chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Initial information received on 30-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 64 years old female patient who received vaccine FLUZONE HIGH DOSE lot number not reported via unknown route in the left deltoid (dose and expiry date not reported) on 25-Oct-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was actual medication error due to overdose and inappropriate age at vaccine administration. No symptoms were 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. Documents held by sender: none
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia
Clinical narrative: Initial information received on 30-Oct-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 77 years old female patient who experienced fever, while she received vaccine FLUZONE HIGH DOSE. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 27-Oct-2018, the patient received 0.5 ml dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot UJ051AB, expiry date: 05 Jun 2019 via intramuscular route in the left deltoid. On an unspecified date, the patient developed a non-serious fever (pyrexia) Unknown latency following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. Lab data not reported. Final diagnosis was fever. It was not reported if the patient received a corrective treatment. The event outcome was reported as Unknown for fever. List of documents held by sender: none.
Sex: U
Vaccine: FLU3, PNC13
Symptoms: No adverse event, Product storage error
Clinical narrative: Initial information received on 30-Oct-2018 regarding an unsolicited valid non-serious case received from non-healthcare professional (reported as Pharmacy technician). This case involves a 65 years old patient who received 0.5ml of vaccine FLUZONE HIGH DOSE (batch number: UJ044AB) (expiry date and site of administration were not reported) via intramuscular route in the left deltoid on 29-Oct-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included PREVNAR 13 for Immunization. It was case of actual medication error due to incorrect product storage. 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. List of documents held by sender: none.
Age: 1.25
Sex: M
Vaccine: DTAPIPVHIB, FLU4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Initial information received on 30-Oct-2018 regarding an unsolicited valid non-serious case received from a Healthcare professional. This case involves 15 months old male patient who was vaccinated with a 0.5 ml dose of FLUZONE QUADRIVALENT (batch number: U6302AA, expiration date: 30-Jun-2019, route was not reported in left thigh) on 30-Oct-2018. The patient's medical history and concomitant medications were not reported. It was an actual medication error due to overdose. It was unknown whether the patient had any 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. List of documents held by sender: none.
Age: 73.0
Sex: U
Vaccine: FLU4
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Initial information received on 30-Oct-2018 regarding an unsolicited valid non-serious case received from a physician. This case involves 73-years old patient (gender not reported) who was vaccinated with 0.5 ml FLUZONE QUADRIVALENT (batch number: UJ046AB, expiration date: 30-Jun-2019, route was not reported, in right deltoid) instead of a FLUZONE HIGH DOSE (lot number and expiry date were not reported) on 29-Oct-2018. The patient's medical history and concomitant medications were not reported. It was an actual medication error due to wrong vaccine administered. 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. List of documents held by sender: none.
Age: 2.0
Sex: U
Vaccine: FLU4
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Initial information received on 30-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 24 months old patient (gender not reported), who was inadvertently vaccinated with 0.5 ml dose of FLUZONE QUADRIVALENT (Batch number: UT6310NA and expiry date: 30-Jul-2019) via intramuscular route in the left thigh on 09-Oct-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. No other vaccines given. It was a case of actual medication error due to overdose because the patient was inadvertently vaccinated with 0.5mL dose instead of the 0.25mL. No AE symptoms reported since injection. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
Sex: U
Vaccine: DTAP, FLU4, IPV, MMR, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Initial information received on 30-Oct-2018 regarding an unsolicited valid non-serious case received from a other health professional. This case was linked with case 2018SA302269 (same reporter). This case involves a three patients who was vaccinated with a IPOL lot P1A251M, expiry date 02 May 2020, route and site of administration were not reported on 27-Oct-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient's concomitant medications included FLUZONE QUADRIVALENT for Immunisation; DTAP for Immunisation; MMR for Immunisation; and VARICELLA VACCINE for Immunisation. It was a case of actual medication error due to incorrect product storage. It was reported that the vaccines exposed to a temperature excursion twice on 22-Sep-2018 with temp up to 8.29 C for 1 hour and on 19-Oct-2018, at 8.33 C for 1 hour. The patient didn't experience any adverse events following the vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Age: 10.0
