chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 62.0
Sex: F
Vaccine: TDAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: patient receivced an expired Adacel, no AE; Initial information received on 28-Oct-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 62 years old female patient who received a 0.5 ml dose of expired vaccine DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE (ADACEL) (lot: C5263AA, expiry date: 12-Sep-2019), via intramuscular route in the left arm on 28-Oct-2019.  Medical history, medical treatments, vaccinations and family history were not provided.  It was an actual medication error due to the expired vaccine use.  At the time of reporting, the patient had no adverse event.  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: FLUR4
Symptoms: Incorrect route of product administration, Wrong technique in product usage process
Clinical narrative: received the Flublok vaccine subcutaneously instead of in the muscle, no adverse event; improper needle size, 25g 5/8th inches/ no adverse event; Initial information received on 01-Nov-2019 regarding an unsolicited valid non-serious case received from an other health professional.  This case is linked to case 2019SA307015.  This case involves a male patient who received the INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV]subcutaneously instead of in the muscle (Incorrect route of product administration) (lot QFAA1910, Exp.date- 26-May-2020) via subcutaneous route in the deltoid nos on 30-Oct-2019  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  No concomitant therapies were given.   It was a case of actual medication error due to Incorrect route of product administration and also a case of improper needle size, 25g 5/8th inches (Incorrect needle gauge used).  No symptoms reported following 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.  Outcome was not applicable for the events.  No further information was reported.
Sex: F
Vaccine: FLU3
Symptoms: No adverse event, Syringe issue
Clinical narrative: while giving the shot to the patient and there was some leaking from the syringe, no AE; while giving the shot to the patient and there was some leaking from the syringe, no AE; Initial information received on 08-Oct-2019 regarding an unsolicited valid non-serious case from a pharmacist.  This case involves a female patient of an unknown age who received a partial dose of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] (lot number: UJ282AA and expiry date: 23-May-2020) via unknown route in unknown administration site on an unknown date.  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was a case of vaccine underdose and syringe leak.   The pharmacist stated that while giving the shot to the patient and there was some leaking from the syringe. It did not leak until giving the shot. Needle was tightened like it was supposed to be. It was not known how much of a dose that the patient received. The syringe was not available for return. It was discarded. Replacement product was not requested.  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: FLU4
Symptoms: Exposure via skin contact, No adverse event, Syringe issue, Underdose
Clinical narrative: prefilled syringe leaked around hub when plunger was pushed down in syringe, leaking vaccine onto patient's arm, no AE; prefilled syringe leaked around hub when plunger was pushed down in syringe, leaking vaccine onto patient's arm, no AE; prefilled syringe leaked around hub when plunger was pushed down in syringe, leaking vaccine onto patient's arm, no AE; Initial information received on 31-Oct-2019 regarding an unsolicited non-serious case received from a pharmacist.   This case involves a patient of unknown demographics who received a dose of vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] prefilled syringe (lot: UT6695LA, expiry date: 30-Jun-2020) via unknown route in arm NOS, on an unknown date.   It was an actual medication error case due to vaccine underdose and Exposure via skin contact. It was reported that prefilled syringe leaked around hub when plunger was pushed down in syringe, leaking vaccine onto patient's arm. No note problems with product prior to administration.  It was also a case of syringe issue.   At the time of this 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: U
Vaccine: FLU4
Symptoms: Exposure via skin contact, No adverse event, Syringe issue, Underdose
Clinical narrative: medication started to leak and then went down the patients' arm, no AE; there was leakage at the hub of the syringe, where the needle attached, no AE; medication started to leak and then went down the patients' arm, no AE; Initial information received on 31-Oct-2019 regarding an unsolicited valid non-serious case received from a pharmacist.    This case involves a patient of unknown demographics who received a dose of vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] prefilled syringe (lot: UT6647LA, expiry date: 30-Jun-2020) via unknown route in arm NOS, on an unknown date.  It was an actual medication error case due to vaccine underdose and Exposure via skin contact. It was reported that the junction between the needle and the medication started to leak and then went down the patients' arm..  It was also a case of syringe issue.   At the time of this 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: U
Vaccine: FLU3
Symptoms: Exposure via skin contact, Injection site extravasation, No adverse event, Underdose
