chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 4.0
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Expired product administered
Clinical narrative: have administered an expired Pentacel with no reported adverse event; Initial information received on 27-Jul-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 4 years old female patient who was administered an expired Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(MRc5)/HIB(PRP/T) Vaccine [Pentacel] with no reported adverse event.  Concomitant medications included MEASLES VACCINE LIVE (ENDERS-EDMONSTON), MUMPS VACCINE LIVE (JERYL LYNN), RUBELLA VACCINE LIVE (WISTAR RA 27/3), VARICELLA ZOSTER VACCINE LIVE (OKA/MERCK) (PROQUAD) for Immunisation; and PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) for Immunisation.  On 26-Jul-2022, the patient received a 3rd dose (0.5ml, Once) of suspect Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(MRc5)/HIB(PRP/T) Vaccine (lot UJ530AAA, expiry date: 10-Jul-2022; strength: Standard, formulation: unknown) via intramuscular route in the right thigh for immunization.  On 26-Jul-2022, (latency: same day) the patient was administered an expired pentacel with no reported adverse event (expired product administered).  First time product used: No  Still using product: No  Action taken: Not applicable.  Outcome: Unknown.  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 the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: M
Vaccine: RAB
Symptoms: Inappropriate schedule of product administration, Incomplete course of vaccination
Clinical narrative: patient received 2 doses of the rabies vaccine back in 1975, but he did not complete the 3 doses, with no adverse event; Initial information received on 27-Jul-2022 regarding an unsolicited valid non-serious case received from nurse.  This case involves an unknown age male patient who experienced patient received 2 doses of the rabies vaccine back in 1975, but he did not complete the 3 doses, with no adverse event while receiving vaccine rabies vaccine.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.   On an unknown date in 1975, the patient received suspect rabies vaccine produced by unknown manufacturer at an unknown dose (lot number, expiry date, form, strength: not reported) via unknown route in unknown administration site for immunisation.  On an unknown date the patient received 2 doses of the rabies vaccine back in 1975, but he did not complete the 3 doses, with no adverse event (inappropriate schedule of product administration) (unknown latency).  Nurse was inquiring if the patient can have a booster of IMOVAX or if the complete series needs to be administered. The patient was unsure of what rabies vaccine they received in 1979. The nurse indicated that the doses were already drawn up and she may give the booster as 47 years has passed.  Action taken: Not applicable.  Outcome: Unknown for the event patient received 2 doses of the rabies vaccine back in 1975, but he did not complete the 3 doses, with 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 the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 12.0
Sex: F
Vaccine: MNQ
Symptoms: Extra dose administered, No adverse event
Clinical narrative: was mistakenly given another dose of Menactra with no reported adverse event; Initial information received on 27-Jul-2022 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 12 year old female patient who was mistakenly given another dose of meningococcal A-C-Y-W135 (D CONJ) vaccine (Menactra) with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.  On an unknown date in 2021(last year), the patient received Menactra at an unknown dose (lot number and expiry date, form, strength: not reported) via unknown route in unknown administration site for immunization. On 14-Jul-2022, the patient was mistakenly given another dose of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE at a dose of 0.5 ml total (lot U7492AA, expiry date: 26-Oct-2023) via intramuscular route in the left deltoid for immunization with no adverse event(latency: same day). Caller stated that the patient had provided a vaccine record from out of state and a note from the school stating that she needed Tdap and Menactra. Employee gave the vaccines to the patient and then realized that the patient had received those vaccines last year.  Action taken: Not applicable.  Outcome: Unknown for the event menactra last year and was mistakenly given another dose of vaccines with no reported 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 the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 0.67
Sex: M
Vaccine: UNK
Symptoms: Product preparation error
