chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: M
Vaccine: FLUR4, TDAP
Symptoms: Product storage error
Clinical narrative: Initial information received on 13-Nov-2018 regarding an unsolicited valid non-serious case received from other health care professional. This case is linked to cases 2018SA315882, 2018SA315883, 2018SA315878, 2018SA315885, 2018SA315886, 2018SA315887 and 2018SA315888 (same reporter). This case involves a 65 years old male patient who received 0.5 ml dose of FLUBLOK QIV lot number QFAA1815, expiry date-30-06-2019 via intramuscular route in the left deltoid on 07-NOV-2018. Concomitant medications included was BOOSTRIX for Immunisation in the right deltoid on the same day. The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was actual medication error due to incorrect product storage. It was reported that vaccines were exposed to a maximum temperature of 52 F for 27 hours patient inadvertently received FLUBLOK QUADRIVALENT. It was unknown whether patient experienced any adverse event following 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.
Age: 52.0
Sex: M
Vaccine: FLUR4
Symptoms: Product storage error
Clinical narrative: Initial information received on 13-Nov-2018 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 52 years old male patient who was vaccinated with 0.5 ml FLUBLOK QIV (batch number: QFAA1815, expiration date 30-Jun-2019, and site of administration was not reported) via intramuscular route, on 06-Nov-2018, which was kept at 52 degrees for 27 hours. The patient's medical history and concomitant medications were not reported. It was an actual medication error due to incorrect product storage. 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: 70.0
Sex: M
Vaccine: FLUR4
Symptoms: Product storage error
Clinical narrative: Initial information received on 13-Nov-2018 regarding an unsolicited valid non-serious case received from other health professional. This case involves a 70 years old male patient who received 0.5 mL dose of vaccine FLUBLOK QIV lot number QFAA1815, expiry date-30-06-2019 via intramuscular route in the right deltoid on 06-NOV-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 incorrect product storage. It was reported that vaccines were exposed to a Max temp of 52 F for 27 hours- patient inadvertently received FLUBLOK QUADRIVALENT. It was unknown if any adverse event was 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 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: 71.0
Sex: M
Vaccine: FLUR4
Symptoms: Product storage error
Clinical narrative: Initial information received on 13-Nov-2018 regarding an unsolicited valid non-serious case received from other health professional. This case is linked with cases 2018SA315884, 2018SA315882, 2018SA315878, 2018SA315886, 2018SA315885, 2018SA315888 and 2018SA315883 (same reporter). This case involves a 71 years old male patient who was vaccinated with a 0.5 ml dose of FLUBLOK QIV (lot number: QFAA1815, expiry date: 30-Jun-2019) via intramuscular route in the left deltoid on 06-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 incorrect product storage as Vaccines were exposed to a Max temp of 52 F for 27 hours- patient inadvertently received FLUBLOK QUADRIVALENT. It was not reported whether the patient had any adverse 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: M
Vaccine: FLU4
Symptoms: Product storage error
Clinical narrative: Initial information received on 13-Nov-2018 regarding an unsolicited valid non-serious case received from a other health professional. This case is linked with 2018SA315883, 2018SA315878, 2018SA315885, 2018SA315886, 2018SA315887, 2018SA315882, 2018SA315884. This case involves a 2 years old male patient who for whom vaccines were exposed to a max temp of 52 F for 27 hours was reported, while he received vaccine FLUZONE QUADRIVALENT. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. No other vaccines given that day. On an unknown date, the patient received a 0.25 ml dose 1 of suspect INFLUENZA QUADRIVAL A-B VACCINE lot UT625QNA expiry date: 30-Jun-2019 via intramuscular route in the right thigh. The patient received vaccines which were exposed to a max temp of 52 F for 27 hours following the administration of INFLUENZA QUADRIVAL A-B VACCINE. It was reported that this excursion was on 02-Nov-2018 prior to the 12-Nov-2018, excursion already reported, they found that one patient inadvertently received FLUZONE QUADRIVALENT. Lab data was not reported. Final diagnosis was vaccines were exposed to a max temp of 52 F for 27 hours. It was an actual medication error due to incorrect product storage. It was not reported that if any adverse event occurred or not. Outcome of event was not applicable. 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: 8.0
