chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 26.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Basedow's disease, Blood test, Goitre, Scan thyroid gland
Clinical narrative: Graves disease; Information has been received from Food And Drug Administration (FDA) on 17-AUG-2022.  This spontaneous report was received from a 26 years old female consumer referring to herself. The patient's concurrent condition included seasonal allergy. The prescriptions, over-the-counter medications, dietary supplements, or herbal remedies being taken at the time of vaccination included loratadine, ibuprofen and ethinylestradiol (+) etonogestrel (NUVARING). The patient had no other illness at the time of vaccination and up to one month. The patient had no chronic or long-standing health conditions.  On an unknown date, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (lot #1602284, expiration date: 26-SEP-2021; dose and strength were unknown) intramuscularly at arm for prophylaxis. On 26-SEP-2019, at 12:20, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (lot #1621934, expiration date: 29-JAN-2022; dose and strength were unknown) intramuscularly at arm for prophylaxis.  On 07-OCT-2019 (also reported as two weeks later after the second dose), at 11:00, the patient's thyroid was swollen. The regular doctor send the patient to get the thyroid scan done and blood work. Later the patient was diagnosed with Graves disease by endocrinology doctor. At the time of reporting, the patient had not recovered from the event of Graves disease. The result/outcome of the event included doctor or other healthcare professional office/clinic visit and disability or permanent damage. The patient had not had an adverse event following any previous vaccine.  The causal relationship between Graves disease and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not provided.  This report was reported as serious by agency due to disability.  As of 07-SEP-2022, all telephone attempts trying to obtain additional information has been unsuccessful.
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: No additional adverse event; Caller reported vaccine administered after temperature excursions.; This spontaneous report was received from a medical assistant regarding to a patient of unspecified age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 17-AUG-2022, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) 0.5 ml, lot #W012166, expiration date: 12-APR-2024, administered subcutaneously (SQ), (strenght was not provided) as prophylaxis (Product storage error).  The improperly stored vaccine underwent a temperature excursion of 10.9 degrees Fahrenheit (F) for 5 hours and 30 minutes without previous excursions.   This is one of several cases received from the same reporter.; Sender's Comments:  US-009507513-2209USA000179: US-009507513-2209USA000350: US-009507513-2209USA000177: US-009507513-2209USA000361: US-009507513-2209USA000374: US-009507513-2209USA000438: US-009507513-2209USA000437:
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event, Product administered at inappropriate site
Clinical narrative: No additional AE; she received her second dose of the GARDASIL 9 vaccine in her buttocks instead of the intramuscular locations in the prescribing information.; received her first dose of the GARDASIL 9 vaccine on 3-MAR-2022, and did not receive the second dose until 01-SEP-2022; This spontaneous report has been received from a consumer and refers to a female patient of an unknown age.  The patient's medical history, concurrent conditions, concomitant therapies and pervious drugs reactions or allergies were not reported. Historical vaccine included Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL).  On 03-MAR-2022, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) administered for prophylaxis (dose description, lot #, expiry date, and route of administration were not provided). On 01-SEP-2022, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose description, lot #, expiry date were not provided) (inappropriate schedule of vaccine administered) intramuscularly in her buttocks instead of the location in the prescribing information as prophylaxis (Vaccine administered at inappropriate site). Patient mentioned that she had not experienced any symptoms (no adverse event). The outcome of the events was not provided.
Age: 0.33
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs were reported; The healthcare worker reported that a patient received improperly stored vaccine.; This spontaneous report has been received from a health care worker, concerning a 4-month-old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions, allergies, and concomitant medications were not provided.  On 18-AUG-2022, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid (valid lot number W004504 [expiration date 16-JUN-2023]) (valid lot number W002562 [expiration date 12-OCT-2023]) (the patient received only one dose, but the health care worker did not specify which actual lot the patient received), for prophylaxis, after a temperature excursion of 11.3 degrees Celsius (C) with a time frame of 34 minutes (min) (product storage error) (dose, vaccination scheme, and frequency were not provided). No previous temperature excursion was reported.   No additional adverse events (AE) were reported.