Clinical narrative: when she administered the vaccine into the muscle A large amount came out maybe about less than half came dripping down patients arm/ with no AE; when she administered the vaccine into the muscle A large amount came out maybe about less than half came dripping down patients arm/ with no AE; Initial information received on 31-Oct-2019 regarding an unsolicited valid non-serious case received from a Pharmacist.   This case involves (unknown age and gender) patient who received INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] (lot number: UJ292AA, Expiry date: 10-Jun-2020) into the muscle in arm and a part of the vaccine touched the skin of the patient on an unknown date.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was an actual medication Exposure via skin contact and vaccine underdose.   It was reported that Pharmacist stated that when she administered the vaccine into the muscle a large amount came out maybe about less than half came dripping down patients arm..  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: U
Vaccine: HIBV
Symptoms: Product preparation issue
Clinical narrative: administered the Dtap and Polio portion but forgot the ActHib; transfer button was not working; Initial information received on 04-Nov-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves a patient of unknown demographics who was administered the Dtap and polio portion but forgot the ActHib (Preferred term: Product preparation issue) and transfer button was not working (Preferred term: Device issue), while he/she received vaccine HIB (PRP/T) VACCINE [ACT-HIB].  The patient's past medical history, medical treatment, vaccination and family history were not provided.   No concomitant medication was reported.  On an unknown date, the patient received a dose of suspect HIB (PRP/T) VACCINE lot number not reported via unknown route in unknown administration site.  On an unknown date, it was reported that the patient was administered the Dtap and polio portion but forgot the ActHib (Preferred term: Product preparation issue) and transfer button was not working (Preferred term: Device issue).  The event outcome was reported as not applicable.
Age: 68.0
Sex: M
Vaccine: FLU4
Symptoms: No adverse event, Product distribution issue, Product storage error
Clinical narrative: shipment is delayed by more than 2 days, product was administered to the patient /no AE; shipment is more than 2 days not to use and to obtain a replacement of the products/no AE; Initial information received on 04-Nov-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to cases 2019SA308920, 2019SA308921 and 2019SA308846 (same reporter).  This case involves a 68 years old male patient who received a 0.5 mL dose of vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (lot: UT6695JA, Exp. Date: 30-Jun-2020) via intramuscular route at an unknown site on 04-Nov-2019 that had a shipment delay.  Relevant medical history and concomitant medication were unknown.  It was an actual medication error case due to incorrect product storage and Product shipment delay.  It was reported that the vaccines were shipped 30-Oct-2019 and were delivered this morning 04-Nov-2019. She has taken care of the replacements. Before they received the email, one dose of FLUZONE QUADRIVALENT had been administered to this patient.  It was reported that 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.
Sex: F
Vaccine: FLU3
Symptoms: No adverse event, Product distribution issue, Product storage error
Clinical narrative: received a Fluzone Quadrivalent after 2 days of shipping, vaccines were nonviable, no adverse event; received a Fluzone Quadrivalent after 2 days of shipping, vaccines were nonviable, no adverse event; Initial information regarding this unsolicited valid non-serious case received from a pharmacist on 05-Nov-2019.  This case is linked to 2019SA310489 and 2019SA310491.  This case involves a 39 year old female patient who received a dose of 0.5 ml of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot UJ270AA, Expiration date 30-JUN-2020) via intramuscular route in the left deltoid on 04-Nov-2019 after 2 days of shipping, vaccines were nonviable.  The patient's past medical history, medical treatment(s), vaccination(s), and family history were not provided.  No other vaccine was given.   It was a case of actual medication error due to product storage error and product distribution issue.  it was reported that patient received a Fluzone Quadrivalent after 2 days of shipping which were not viable.  At the time of report no adverse events were observed.  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 Disclaimer: 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: 0.42
Sex: F
Vaccine: FLU4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: a 5 month, 22 day old patient received a dose of Fluzone Quadrivalent vaccine, no AE; Initial information received on 06-Nov-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 5 months 22 days old female patient who received a 0.5 ml dose of influenza quadrival a-b vaccine (Fluzone Quadrivalent) (batch number: UJ211AA and expiration date 30-Jun-2020) via intramuscular route in left thigh on 15-Oct-2019.  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was a case of actual medication error due to inappropriate age at vaccine administration.  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 holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Disclaimer: 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: FLU4
Symptoms: Rhinorrhoea, Sneezing
Clinical narrative: sneezing and a runny nose off and on; sneezing and a runny nose off and on; Initial information received on 06-Nov-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 33 years old male patient who experienced sneezing and a runny nose off and on [Sneezing and Rhinorrhoea], while he 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 an unknown date in fall of 2018, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE [lot number and Exp. Date not reported] via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, (latency unknown) the patient experienced sneezing and a runny nose off and on [Sneezing and Rhinorrhoea], following administration of vaccine.  (Other relevant tests included no lab data)  Final diagnosis was runny nose and sneezing.   It was not reported if the patient received a corrective treatment.  The patient outcome is reported as Unknown for runny nose and as Unknown for sneezing.  Information on the batch number was requested.
