chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: IPV
Symptoms: Medication error, No adverse event, Poor quality product administered, Product storage error
Clinical narrative: opened IPOL was exposed to temperature of 50.9 F due to refrigerator door was left open (human error) and the product was administered to a patient with no reported adverse event; opened IPOL was exposed to temperature of 50.9 F due to refrigerator door was left open (human error) and the product was administered to a patient with no reported adverse event; Initial information received on 01-Aug-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves opened IPV (VERO) [Ipol] which was exposed to temperature of 50.9 F due to refrigerator door was left open (human error) and was administered to patient of unknown age and gender with no reported adverse event.  On an unknown date patient received an opened ipol (Suspension for injection) (lot: V18891M; expiry date: 01-Jan-2024) (strength, route, administration site unknown) which was exposed to temperature of 50.9 F due to refrigerator door was left open (human error) with no reported adverse event (product storage error) (unknown latency) (poor quality product administered) (latency: same day).  It was reported, "Does extended stability data cover the excursion? No for opened IPOL If negative advice, was the product administered to a patient? Yes There is data to support the excursion of daptacel, adacel, pentacle, tenivac and ACTHIB but for the opened IPOL, stability over the recommendation was not yet evaluated."   Action taken was not applicable.  At time of reporting, the outcome was Unknown for both 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 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: 0.25
Sex: F
Vaccine: DTAPHEPBIP, UNK
Symptoms: Extra dose administered, Medication error
Clinical narrative: 3-month old female patient received both pentacel and pediarix today, the patient accidentally received a double dose of DTaP-IPV vaccine with no reported adverse event; Initial information received on 01-Aug-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked to case 2023SA236480.  This case involves a 3 months old female patient for whom both Diphtheria/Tetanus/5 Hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (Vero)] and Diphtheria Vaccine Toxoid, Hepatitis B Vaccine Rhbsag (YEAST), Pertussis Vaccine Acellular 3-Component, Polio Vaccine Inact 3V (VERO), Tetanus Vaccine Toxoid [Pediarix] on the same day, the patient accidentally received a double dose of dtap-ipv vaccine 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 Rotavirus Vaccine and Pneumococcal Vaccine CONJ 13v (CRM 197) (Prevnar 13) for Prophylactic vaccination.  On 01-Aug-2023, the patient received a dose 1 of 0.5 ml (frequency: once) of standard strength of suspect Diphtheria/Tetanus/5 Hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (Vero)] suspension for injection (lot: UJ84LAA) via intramuscular route in the right thigh and and dose of suspect PEDIARIX (strength, formulation, expiry date and lot number not reported) not produced by Sanofi Pasteur via unknown route in unknown administration site, both for prophylactic vaccination (immunization), the patient accidentally received a double dose of dtap-ipv vaccine with no reported adverse event (extra dose administered) (latency: same day).  Information on the batch number was requested.  Action taken: not applicable.  At time of reporting, the outcome was 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: 5.0
Sex: M
Vaccine: DTAP
Symptoms: Medication error, No adverse event, Routine immunisation schedule incomplete
Clinical narrative: patient has missed his 5th dose of DAPTACEL when he was about 5 years of age, with no reported adverse event; Initial information received on 01-Aug-2023 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 5 years old male patient who had missed his 5th dose of diphtheria-15/tetanus/5 AC pertussis vaccine [Daptacel] when he was about 5 years of age, with no reported adverse event while receiving vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included diphtheria vaccine toxoid, pertussis vaccine acellular 5-component, tetanus vaccine toxoid (Adacel) for Immunisation.  On an unknown date, the patient received unknown dose of suspect diphtheria-15/tetanus/5 AC pertussis vaccine, Suspension for injection (batch number, expiry date unknown) via unknown route in unknown administration site for Immunization. Information on the batch number was requested.  On an unknown date the patient had missed his 5th dose of diphtheria-15/tetanus/5 AC pertussis vaccine (daptacel) when he was about 5 years of age, with no reported adverse event (routine immunisation schedule incomplete) (unknown latency).  Reportedly, reporter asked for recommendation whether to give a 5th dose of DAPTACEL or first dose of ADACEL to a male patient; caller states the patient has missed his 5th dose of DAPTACEL when he was about 5 years of age, his 4th DAPTACEL dose was given on his 15th month; now that the patient is already 7 years old, they want to know which vaccine or schedule is recommended  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event patient has missed his 5th dose of daptacel when he was about 5 years of age, 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 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.; Sender's Comments:  US-SA-2023SA236781:01713014
Age: 1.5
Sex: F
Vaccine: HIBV