Sex: F
Vaccine: DTAPIPVHIB, FLU4, HEP, MMR
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Initial information received on 30-Oct-2018 regarding an unsolicited valid non-serious case received from an other health care professional. This case involves a 10 years old female patient who was vaccinated with 0.5 ml first dose of PENTACEL (lot number: C5518AA and expiry date: 15-Sep-2019) injection via intramuscular route in the left arm on 29-Oct-2019. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant vaccines included MMR, HEPATITIS B VACCINE; and FLUZONE QUADRIVALENT for Immunisation. It was a case of actual medication error due to inappropriate age at vaccine administration because the vaccine was administered to a 10 years old patient. No adverse reactions have occurred at this time as a result of the vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
Sex: U
Vaccine: RAB
Symptoms: Product administered at inappropriate site
Clinical narrative: Initial information received on 30-Oct-2018 regarding an unsolicited valid non-serious case received from a consumer. This case involves a patient who was vaccinated with IMOVAX RABIES that accidentally injected into the gluteal region (batch number, expiration date, dose, route and site of administration was not reported) on 30-Oct-2018. The patient's medical history and concomitant medications were not reported. It was an actual medication error due to inappropriate site of administration. No AE was noted at the time of the injection. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Age: 1.0
Sex: U
Vaccine: HIBV
Symptoms: Product preparation error, Product preparation issue
Clinical narrative: Initial information received on 30-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 12 months old patient who was vaccinated with a 0.5 ml dose of ACT-HIB lot UI861AAB, 2 Feb 2019 via intramuscular route in the right thigh on 29-Oct-2018. 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 inappropriate reconstitution technique as patient was administered ACTHIB but it was reconstituted with sterile water instead of 0.4% saline diluent. It was not reported whether the patient experienced any adverse events following the vaccination. The patient had a visit to the doctor on 29-Oct-2018. 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: F
Vaccine: FLU4
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Initial information received on 30-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to case 2018SA302580 (same reporter). This case involves a seven years old female patient who was vaccinated with a 0.25 ml dose of FLUZONE QUADRIVALENT (lot UT6262NA, expiry date: 30-Jun-2019 via intramuscular route in the right deltoid) on 25-Oct-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not It was a case of actual medication error due to vaccine underdose. It was reported that 2 sisters ages 7 and 11 received 0.25mL's each of FLUZONE QUADRIVALENT in error. The patient didn't experience any adverse events following the vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Sex: F
Vaccine: FLU4
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Initial information received on 30-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to case 2018SA302578 (same reporter). This case involves a 11 years old female patient who was vaccinated with a 0.25 ml (instead of 0.5 ml) dose of FLUZONE QUADRIVALENT (lot UT6262NA via intramuscular route in the right deltoid) on 25-Oct-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not It was a case of actual medication error due to vaccine underdose. The patient didn't' t experience any adverse events following the vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Age: 0.5
Sex: F
Vaccine: FLU4
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Initial information received on 31-Oct-2018 regarding an unsolicited valid non-serious case received from an other health professional. This case is linked to case 2018SA302788 (same reporter). This case involves a 6 months old female patient (reported as 6 month 25 day old) who received single 0.5 ml of vaccine FLUZONE lot UJ005AD (expiry date: 30-Jun-2019) instead of 0.25 ml on 22-Oct-2018 by error. The patient's past medical history and concomitant medication were not provided. It was a case of actual medication error due to Product selection error and accidental overdose. Patient was given 0.5 ml of FLUZONE QIV in error instead of 0.25 ml as the administering physician did not know needle size and gauge. No adverse event occurred. 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 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: Incorrect dose administered
Clinical narrative: Initial information received on 31-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to case 2018SA302806. This case involves a patient (age between 6 months to 3 years old and gender not reported) who was vaccinated with a 0.5 ml instead of 0.25 ml dose of FLUZONE QUADRIVALENT lot number and Exp. date not reported via unknown route in unknown administration site on an unspecified date. The patient's medical history and concomitant medications were not reported. It was an actual medication error due to vaccine overdose. It was not reported whether the patient experience any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Sex: U