Clinical narrative: a medication error with PENTACEL described as only the liquid DTap-IPV portion was given and not the Hib portion due to the products not being mixed with no reported adverse event; Initial information received on 27-Jul-2022 regarding an unsolicited valid  non-serious case received from a nurse .  This case involves a 8 months old male patient and it reported a medication error with Pentacel described as only the liquid Dtap-ipv portion was given and not the hib portion due to the products not being mixed with no reported adverse event , for receiving vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ (PNEUMOCOCCAL CONJUGATE VACCINE).  On 25-Jul-2022, the patient received  a dose of 0.5 ml (once) of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE , (lot: UJ577AA ; expiry date: 10-Sep-2022)   in unknown administration site for immunization.  It was reported that a medication error with Pentacel described as only the liquid dtap-ipv portion was given and not the hib portion due to the products not being mixed with no reported adverse event (product preparation error) following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE.  Action taken: not applicable.  Outcome: unknown   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 the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 6.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: 6 year old patient being behind on vaccination schedule and being administered QUADRACEL as her 4th DTAP dose instead of her 5th DTAP dose with no reported adverse event; Initial information received on 27-Jul-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 6 years old female patient who was being behind on vaccination schedule and being administered DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] as her 4th dtap dose instead of her 5th dtap dose with no reported adverse event.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS A VACCINE (HEPA [HEPATITIS A VACCINE]) for Prophylactic vaccination; and MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) for Prophylactic vaccination.  On 27-Jul-2022, the patient received a 0.5ml dose of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE(formulation, strength was unknown, lot UJ570AA and expiry date was unknown) via intramuscular (Vastus lateralis ) route (unsure of which side) in the thigh nos for Immunization. Information regarding batch and expiry date was unknown.  On 27-Jul-2022 the patient developed a non-serious 6 year old patient being behind on vaccination schedule and being administered quadracel as her 4th dtap dose instead of her 5th dtap dose with no reported adverse event (inappropriate schedule of product administration, latency: unknown) following the administration of DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE.  Action taken : not applicable.  Outcome: Unknown  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 the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: No adverse event, Poor quality product administered, Product storage error
Clinical narrative: excursion lasted for 2 hours and 20 minutes. The minimum temperature of the refrigerator reached 29.1 degrees Fahrenheit with no reported adverse event; MENACTRA was given to patient post excursion with no adverse event; Initial information received on 27-Jul-2022 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 16 years old female patient who reported excursion lasted for 2 hours and 20 minutes. the minimum temperature of the refrigerator reached 29.1 degrees fahrenheit with no reported adverse event and menactra was given to patient post excursion with no adverse event while receiving vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included althaea officinalis root, cinnamomum camphora essential oil, citrus aurantium oil, eucalyptus globulus leaf essential oil, mentha x piperita essential oil (GARDISIL); and diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (TDAP) for Prophylactic vaccination.  On 26-Jul-2022, the patient received suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE at a dose of 0.5 ml once (lot U7483AB, expiry date: 20-Oct-2023) via intramuscular route in the left arm for immunisation.  On an unknown date there was excursion that lasted for 2 hours and 20 minutes. The minimum temperature of the refrigerator reached 29.1 degrees fahrenheit with no reported adverse event (product storage error) (unknown latency) following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE. On 26-Jul-2022 the patient developed a non-serious menactra was given to patient post excursion with no adverse event (poor quality product administered, latency same day).  Action taken: Not applicable.  At time of reporting, the outcome was Unknown for the event excursion lasted for 2 hours and 20 minutes. the minimum temperature of the refrigerator reached 29.1 degrees fahrenheit with no reported adverse event and was Unknown for the event menactra was given to patient post excursion with 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 the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: M