Symptoms: Medication error, No adverse event, Product preparation error
Clinical narrative: nurses has administered ACTHIB that has been reconstituted with sterile water instead of the saline diluent, with no reported adverse event; Initial information received on 01-Aug-2023 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 1 year old female patient who was administered HIB (PRP/T) vaccine [ACT-HIB] that has been reconstituted with sterile water instead of the saline diluent, 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 pneumococcal vaccine CONJ 7V (CRM197) (Prevnar) for Prophylactic vaccination (immunization).  On 01-Aug-2023, the patient received 0.5 mL dose 4 of suspect HIB (PRP/T) vaccine, Powder and solvent for solution for injection (batch number: UJ803AA; expiry date: 13-Aug-2023) via intramuscular route in the right thigh for Immunization that had been reconstituted with sterile water instead of the saline diluent, with no reported adverse event (product preparation error) (same day latency) following the administration of HIB (PRP/T) vaccine.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event nurses has administered acthib that has been reconstituted with sterile water instead of the saline diluent, 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 Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 18.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Medication error, No adverse event, Wrong product administered
Clinical narrative: accidently given a menactra instead of the bexsero dose with no reported adverse event; Initial information received on 02-Aug-2023 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves a 18 years old male patient who was accidently given a menactra instead of the bexsero 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 booster dose of tozinameran (pfizer biontech covid-19 vaccine) for Immunisation.  On 17-Jul-2023, the patient received 0.5 ml (dose 3) of suspect meningococcal A-C-Y-W135 (D CONJ) Vaccine, Solution for injection lot U7449AA via intramuscular route in the right deltoid for immunization (strength, expiry date: unknown) and suspect meningococcal vaccine B RFHBP/NADA/NHBA OMV not produced by Sanofi Pasteur lot number not reported via unknown route in unknown administration site for prophylactic vaccination (strength, formulation, dose, batch number, expiry date: unknown), the patient was accidently given a menactra instead of the bexsero dose with no reported adverse event (wrong product administered)(latency same day).  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event (wrong product administered).  Outcome was Unknown for the event wrong product administered.  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: 5.0
Sex: U
Vaccine: DTAPIPV
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: administering an expired vaccine to a patient with no reported adverse event; Initial information received on 02-Aug-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 5 years old and unknown gender patient who was administering an expired Diphtheria-15/Tetanus/5 Hybrid AC Pertussis/IPV (MRC5) Vaccine [Quadracel] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 26-Jul-2023, the patient received a 0.5 ml dose of Expired suspect Diphtheria-15/Tetanus/5 Hybrid AC Pertussis/IPV (MRC5) Vaccine Suspension for injection (lot number, strength not reported) (Expiry date: 6-Jul 2023) via unknown route at unknown location as immunization (expired product administered) (latency: same day).  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 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: 14.0
Sex: M
Vaccine: IPV
Symptoms: No adverse event, Poor quality product administered, Product storage error
Clinical narrative: ipol excursion was for 3 hours to a maximum temperature of 12.6°C with no reported adverse event; received IPOL from a vial that was exposed to a temperature excursion when punctured with no reported adverse event; Initial information received on 03-Aug-2023 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 14 years old male patient who received IPV (vero) [IPOL] from a vial that was exposed to a temperature excursion when punctured, excursion was for 3 hours to a maximum temperature of 12.6°c with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 29-Jun-2023, the patient received 0.5 mL dose of suspect IPV (vero), suspension for injection (batch number: W1A101M; expiry date: 10-Feb-2025) via unknown route in unknown administration site for Immunization from a vial that was exposed to a temperature excursion when punctured, excursion was for 3 hours to a maximum temperature of 12.6°c with no reported adverse event (product storage error) (poor quality product administered) (same day latency).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event ipol excursion was for 3 hours to a maximum temperature of 12.6°c with no reported adverse event and was Unknown for the event received ipol from a vial that was exposed to a temperature excursion when punctured 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:  US-SA-2023SA239251:01716102
Age: 16.0
Sex: F
Vaccine: MEN
Symptoms: Extra dose administered, No adverse event
