019.  The date of last menstrual period was not reported.  The estimated due date was not reported.  The actual date of delivery was not reported.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  The patient's previous pregnancy details were not reported.   It was an actual medication error case due to wrong product administered and exposure during pregnancy.  No adverse event reported at the time of reporting.  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.
Sex: M
Vaccine: FLUX
Symptoms: Hypersensitivity
Clinical narrative: he received flu shot 5 years ago having mercury and he had a reaction to it.; Initial information received on 06-Jan-2020 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional.  This case involves male patient(unknown demographics) who received flu shot 5 years ago having mercury and he had a reaction to it(hypersensitivity) of vaccine INFLUENZA VACCINE. It was also reported that then he received a mercury free flu shot and has been okay.  The patient's past medical history, concomitant therapy, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site.  The patient developed a non-serious allergic reaction (hypersensitivity) Unknown latency following the administration of INFLUENZA VACCINE.  No lab data was reported.  Final diagnosis hypersensitivity.  It was not reported if the patient received a corrective treatment.  On an unknown date, event outcome was reported as unknown for hypersensitivity.  Information on the batch number was requested.
Sex: F
Vaccine: FLU4
Symptoms: Pain, Pain in extremity
Clinical narrative: severe pain and soreness. She describes it as so painful; 15 months later that (right) arm is still hurting; Initial information received on 07-Jan-2020 regarding an unsolicited valid non-serious case received from a consumer.  This case is linked to case 2020SA007885.  This case involves a 68 years old female patient who experienced severe pain and soreness she describes it as so painful (pain) and 15 months later that (right) arm is still hurting (pain in extremity), while she received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 15-Oct-2018, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot number not reported via unknown route in unknown administration site.  On an unknown date, the patient developed a non-serious severe pain and soreness she describes it as so painful (pain) (Unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  On an unknown date (15 months later), the patient developed a non-serious (right) arm is still hurting (pain in extremity) (Unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  (Other relevant tests included no lab data.) Final diagnosis was pain and Painful R arm.  It was not reported if the patient received a corrective treatment.  The event outcome is reported as Unknown for severe pain and as Not Recovered for Painful R arm..  Information on the batch number was requested.
Sex: U
Vaccine: FLUR4
Symptoms: Peripheral swelling, Pruritus, Urticaria
Clinical narrative: Swelling on arm; itching; larger wheal on arm the size of sand dollar; Initial information was received on 07-Jan-2020 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional.  This case involves patient(unknown demographics) who experienced swelling on arm(peripheral swelling), itching (pruritus) and larger wheal on arm the size of sand dollar(urticaria), while he/she received vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV].  Medical history, concomitant therapy, medical treatment, vaccination and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (lot number and other dosing details were not reported) via an unknown route at an unknown administration site.  On an unknown date, the patient developed non-serious swelling on arm (peripheral swelling), itching (pruritus) and larger wheal on arm the size of sand dollar(urticaria) Unknown latency following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE.  Detail of laboratory data were not reported.  Final diagnosis were peripheral swelling, pruritus and urticaria.  It was not reported if the patient received any corrective treatment.  On an unknown date, the outcome of the events was reported as Unknown.  Information on the batch number was requested.
Sex: F
Vaccine: FLUR4
Symptoms: Pruritus, Rash
Clinical narrative: Severe itching; large rash; Initial information was received on 07-Jan-2020 regarding an unsolicited valid non-serious case received from consumer/Non-Healthcare Professional.  This case involves a female patient who experienced severe itching(pruritus) and large rash(rash), while she received vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV].  Medical history, concomitant therapy, medical treatment, vaccination and family history were not provided.   On an unknown date, the patient received dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (lot QFAA1944) via an unknown route at an unknown administration site.  On an unknown date, the patient developed non-serious severe itching (Pruritus) and large rash(Rash) Unknown latency following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE.  Detail of laboratory data were not reported.  Final diagnosis were pruritus and rash.  It was not reported if the patient received any corrective treatment.  On unknown date, the outcome of the events had reported as unknown.