Sex: F
Vaccine: FLU3
Symptoms: No adverse event, Product storage error
Clinical narrative: fluzone hd stored at around 80F and appeared to be warm to touch and was administered to the patient with no ae; Initial information received on 06-Nov-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp (patient's son).  This case involves an unknown age female patient who received a dose of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] (batch number, exp date not reported) via unknown route and site of administration on unknown date.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  This an actual medication error due to Incorrect product storage. It was reported that fluzone hd stored at around 80F and appeared to be warm to the touch with no ae.   At the time of reporting, the patient had no adverse event.  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.  Batch number was requested.
Age: 60.0
Sex: M
Vaccine: FLU3
Symptoms: No adverse event, Overdose, Product administered to patient of inappropriate age
Clinical narrative: Fluzone High Dose was administered to a 60 year old male with no ae; Fluzone High Dose was administered to a 60 year old male with no ae; Initial information received on 06-Nov-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves a 60 years old male patient who received 0.5 ml dose of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] (Lot no: US293AA, expiry date: 15-Jun-2020) via intramuscular route in right deltoid on 06-Nov-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was an actual medication error due to Product administered to patient of inappropriate age and overdose. It was reported that fluzone high dose which was administered to a 60 year old male with no ae.   At the time of reporting, the patient had no adverse event  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: FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: patient had gotten Flublok Quadrivalent who was under the age of 18, no AE; Initial information received on 06-Nov-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a patient (under the age of 18) who was vaccinated with vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV].  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 INFLUENZA QUADRIVALENT RECOMBINANT VACCINE lot QFAA1914, exp date: 30 June 2020 via unknown route in unknown administration site.  It was a case of actual medication error due to Inappropriate age at vaccine administration.  At the time of the 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: F
Vaccine: FLU3
Symptoms: Dysphonia, Lymphadenopathy
Clinical narrative: hoarseness in her voice; swollen glands in the neck; Initial information received on 06-Nov-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves Elderly female patient who experienced swollen glands (lymphadenopathy) in the neck accompanied by hoarseness in her voice (dysphonia), while she received vaccine 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.   On an unknown date, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot number not reported via unknown route in unknown administration site.  On an unknown date, The patient developed a non-serious swollen glands in the neck (lymphadenopathy) 1 day following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. On an unknown date, The patient developed a non-serious hoarseness in her voice (dysphonia) 1 day following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE.  (Other relevant tests included no lab data.)  Final diagnosis was hoarseness in her voice and swollen glands in the neck.   It was not reported if the patient received a corrective treatment.  The patient outcome is reported as Unknown for swollen glands in the neck and as Unknown for hoarseness in her voice.  Information on the batch number was requested.