Sex: M
Vaccine: FLU3
Symptoms: Wrong product administered
Clinical narrative: Initial information received on 12-Nov-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case is linked to cases 2018SA315983, 2018SA315982 and 2018SA315981 (same reporter). This case involves an 8 years old male patient who was vaccinated with FLUZONE HIGH DOSE 0.5ml (batch number: UJ000AB) rather than FLUZONE QUADRIVALENT 0.5ml in left deltoid on 18-OCT-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It is an actual medication case error due to wrong vaccine administered, overdose and inappropriate age at vaccine administration. It was unknown if patient had 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: 8.0
Sex: M
Vaccine: FLU3
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Initial information received on 12-Nov-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case is linked to 2018SA315975, 2018SA315981, 2018SA315982 and 2018SA315983 (same reporter). This case involves an eight-year-old male patient who was vaccinated with 0.5 FLUZONE HIGH DOSE lot UJ000AB (expiry date: 28-Mar-2019) via unknown route in the left deltoid instead of 0.5 ml dose of FLUZONE QUADRIVALENT (Batch number, expiration date, dose and site of administration was not reported) on 18-Oct-2018. 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 wrong vaccine administered, vaccine administered at inappropriate site and overdose. It was reported that 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: 13.0
Sex: M
Vaccine: FLU3
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Initial information received on 12-Nov-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case is linked with 2018SA315975, 2018SA315981 and 2018SA315982 (same reporter). This case involves a 13-years old male patient who was vaccinated with a 0.5 ml dose of FLUZONE HIGH DOSE (lot number: UJ000AB, expiry date: 28-Mar-2019) the left deltoid on 18-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 wrong vaccine administered, overdose and inappropriate age at vaccine administration. No adverse effects reported at this time. 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.
Sex: F
Vaccine: FLU4
Symptoms: Incorrect dose administered
Clinical narrative: Initial information received on 14-Nov-2018 regarding an unsolicited valid non-serious case received from a consumer. This case involves a 17-years old female patient who received FLUZONE QUAD 0.25 instead of the 0.5 ml, while she received vaccine FLUZONE QUADRIVALENT. The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. It was actual medication error due to vaccine underdose. It was not reported that 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: FLUR4
Symptoms: Anaphylactic reaction, Choking sensation, Swollen tongue, Throat tightness
Clinical narrative: Initial information received on 14-Nov-2018 regarding an unsolicited valid serious case received from a consumer. This case involves female patient of an unknown age who experienced anaphylactic reaction, throat closing down, tongue swelling, while she received vaccine FLUBLOK QIV. It was reported that, patient had known allergies to: plants, mold, mildew, trees, wheat, barley, oats, rice, corn, and peanuts. Patient had mentioned previous to her FLUBLOK injection she had been getting "mild hives" on her jawline, and couldn't determine what they were from, and was taking a preventative tablet of BENADRYL each day. On 13-Nov-2018, the patient received a dose of suspect FLUBLOK QIV lot QFAA1826 via intramuscular route (dose, expiry date and site of administration were not reported). On an unknown date, patient developed a serious anaphylactic reaction following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE. This event was assessed as medically significant. Patient was then transported by ambulance to the Emergency room around at 23.00. On an unknown date, patient developed a non-serious throat closing down (choking sensation), tongue swelling (swollen tongue) following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE. Other relevant tests included no lab data. Final diagnosis was tongue swelling, throat closing down and anaphylactic reaction. The patient was treated with BENADRYL, Steroids (in Buttock) and EPINEPHRINE for Product used for unknown indication. The outcome of the event was reported as unknown. Sender's Comments: This case concerns a patient of unknown age who presented with anaphylactic reaction after use of FLUBLOK QIV. The time to onset is not known and the events are expected with this vaccine. However, allergic history and tolerance to previous vaccinations are important points to consider in this case, which is missing at present. Based upon the reported information, the role of the vaccine cannot be assessed.