Age: 0.17
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product prescribing error, Wrong product administered
Clinical narrative: no adverse event; PNEUMOVAX 23 was mistakenly given to a 2 month old instead of Prevnar 13; input error by the prescribing HCP; This spontaneous report was received from other health professional and refers to a 2-month-old patient of unknown gender.  The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 07-SEP-2022, the patient was mistakenly vaccinated with a dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) 0.5 milliliter, lot #U039928, expiration date: 31-JAN-2024 (strength, anatomical location, and route of administration were not provided) administered for prophylaxis, instead of pneumococcal vaccine conj 13v (CRM197) (PREVNAR 13) (wrong vaccine administered). It was stated that this was not a product confusion but an input error by the prescribing health care professional (Product prescribing error). No adverse event was reported.
Age: 15.0
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AEs were reported.; patient received an expired MMRII vaccine today 9/7/2022.; This spontaneous report was received from a medical assistant referring to a 15-year-old patient.  The patient's pertinent medical history, concurrent conditions, previous drug reactions or allergies were not reported. The patient's concomitant medications included sterile diluent (manufacturer unknown).   On 07-SEP-2022, the patient was vaccinated with an expired measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection, 1 dose, lot number T027935, expiration date: 18-AUG-2022, administered subcutaneously for prophylaxis (dose was not provided) (expired product administered).  No additional adverse event (AE) information was provided (no adverse event).
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE details were provided.; patient that was administered PROQUAD after it was involved in a temperature excursion; This spontaneous report has been received from a medical assistant concerning a patient of unknown age and gender. The patient's concurrent conditions, medical history, drug reactions/allergies, and concomitant medications were not provided.  On 06-SEP-2022, the patient was vaccinated with an improperly storage dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live recombinant human albumin (rHA) (PROQUAD) 0.5 ml subcutaneously, administered as prophylaxis, lot number W019626 with expiration date of 19-DEC-2023. The mentioned vaccine underwent an excursion of -9.5 degrees Celsius (C) for 3 hours, and also had a previous temperature excursion of -10.2 C for 1 hour. No additional adverse event details were provided (No adverse event).
Age: 0.33
Sex: F
Vaccine: PPV, RV5, UNK
Symptoms: Pyrexia, Vomiting
Clinical narrative: fever; vomiting; This spontaneous report was received from a physician via a company representative, referring to a 4-month-old female patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 19-APR-2022, the patient was vaccinated with a dose of rotavirus vaccine, live, oral, pentavalent (manufacturer unknown) oral liquid, orally, lot #U037808, expiration date: 26-MAR-2023, (strength was not provided); the patient also was vaccinated with a dose of pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) injection, lot number reported as "EW2019", expiration date: 15-APR-2024, (strength and route of administration were not provided) and with a dose of diphtheria toxoid (+) hepatitis b virus vaccine rhbsag (yeast) (+) hib conj vaccine (ompc) (+) pertussis acellular 5-component vaccine (+) poliovirus vaccine inactivated (vero) (+) tetanus toxoid (VAXELIS) injection, 0.5 milliliter, lot #U7125AA, expiration date: 15-JUL-2024 (strength and route of administration were not provided); all vaccines administered for prophylaxis.  On the same date (19-APR-2022), the patient was taken to emergency room due to fever (body temperature showed 105 (units not provided)) and vomiting. It was reported that the patient was hospitalized on an unspecified date due to the events. On an unknown date in 2022, the patient recovered from the events. No treatment was given for fever or the vomiting.  The causal relationship between fever and vomiting with rotavirus vaccine, live, oral, pentavalent (manufacturer unknown) and pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) was unknown and the causal relationship between the aforementioned events and diphtheria toxoid (+) hepatitis b virus vaccine rhbsag (yeast) (+) hib conj vaccine (ompc) (+) pertussis acellular 5-component vaccine (+) poliovirus vaccine inactivated (vero) (+) tetanus toxoid (VAXELIS) was reported as related.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Expired product administered
Clinical narrative: received an expired dose; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 11-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number unknown, expiry date 30th August 2022) for prophylaxis.   On 1st September 2022, the patient received Menveo. On 1st September 2022, unknown after receiving Menveo, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.       Additional Information: GSK Receipt Date: 2-Sep-2022 Reporter's Comment: Reporter reported that 11 years old patient received the expired dose of Menveo. The reporter consented to follow up. Additional Supportive Information: Patient received expired dose of Menveo which was already expired on 2nd September 2022 which led to expired vaccine used.