Vaccine: FLU4
Symptoms: Incorrect dose administered
Clinical narrative: Initial information received on 31-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to case 2018SA302803 (same reporter). This case involves a patient (between the ages of 6 months to 3 years and gender was not reported) who received 1.0ml of vaccine FLUZONE QUADRIVALENT (number not reported) via unknown route in unknown administration site instead of 0.5ml on an unknown date. 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 overdose. It was not reported if the patient had any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Sex: F
Vaccine: FLU4
Symptoms: Incorrect dose administered
Clinical narrative: Initial information received on 31-Oct-2018 regarding an unsolicited valid non-serious case received from a health professional. This case involves a 10 months old female patient who was vaccinated with a 0.5 ml dose instead of 0.25 ml dose of vaccine FLUZONE QUADRIVALENT (lot UJ068AB and Exp. Date 30 Jun 2019) via unknown route in the left thigh on 27-Oct-2018. The patients medical history and concomitant medications were not reported. It was an actual medication error due to overdose. It was unknown whether the patient had any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Age: 19.0
Sex: F
Vaccine: MNQ
Symptoms: Expired product administered, Product label confusion
Clinical narrative: Initial information received on 31-Oct-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case was linked to 2018SA302869 (same reporter). This case involves a 19 years old female patient who received expired dose of vaccine, MENACTRA lot U5462AB via (Expiry date: 19-Jan-2018) unknown route in unknown administration site. The patient's past medical history and concomitant medication were not provided. It was a case of actual medication error due to issue with the imprint of expiration date (two digit year) on the vials which caused confusion (Product leaflet confusion) eventually led to administration of the expired vaccine (expired vaccine used). It was unknown whether patient experienced any 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. Documents held by sender: none.
Age: 74.0
Sex: M
Vaccine: FLU4
Symptoms: Dermatitis, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Initial information received on 31-Oct-2018 regarding an unsolicited valid non-serious case received from a consumer. This case involves a 74 years old male patient who experienced this reaction severe dermatitis, pain was so bad that he thought he tore his right rotator cuff, swelling started 4 days after the injection in his right shoulder, redness and warmth started at the injection site, while he received vaccine FLUZONE QUADRIVALENT. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 17-Oct-2018, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot number not reported) via intradermal route in an unknown site. On an unknown date, the patient developed a non-serious severe dermatitis, pain was so bad that he thought he tore his right rotator cuff, swelling started 4 days after the injection in his right shoulder, and redness and warmth started at the injection site (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE. It was also reported that the redness and warmth started at the injection site and spread to different parts of his arm. It then spread to the back of his arm. Pain was so bad that he thought he tore his right rotator cuff. It was a case of actual medication error case due to Wrong injection technique (reporter stated he doesn't think the RPh knew what he was doing because he went in at an angle instead of straight in) and inappropriate route of vaccination. No lab data was reported. Final diagnosis was redness and warmth started at the injection site, swelling started 4 days after the injection in his right shoulder, pain was so bad that he thought he tore his right rotator cuff and this reaction severe dermatitis. As a corrective treatment the patient placed an ice pack on his right arm at first and that seemed to help. The HCP started him on a high dose of prednisone (40 mg x 4 days and 20 mg x 5 days). The event outcome was reported as unknown for all the events. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Sex: F
Vaccine: FLU4, MNQ
Symptoms: Expired product administered
Clinical narrative: Initial information received on 31-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 16 years old female patient who received an expired MENACTRA (frequency once) lot number: U5712AA and expiry date 11-Oct-2018 via intramuscular route in the left deltoid on 29-Oct-2018. The patients past medical history, medical treatments, vaccinations and family history were not provided. Concomitant medications included FLUARIX QUADRIVALENT for Immunisation. It is an actual medication error case due to expired vaccine used. It was not reported whether the patient had any adverse event. 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. List of documents held by sender: none.