Age: 3.0
Sex: F
Vaccine: FLU4
Symptoms: Incorrect dose administered
Clinical narrative: Initial information received on 14-Nov-2018 regarding an unsolicited valid non-serious case received from a Nurse. This case involves a 3 years old (reported as 3 years and 3 months old) female patient who was vaccinated with 0.25 ml dose of FLUZONE QUADRIVALENT (batch number: UT6315RA and expiry date: 14-Jun-2019) via intramuscular route on 14-Nov-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications were not reported. It was a case of actual medication error due to vaccine underdose because the patient should be vaccinated with recommended 0.5 ml dose. It was unknown if any adverse event occurred or not following the vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization 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: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PPV, RVX
Symptoms: Product preparation issue
Clinical narrative: Initial information received on 14-Nov-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 4 months old female patient who was mistakenly given the DTaP/IPV diluent component of PENTACEL without it being used to reconstitute the ActHIB portion. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient was vaccinated with PEDVAXHIB and PEDIARIX at the age of 2 months. Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) and ROTAVIRUS VACCINE for Immunisation on an unknown date. On 12-Nov-2018, the patient received a 0.5 ml second dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot number: C5408AB and expiry date not reported) via intramuscular route in the right thigh. It was a case of actual medication error due to inappropriate reconstitution technique because only the DTaP/IPV diluent portion of PENTACEL was given separately without it being used to reconstitute the ACTHIB portion. It was unknown if any adverse event occurred or not following the administration of vaccine. 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: 58.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Hypersensitivity
Clinical narrative: Initial information received on 14-Nov-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 58 years old female patient who had an allergic reaction/red spots on both arms, while she received vaccine ADACEL. The patient's past medical history included Allergy to Thimerosal (Chemical). The patient's past medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications were none. On 18-Oct-2018, the patient received a 0.5 ml dose of suspect ADACEL (lot C5228AA and expiration date 26-Jun-2019) via intramuscular route in the left arm. On an unknown date, patient developed a non-serious allergic reaction/red spots on both arms (hypersensitivity)(erythema) (latency was unknown) following the administration of ADACEL. On 20-Oct-2018, the patient visited doctor for red spots on both arm. No lab data was reported. Final diagnosis was she had an allergic reaction/red spots on both arms. It was not reported if the patient received a corrective treatment. The outcome was Unknown for she had an allergic reaction/red spots on both arms. List of documents held by sender: none.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RVX
Symptoms: Product preparation issue
Clinical narrative: Initial information received on 14-Nov-2018 regarding an unsolicited valid non-serious case received from a physician. This case involves a five-months old male patient who received only the liquid portion of the PENTACEL, while he received vaccine PENTACEL. Concomitant medications included PREVNAR 13 for Immunisation; and ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) for Immunisation. On 09-Nov-2018, the patient received a once dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot C5518AA in the right thigh (It was reported that the vaccine was administered in right vastus). It was actual medication error due to Inappropriate reconstitution technique. (It was reported that patient who received only the liquid portion of the PENTACEL). It was not reported that 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: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Skin disorder
Clinical narrative: Initial information received on 14-Nov-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves an unknown age female patient who experienced uneven skin and injection site pain, redness and itching, 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 04-Oct-2018, the patient received 0.5 ml dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot number not reported. On an unspecified date, the patient developed a non-serious uneven skin, unknown latency following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. On an unspecified date, the patient developed a non-serious injection site pain, redness and itching unknown latency following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. (Other relevant tests included no lab test.) Final diagnosis was injection site pain, redness and itching and uneven skin. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for injection site pain, redness and itching and as Unknown for uneven skin. List of documents held by sender: none.