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: Minimum temperature in the fridge went down to 34.4 F/ temperature in the fridge went down to 33 or 34 last week; no adverse event; dose administered after excursion; This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (dose administered after excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (Minimum temperature in the fridge went down to 34.4 F/ temperature in the fridge went down to 33 or 34 last week) and NO ADVERSE EVENT (no adverse event) in a male patient of an unknown age who received mRNA-1273 (Spikevax) (batch no. 011B22A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Sep-2022, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 06-Sep-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (dose administered after excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Minimum temperature in the fridge went down to 34.4 F/ temperature in the fridge went down to 33 or 34 last week) and NO ADVERSE EVENT (no adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (dose administered after excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (Minimum temperature in the fridge went down to 34.4 F/ temperature in the fridge went down to 33 or 34 last week) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (dose administered after excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Minimum temperature in the fridge went down to 34.4 F/ temperature in the fridge went down to 33 or 34 last week).    No concomitant medications was reported. The temperature in the fridge went down to 33 or 34 last week. It had been out of range for 100 days no one had checked it. The nurse is not sure if the Moderna vaccines were even in the fridge during that time.  The nurse had the DDLs. The probe was pushed in,and the state department had given them a new one It was reported that storage condition at the time of excursion in fridge was little bit below 36 degrees.  Minimum temperature reached to 34.4 F. The vial moved from freezer to refrigerator was 19-Aug-2022. 1 dose was administered and other doses was wasted. 1 vial punctured and no previous excursions. No treatment drug details was reported.
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: This spontaneous case was reported by a patient family member or friend and describes the occurrence of INFLUENZA LIKE ILLNESS (flu-like symptoms) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. In April 2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (flu-like symptoms). At the time of the report, INFLUENZA LIKE ILLNESS (flu-like symptoms) had resolved. No concomitant medications was reported.  It was reported that the flu like symptoms only lasted a day and were not serious.  No treatment medications was reported.   Reporter did not allow further contact
Sex: M
Vaccine: COVID19
Symptoms: Chills, Vaccination site erythema
Clinical narrative: experienced chills just for one night; had a red circle on his arm that did not hurt, but it went away eventually; This spontaneous case was reported by a patient and describes the occurrence of CHILLS (experienced chills just for one night) and VACCINATION SITE ERYTHEMA (had a red circle on his arm that did not hurt, but it went away eventually) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In April 2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CHILLS (experienced chills just for one night) and VACCINATION SITE ERYTHEMA (had a red circle on his arm that did not hurt, but it went away eventually). At the time of the report, CHILLS (experienced chills just for one night) and VACCINATION SITE ERYTHEMA (had a red circle on his arm that did not hurt, but it went away eventually) had resolved.            No concomitant drug was reported. The patient received the Moderna primary series and two boosters. No treatment drug was reported.   Reporter did not allow further contact
Sex: F
Vaccine: DF
Symptoms: Haematology test, Malaise, Platelet count decreased, Pyrexia, Rash
Clinical narrative: low platelets; rash; possible case of Dengue Fever; Initial information received on 24-Aug-2022 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves an unknown age female patient who had possible case of dengue fever after receiving vaccine TETRAVALENT (CHIMERIC) DENGUE VACCINE [DENGVAXIA].  The patient's past medical history, medical treatment(s), concomitant medication, vaccination(s) and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect TETRAVALENT (CHIMERIC) DENGUE VACCINE (strength, formulation, lot number and expiry date was unknown) via intramuscular route in unknown administration site for prophylactic vaccination.  On 15-Aug-2022 the patient developed a non-serious event of possible case of dengue fever (Dengue fever). No dengue fever test was performed. Patient had fever and rash (onset date: 15-Aug-2022, Latency for 6 days with no bleeding or significant pain. Hematology report had low platelets which returned to normal on Day 8 (platelet count decreased) (onset and latency: unknown). Patient last week became ill with what patient assume was dengue fever (based on low platelets from her hematology,  she don't think an actual dengue test was performed).  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event.   Outcome: Recovered / Resolved.