Age: 6.0
Sex: M
Vaccine: TYP
Symptoms: Exposure via skin contact, Extra dose administered, Syringe issue
Clinical narrative: Initial information received on 31-Oct-2018 regarding an unsolicited valid non-serious case received from a physician. This case involves a 6 years old male patient who received an unknown dose (0.5 ml reported as the content of the syringe) of the vaccine TYPHIM VI (lot N1K81, expiration date 19-Oct-2019) via intramuscular route in unknown administration site when it was reported that the barrel goes down may be a hole and when the nurse went to push there was leakage from lower part of needle (syringe issue). It was reported that the product emptied during administration, unclear how much went inside or leaked out on to patient (underdose), the fluid shot out sideways, before reaching the lure lock adaptor. Fluid was all over the patient during administration while needle was in patient skin (exposure via skin contact). On the next day 26-Oct-2018, the patient was vaccinated with a dose of the same vaccine with an unknown batch number via unknown route in the left thigh (extra dose administered). 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 exposure via skin contact, syringe issue, underdose and extra dose administered. It was not reported if the patient had any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Expired product administered
Clinical narrative: Initial information received on 31-Oct-2018 regarding an unsolicited valid non-serious case received from other health care professional. This case involves a patient (age and gender was not reported) who received vaccine PENTACEL expired on 29-Oct-2018. The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. On an unknown date, the patient received a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (expiry date: 29-Oct-2018, lot number, dose, dose in series, route and site of administration was not reported). It was a case of actual medication error due to expired vaccine used. It was unknown if the patient had any 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. List of documents held by sender: none.
Sex: F
Vaccine: FLUR4
Symptoms: No adverse event, Syringe issue, Underdose
Clinical narrative: Initial information received on 31-Oct-2018 regarding an unsolicited valid non-serious case received from other health care professional (practice manager). This case involves a 78 years old female patient who received vaccine FLUBLOK QIV. The patients past medical history, concomitant medications and family history were not provided. On 27-Sep-2018, the patient received a 0.5ml dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE lot QFAA1821, expiry date 30-Jun-2019 via intramuscular route in the left deltoid. It was an actual medication error due to vaccine underdose and syringe issue. It was reported that FLUBLOK QUADRIVALENT syringe malfunctioned and product ran out of both sides and bottom of needle. Leaking from out from the base of the needle where it meets the tip cap. The patient did not experience any adverse reaction after the injection. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender- none.
Age: 4.0
Sex: U
Vaccine: FLUR4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Initial information received on 30-Oct-2018 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 4 years old patient (gender was not reported) who received a dose of vaccine FLUBLOK QIV (lot number not reported) via unknown route in unknown administration site on 30-Oct-2018. 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 inappropriate age at vaccine administration. It was not reported if the patient had any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Age: 0.33
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Expired product administered
Clinical narrative: Initial information received on 31-Oct-2018 regarding an unsolicited valid non-serious case received from a consumer/non-HCP. This case involves a two four-months old patient who was vaccinated with a 0.5 ml doses of PENTACEL (lot number: C5439AA; expiry date: 29-Oct-2018) each via unknown route in the thigh NOS (most likely) on 30-Oct-2018. 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. It was unknown if any adverse event occurred following the vaccinations. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Age: 0.08
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Expired product administered
Clinical narrative: Initial information received on 31-Oct-2018 regarding an unsolicited valid non-serious case received from a physician. This case involves a 5 weeks old female patient who experienced inadvertently administering expired PENTACEL to client, who is 5 weeks and 3 days old, while she received vaccine PENTACEL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Patient received Hepatitis B vaccine, PREVENAR 13 and ROTATEQ as concomitant medication. On 30-Oct-2018, the patient received a first dose of 0.5 ml of suspect PENTACEL lot C5440AA, expiry date- 29-Oct-2018 via intramuscular route in right leg. It was a case of actual medication error due to expired vaccine used. The patient outcome is reported as Not Applicable for inadvertently administering expired PENTACEL to client, who is 5 weeks and 3 days old. 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: MNQ
Symptoms: Extra dose administered
Clinical narrative: Initial information received on 01-Nov-2018 regarding an unsolicited valid non-serious case received from a health care professional. This case involves a 17 years old patient who experienced was inadvertently vaccinated with third dose of MENACTRA (lot U5989AA and Exp. Date not reported) via intramuscular route in the left deltoid on an unspecified date in September of 2018. It was reported that, the first dose was in 2013, the second dose was in November of 2017. The patients medical history and concomitant medications were not reported. It was an actual medication error due to extra dose administered. It was unknown whether the patient had any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, HIBV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Initial information received on 01-Nov-2018 regarding an unsolicited valid non-serious case received from a nurse via phone. This case involves a six-months old male patient who was vaccinated with a 0.5 ml dose of PENTACEL (lot C5466AB, expiry date: 05-Sep-2019, via intramuscular route in the right thigh) and 0.5 ml dose of ACT-HIB (lot UI902AA) via intramuscular route in the left thigh on 01-Nov-2018. 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 extra dose administered. The patient received a double dose of ACT HIB by having both the vaccines. It was reported that the patient did not experience any adverse event following the vaccination. 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 party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Age: 0.42
Sex: F
Vaccine: DTAPIPVHIB, HIBV
Symptoms: No adverse event, Vaccination error
Clinical narrative: No reaction to vaccine- she was given a PENTACEL vaccine and a HIB vaccine in error- no reaction.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Erythema, Peripheral swelling
Clinical narrative: Red, swollen arm 2 days post vaccine. Went to urgent care and was put on an antibiotic. Was told she was being treated for cellulitis.