Vaccine: MNQ
Symptoms: No adverse event, Product storage error
Clinical narrative: the minimum temperature of the refrigerator reached 29.1 degrees fahrenheit/excursion lasted for 2 hours and 20 minutes with no reported adverse event; Menactra was given to patient post excursion with no reported adverse event; Initial information received on 27-Jul-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 13 years old male patient  and it was reported that the minimum temperature of the refrigerator reached 29.1 degrees fahrenheit/excursion lasted for 2 hours and 20 minutes with no reported adverse event for the vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] and Menactra was given to patient post excursion with no reported adverse event vaccine   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 26-Jul-2022, the patient received a  first dose of 0.5 ml of  suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE, once,  (lot: U7483AB; 20-Oct-2023)  via intramuscular route in the left arm for immunization and tuberculin test (TB test).   On an unknown date , the minimum temperature of the refrigerator reached 29.1 degrees fahrenheit/excursion lasted for 2 hours and 20 minutes with no reported adverse event (product storage error) (latency: unknown) . The data logger did not go off.  The patient was administered the vaccine of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE post excursion (onset date: 26-Jul-2022; latency: same day)  Action taken: not applicable.  Outcome: unknown   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 the guidelines. 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: UNK
Symptoms: Expired product administered, No adverse event
Clinical narrative: 2-month-old patient was given expired Pentacel vaccine with no reported adverse event; Initial information received on 27-Jul-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 2 months old and unknown gender patient was given expired diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (Vero)] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient was given an expired dose of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine, suspension for injection (dose, strength and lot number not reported; expiry date: 22-Jul-2022) via unknown route in unknown administration site for immunization with no reported adverse event (expired product administered) (unknown latency).  Action taken : not applicable.  Outcome : Unknown.   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 the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 62.0
Sex: F
Vaccine: HIBV
Symptoms: No adverse event, Off label use, Product prescribing issue
Clinical narrative: adult patient who is going to be having surgery, and the doctor wrote a prescription for the patient to get one 0.5 mL dose of acthib prior to the surgery,with no reported adverse event; adult patient who is going to be having surgery, and the doctor wrote a prescription for the patient to get one 0.5 mL dose of acthib prior to the surgery,with no reported adverse event; Initial information received on 27-Jul-2022 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves a 62 years old female patient who experienced adult patient who is going to be having surgery, and the doctor wrote a prescription for the patient to get one 0.5 ml dose of acthib prior to the surgery,with no reported adverse event and adult patient who is going to be having surgery, and the doctor wrote a prescription for the patient to get one 0.5 ml dose of acthib prior to the surgery,with no reported adverse event while receiving vaccine HIB (PRP/T) VACCINE [ACT-HIB].  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 0.5ml dose of suspect HIB (PRP/T) VACCINE  (0.5 mL 1X) (strength, formulation, route,lot number not reported) in unknown administration site for prophylactic vaccination.  On an unknown date the patient reported adult patient who is going to be having surgery, and the doctor wrote a prescription for the patient to get one 0.5 ml dose of acthib prior to the surgery,with no reported adverse event (product prescribing issue) and  (off label use)(unknown latency) following the administration of HIB (PRP/T) VACCINE.  Action taken: not applicable.   At time of reporting, the outcome was Unknown for 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 the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 7.0
Sex: M
Vaccine: IPV