Age: 50.0
Sex: F
Vaccine: FLUX
Symptoms: Allergy to vaccine, Cardiac discomfort, Joint swelling
Clinical narrative: allergic to the flu vaccine; left shoulder swells up and the swelling went down into her heart; left shoulder swells up and the swelling went down into her heart; Initial information received on 17-Aug-2022 regarding an unsolicited valid  non-serious case received from a consumer from a patient support program.  This case involves a 50 years old female patient who experienced allergy to vaccine, joint swelling and cardiac discomfort while receiving vaccine influenza vaccine and while treated with treprostinil sodium.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing Pulmonary arterial hypertension.  Concomitant medications included sildenafil citrate; and rivaroxaban (Xarelto).  On 19-Jul-2022, the patient started taking treprostinil sodium Inhalation Gas at a dosage of 18 ug (3 breaths), four times a day (QID) via inhalation route (lot - 2102185, expiry date: 31-Oct-2023) for Pulmonary arterial hypertension.  On an unknown date, the patient received an unspecified dose of suspect influenza vaccine produced by unknown manufacturer (formulation and strength not reported; lot 2102185) via unknown route in unknown administration site for influenza immunization.  On an unknown date in 2022, the patient developed non-serious events of allergic to the flu vaccine (allergy to vaccine) and left shoulder swells up and the swelling went down into her heart (joint swelling) and (cardiac discomfort) (unknown latency) following the first dose intake of treprostinil sodium and (unknown latency) following the administration of influenza vaccine.  It was reported that the patient was allergic to the flu vaccine (allergy to vaccine), left shoulder swells up and the swelling went down into her heart (joint swelling and cardiac discomfort).   Action taken was unknown with treprostinil sodium and not applicable with influenza vaccine.  It was not reported if the patient received a corrective treatment for the events (allergy to vaccine, joint swelling, cardiac discomfort).  At time of reporting, the outcome was Unknown for all the events.
Age: 0.33
Sex: U
Vaccine: UNK
Symptoms: Product preparation error
Clinical narrative: only one component of Pentacel was given to a 4 month old patient with no adverse event; Initial information received on 17-Aug-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 4 months old and unknown gender patient who was given only one component of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 17-Aug-2022, the patient received a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE, Suspension for injection (once, 1 day) (dose, strength, lot number: unknown) via intramuscular route in unknown administration site as prophylactic vaccination.  On 17-Aug-2022 (latency: same day), the patient developed a non-serious event "only one component of pentacel was given to a 4 month old patient with no adverse event" (product preparation error) following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE. It is unknown if the patient experienced any additional symptoms/events.   It was reported that "there is no information provided which component of vaccine is given."  Action taken was 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 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: FLU3
Symptoms: No adverse event, Off label use
Clinical narrative: off label use with no adverse event; Initial information received on 17-Aug-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp (patient).  This case involves a 64 years old male patient who was given INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HD] for off label use with no 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 received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE , Suspension for injection in pre-filled syringe (dose, strength, lot number: unknown) via unknown route in unknown administration site as prophylacticvaccination.  On an unknown date the patient developed a non-serious off label use with no adverse event (off label use) (unknown latency) following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. is unknown if the patient experienced any additional symptoms/events.  Action taken with INFLUENZA VACCINE TRIVALENT (FLUZONE HD) was not applicable.  At time of reporting, the outcome was Unknown for the event.
Sex: U
Vaccine: YF
Symptoms: Headache, Pain in extremity, Pyrexia
Clinical narrative: sore arm; occasionally a headache; mild fever; Initial information received on 19-Aug-2022 regarding an unsolicited valid  non-serious courtesy case received from a other health professional via Pfizer.  This case involves a 59 years old and unknown gender patient who experienced sore arm, occasionally a headache and mild fever while receiving vaccine yellow fever vaccine  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 yellow fever vaccine produced by unknown manufacturer (with an unknown strength, formulation, batch number and expiry date) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed sore arm (pain in extremity), occasionally a headache (headache) and mild fever (pyrexia) (unknown latency).  Action taken : not applicable.  It was not reported if the patient received a corrective treatment for all the events.  At time of reporting, the outcome was Unknown for all the events.