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Product administered at inappropriate site, Vaccination site inflammation
Clinical narrative: Redness and Swelling at the injection site; Redness and Swelling at the injection site; Redness and Swelling at the injection site; vaccine was given in Left Vastus Lateralis to 8 year old; Initial information received regarding an unsolicited valid non-serious case received from a nurse and was transmitted to Sanofi on 07-Nov-2019.  This case is linked to case 2019SA312611.  This case involves a 8 years old female patient who experienced redness and swelling at the injection site and redness (vaccination site inflammation) while they received vaccine INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [FLUZONE].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   Concomitant medications were none.  On 05-Nov-2019, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [FLUZONE] lot number UJ237AB and exp date 30Jun20 via intramuscular route in Left Vastus Lateralis.  On an unknown date (latency unknown), the patient developed a non-serious redness and swelling at the injection site (vaccination site inflammation with symptoms vaccination site swelling and vaccination site erythema) following the administration of ENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED vaccine.  It was a case of actual medication error due to Vaccine administered at inappropriate site.  It was not reported if the patient received a corrective treatment.  The event outcome was reported as Unknown for injection site swelling and injection site erythema.  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: DTAP, HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: child received an expired ActHIB and Daptacel, no AE; Initial information received on 08-Nov-2019 and additional information received on 11-Nov-2019 and 12-Nov-2019  regarding an unsolicited valid non-serious case received from a Non-Healthcare Professional.   This case involves a patient of an unknown demographics who received an expired dose of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (lot: C5281AA, expiry date: 05-Oct-2019) and HIB (PRP/T) VACCINE [ACT-HIB] (lot: U1937AA, expiry date: 05-Nov-2019) via an unknown route in an unknown administration site.  Medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was a case of actual medication error due to expired vaccine used.  Reporter stated that he did not have any other information at this time, and did not know if it was 2 children receiving expired vaccine or if the same child received both.  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 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: 60.0
Sex: F
Vaccine: FLUX
Symptoms: Ageusia, Chest X-ray normal, Cough, Fatigue, Hyposmia
Clinical narrative: loss of sense of smell; loss of sense of taste; frequent sneezing; fever; cough; fatigue.; Initial information received on 11-Nov-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves a 60 years old female patient who had frequent sneezing (PT: Sneezing), fever (PT: Pyrexia), cough (PT: Cough) and fatigue (PT: fatigue) and experienced loss of sense of smell and taste (Ageusia and Hyposmia) while she was vaccinated with INFLUENZA VACCINE [FLU vaccine].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 03-Sep-2019, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number, expiration date unknown) for immunization.  On 05-Sep-2019, 2 days following the administration of INFLUENZA VACCINE, the patient had frequent sneezing (PT: Sneezing), fever (PT: Pyrexia), cough (PT: Cough) and fatigue (PT: fatigue). One week later patient  went back to PCP, was told to continue antibiotic, lungs sounds clear. Patient went back to PCP 2 days later, told to increase fluid intake. Patient went to ENT on 25 Oct 2019. Patient was put on steroid taper, no relief. Patient went to allergist 31 Oct 2019 and was prescribed nystatin, unsure of dosage.  On an unspecified date, patient experienced loss of sense of smell and taste (Ageusia and Hyposmia) unknown latency following the administration of INFLUENZA VACCINE  laboratory test included, On an unknown date, CXR clear, told to increase fluid intake.  Final diagnosis was fatigue., cough, fever, frequent sneezing, loss of sense of taste and loss of sense of smell.  Corrective treatment included Zithromax steroid taper, nystatin.  Event outcome was not resolved for all the event at the time of reporting.  Information on the batch number was requested.
Age: 60.0
Sex: F
Vaccine: FLUX
Symptoms: Pyrexia, Sneezing
Clinical narrative: loss of sense of smell; loss of sense of taste; frequent sneezing; fever; cough; fatigue.; Initial information received on 11-Nov-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves a 60 years old female patient who had frequent sneezing (PT: Sneezing), fever (PT: Pyrexia), cough (PT: Cough) and fatigue (PT: fatigue) and experienced loss of sense of smell and taste (Ageusia and Hyposmia) while she was vaccinated with INFLUENZA VACCINE [FLU vaccine].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 03-Sep-2019, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number, expiration date unknown) for immunization.  On 05-Sep-2019, 2 days following the administration of INFLUENZA VACCINE, the patient had frequent sneezing (PT: Sneezing), fever (PT: Pyrexia), cough (PT: Cough) and fatigue (PT: fatigue). One week later patient  went back to PCP, was told to continue antibiotic, lungs sounds clear. Patient went back to PCP 2 days later, told to increase fluid intake. Patient went to ENT on 25 Oct 2019. Patient was put on steroid taper, no relief. Patient went to allergist 31 Oct 2019 and was prescribed nystatin, unsure of dosage.  On an unspecified date, patient experienced loss of sense of smell and taste (Ageusia and Hyposmia) unknown latency following the administration of INFLUENZA VACCINE  laboratory test included, On an unknown date, CXR clear, told to increase fluid intake.  Final diagnosis was fatigue., cough, fever, frequent sneezing, loss of sense of taste and loss of sense of smell.  Corrective treatment included Zithromax steroid taper, nystatin.  Event outcome was not resolved for all the event at the time of reporting.  Information on the batch number was requested.