Sex: U
Vaccine: FLUX
Symptoms: Pain
Clinical narrative: sharp pain; Initial information was  received on 07-Jan-2020 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional.  This case involves patient (of unknown demographics) who experienced sharp pain (pain), while he/she received vaccine INFLUENZA VACCINE.  Medical history, concomitant, medical treatment, vaccination and family history were not provided.   On 31-Oct-2017, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number not reported of unknown Expiration date) via unknown route at an  unknown administration site.  On 01-Nov-2017, the patient developed a non-serious sharp pain (pain) 1 day following the administration of INFLUENZA VACCINE.  Laboratory data was not provided.  Final diagnosis was pain.   It was not reported if the patient received any corrective treatment.  The patient outcome is reported as unknown for pain.  Information on the batch number is requested.
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Incorrect product formulation administered, Product preparation issue
Clinical narrative: patient received the DTaP-IPV portion of Pentacel, but did not receive the Hib portion/no AE; Initial information received on 08-Jan-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 4 months old male patient who received only the dtap-ipv portion of vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] without the HiB portion.  The patient medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) for Immunisation; and ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ) for Immunisation.  On 08-Jan-2020, the patient received a second dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot UJ206AA/U6615AB via unknown route in the left thigh.  It was of actual medication error due to Inappropriate reconstitution technique.  It was unknown whether adverse event was experienced 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 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.
Age: 1.25
Sex: F
Vaccine: DTAPIPV
Symptoms: Injection site reaction, Injection site swelling, Pyrexia
Clinical narrative: Fever, swelling and redness located at the injection site.
Age: 56.0
Sex: F
Vaccine: FLUC4
Symptoms: Mobility decreased, Musculoskeletal pain, Pain, Sleep disorder
Clinical narrative: Pain right shoulder, pain to touch and constant pain.  Disrupted sleep on that side.  Limited mobility.
Age: 1.17
Sex: M
Vaccine: HIBV, MMRV, PNC13, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: The patient was given BOTH varicella and ProQuad (MMR+Varicella).  Parent has not noted any adverse effects as of 1/10/2020
Age: 63.0
Sex: F
Vaccine: PPV
Symptoms: Muscular weakness, Pain in extremity, Periarthritis, Urticaria
Clinical narrative: Pain and weakness in right arm. Frozen right shoulder. Urticaria.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Myalgia
Clinical narrative: Whole body muscle pain, injection site pain
Age: 29.0
Sex: M
Vaccine: ANTH, YF
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Local reaction
Clinical narrative: Delayed-onset localized reaction to one of the above vaccines (given in the same arm). Injection site with redness, swelling and warm to touch.
Age: 1.0
Sex: U
Vaccine: MMRV
Symptoms: Circumstance or information capable of leading to medication error, Incorrect dose administered, No adverse event
Clinical narrative: no symptoms being reported; patient probably received 90% of the vaccine; This spontaneous report was received from a medical assistant referring to a 12 month old patient of unknown gender. The patient's pertinent medical history, concurrent conditions and drug reactions/ allergies were not provided. Concomitant therapies included sterile diluent, hepatitis a vaccine, inactivated (VAQTA) and pneumococcal 13v conj vaccine (crm197) (PREVNAR 13). On 09-JAN-2020, the patient was vaccinated with first dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) for prophylaxis, lot number S017244 and expiry date 01-DEC-2020, (exact dose, route of administration and anatomical location were not reported). It was reported that as the medical assistant was about to finish vaccination, the patient pulled away and some vaccine was sprayed (incorrect dose administered) and the patient probably would have received 90% of the vaccine. No adverse events were reported. No product quality complaint (PQC) was reported.  This is one of the two reports from the same reporter.; Sender's Comments:  US-009507513-2001USA003805:
Sex: M
Vaccine: MNQ
Symptoms: Urticaria
Clinical narrative: Hives; This case was reported by a nurse via call center representative and described the occurrence of hives in a 16-year-old male patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo at an unknown dose. On an unknown date, unknown after receiving Menveo, the patient experienced hives. On an unknown date, the outcome of the hives was unknown.   It was unknown if the reporter considered the hives to be related to Menveo.  Additional details was provided as follows: The age at vaccination was not reported. The patient developed hives after receiving Menveo. No further information was provided.