Sex: F
Vaccine: HIBV
Symptoms: Product preparation issue
Clinical narrative: Initial information received on 14-Nov-2018 regarding an unsolicited valid non-serious case received from a heath care professional (MA). This case involves a six months old female patient who was inadvertently received 0.4% NaCl diluent and not the powder, while she received vaccine ACT-HIB.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. On 14-Nov-2018, the patient received a dose of 0.6 ml of only diluent of suspect HIB (PRP/T) VACCINE (lot number: U6074AAand expiry date: 27-Oct-2019) via intramuscular route in the left thigh. It was a case of actual medication error due to Product preparation error and overdose. No known symptoms. 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: 0.83
Sex: F
Vaccine: FLU4
Symptoms: Incorrect dose administered
Clinical narrative: Initial information received on 14-Nov-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 10 months old female patient who was administered 0.5 ml dose as the second dose in series for routine vaccination, while she received vaccine FLUZONE QUADRIVALENT instead of 0.25 ml. The patient received first dose of FLUZONE QUADRIVALENT 0.25 ml on 17-Oct-2018. The patient's past medical history, medical treatment(s), and family history were not provided. No concomitant vaccines were given. On 14-Nov-2018, the patient received a dose of 0.5 ml suspect INFLUENZA QUADRIVAL A-B VACCINE (lot number: U6260BA and expiry date: 30-Jun-2019) via intramuscular route in the left thigh. It was a case of actual medication error due to overdose. It was not reported if any 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 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: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Wrong product administered
Clinical narrative: Initial information received on 14-Nov-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 61 years old female patient and reported that the consumer was supposed to get a PNEUMOVAX instead of a Flu shot and inappropriate age at vaccine administration, while she received vaccine FLUZONE HIGH DOSE. The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. On 14-Nov-2018, the patient received a 2nd dose of 0.5 ml suspect Influenza USP Trival A-B High Dose Subvirion Vaccine (lot number: UJ047AA) Suspension for injection in pre-filled syringe (expiry date: 28 May 2019, route and site of administration was not reported). The patient received the first dose of FLUZONE HD on 04 Oct 2018. It was a case of actual medication error due to wrong vaccine administered, overdose, extra dose administered and inappropriate age at vaccine administration. 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 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: 34.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Joint range of motion decreased, Product administered at inappropriate site
Clinical narrative: Initial information received on 14-Nov-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 34 years old female patient who experienced difficulty with range of motion of the left arm and had pain in shoulder, while she received vaccine  FLUZONE QUADRIVALENT. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications were not reported. On 15-Oct-2018, the patient received a 0.5 ml dose of suspect Influenza Quadrival A-B Vaccine, lot number not reported via unknown route in the left shoulder joint instead of left deltoid. On an unknown date, the patient developed a non-serious difficulty with range of motion of the left arm (Injected limb mobility decreased) and had pain in shoulder (shoulder pain) following the administration of Influenza Quadrival A-B Vaccine. It was a case of actual medication error due to vaccine administered at inappropriate site. (Other relevant tests included No lab data). Final diagnosis was difficulty with range of motion of the left arm and pain in shoulder. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for difficulty with range of motion of the left arm and pain in shoulder. 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 15-Nov-2018 regarding an unsolicited valid non-serious case received from a healthcare professional. This case involves a 31 months old patient who was vaccinated with a 0.5 ml dose of FLUZONE QUADRIVALENT (lot UJ045AA; expiry date: not reported) via intramuscular route in the right thigh on 14-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 overdose. It was not reported whether the patent had any adverse reactions. On 14-Nov-2018, the patient had a doctor visit. 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.
Sex: U
Vaccine: FLU3
Symptoms: Increased upper airway secretion
Clinical narrative: Initial information received on 13-Nov-2018 regarding an unsolicited valid non-serious case received from a physician. This case involves an elderly patient who developed secretions in his throat, while he/she received 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. On an unknown date, the patient developed a non-serious secretions in his throat (Increased upper airway secretion) following the administration of Influenza USP Trival A-B High Dose Subvirion Vaccine. No lab data reported. Final diagnosis was secretions in his throat. It was not reported if the patient received a corrective treatment. The patient outcome is reported as unknown for secretions in his throat.
Sex: M
Vaccine: FLU4
Symptoms: Rash generalised
Clinical narrative: Initial information received on 15-Nov-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case is linked to case 2018SA317816 same reporter. This case involves a 57 years male patient who experienced rash all over, while he received vaccine FLUZONE QUADRIVALENT. 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 Quadrival A-B Vaccine lot number not reported. On an unknown date, the patient developed a non-serious rash all over (rash) few days later following the administration of Influenza Quadrival A-B Vaccine. Other relevant tests included no lab data. Final diagnosis was rash all over. It was not reported if the patient received a corrective treatment. The outcome of the event was not reported. List of documents held by sender- none.