Clinical narrative: given an extra dose of Menquadfi to a patient with no reported adverse event; Initial information was received on 03-Aug-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 16 years old female patient who received an extra dose of meningococcal a-c-y-w135 (t conj) vaccine [Menquadfi] to a patient 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 meningococcal vaccine b rfhbp/nada/nhba omv (Bexsero) for Prophylactic vaccination (immunisation).  On 02-Aug-2023, the patient received an extra dose of dose 3 suspect meningococcal a-c-y-w135 (t conj) vaccine Solution for injection (strength: standard) at dose of 0.5 ml (lot number: U7616AA, expiration date: 11-Apr-2025) via intramuscular route in the left deltoid for Immunization (immunisation) with no reported adverse event (extra dose administered) (latency: same day).  No lab data reported.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event given an extra dose of menquadfi to a patient 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: 16.0
Sex: F
Vaccine: MEN
Symptoms: No adverse event, Poor quality product administered, Product storage error
Clinical narrative: Menquadfi administered to patient after temperature excursion at 31.5° Fahrenheit for 2 hours 45 minutes with no reported adverse event; Initial information received on 03-Aug-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked to cases 2023SA240011, 2023SA238269, 2023SA240457, 2023SA240518, 2023SA240546, 2023SA239548, 2023SA239679 and 2023SA239960.  This case involves a 16 years old female patient to whom MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE [MENQUADFI] administered after temperature excursion at 31.5° fahrenheit for 2 hours 45 minutes 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 MENINGOCOCCAL VACCINE B RFHBP/NADA/NHBA OMV (BEXSERO) for Prophylactic vaccination.  On an unknown date, the patient received 0.5 ml dose of suspect MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE (Solution for injection) (Frequency = once), (Strength = standard) (lot number and expiry date not reported) via intramuscular route in unknown administration site for immunization. Information on the batch number was requested.  On an unknown date the patient was administered MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE after temperature excursion at 31.5° fahrenheit for 2 hours 45 minutes with no reported adverse event (poor quality product administered) (unknown latency).  It was reported that "Products involved? ADACEL, DAPTACEL, IPOL, MENQUADFI, PENTACEL, QUADRACEL, TENIVAC, VAXELIS Product activated/prepared? NO Ask how the situation occurred? POTENTIAL MECHANICAL ISSUE WITH THE REFRIGERATOR.Did it occur due to a human error? NO. Does extended stability data cover the excursion: NO. Was the product used by/ administered to the patient: YES. These vaccines were administered to 40 patients over a span of 1 week, starting on 15Jun2023 till stopping at 22Jun2023. MENQUADFI administered."   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, PPV
Symptoms: No adverse event, Wrong product administered
Clinical narrative: administered ipol vaccine instead of pneumococcal vaccine with no reported adverse event; Initial information was received on 03-Aug-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case is linked to case 2023SA239268.  This case involves an unknown age and unknown gender patient who was administered IPV (VERO) [IPOL] instead of pneumococcal vaccine 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 received a 0.5 ml dose of suspect IPV (VERO) Suspension for injection, unknown dose of suspect pneumococcal vaccine produced by unknown manufacturer (unknown formulation) (lot number, expiry date, strength, was unknown) via unknown route in unknown administration site for prophylactic vaccination  (Immunization). The information on the batch number was requested.  On an unknown date the patient was administered ipol vaccine instead of pneumococcal vaccine with no reported adverse event (wrong product administered) (latency: same day) following the administration of IPV (VERO) and (unknown latency) following the administration of pneumococcal vaccine.  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 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: M
Vaccine: MNQ
Symptoms: Headache, Migraine
Clinical narrative: little headache; Initial information was received on 03-Aug-2023 regarding an unsolicited valid non-serious case received from a consumer/non-health-care professional.  This case involves 16 years old male patient who experienced little headache after receiving meningococcal a-c-y-w135 (d conj) vaccine [Menactra].  The patient's past medical history included Crying, General body pain, Vomiting with migraine is so intense, Flu with gotten flu 4 or 5 times, Streptococcal infection, Feverish and Exhaustion. The patient's past medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing Migraine.  On an unknown date in 2017, the patient received a unknown dose of suspect meningococcal a-c-y-w135 (d conj) vaccine (Solution for injection) (strength, expiry date, lot number not reported) via unknown route in unknown administration site for Immunization. The information on batch number was requested.  On an unknown date the patient developed a non-serious event of little headache (unknown latency) following the administration of meningococcal a-c-y-w135 (d conj) vaccine.  Relevant laboratory test results included: Body temperature - On an unknown date: [high fevers]  Action taken with meningococcal vaccine (Menactra) was not applicable.  It was not reported if the patient received a corrective treatment for the event (little headache).  At time of reporting, the outcome was Recovered on an unknown date for the event little headache.