Sex: M
Vaccine: FLU4
Symptoms: Myalgia, Pain in extremity
Clinical narrative: muscle aches; pain in lower legs; Initial information received on 12-Nov-2019 regarding an unsolicited valid non-serious case received from a health care professional.  This case is linked with case 2019SA322627 (same reporter)  This case involves a male patient of unknown age who experienced muscle aches (PT: myalgia), pain in lower legs (PT: pain in extremity) while he received vaccines INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient's past medical history, medical treatment, vaccination and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] prefilled syringe lot number and expiry date not reported via unknown route in unknown administration site.  On an unknown date, (Unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE, patient experienced muscle aches (myalgia) and pain in lower legs (pain in extremity).  No laboratory data was reported.  It was not reported if the patient received a corrective treatment.  Event outcome for both the events was reported as recovered (took about 2 months to get better).  Information on the batch number was requested.
Age: 1.0
Sex: U
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired ActHIB was administered to a patient today with no adverse event; Initial information received on 13-Nov-2019 regarding an unsolicited valid non-serious case received from a Nurse.   This case involves 12 month old male patient who was vaccinated with an expired dose of  HIB (PRP/T) VACCINE 0.5 ml (lot number UI921AAA, Expiry date 09-NOV-2019) once via intramuscular route in the left thigh on 12-Nov-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was a case of actual medication error due to Expired vaccine used.  At the time of this 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: 5.0
Sex: F
Vaccine: IPV
Symptoms: No adverse event, Product storage error
Clinical narrative: the vaccine has been administered to a patient after it was out of range with no adverse event; Initial information regarding this unsolicited valid non-serious case received from a consumer (Office Staff) on 13-Nov-2019.  This case involves a 5 years old female patient for whom it was reported that the vaccine has been administered to a patient after it was out of range with no adverse event (Preferred Term: Product storage error), while she received vaccine ipv (vero) [Ipol].  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.  On 16-Sep-2019, the patient received a dose of suspect IPV (VERO) (lot number: P1A242M, expiration date: 26-APR-2020) via intramuscular route in the left arm.  This is a case of actual medication error due to Product storage. It was reported that the vaccine has been administered to a patient after it was out of range with no adverse event (Preferred Term: Product storage error), while she received vaccine ipv (vero).  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: TYP
Symptoms: Expired product administered, No adverse event
Clinical narrative: patient received an expired vaccine, no AE; Initial information received on 13-Nov-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves an unknown demographic patient who was vaccinated with an expired dose of TYPHOID VACCINE [TYPHIM VI] (lot number N1K901, expiration date 24 Oct 2019) on 28 Oct 2019 (Other dosing details not reported).  Medical history and concomitant medications were not reported.  It was an actual medication error case due to expired vaccine used.  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.