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: expired IPOL was accidentally given with no reported adverse event; Initial information received on 27-Jul-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 7 years old male patient who was administered expired ipol was accidentally with no reported adverse event after receiving vaccine IPV (VERO) [IPOL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) for Immunisation; VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) for Immunisation; and HEPATITIS A VACCINE (HEPATITIS A) for Immunisation.  On 27-Jul-2022, the patient received a  total dose of suspect IPV (VERO)( lot T1D482M and expiration date: 25-Jul-2022) at a dose of 0.5ml once via unknown route in the right deltoid as prophylactic vaccination.  On 27-Jul-2022 (latency: same day), the patient developed a non-serious event of expired ipol was accidentally given with no reported adverse event  (expired product administered) following the administration of IPV (VERO).  Action taken: Not applicable.  Outcome: Unknown   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 the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Arthralgia, Chills, Dysphagia, Ear infection, Eye swelling
Clinical narrative: body aches; Swelling; neck pain; hives; increase in eye and face swelling; increase in eye and face swelling; It was hard to swallow; face was swollen; eye swelling; ear infection; malaise; Joint pain; chills and fever; muscle pain; bad headaches; Initial information received on 28-Jul-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case involves a 17 years old female patient who noticed that it was hard to swallow, face was swollen, eye swelling, ear infection, body aches, swelling, neck pain, malaise, hives, joint pain, chills and fever, muscle pain and bad headaches while receiving vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA].  The patient's past vaccination(s) included MENACTRA in 2016 with no issues. The patient's past medical history, medical treatment(s) and family history were not provided.   On 12-Jul-2022, the patient received a dose of 0.5 ml of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE, injection (strength: unknown) lot U7273BA via intramuscular route in the left shoulder as Immunization.  On 13-JUL-2022, within 12 hours, the patient had malaise, joint pain (arthralgia), chills and fever (pyrexia), muscle pain (myalgia) bad headaches (headache)1 day following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE.  On 15-JUL-2022 the face was swollen (swelling face) eye swelling, ear infection 3 days following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE. The patient went to doctor with the swelling and they stated that it looks like an ear infection and was prescribed amoxicillin.  Doctor visit on 15JUL2022 and given Amoxicillin, Benadryl, Advil, Zyrtec.  On 16-JUL-2022 , it was hard to swallow (dysphagia) 4 days following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE. The patient went to Went to Emergency room due to this and they gave 80 mg injection prednisone. and discharged home with prednisone. Still having symptoms 2nd doctors visit on 19JUL2022 and was given famotidine and kidney function test performed(came back normal). Doctor recommended consult to infectious disease and ER if symptoms worsened  On 19-JUL-2022 the patient had increase in eye and face swelling (condition aggravated) 7 days following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE.  On 22-JUL-2022 the patient had body aches (pain) swelling, neck pain and hives (urticaria) 10 days following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE.  Relevant laboratory test results included: Renal function test - On 19-Jul-2022: [normal]  Action taken was not applicable.  The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]), IBUPROFEN (ADVIL [IBUPROFEN]), CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]), AMOXICILLIN (AMOXICILLIN) for Eye swelling, Swelling face and Ear infection, PREDNISONE (PREDNISONE) for Dysphagia and FAMOTIDINE (FAMOTIDINE).  At time of reporting, the outcome was Not Recovered / Not Resolved for all.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Headache, Malaise, Myalgia, Neck pain, Pain
Clinical narrative: body aches; Swelling; neck pain; hives; increase in eye and face swelling; increase in eye and face swelling; It was hard to swallow; face was swollen; eye swelling; ear infection; malaise; Joint pain; chills and fever; muscle pain; bad headaches; Initial information received on 28-Jul-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case involves a 17 years old female patient who noticed that it was hard to swallow, face was swollen, eye swelling, ear infection, body aches, swelling, neck pain, malaise, hives, joint pain, chills and fever, muscle pain and bad headaches while receiving vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA].  The patient's past vaccination(s) included MENACTRA in 2016 with no issues. The patient's past medical history, medical treatment(s) and family history were not provided.   On 12-Jul-2022, the patient received a dose of 0.5 ml of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE, injection (strength: unknown) lot U7273BA via intramuscular route in the left shoulder as Immunization.  