Age: 11.0
Sex: F
Vaccine: TDAP
Symptoms: Product storage error
Clinical narrative: temperature excursion that exceeded the stability data documented in the local labelling and additional supporting stability data.these vaccines were administered with no reported ae; Initial information was received on 03-Aug-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves 11 years old female patient who reported that the temperature excursion that exceeded the stability data documented in the local labelling and additional supporting stability data.these vaccines were administered with no reported ae after receiving 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.  On an unknown date, the patient received a dose of 0.5 ml of suspect diphtheria-2/tetanus/5 ac pertussis vaccine (Suspension for injection) (strength, expiry date, lot number not reported) via intramuscular route in unknown administration site for Immunization for temperature excursion that exceeded the stability data documented in the local labelling and additional supporting stability data.these vaccines were administered with no reported ae (poor quality product administered) (latency : same day). The information on batch number was requested.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event temperature excursion that exceeded the stability data documented in the local labelling and additional supporting stability data.these vaccines were administered with no reported ae.  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: MEN
Symptoms: Extra dose administered, No adverse event
Clinical narrative: was given a third dose of menquadfi by one of their nurses with no reported adverse event; Initial information was received on 03-Aug-2023 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 16 years old female patient who was given a third dose of meningococcal A-C-Y-W135 (T CONJ) vaccine [Menquadfi] by one of their nurses 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 received a (dose 3) of suspect meningococcal A-C-Y-W135 (T CONJ) vaccine (Solution for injection) (lot: U7643AA, expiry date: 27-Jun-2025, strength: unknown) via unknown route in unknown administration site for Immunization.  On an unknown date the patient was given a third dose of menquadfi by one of their nurses with no reported adverse event (extra dose administered) (latency: same day).  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 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: M
Vaccine: MEN
Symptoms: No adverse event, Poor quality product administered, Product storage error
Clinical narrative: menquadfi temperature excursion that exceeded the stability at temperature 31.5 Fahrenheit and duration: 2 hours 45 minutes and vaccines were administered with no reported adverse event; Initial information was received on 03-Aug-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves meningococcal a-c-y-w135 (t conj) vaccine [menquadfi] temperature excursion that exceeded the stability at temperature 31.5 Fahrenheit and duration: 2 hours 45 minutes and and was administered to a 16 years old male patient 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 meningococcal vaccine b rfhbp/nada/nhba omv (Bexsero) for Immunisation.  On an unknown date, a dose of suspect meningococcal a-c-y-w135 (t conj) vaccine Solution for injection and a patient received at dose of 0.5 ml total via intramuscular route (strength: standard, lot number, expiration date, administration site: Unknown) for immunization (immunisation) temperature excursion that exceeded the stability at temperature 31.5 Fahrenheit and duration: 2 hours 45 minutes and vaccine was administered with no reported adverse event (poor quality product administered) (latency: same day). Information on the batch number was requested.   It was reported that "The products Adacel, Daptacel, Ipol, Menquadfi, Pentacel, Quadracel, Tenivac, Vaxelis at temperature 31.5 Fahrenheit and duration: 2 hours 45 minutes. These vaccines were administered to 40 patients over a span of 1 week, starting on 15-Jun-2023 till stopping at 22-Jun-2023. Menquadfi administered."  No lab data reported.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event menquadfi temperature excursion that exceeded the stability at temperature 31.5 Fahrenheit and duration: 2 hours 45 minutes and vaccines were administered 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 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.; Sender's Comments:  US-SA-2023SA240011:01715866 US-SA-2023SA238269:01715866
Age: 27.0
Sex: F
Vaccine: HEPAB
Symptoms: No adverse event
Clinical narrative: None stated.