Age: 18.0
Sex: M
Vaccine: FLU4
Symptoms: No adverse event, Product distribution issue, Product storage error
Clinical narrative: Fluzone Quad had given to a patient yesterday that was invalid, due to delay in shipping time, no AE; Fluzone Quad had given to a patient yesterday that was invalid, due to delay in shipping time, no AE; Initial information received on 12-Nov-2019 regarding an unsolicited valid non-serious case received from other health professional.  This case is linked to cases 2019SA317566, 2019SA320727, 2019SA320728, 2019SA320730 and 2019SA320731 (same reporter).  This case involved an 18 year old male patient who received a dose of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (lot number-UJ3058A, Expiry date- 20-Jun-2020) via an unknown route in an unknown administration site on 11-Nov-2019, which was delay in shipping time.  Medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant drug were not reported.   It was a case of actual medication error due to incorrect product storage and product shipment delay. Vaccine was invalid due to prolonged shipping time.  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 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: 17.0
Sex: M
Vaccine: FLU4
Symptoms: No adverse event, Product distribution issue, Product storage error
Clinical narrative: Fluzone Quad had given to a patient which was delay in shipping time, no AE; Fluzone Quad had given to a patient which was delay in shipping time, no AE; Initial information received on 12-Nov-2019 regarding an unsolicited valid non-serious case received from other health professional.  This case is linked to cases 2019SA317566, 2019SA320727, 2019SA320728, 2019SA320731 and 2019SA320729 (same reporter).  This case involved a 17 years old male patient who received a dose of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (lot number-UJ3058A, Expiry date- 20-Jun-2020) via an unknown route in an unknown administration site on 11-Nov-2019, which was delay in shipping time.  Medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant drug were not reported.   It was a case of actual medication error due to incorrect product storage and product shipment delay. Vaccine was invalid due to prolonged shipping time.  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 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: 14.0
Sex: F
Vaccine: FLU4
Symptoms: No adverse event, Product distribution issue, Product storage error
Clinical narrative: Fluzone Quad had given to a patient yesterday that was invalid, due to delay in shipping time, no AE; Fluzone Quad had given to a patient yesterday that was invalid, due to delay in shipping time, no AE; Initial information received on 12-Nov-2019 regarding an unsolicited valid non-serious case received from other health professional.  This case is linked to cases 2019SA317566, 2019SA320727, 2019SA320728, 2019SA320730 and 2019SA320729 (same reporter).  This case involved a 14 years old female patient who received a dose of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (lot number-UJ3058A, Expiry date- 20-Jun-2020) via an unknown route in an unknown administration site on 11-Nov-2019, which was delay in shipping time.  Medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant drug were not reported.   It was a case of actual medication error due to incorrect product storage  It was a case of product shipment delay. Vaccine was invalid due to prolonged shipping time.  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 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: RAB
Symptoms: Mobility decreased, Muscle rigidity, Muscle spasms, Nausea, Vomiting
Clinical narrative: Nausea; muscle cramps; vomiting; muscle rigidity in jaw, neck and tongue; unable to open his jaw; Initial information received on 18-Nov-2009 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 66 years old male patient who experienced nausea, muscle cramps, vomiting, muscle rigidity in jaw, neck and tongue and unable to open his jaw, while he 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 15-Oct-2019, the patient received a dose  dose of suspect RABIES (HDC) VACCINE lot TIC85 via unknown route in unknown administration site.  The patient developed a non-serious nausea <<Unknown latency>> following the administration of RABIES (HDC) VACCINE. The patient developed a non-serious muscle cramps (muscle spasms) <<Unknown latency>> following the administration of RABIES (HDC) VACCINE. The patient developed a non-serious vomiting <<Unknown latency>> following the administration of RABIES (HDC) VACCINE. The patient developed a non-serious muscle rigidity in jaw, neck and tongue (muscle rigidity) <<Unknown latency>> following the administration of RABIES (HDC) VACCINE. The patient developed a non-serious unable to open his jaw (trismus) <<Unknown latency>> following the administration of RABIES (HDC) VACCINE. Final diagnosis was unable to open his jaw, muscle rigidity in jaw, neck and tongue, Severe vomiting, Severe muscle cramps and Severe nausea.    It was not reported if the patient received a corrective treatment.  The patient outcome is reported as Unknown for nausea, as Unknown for muscle cramps, as Unknown for vomiting, as Unknown for muscle rigidity in jaw, neck and tongue and as Unknown for unable to open his jaw.
Age: 51.0
Sex: M
Vaccine: PNC13
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Pt received a does of prevnar 13 prior to the age of 65, with no indications for the vaccine.
Age: 36.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Paraesthesia
Clinical narrative: Dull ache at injection site x 3 weeks. Some tingling to digits on left hand.