Sex: F
Vaccine: VARZOS
Symptoms: Oral herpes
Clinical narrative: cold sore on her bottom lip; This case was reported by a consumer via call center representative and described the occurrence of cold sores lip in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included cancer.   On 9th November 2019, the patient received the 1st dose of Shingrix. In December 2019, 1 month after receiving Shingrix, the patient experienced cold sores lip. On an unknown date, the outcome of the cold sores lip was unknown.   It was unknown if the reporter considered the cold sores lip to be related to Shingrix.  Additional details was provided as follows: The age at vaccination was not reported. The patient experienced a cold sore on her bottom lip about 1 month later after receiving 1st dose of Shingrix. Consent to follow up was denied.
Age: 18.0
Sex: M
Vaccine: HEP, HEPA
Symptoms: Unevaluable event
Clinical narrative: Adult vaccine doses given to 18 year old.
Age: 36.0
Sex: U
Vaccine: PNC13
Symptoms: Injection site erythema, Mobility decreased, Musculoskeletal pain, Pain in extremity, Peripheral swelling
Clinical narrative: Received Pneumo Polysaccharide vaccine at the office of Dr. Right upper arm. Redness at injection site, approximately the size of an apple. Soreness/swelling at shoulder and upper arm. Difficulty moving arm and lifting objects. Will seek medical attention if symptoms worsen.
Age: 36.0
Sex: U
Vaccine: PNC13
Symptoms: Swelling
Clinical narrative: Received Pneumo Polysaccharide vaccine at the office of Dr. Right upper arm. Redness at injection site, approximately the size of an apple. Soreness/swelling at shoulder and upper arm. Difficulty moving arm and lifting objects. Will seek medical attention if symptoms worsen.
Age: 22.0
Sex: F
Vaccine: HEPAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient received Twinrix #3. She was too early for time for Hepatitis B, but too early for her Hepatitis A. Patient was advised to return to test for Hepatitis A immunity. If immune, patient will not have to receive her last Hepatitis A dose, if not, patient agreed to vaccination.
Age: 69.0
Sex: M
Vaccine: FLUA3
Symptoms: Fatigue, Feeling abnormal, Feeling hot, Head injury, Hyperhidrosis
Clinical narrative: Patient is a 69 y.o. male here after an episode of seizure like activity last night.  Patient got up to go the bathroom and fill the toilet and on to the for and has seizure-like activity that lasted about 30-40 seconds.  Witnessed by wife.  She described seeing his eyes stay open, arms clenched, legs extended, and unresponsive, no tremors.  He hit his head on the ground.  Patient did vomit and was incontinent.  This morning patient feels tired.  Patient declined going to the ER last night.  Denies having seizures in the past however he does have history of syncopal episodes due to low blood glucose.  He is not on any diabetic medications. HPI Patient came in and got influenza vaccination. Three to four hours later, he did not feel quite right. His wife told him that the flu vaccine always makes a person feel achy. He says he had right shoulder burning and felt like pins and needles. He says around 11 AM, he went to pee. His wife asked him to sit down. He then began vomiting. After this, he had sweats and felt hot. He then passed away. She did not bite tongue. He did urinate but on the other hand, it occurred when he was planning to use the restroom to pee. He was unconscious for less than 1 minute.
Age: 69.0
Sex: M
Vaccine: FLUA3
Symptoms: Incontinence, Injection site pain, Injection site reaction, Loss of consciousness, Magnetic resonance imaging brain normal
Clinical narrative: Patient is a 69 y.o. male here after an episode of seizure like activity last night.  Patient got up to go the bathroom and fill the toilet and on to the for and has seizure-like activity that lasted about 30-40 seconds.  Witnessed by wife.  She described seeing his eyes stay open, arms clenched, legs extended, and unresponsive, no tremors.  He hit his head on the ground.  Patient did vomit and was incontinent.  This morning patient feels tired.  Patient declined going to the ER last night.  Denies having seizures in the past however he does have history of syncopal episodes due to low blood glucose.  He is not on any diabetic medications. HPI Patient came in and got influenza vaccination. Three to four hours later, he did not feel quite right. His wife told him that the flu vaccine always makes a person feel achy. He says he had right shoulder burning and felt like pins and needles. He says around 11 AM, he went to pee. His wife asked him to sit down. He then began vomiting. After this, he had sweats and felt hot. He then passed away. She did not bite tongue. He did urinate but on the other hand, it occurred when he was planning to use the restroom to pee. He was unconscious for less than 1 minute.