Age: 2.0
Sex: M
Vaccine: FLUA3
Symptoms: Contusion, Erythema
Clinical narrative: 10x10cm area of erythema/bruising that developed over the course of about 24 hours after vaccine was given.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Injection site pain
Clinical narrative: Soreness at injection site, one 10 minute shivering event 10 hours after vaccination, tiredness.
Age: 32.0
Sex: F
Vaccine: HEPA, TDAP, TYP
Symptoms: Cellulitis, Hypersensitivity, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Pt called back to clinic on Tuesday 11-7-2018 at 8:17 AM to report that after receiving the vaccines listed above on Thursday 11/01/18 she developed soreness of the right arm. Reports she had mild body aches on Friday with the soreness in the right arm. Reports that while at work on Sunday a co-worker noticed that she had redness and swelling of the right arm about 2 inches from her shoulder. They marked the area of swelling and redness. Reports that by the time she got off of work the swelling had progressed and was "halfway around her upper arm, and 2 inches down from the shoulder to about 2 inches above her elbow" she also reports the area was warm to touch. Patient went to the local urgent care on Sunday and according to the patient they advised her that it was either a delayed allergic reaction or Cellulitis. They treated her for Cellulitis. Reports that they gave her a "cream" but does not know the name. She states the cream did not help her symptoms, and they advised her to start taking an oral dose KEFLEX and Prednisone if the cream did not help. She reports Monday morning she began taking the KEFLEX and Prednisone, and that as of 11/07/18 morning the swelling had gone down to only at the injection site with redness still present at the injection site.
Age: 32.0
Sex: F
Vaccine: HEPA, TDAP, TYP
Symptoms: Pain, Pain in extremity
Clinical narrative: Pt called back to clinic on Tuesday 11-7-2018 at 8:17 AM to report that after receiving the vaccines listed above on Thursday 11/01/18 she developed soreness of the right arm. Reports she had mild body aches on Friday with the soreness in the right arm. Reports that while at work on Sunday a co-worker noticed that she had redness and swelling of the right arm about 2 inches from her shoulder. They marked the area of swelling and redness. Reports that by the time she got off of work the swelling had progressed and was "halfway around her upper arm, and 2 inches down from the shoulder to about 2 inches above her elbow" she also reports the area was warm to touch. Patient went to the local urgent care on Sunday and according to the patient they advised her that it was either a delayed allergic reaction or Cellulitis. They treated her for Cellulitis. Reports that they gave her a "cream" but does not know the name. She states the cream did not help her symptoms, and they advised her to start taking an oral dose KEFLEX and Prednisone if the cream did not help. She reports Monday morning she began taking the KEFLEX and Prednisone, and that as of 11/07/18 morning the swelling had gone down to only at the injection site with redness still present at the injection site.
Age: 20.0
Sex: M
Vaccine: HPV9
Symptoms: Fall, Loss of consciousness
Clinical narrative: Patient received vaccine and was sitting a chair. About 8 minutes after receiving vaccine he had a brief loss of consciousness and fell out of chair onto floor.
Age: 46.0
Sex: F
Vaccine: FLU4
Symptoms: Immediate post-injection reaction, Injection site pain
Clinical narrative: Patient noted that she had immediate pain at injection site in left deltoid after vaccination. Pain  and tenderness continued in left deltoid and shoulder throughout the day and evening for a few weeks afterwards; then subsided during the day and was only in the evenings when laying in the bed. Patient described it as "achey." No associated numbness, tingling, weakness. No redness or swelling near injection site. Her pain resolved completely by 10/27/18. She did not seek any medical evaluation for symptoms during this time. I offered her examination now, however declined examination now, as symptoms resolved.