Sex: F
Vaccine: FLUX
Symptoms: Hypersensitivity
Clinical narrative: Allergy; Initial information received on 19-Aug-2022 regarding an unsolicited valid  non-serious courtesy case received from a consumer/non-hcp via Pfizer.   This case involves a 62 years old female patient who experienced allergy after receiving vaccine influenza vaccine.  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 vaccine produced by unknown manufacturer (with an unknown strength, formulation, batch number and expiry date) via unknown route in unknown administration site for Immunisation.  On an unknown date the patient developed allergy (hypersensitivity) (unknown latency).  Action taken : not applicable.  It was not reported if the patient received a corrective treatment for the event (Allergy).  At time of reporting, the outcome was Unknown for the event allergy.
Sex: U
Vaccine: UNK
Symptoms: Wrong technique in product usage process
Clinical narrative: patient was administered Pentacel that was not diluted with no reported adverse event; Initial information received on 22-Aug-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves an unknown age and unknown gender patient who was administered DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] that was not diluted with no reported adverse event.  The patient's past medical history, medical treatment(s), concomitant medication, vaccination(s) and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE Suspension for injection (strength, lot number and expiry date was unknown) via unknown route in unknown administration site for prophylactic vaccination. Information for batch and expiry date was requested.  On an unknown date the patient developed a non-serious event of was administered pentacel that was not diluted with no reported adverse event (wrong technique in product usage process) (latency: unknown). Repoirter was inquiring if the patient needs to be revaccinated   Action taken with DIPHTHERIA, TETANUS, AC PERTUSSIS, IPV AND HIB VACCINE (PENTACEL (VERO)) was not applicable.  It was not reported if the patient received a corrective treatment for the event (patient was administered Pentacel that was not diluted with no reported adverse event).  At time of reporting, the outcome was Unknown for the event patient was administered pentacel that was not diluted 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.; Sender's Comments:  02230423:
Sex: F
Vaccine: MNQ
Symptoms: Medication error, No adverse event, Wrong product administered
Clinical narrative: I have a patient who came in for her Menquadfi and after the fact one of the nurses noted that the lot number documented was for Tdap withno adverse event; Initial information received on 29-Aug-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves an unknown age female patient who experienced i have a patient who came in for her menquadfi and after the fact one of the nurses noted that the lot number documented was for tdap with no adverse event while receiving vaccine MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE [MENQUADFI].  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 (T CONJ) VACCINE (strength, dose, route, lot number and administration site: unknown) for Prophylactic vaccination (Immunisation).  Reportedly patient who came in for her Menquadfi and after the fact one of the nurses noted that the lot number documented was for Tdap (wrong product administered) (event onset and latency: unknown). The nurse that gave it cant be 100 percentage sure if this was the wrong shot given or the right shot and the wrong lot number aren't right near each other.  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: 34.0
Sex: F
Vaccine: FLU4
Symptoms: Exposure during pregnancy
Clinical narrative: vaccine exposure during pregnancy; Initial information received on 02-Sep-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 34 years old female patient who was exposed to vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT]  in context of vaccine exposure during pregnancy.   Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known. The reported vaccine exposure during pregnancy occurred at 16 weeks of pregnancy and the patient was exposed to INFLUENZA QUADRIVAL A-B VACCINE at 16 weeks of pregnancy, during second pregnancy trimester for INFLUENZA QUADRIVAL A-B VACCINE.   The date of last menstrual period was reported as 20-May-2022. The estimated due date is 23-Feb-2023. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.    On 01-Sep-2022, the patient received a  dose of suspect INFLUENZA QUADRIVAL A-B VACCINE Suspension for injection (lot uT7682KA) via intramuscular route in the left deltoid for prophylactic vaccination.  On 01-SEP-2022 the patient reported a non-serious event vaccine exposure during pregnancy (exposure during pregnancy) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event exposure during pregnancy.  Additionally, at time of reporting, the pregnancy is still ongoing.