Age: 48.0
Sex: F
Vaccine: TYP
Symptoms: Abdominal pain, Diarrhoea, Haematochezia
Clinical narrative: Dr. was seen for pretravel consultation on 7/26/23 and received Hepatitis A, yellow fever vaccines and advised to complete oral typhoid vaccination series of 4 capsules that the patient self-administers.  Dr. completed the oral typhoid as directed finishing the fourth dose on 8/2/23.  The following day, 8/3/23 she noted loose diarrheal stools, abdominal cramping and one of the stools was streaked with red blood.  She called this afternoon and spoke with RN and I am returning the call now at 4 pm.   Dr. confirmed the above information during our call and reported that this morning, 8/4, she again noticed a loose stool that was streaked with blood.  She has not had any stools this afternoon and has been able to work.  She denies any other systemic symptoms, specifically no fever, chills or vomiting.   I reviewed with Dr., who advised patient be seen on Monday, 8/7/23 for evaluation and consideration of potential need to receive treatment for typhoid (given this is an attenuated bacterial vaccine).  It is noteworthy that if it is decided to treat for typhoid, the patient would have had the time to develop antibody protection and would not need to be revaccinated with injectable typhoid.  Patient understands that if her symptoms progress such as fever, chills or other systemic symptoms suggestive of infection, she should seek evaluation if the ED over the weekend.   I have asked my staff to arrange a patient appointment for Dr. on the calendar for Monday, 8/7/23 afternoon and to notify the Dr. of the time.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Rash
Clinical narrative: Rash covering the entire deltoid
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site urticaria, Rash macular, Urticaria
Clinical narrative: within minutes of receiving the TdaP vaccine, pt. developed urticaria at the site of the injection that spread around the deltoid and down to the mid arm. The welts were not itchy and patient did not have any dyspnea, wheezing or anaphylactic reaction and BP/VS remained stable.  Patient had a dose of Benadryl 25 my orally and observed for 1 hour in the office. The Urticaria (welts) started going away after 30 minutes and by 1 hours only a macular rash remained.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site urticaria, Rash macular, Urticaria
Clinical narrative: Patient developed urticaria at the site of injection within 3 minutes. the welts involved most of the deltoid and spread down tot eh mid upper arm.  the welts were not itchy and patient had no symptoms of anaphylaxis. VS remained stable. patient was given Benadryl 25 mg immediately and observed for 1 hour. Within 30 minutes, the welts disappeared an a macular rash remained
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test normal, Body temperature increased, Chest X-ray normal, Malaise, Pain in extremity
Clinical narrative: Patient states after the injection she had a sore arm and didn't feel well. Stated she can't remember the times it all happened. Stated she went to sleep. Stated her son in law came home from work at around 11:00 pm and woke her up. Stated she told him she didn't feel well, he took her temperature and that it was 102. He took her to the ER. Stated she had blood work and a chest x-ray in the ER and results negative. She was there for a few hours and they sent her home.  Patient stated she feels fine now.
Age: 56.0
Sex: F
Vaccine: HEP
Symptoms: Acoustic stimulation tests abnormal, Antibody test, Antineutrophil cytoplasmic antibody, Antinuclear antibody negative, Blood test
Clinical narrative: Sudden onset of deafness of the right ear. 9 days after having received the first dose of  Heplisav-B, I woke up with pressure and ringing on both ears. The symptoms continued on and off for a couple of days. On day three, the symptoms were gradually getting worse, and by the end of day 3, at around 10:00 p.m., I discovered that I had completely loss hearing on my right ear. I went to Urgent Care on August 1, 2023, and the doctor confirmed I could indeed not hear out of my right ear and ordered a hearing test, and a referral to an ENT specialist. I had the hearing test done on August 1, and also saw the ENT doctor on the same day. Both hearing test and ENT doctor confirmed total hearing loss. My middle ear was very swollen.  The ENT doctor gave me an injection of steroids right into the ear, and prescribed  predniSONE 20mg tablets, to take 3 tablets (60mg) once a day for 10 days.  The first 3 tablets were taken at night, the same day I received the injection in the ear.  I have taken predniSONE for 7 days and today I started hearing a little bit (~20%) out of my right ear.