Age: 0.92
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reaction or allergies and concomitant therapies were unknown. In approximately April 2018 (reported as an unspecified date since 03-APR-2018), the patient was vaccinated with an improperly stored dose of VARIVAX (lot # N009768, expiry date: 24-MAR-2019) which was reconstituted for prophylaxis with properly stored sterile diluent (MERCK) (lot # N021894, expiry date unknown). Dosing details were not reported. No adverse effects were reported. The temperature excursion occurred at a temperature range between -14 degrees Celsius (°C) to -10°C (-13.3C) for a time frame of 10 minutes. No previous temperature excursion occurred. The call was because of a data logger. No adverse effects were reported. Product quality complaint (PQC) was not involved. This case was considered to be non-valid due to lack of patient identifiers. A phone call was placed to the registered nurse on 26-SEP-2018, a request was made for patient identifiers and for the dates of vaccination. Upon receipt of the follow up information, the case has now become valid after updating the patient identifiers. Follow up information has been received from the nurse on 26-SEP-2018. The nurse reported that a 11 minute temperature excursion of - 13.3 degrees Celsius occurred on 03-APR-2018. All other temperatures were in range and average temperatures remained stable. The vaccine in the freezer at the time of excursion was PROQUAD of lot # N015623 with an expiry date of 15-NOV-2018 and VARIVAX of lot # N022981 with an expiry date of 23-AUG-2019. No doses of PROQUAD was given since excursion. It was reported that one dose of VARIVAX was administered. No adverse vaccine reactions reported. The nurse reported that this was a "supported temperature excursion" since it was between - 10 and - 14 (Units unspecified) for a period of 11 minutes and that supply could remain in stock and was viable. This is one of several reports received from the same reporter.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Laboratory test, Myalgia, Pain
Clinical narrative: Extreme muscle pain in arm and then became generalized to entire body requiring office visit to Dr.  These symptoms continue with little to no relief from anti-inflammatory medication taken as prescribed by PCP.
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: Hives on left side of lower back.
Age: 32.0
Sex: F
Vaccine: UNK
Symptoms: Dizziness, Hyperhidrosis, Nausea
Clinical narrative: Next day dizziness, sweating, nausea - lasting 1 hr in the morning - feeling faint.
Age: 1.08
Sex: M
Vaccine: DTAPHEPBIP, FLU4, HEPA, HIBV, MMR, MNQ, VARCEL
Symptoms: No adverse event, Wrong product administered
Clinical narrative: MENACTRA was given to patient accidently by LPN instead of PREVNAR 13. Patient with no ill sx's, no adverse rxn. Mother was contacted. Incident explained and scheduled patient for correct vaccine. Policy/protocol being followed at our office to prevent this from happening again.
Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: Deafness unilateral, Guillain-Barre syndrome
Clinical narrative: Applied to Employee Health Services for an influenza vaccination medical exemption in October 2018. Physician documented reason as patient having developed GBS within six weeks of her previous influenza vaccination, which was administered by us in 2017. That is how we learned of her adverse reaction. Patient reports developing hearing loss in her right ear on 10/21/17 which progressed to other signs/symptoms resulting in acute hospitalization and subsequent transfer to a rehabilitation center.
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: Chills, Fever, Body Aches, Three days intense, some body ache after a week.
Age: 35.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site pain, Musculoskeletal stiffness, Pain
Clinical narrative: Persistent pain in upper left arm, stiffness in neck and shoulder due to pain, pain radiating from nervous system as well (intermittent).
Age: 43.0
Sex: F
Vaccine: TDAP
Symptoms: Bedridden, Gait inability, Hypoaesthesia, Loss of personal independence in daily activities, Pain
Clinical narrative: Friday (11/2/18) around supper experienced severe pain in left arm. Later same evening arm went numb down to fingertips. On Saturday (11/3) experienced entire body aches (not face). Sunday (11/4) was bedridden due to all the pain. Monday (11/5) called into work due to severe pain, especially left foot. Says had to crawl as she could not walk. Began taking pain medications. Tuesday (11/6) returned to work but still experienced some pain. Wednesday (11/7) reported information to Health Dept Immunization Clinic; not in as much pain. Says continues to take pain medication but pain is not as severe; gets still if she does not keep moving.