Age: 32.0
Sex: F
Vaccine: FLU4
Symptoms: Delivery, Exposure during pregnancy, No adverse event
Clinical narrative: Vaccine fluzone QV given in pregnancy with no reported adverse event; Initial information received on 02-Sep-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves Adult female patient who was exposed to vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV] in context of vaccine fluzone qv given in pregnancy with no reported adverse event.   Data regarding this pregnancy were received retrospectively, i.e. after pregnancy outcome was known. The reported Vaccine fluzone QV given in pregnancy with no reported adverse event occurred at 7 weeks of pregnancy and the patient was exposed to INFLUENZA QUADRIVAL A-B VACCINE at 7 weeks of pregnancy, during first pregnancy trimester for INFLUENZA QUADRIVAL A-B VACCINE.  The date of last menstrual period was reported as 26-Jul-2022. The estimated due date is 02-May-2023. The actual date of delivery is 30-Apr-2022. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient had unknown previous pregnancy/ies.   On 31-Aug-2022, the patient received a 1 unknown dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (strength, formulation was unknown, lot uT7682KA and expiry date: 30-Jun-2023) via intramuscular route in the right deltoid for prophylactic vaccination.  On 31-Aug-2022 the patient developed a non-serious event of vaccine fluzone qv given in pregnancy with no reported adverse event (exposure during pregnancy) (latency: same day) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  Action taken : not applicable.  Outcome: Unknown.  Additionally, at time of reporting, the patient delivered a baby at unknown weeks of gestation on 30-Apr-22.  Outcome of the pregnancy was reported as unknown and fetal outcome was reported as unknown.
Age: 30.0
Sex: F
Vaccine: FLU4
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Vaccine exposure during pregnancy with no reported adverse event; Initial information received on 02-Sep-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 30 years old female patient who was exposed to vaccine influenza quadrival A-B vaccine [Fluzone QIV] in context of vaccine exposure during pregnancy with no reported adverse event.   Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known. The reported Vaccine exposure during pregnancy with no reported adverse event occurred at 15 weeks of pregnancy and the patient was exposed to influenza quadrival A-B vaccine at 15 weeks of pregnancy, during second pregnancy trimester for influenza quadrival A-B vaccine.  The date of last menstrual period was reported as 14-May-2022. The estimated due date is 19-Feb-2023. The patient has Twin pregnancy. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient had unknown previous pregnancy/ies.  On 31-Aug-2022, the patient received a dose of suspect influenza quadrival A-B vaccine Suspension for injection (strength and dose not reported; lot uT7682KA, expiry date: 30-Jun-2023) via intramuscular route in unknown administration site for prophylactic vaccination.  On 31-Aug-2022, (latency: same day) the patient had vaccine exposure during pregnancy with no reported adverse event (exposure during pregnancy) following the administration of influenza quadrival A-B vaccine.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event. Additionally, at time of reporting, the pregnancy is still ongoing.