On 13-JUL-2022, within 12 hours, the patient had malaise, joint pain (arthralgia), chills and fever (pyrexia), muscle pain (myalgia) bad headaches (headache)1 day following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE.  On 15-JUL-2022 the face was swollen (swelling face) eye swelling, ear infection 3 days following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE. The patient went to doctor with the swelling and they stated that it looks like an ear infection and was prescribed amoxicillin.  Doctor visit on 15JUL2022 and given Amoxicillin, Benadryl, Advil, Zyrtec.  On 16-JUL-2022 , it was hard to swallow (dysphagia) 4 days following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE. The patient went to Went to Emergency room due to this and they gave 80 mg injection prednisone. and discharged home with prednisone. Still having symptoms 2nd doctors visit on 19JUL2022 and was given famotidine and kidney function test performed(came back normal). Doctor recommended consult to infectious disease and ER if symptoms worsened  On 19-JUL-2022 the patient had increase in eye and face swelling (condition aggravated) 7 days following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE.  On 22-JUL-2022 the patient had body aches (pain) swelling, neck pain and hives (urticaria) 10 days following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE.  Relevant laboratory test results included: Renal function test - On 19-Jul-2022: [normal]  Action taken was not applicable.  The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]), IBUPROFEN (ADVIL [IBUPROFEN]), CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]), AMOXICILLIN (AMOXICILLIN) for Eye swelling, Swelling face and Ear infection, PREDNISONE (PREDNISONE) for Dysphagia and FAMOTIDINE (FAMOTIDINE).  At time of reporting, the outcome was Not Recovered / Not Resolved for all.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Pyrexia, Renal function test normal, Swelling, Swelling face, Urticaria
Clinical narrative: body aches; Swelling; neck pain; hives; increase in eye and face swelling; increase in eye and face swelling; It was hard to swallow; face was swollen; eye swelling; ear infection; malaise; Joint pain; chills and fever; muscle pain; bad headaches; Initial information received on 28-Jul-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case involves a 17 years old female patient who noticed that it was hard to swallow, face was swollen, eye swelling, ear infection, body aches, swelling, neck pain, malaise, hives, joint pain, chills and fever, muscle pain and bad headaches while receiving vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA].  The patient's past vaccination(s) included MENACTRA in 2016 with no issues. The patient's past medical history, medical treatment(s) and family history were not provided.   On 12-Jul-2022, the patient received a dose of 0.5 ml of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE, injection (strength: unknown) lot U7273BA via intramuscular route in the left shoulder as Immunization.  On 13-JUL-2022, within 12 hours, the patient had malaise, joint pain (arthralgia), chills and fever (pyrexia), muscle pain (myalgia) bad headaches (headache)1 day following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE.  On 15-JUL-2022 the face was swollen (swelling face) eye swelling, ear infection 3 days following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE. The patient went to doctor with the swelling and they stated that it looks like an ear infection and was prescribed amoxicillin.  Doctor visit on 15JUL2022 and given Amoxicillin, Benadryl, Advil, Zyrtec.  On 16-JUL-2022 , it was hard to swallow (dysphagia) 4 days following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE. The patient went to Went to Emergency room due to this and they gave 80 mg injection prednisone. and discharged home with prednisone. Still having symptoms 2nd doctors visit on 19JUL2022 and was given famotidine and kidney function test performed(came back normal). Doctor recommended consult to infectious disease and ER if symptoms worsened  On 19-JUL-2022 the patient had increase in eye and face swelling (condition aggravated) 7 days following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE.  On 22-JUL-2022 the patient had body aches (pain) swelling, neck pain and hives (urticaria) 10 days following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE.  Relevant laboratory test results included: Renal function test - On 19-Jul-2022: [normal]  Action taken was not applicable.  The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]), IBUPROFEN (ADVIL [IBUPROFEN]), CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]), AMOXICILLIN (AMOXICILLIN) for Eye swelling, Swelling face and Ear infection, PREDNISONE (PREDNISONE) for Dysphagia and FAMOTIDINE (FAMOTIDINE).  At time of reporting, the outcome was Not Recovered / Not Resolved for all.