Age: 56.0
Sex: F
Vaccine: HEP
Symptoms: Deafness unilateral, Ear discomfort, Ear swelling, Sudden hearing loss, Tinnitus
Clinical narrative: Sudden onset of deafness of the right ear. 9 days after having received the first dose of  Heplisav-B, I woke up with pressure and ringing on both ears. The symptoms continued on and off for a couple of days. On day three, the symptoms were gradually getting worse, and by the end of day 3, at around 10:00 p.m., I discovered that I had completely loss hearing on my right ear. I went to Urgent Care on August 1, 2023, and the doctor confirmed I could indeed not hear out of my right ear and ordered a hearing test, and a referral to an ENT specialist. I had the hearing test done on August 1, and also saw the ENT doctor on the same day. Both hearing test and ENT doctor confirmed total hearing loss. My middle ear was very swollen.  The ENT doctor gave me an injection of steroids right into the ear, and prescribed  predniSONE 20mg tablets, to take 3 tablets (60mg) once a day for 10 days.  The first 3 tablets were taken at night, the same day I received the injection in the ear.  I have taken predniSONE for 7 days and today I started hearing a little bit (~20%) out of my right ear.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Fever, swelling, redness , pain in both thighs started after vaccination. Seen 8/3/23 in clinic, treated for cellulitis with PO Clindamycin, today at followup call pt improved.
Age: 55.0
Sex: F
Vaccine: UNK
Symptoms: Dizziness, Nausea, Pain, Pruritus, Rash
Clinical narrative: Rash about 6 inches across, pain, swelling, heavy itching, lump under skin, warmth, nausea. Nausea and most pain subsided after a couple of days but the rash is hanging on and it keeps getting itchier.
Age: 55.0
Sex: F
Vaccine: UNK
Symptoms: Rash pruritic, Swelling
Clinical narrative: Rash about 6 inches across, pain, swelling, heavy itching, lump under skin, warmth, nausea. Nausea and most pain subsided after a couple of days but the rash is hanging on and it keeps getting itchier.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Chills, Eye pain, Headache, Hypersomnia, Malaise
Clinical narrative: From pt directly: "The evening I went to bed after the vaccine, I woke up in the middle of the night in severe arm pain. I slept through most of the next day and had severe arm pain, body aches, and chills. I was feeling a lot of eye pain, and I couldn't open my eyes for more than 20 minutes at a time. I also had a persistent headache for the next few days. I think it is the sickest I have ever been. Those intense symptoms subsided after a day. It did take me 3 days to feel fully back to normal health."
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Pain, Pain in extremity, Sleep disorder
Clinical narrative: From pt directly: "The evening I went to bed after the vaccine, I woke up in the middle of the night in severe arm pain. I slept through most of the next day and had severe arm pain, body aches, and chills. I was feeling a lot of eye pain, and I couldn't open my eyes for more than 20 minutes at a time. I also had a persistent headache for the next few days. I think it is the sickest I have ever been. Those intense symptoms subsided after a day. It did take me 3 days to feel fully back to normal health."
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema
Clinical narrative: Redness of chest / face kind of a V shape but both sides. It goes away, not constant by has happened at least once every day since receiving the shot. Went to doctor office and was given steroids and zyrtec.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: itchiness, redness around the spot. going  down
Age: 73.0
Sex: M
Vaccine: PPV
Symptoms: Expired product administered
Clinical narrative: As I was documenting inputting vaccine information in patients chart I realized vaccine had expired 4 days ago. Patient had already left office and I reached out to leadership right away to let them know and informed the provider about vaccine expiration.
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: Type 1 diabetes mellitus
Clinical narrative: Onset of type 1 diabetes - August 8, 2022
Age: 2.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Patient received covid shot after beyond use date.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Condition aggravated, Exostosis, Impaired work ability, Intervertebral disc space narrowing
Clinical narrative: 04/13/2021:  Painful swelling starts behind left knee. 04/19/2021:  I reported painful swelling (I feared it was a blood clot). 04/20/2021:  Nurse expects a Baker's cyst. 05/04/2021:  Dr. diagnoses Baker's cyst; prescribes TED hose. 05/21/2021:  I am prescribed cane, ACE wraps, elevation pillow, and ice. 07/02/2021:  I received cane, ACE wraps, and elevation pillow, taken off work three weeks (yard crew). 12/09/2021:  I am removed from work another week. 12/28/2021:  This may be the day I am medically unemployable.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Joint swelling, Osteoarthritis, Spinal X-ray abnormal, Synovial cyst, Ultrasound Doppler normal
Clinical narrative: 04/13/2021:  Painful swelling starts behind left knee. 04/19/2021:  I reported painful swelling (I feared it was a blood clot). 04/20/2021:  Nurse expects a Baker's cyst. 05/04/2021:  Dr. diagnoses Baker's cyst; prescribes TED hose. 05/21/2021:  I am prescribed cane, ACE wraps, elevation pillow, and ice. 07/02/2021:  I received cane, ACE wraps, and elevation pillow, taken off work three weeks (yard crew). 12/09/2021:  I am removed from work another week. 12/28/2021:  This may be the day I am medically unemployable.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Walking aid user, X-ray limb abnormal
Clinical narrative: 04/13/2021:  Painful swelling starts behind left knee. 04/19/2021:  I reported painful swelling (I feared it was a blood clot). 04/20/2021:  Nurse expects a Baker's cyst. 05/04/2021:  Dr. diagnoses Baker's cyst; prescribes TED hose. 05/21/2021:  I am prescribed cane, ACE wraps, elevation pillow, and ice. 07/02/2021:  I received cane, ACE wraps, and elevation pillow, taken off work three weeks (yard crew). 12/09/2021:  I am removed from work another week. 12/28/2021:  This may be the day I am medically unemployable.