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Loss of consciousness
Clinical narrative: Initial information received on 09-Nov-2018 regarding an unsolicited valid serious case received from an Office Staff. This case involves female patient of an unknown age who experienced children passed out, while she received vaccines MENACTRA and ADACEL. 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 MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE and DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (batch number, expiry date, route and site of administration were unknown). On an unknown date, the patient developed a serious children passed out (loss of consciousness) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE and MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE. This event was assessed as medically significant. It was reported that the patient hadn't slept well or eaten anything prior to the visit. State this happened maybe during the summer. Other relevant tests included no lab data. Final diagnosis was children passed out. It was not reported if the patient received a corrective treatment. The outcome of the event was reported as unknown. List of documents held by sender- none. Sender's Comments: This case involves female patient of an unknown age who passed out post vaccination with MENACTRA and ADACEL. Time to onset is unknown. Moreover, it was reported that the patient hadn't slept well or eaten anything prior to the visit and this maybe during the summer which could be the possible cause of the event. Additional information including patient's medical history, history of similar episode, lab test excluding alternate etiology is needed to complete assessment. Based upon the reported information, the role of the vaccine cannot be assessed.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Pyrexia
Clinical narrative: Fever, chills, fatigue, headache.
Age: 65.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Headache, Respiratory tract congestion
Clinical narrative: Patient came to me 11/19 about 5:00pm stating  that he feels like he as been having a reaction to the vaccine. He states he started getting a headache the next day after administration and it keeps getting worse. I asked him if he was taking anything for the reaction. He said he was taking some over the counter phenylephrine. I told him he needed to be doing an antihistamine and some Advil if able to tolerate those medications. He said he was also feeling very congested following administration. He was not willing to do the Advil or antihistamine and walked off.
Age: 38.0
Sex: F
Vaccine: FLUC4
Symptoms: Pain, Pain in extremity, Product administered at inappropriate site
Clinical narrative: Seasonal flu shot (not sure what type). Injection was done too high on my arm and I have had pain since the shot. I am unable to lift my arm or move it backward without pain. I think that this is SIRVA due to the injection being done wrong.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Wrong product administered
Clinical narrative: This spontaneous report was received from the nurse referred to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unspecified date, the patient was vaccinated with VARIVAX (lot: R006221; expiry date: 29-FEB-2020) intramuscularly in the left arm instead of SHINGRIX (wrong product administered). No adverse effects reported.
Age: 11.0
Sex: M
Vaccine: FLU4, HPVX, IPV, MNQ, TDAP, VARCEL
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Initial information received on 13-Nov-2018 regarding an unsolicited valid non-serious case received from an other health professional. This case involves an 11 years old male patient who accidently received 0.25 ml dose of vaccine, FLUZONE QUADRIVALENT (Suspension for injection). The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included HPV Vaccine for Immunisation; IPV for Immunisation; MENACTRA for Immunisation; Varicella Vaccine for Immunisation; and TDAP for Immunisation. On 12-Nov-2018, the patient received a single 0.25 ml instead of 0.5 mL dose of suspect Influenza Quadrival A-B Vaccine, lot UT6259KA (expiry date: 30-Jun-2019) via intramuscular route in the left arm. It was a case of actual medication error due to accidental underdose. It was reported that 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 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: FLU4
Symptoms: Product administered at inappropriate site
Clinical narrative: Initial information received on 13-Nov-2018 regarding an unsolicited valid non-serious case received from other health professional. This case involves patient of an unknown demographics who received vaccine FLUZONE QUADRIVALENT (batch number, expiry date, route and site of administration were not reported) on an unknown date. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was actual medication error due to wrong injection technique. It was reported that received Flu shot FLUZONE QIV felt it was not injected properly into Deltoid muscle. (was injected into head of deltoid/ most proximal aspect). It was unknown if any adverse event was 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 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: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Extra dose administered
Clinical narrative: Initial information received on 12-Nov-2018 regarding an unsolicited valid non-serious case received from other healthcare professional. This case involves a 66 years old male patient who was inadvertently given a second dose of FLUZONE HIGH DOSE lot UJ044AB and Exp. date 04-JUN-2019 via intramuscular route in unknown administration site(extra dose administered), on 12-Nov-2018 and on 10-Nov-2018, the patient received a first dose. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was as actual medication error case due extra dose administered. It was unknown whether the patient had any adverse reactions. 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: 65.0