Age: 1.0
Sex: M
Vaccine: HEPA, MMRV, VARCEL
Symptoms: Injection site reaction, Injection site swelling, Pyrexia, Rash, Rhinorrhoea
Clinical narrative: Fever, runny nose and rash all over. First rash started on November 22, 2019 and ended on November 26, 2019. The rash came back on December 1, 2019 with a fever except the rash was worse and covered his entire face, cheeks and ears. It?s also on his body and the injection site on his left thigh is swollen with a mark.
Age: 28.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site pain
Clinical narrative: Persistent pain at left shoulder for 1 month following vaccine administration.
Age: 62.0
Sex: F
Vaccine: FLUC4
Symptoms: Pain in extremity, Swelling
Clinical narrative: Patient having persistent arm pain and some swelling after injection
Age: 73.0
Sex: M
Vaccine: FLU3
Symptoms: CSF test, Computerised tomogram, Guillain-Barre syndrome, Laboratory test, Lumbar puncture
Clinical narrative: Initial symptoms started on 11/14/19 with ER visit, 11/17/19 Hospital ER visit, 11/19/19 Medical Center ER visit, 11/22/19 clinic visit with PCP Dr. directly admitted to Hospital 11/22/19 to 11/25/19 then transferred to Medical Center on 11/25/19 for further neurological evaluation.  Diagnosed with Guillian Barre Syndrome on 12/2/19; continues to be hospitalized and receiving plasma treatments to date.  At time of this report, the hospital days was at 11 days.
Age: 73.0
Sex: M
Vaccine: FLU3
Symptoms: Plasmapheresis, X-ray
Clinical narrative: Initial symptoms started on 11/14/19 with ER visit, 11/17/19 Hospital ER visit, 11/19/19 Medical Center ER visit, 11/22/19 clinic visit with PCP Dr. directly admitted to Hospital 11/22/19 to 11/25/19 then transferred to Medical Center on 11/25/19 for further neurological evaluation.  Diagnosed with Guillian Barre Syndrome on 12/2/19; continues to be hospitalized and receiving plasma treatments to date.  At time of this report, the hospital days was at 11 days.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Decreased appetite, Discomfort, Headache
Clinical narrative: Severe sweating and chills, vomiting, raging headache, muscle aches, total weakness,  for 24-30 hours. no appetite for 48 hours and still weak.  I was unable to do anything but writhe in discomfort
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Hyperhidrosis, Myalgia, Vomiting
Clinical narrative: Severe sweating and chills, vomiting, raging headache, muscle aches, total weakness,  for 24-30 hours. no appetite for 48 hours and still weak.  I was unable to do anything but writhe in discomfort
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Pruritus, Pyrexia
Clinical narrative: PATIENT DESCRIBES FEVER AND ITCHINESS WITH BLISTERING ON UPPER AND LOWER EXTREMITIES AND NECK FOLLOWING VACCINE
Age: 21.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site pruritus, Injection site reaction, Injection site swelling, Injection site warmth, Skin tightness
Clinical narrative: Onset 7 days after vaccination: Remarkable L deltoid swelling, warmth, itch. No erythema. Skin around full deltoid quite taut.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Myalgia, Nausea
Clinical narrative: nausea, vomiting, headache, muscle pain, shivering, fatigue
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Vomiting
Clinical narrative: nausea, vomiting, headache, muscle pain, shivering, fatigue
Age: 74.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Loss of personal independence in daily activities, Musculoskeletal pain, Neck pain, Pain in extremity
Clinical narrative: Severe pain in arm, shoulder, and neck. Patient unable to maintain daily activities
Age: 74.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Headache, Injection site pain, Injection site reaction, Nausea
Clinical narrative: Severe pain in arm, shoulder, and neck. Patient unable to maintain daily activities
Age: 74.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Neck pain, Neuralgia, Pain, Pain in extremity, Pyrexia
Clinical narrative: Severe pain in arm, shoulder, and neck. Patient unable to maintain daily activities
Age: 74.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash
Clinical narrative: Severe pain in arm, shoulder, and neck. Patient unable to maintain daily activities