Sex: M
Vaccine: MENB, MNQ
Symptoms: Medication error, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Menactra given to each patient other that they are currently around 60 years of age with no reported adverse event; Initial information regarding an unsolicited valid non-serious case received via health professional on 28-Jul-2022. (Agency Inquiry Number: 01211040)  This case involves adult male currently around 60 years of age who received vaccine Bexsero and Meningococcal A-C-Y-W135 (D CONJ) Vaccine [Menactra] given to each patient with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Related case ID 2022SA312085 for second patient.  Concomitant medications included Octinoxate, Octocrilene (Solaris) for Immunization.  On an unknown date in 2020, the patient currently around 60 years of age  received a 1 dosage form of suspect Menactra vaccine and 1 dosage form of suspect Bexsero not produced by Sanofi Pasteur at (unknown: formulation, strength, lot number, route in unknown administration site) as prophylactic vaccination (product administered to patient of inappropriate age) at same day latency. No adverse event was reported. Lot numbers were requested.  It was reported that "Caller had 2 male patients who were on Solaris and would be going switch to Ultomiris, which would pose an increased risk for meningitis. Both patients received 1 dose of MENACTRA and 1 dose of Bexsero 2 years ago and that they never received their second doses. Caller stated she thinks that both patients need to repeat the entire series because the guidelines state that a booster was recommended at different years after vaccination but that these 2 patients were never fully vaccinated. Caller stated it is unknown why neither patient received their second dose. Caller stated: Can you just confirm that they need to have the full series and the ACWY (full form not reported) says at least 8 weeks after day zero, because if you just get 1 dose of those, it's not truly a booster since they were not fully vaccinated. Off label use for Menactra due to age. There was no specific information on each patient other that they are currently around 60 years of age and received the dose within the past 2 to 3-years. The patients are immunocompromised and following guidelines for the medication Ultomiris (ravulizumab-cwvz) and being at higher risk for meningitis."  Action taken: Not applicable.  At time of reporting, the outcome was Unknown for the 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 the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 8.0
Sex: F
Vaccine: IPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired IPOL was accidentally given with no reported adverse event; Initial information received on 28-Jul-2022 regarding an unsolicited valid  non-serious case received from a nurse.  This case is linked to case 2022SA311619.  This case involves a 8 years old female patient to whom  expired IPV (VERO) [IPOL] was accidentally given with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included measles vaccine, mumps vaccine, rubella vaccine (MMR) and varicella zoster vaccine (varicella vaccine) for Immunization.  On 27-Jul-2022, the patient received 0.5ml  dose of suspect IPV (VERO) once, suspension for injection, (strength: unknown) (lot T1D482M and expiration date: 25-Jul-2022) via unknown route in the left deltoid for immunization was accidentally given with no reported adverse event (expired product administered) (latency: same day).  Action taken : not applicable.  Outcome: unknown.   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 the guidelines. 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: IPV
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: had given an expired dose of Ipol, with no reported adverse event; Initial information received on 28-Jul-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a patient of unknown demographics who had given an expired dose of ipol, with no reported adverse event while receiving vaccine IPV (VERO) [IPOL].  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 0.5 ml of suspect IPV (VERO) (formulation, strength: unknown) lot number not reported in unknown administration site as immunization. Lot number was requested.  On an unknown date the patient had given an expired dose of ipol, with no reported adverse event (expired product administered) (unknown latency) following the administration of IPV (VERO).The nurse wanted what are the recommendations for course of action.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (had given an expired dose of Ipol, with no reported adverse event).  At time of reporting, the outcome was Unknown for the event had given an expired dose of ipol, with no reported 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 the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 0.5
Sex: F
Vaccine: TD
Symptoms: Accidental exposure to product, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: tenivac was inadvertently given to a 6 month old patient with no adverse event; Initial information received on 28-Jul-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 6 months old female patient and it was reported that tenivac (DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT) was inadvertently given to a 6 month old patient with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, HEPATITIS B VACCINE RHBSAG (YEAST), PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, POLIO VACCINE INACT 3V (VERO), TETANUS VACCINE TOXOID (PEDIARIX) for Immunisation; PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) for Immunisation; ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) for Immunisation; and HIB VACCINE CONJ (OMPC) (PEDVAXHIB) for Immunisation.  On 28-Jul-2022, the patient received a  dose of 0.5 ml of suspect DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT (formulation, strength: unknown) lot U7092AA, expiration date: 24-Jun-2023, via intramuscular route in the left thigh as immunization.  On 28-JUL-2022 the tenivac was inadvertently given to a 6 month old patient with no adverse event (accidental exposure to product) same day following the administration of DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the 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 the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 17.0