Sex: F
Vaccine: DT
Symptoms: Allergy to vaccine, Product use in unapproved indication
Clinical narrative: it was believed by two allergists at that time; Patient was given Decavac for Allergy testing component; Initial information received on 03-Aug-2022 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional.  This case is linked to case 2022SA324677.  This case involves an unknown age female patient who reported that it was believed by two allergists at that time and was given decavac for allergy testing component while receiving vaccine DIPHTHERIA AND TETANUS TOXOIDS [DECAVAC].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   In 2011, the patient received a dose of suspect DIPHTHERIA AND TETANUS TOXOIDS lot number not reported at an unknown dose via unknown route in unknown administration site for allergy testing component (product use in unapproved indication) (latency: same day).  On an unknown date, the patient developed a non-serious event of it was believed by two allergists at that time (allergy to vaccine) (unknown latency) following the administration of DIPHTHERIA AND TETANUS TOXOIDS.  Action taken: not applicable  It was not reported if the patient received a corrective treatment for the events (it was believed by two allergists at that time, Patient was given Decavac for Allergy testing component).  Outcome: unknown for both 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.  Based on information previously received, the following information [Recoded Company suspect vaccine DECAVAC to Unknown manufacturer (product coded) as the vaccine seems to be from Merck] has/have been amended
Sex: U
Vaccine: DTAP, UNK
Symptoms: Incorrect route of product administration, No adverse event, Wrong product administered
Clinical narrative: Patient was inadvertently given PPD (Tubersol) intramuscularly instead of TDap, with no reported adverse event; Patient was inadvertently given PPD (Tubersol) intramuscularly instead of TDap, with no reported adverse event; Initial information was received on 10-Aug-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves an unknown age/gender patient who experienced patient was inadvertently given ppd (tubersol) intramuscularly instead of tdap, with no reported adverse event while receiving vaccine DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE and while treated with TUBERCULIN TEST [TUBERSOL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, patient was inadvertently given ppd (tubersol) at an unknown dose (lot number, expiry date, form, strength: not reported) (indication- tuberculin test) intramuscularly instead of tdap (lot number and expiry date: not reported) (indication-prophylactic vaccination), with no reported adverse event (wrong product administered) (unknown latency)   On an unknown date the patient developed a non-serious patient was inadvertently given ppd (tubersol) intramuscularly instead of tdap, with no reported adverse event (incorrect route of product administration) (unknown latency) following the administration of tubersol.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event patient was inadvertently given ppd (tubersol) intramuscularly instead of tdap, with no reported adverse event and was Unknown for the event patient was inadvertently given ppd (tubersol) intramuscularly instead of tdap, 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: 12.0
Sex: M
Vaccine: IPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired dose being administered with no reported adverse event; Initial information received on 17-Aug-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case is linked to case 2022SA343483.  This case involves a 12 years old male patient to whom expired dose was being administered with no reported adverse event for vaccine IPV (VERO) [IPOL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 15-Aug-2022,the patient received a  0.5ml dose (once) of suspect IPV (VERO) , with an unknown formulation and strength, (lot: T1D482M ; expiry date: 25-Jul-2022 ) via subcutaneous route in the left arm. for immunization.  On 15-Aug-2022 an expired dose was administered to the patient with no reported adverse event (expired product administered) (latency: same day) following the administration of IPV (VERO). It was administered by licensed practitioner nurse (LPN).  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: 0.33
Sex: M
Vaccine: UNK
Symptoms: No adverse event, Product preparation issue
Clinical narrative: patient was administered just the liquid diluent component of pentacel without being reconstituted with the lyophilized component of the vaccine with no adverse event; Initial information received on 17-Aug-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 4 months old male patient who was administered just the liquid diluent component of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)]without being reconstituted with the lyophilized component of the vaccine with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) and ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ) for Prophylactic vaccination.  On 17-Aug-2022, the patient received a 0.5ml 1X(once) dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE (strength, formulation was unknown, lot U7256AA and expiry date: 27-Apr-2023) via intramuscular route in the left vastus lateralis for Immunization.  On 17-Aug-2022 the patient developed a non-serious event of patient was administered just the liquid diluent component of pentacel without being reconstituted with the lyophilized component of the vaccine with no adverse event (product preparation issue, Latency: same day). Patient was just administered the diluent liquid component of Pentacel without reconstituting it with the lyophilized powder component. Wanting to know what the next steps are. Reporter also asked where can she get the 0.4 % NACL saline diluent to mix with the ACTHIB component.  No further information provided.  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: 1.5
Sex: F
Vaccine: TDAP
Symptoms: Wrong product administered
Clinical narrative: ADACEL administered to patient under 10 years of age, instead of the intended DAPTACEL.; Initial information received on 18-Aug-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 18 months old female patient and it was reported that adacel administered to patient under 10 years of age, instead of the intended daptacel, after receiving vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS A VACCINE (HEPATITIS A) for Immunisation.  On 17-Aug-2022, the patient received a dose of 0.5 ml of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (formulation, strength: unknown) lot C5854AA, expiration: 14-Apr-2023 via intramuscular route in the Right Vastus Lateralis(Right thigh) as Immunization. Meant to be 4th DTaP, but 1st Tdap.  On 17-AUG-2022 adacel administered to patient under 10 years of age, instead of the intended daptacel (wrong product administered) same day following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE.  Action taken was 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 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.