Age: 69.0
Sex: M
Vaccine: FLUA3
Symptoms: Paraesthesia, Scan with contrast normal, Seizure like phenomena, Unresponsive to stimuli, Vomiting
Clinical narrative: Patient is a 69 y.o. male here after an episode of seizure like activity last night.  Patient got up to go the bathroom and fill the toilet and on to the for and has seizure-like activity that lasted about 30-40 seconds.  Witnessed by wife.  She described seeing his eyes stay open, arms clenched, legs extended, and unresponsive, no tremors.  He hit his head on the ground.  Patient did vomit and was incontinent.  This morning patient feels tired.  Patient declined going to the ER last night.  Denies having seizures in the past however he does have history of syncopal episodes due to low blood glucose.  He is not on any diabetic medications. HPI Patient came in and got influenza vaccination. Three to four hours later, he did not feel quite right. His wife told him that the flu vaccine always makes a person feel achy. He says he had right shoulder burning and felt like pins and needles. He says around 11 AM, he went to pee. His wife asked him to sit down. He then began vomiting. After this, he had sweats and felt hot. He then passed away. She did not bite tongue. He did urinate but on the other hand, it occurred when he was planning to use the restroom to pee. He was unconscious for less than 1 minute.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Hyperhidrosis, Pain, Pain in extremity, Pyrexia
Clinical narrative: Sore arm, then hot red rash on arm next day That night, 102 fever with shivering and chills and aching body That night - Heavy sweats - had to change bedsheets
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash erythematous, Skin warm
Clinical narrative: Sore arm, then hot red rash on arm next day That night, 102 fever with shivering and chills and aching body That night - Heavy sweats - had to change bedsheets
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Fever
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Myalgia
Clinical narrative: Extreme fatigue, muscle soreness
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Myosclerosis, Pain in extremity, Rash, Skin warm
Clinical narrative: patient had sore arm, the muscle was hard, erythema with a rash and warmth. It started the day before the patient came into the clinic. Patient was advised to used Tylenol, Benadryl (if not contraindicated) and ice pack 30 min on each time she use it with an hour or so in between use
Sex: M
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse symptoms; the patient stated that he is "50 year old" and received "the first dose GARDASIL 9 today."; This spontaneous report was received from a 50 year old male patient refers to himself. The patient's pertinent medical history, concomitant medication, drug reactions and allergies were not reported. On 09-JAN-2020, the patient was vaccinated with his first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) for prophylaxis (strength, lot#, expiry date, dose, route of administration and anatomical location were not reported) (product administered to patient of inappropriate age). No adverse symptoms were reported. The outcome of product administered to patient of inappropriate age was unknown. No product quality complaint (PQC) was involved with this report.
Age: 69.0
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Dizziness, Headache, Injection site pain, Myalgia
Clinical narrative: Injection site pain; overall muscle aches; headache; nausea; dizziness; shivering; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 69-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 2nd January 2020 14:00, the patient received the 1st dose of Shingrix. In January 2020, less than a week after receiving Shingrix, the patient experienced injection site pain, muscle pain, headache, nausea, dizziness and shivering. On an unknown date, the outcome of the injection site pain, muscle pain, headache, nausea, dizziness and shivering were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, muscle pain, headache, nausea, dizziness and shivering to be related to Shingrix.  Additional details were provided as follows: The patient experienced injection site pain, muscle pain, headache, nausea, dizziness and shivering after receiving 1st dose of Shingrix. No further details were provided.
Age: 69.0
Sex: U
Vaccine: VARZOS
Symptoms: Nausea
Clinical narrative: Injection site pain; overall muscle aches; headache; nausea; dizziness; shivering; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 69-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 2nd January 2020 14:00, the patient received the 1st dose of Shingrix. In January 2020, less than a week after receiving Shingrix, the patient experienced injection site pain, muscle pain, headache, nausea, dizziness and shivering. On an unknown date, the outcome of the injection site pain, muscle pain, headache, nausea, dizziness and shivering were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, muscle pain, headache, nausea, dizziness and shivering to be related to Shingrix.  Additional details were provided as follows: The patient experienced injection site pain, muscle pain, headache, nausea, dizziness and shivering after receiving 1st dose of Shingrix. No further details were provided.