Sex: M
Vaccine: FLUR4, PNC13
Symptoms: Product storage error
Clinical narrative: Initial unsolicited report received regarding an unsolicited valid non-serious case from other health professional on 13-Nov-2018. This case was linked to 2018SA315878, 2018SA315888, 2018SA315885, 2018SA315886, 2018SA315887, 2018SA315882 and 2018SA315884 (same reporter). This case involves a 65 years old male patient who was vaccinated with a dose of FLUBLOK QIV, (lot QFAA1815, expiry date: 30 Jun 2019) via intramuscular route in the right deltoid, on 07-Nov-2018. The patient's medical history was not reported. Concomitant medication includes PREVENAR 13 on 07 Nov 2018. It was an actual medication error due to incorrect product storage as vaccines were exposed to a max temp of 52 F for 27 hours. It was unknown if patient had 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: TDAP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Initial information received on 15-Nov-2018 regarding an unsolicited valid non-serious case received from an other health professional. This case involves an eight years old female patient who was accidently vaccinated with a 0.5 ml dose of vaccine ADACEL (lot U6069BA and Exp. Date not reported) via intramuscular route in the left thigh on 14-Nov-2018. The patients medical history and concomitant medications were not reported. It was an actual medication error case due to inappropriate age at vaccine administration. 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: 21.0
Sex: M
Vaccine: RAB
Symptoms: Expired product administered
Clinical narrative: Initial information received on 15-Nov-2018 regarding an unsolicited valid non-serious case received from a consumer (Pharmacy Intern). This case involves a 21 years old male patient who was vaccinated with a first dose of IMOVAX RABIES](site of administration: intramuscular, batch number, expiration date and route was not reported) on 11-Nov-2018. The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included IMMUNOGLOBULINS. It was an actual medication error due to expired vaccine used. The consumer received an expired dose of IMOVAX. It was unknown whether patient experienced any adverse event 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 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: 78.0
Sex: M
Vaccine: FLU3
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Initial information received on 15-Nov-2018 regarding an unsolicited valid non-serious case received from other healthcare professional. This case involves a 78 years old male patient who was vaccinated with a 0.5 ml second dose of FLUZONE HIGH DOSE (lot UI994AA; expiry date: 09-Apr-2019) via intramuscular route in the left deltoid on 15-Nov-2018. It was also reported that the patient was vaccinated with a first dose of the same suspect (lot number and expiry date was not reported) on 18-Sep-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. No other vaccine was administered. It was a case of actual medication error due to extra dose administered (Consumer received two FLUZONE HD in one season, inadvertently). No reaction reported, not treatment needed. 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: 11.0
Sex: F
Vaccine: DTAP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Initial information received on 15-Nov-2018 regarding an unsolicited valid non-serious case received from a non-health care professional (Office Staff). This case involves a 11 years old female patient who received vaccine DAPTACEL instead of vaccine ADACEL. The patients past medical history, concomitant medication and family history were not provided. On 14-Nov-2018, the patient received a 0.5ml dose of suspect DAPTACEL lot C5254AB, expiry date 15-Sep-2019 via intramuscular route in the left deltoid instead of suspect ADACEL lot number not reported. It was an actual medication error due to wrong vaccine administered and inappropriate age at vaccine administration. It was reported that 11-year-old patient received an injection of DAPTACEL when they should have received ADACEL. It was unknown whether patient experienced 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 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: 58.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Arthralgia, Asthenia, Headache, Myalgia, Nausea
Clinical narrative: Extreme pain in muscles and joints, Headaches, Nausea, weakness. Symptoms started 12 hrs after injections and lasted 12 hrs. and subsided as quickly as onset.
Age: 78.0
Sex: F
Vaccine: FLUA3
Symptoms: Blood test normal, Loss of personal independence in daily activities, Middle insomnia, Mobility decreased, Musculoskeletal pain
Clinical narrative: 30 minutes after shot arm starting getting really sore. Later that evening severe pain in arm from shoulder to elbow. Severe pain all night and half of next day. For 3 days could not raise arm. Slowly things got better except shoulder. Can't do certain exercises at gym and still wake up at night with shoulder hurting.
Age: 78.0
Sex: F
Vaccine: FLUA3
Symptoms: Pain in extremity
Clinical narrative: 30 minutes after shot arm starting getting really sore. Later that evening severe pain in arm from shoulder to elbow. Severe pain all night and half of next day. For 3 days could not raise arm. Slowly things got better except shoulder. Can't do certain exercises at gym and still wake up at night with shoulder hurting.