Sex: F
Vaccine: IPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: On Ipol, patient was administered an expired dose of IPOL with no reported adverse event; Initial information received on 29-Jul-2022 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 17 years old female patient who was administered an expired dose of IPV (VERO) (IPOL) with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) for Prophylactic vaccination.  On 27-Jul-2022, the patient received suspect IPV (VERO) at a dose of 0.5 ml (lot T1D48, expiry date: 25-Jul-2022) via intramuscular route in the left deltoid for immunisation.  On 27-Jul-2022 the patient was administered an expired dose of ipol with no reported adverse event (expired product administered)(same day latency).  Action taken: Not applicable.  Outcome: Unknown.   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 the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 64.0
Sex: M
Vaccine: TD
Symptoms: Expired product administered, No adverse event
Clinical narrative: given an expired Tenivac to a patient with no reported adverse event; Initial information received on 29-Jul-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 64 years old male patient and it was reported that an expired Tenivac to a patient with no reported adverse event , and the case involves a vaccine DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. No other concomitant was used   On 29-Jul-2022, the patient received a  dose of 0.5 ml  of  suspect DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT, (frequency: once) ( lot: U6669AA ; expiry date: 15-May-2022)  via intramuscular route in the left deltoid for immunization.  It was reported that on 29-Jul-2002,   an expired Tenivac was given to a patient with no reported adverse event (expired product administered) (latency: same day)  Action taken : not applicable.  Outcome: unknown  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 the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Medication error, No adverse event, Product preparation issue
Clinical narrative: liquid portion of PENTACEL being given without the Hib portion, with no reported adverse event; Initial information received on 29-Jul-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 6 months old female patient who was administered liquid portion of pentacel being given without the hib portion, with no reported adverse event while receiving vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included PNEUMOCOCCAL VACCINE (PNEUMOCOCCAL VACCINE) for Immunisation; ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ) for Immunisation; and HEPATITIS B VACCINE (HEPATITIS B VACCINE) for Immunisation.  On 14-Jul-2022, the patient received a 2nd or 3rd  dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot UJ590AAA  at a dose of 0.5ml once via intramuscular route in the left thigh for immunization.  On 14-Jul-2022(latency: same day), the patient developed a non-serious event of liquid portion of pentacel being given without the hib portion, with no reported adverse event (product preparation issue) following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE.  Action taken :not applicable.  It was not reported if the patient received a corrective treatment for the event   Outcome: unknown   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 the guidelines. 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.; Sender's Comments:  01213243:
Age: 1.42
Sex: M
Vaccine: DTAPIPV
Symptoms: Wrong product administered
Clinical narrative: was supposed to receive daptacel, but was accidently administered quadracel instead with no reported adverse event; Initial information received on 29-Jul-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 17 months old male patient who was supposed to receive daptacel, but was accidently administered quadracel instead with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HIB VACCINE CONJ (TET TOX) (ACTHIB) for Prophylactic vaccination.  On 29-Jul-2022, the patient received a  dose of 0.5 ml of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE (formulation, strength: unknown) lot C5862BA, expiration date:01-Apr-2023, via intramuscular route in the right thigh as Immunization    On 29-JUL-2022 the patient was supposed to receive daptacel, but was accidently administered quadracel instead with no reported adverse event (wrong product administered) same day following the administration of DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE. Caller was requesting information on whether the dose was valid or will patient need to receive a DTAP dose. This situation was reported as a medication error due to a patient outside of the indicated age group being administered QUADRACEL instead of the ordered DAPTACEL  Action taken was not applicable.  Corrective treatment : None for the event   At time of reporting, the outcome was Unknown for the 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 the 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.