Age: 4.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Patient received covid shot after beyond use date.
Age: 3.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Patient received covid shot after beyond use date.
Age: 1.33
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received covid shot after beyond use date.
Age: 16.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Diarrhoea, Fatigue, Nausea, Vomiting
Clinical narrative: vaccine given 8/3/23 in the morning. On evening of 8/3/23 patient developed nausea with vomiting. On 8/4/23 patient had fatigue, nausea anal diarrhea. He also experienced this on 8/5/23. Symptoms resolved by 8/6/23.
Age: 3.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Patient received covid shot after beyond use date.
Age: 0.92
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Patient received covid vaccine after beyond use date.
Age: 1.75
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Patient received covid shot after beyond use date.
Age: 1.58
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Patient received covid shot after beyond use date.
Age: 1.67
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Patient received covid shot after beyond use date.
Age: 1.5
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient Received covid shot after beyond use date.
Age: 2.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received covid shot after beyond use date
Age: 1.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received covid shot after beyond use date.
Age: 4.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received covid shot after before use date.
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Rash, Rash papular, Skin abrasion, Vaccine positive rechallenge
Clinical narrative: rash papular excoriations in the injected arm; rash papular excoriations in the injected arm; rash after 5 years of administration/rash similar to a dermatitis going from the back of the deltoid to the wrist; vomiting; itching; This non-serious case was reported by a physician via call center representative and described the occurrence of papular rash in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of rash papular (developed rash papular excoriations in the injected arm (no shingle rash) after getting the first dose of Shingrix in August 2019, refer case US2023103566). Concomitant products included losartan, simvastatin, desvenlafaxine and colecalciferol (Vitamin D3).   In NOV-2019, the patient received the 2nd dose of Shingrix (unknown arm). On 26-JUN-2023, more than 2 years after receiving Shingrix, the patient experienced vomiting (Verbatim: vomiting) and pruritus (Verbatim: itching). On 02-JUL-2023, the patient experienced papular rash (Verbatim: rash papular excoriations in the injected arm), excoriation (Verbatim: rash papular excoriations in the injected arm) and rash (Verbatim: rash after 5 years of administration/rash similar to a dermatitis going from the back of the deltoid to the wrist). Rechallenge with Shingrix was positive. The outcome of the papular rash, excoriation, vomiting and pruritus were not reported and the outcome of the rash was unknown.   It was unknown if the reporter considered the papular rash, excoriation, rash, vomiting and pruritus to be related to Shingrix.     It was unknown if the company considered the papular rash, excoriation, rash, vomiting and pruritus to be related to Shingrix.   Linked case(s) involving the same patient:  US2023103566   Additional Information: GSK receipt date: 28-Jul-2023 The physician reported that the with increase of the same symptoms (rash popular excoriations) during the second dose of Shingrix (greater inflammatory response). The patient was under several medications (Statins, Losartan, simvastatin, desvenlafaxine, Vitamin D3, etc), the same medication that was using during Shingrix administration.  The rash was similar to a dermatitis going from the back of the deltoid to the wrist at the time of vaccination. On 2nd July 2023, the patient after almost 5 years, developed the same reactions as when the vaccines were administered.  On 26th June 2023, the patient started with vomiting, itching and no fever/diarrhea. The reporter asked that it was possible that Shingrix had created an antigenic response to this patient. The reporter was not sure if symptoms were gone by now. The Vaccine Administration Facility was the same as Primary Reporter. Did not consent to follow-up.; Sender's Comments:  US-GSK-US2023103566:Same patient 2 dose