chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 31.0
Sex: M
Vaccine: YF
Symptoms: No adverse event, Product preparation error
Clinical narrative: YF-VAX was reconstituted with sterile water and administered to a patient with no reported adverse event; Initial information received on 27-Feb-2025 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 31 years old male patient who received YELLOW FEVER VACCINE - [YF-VAX] was reconstituted with sterile water and administered 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 DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (TDAP)  and TYPHOID VACCINE (TYPHOID VACCINE) both for Immunisation.  On 31-Jan-2025, the patient received 0.5 ml of suspect YELLOW FEVER VACCINE - Solution for injection (lot UK134AA and expiry 30-Nov-2025) (strength: unknown) was reconstituted with sterile water and administered to a patient with no reported adverse event (product preparation error) (latency same day) via subcutaneous route in the left arm for immunization.  Reportedly:- Nurse explains that he was doing inventory and he noticed that there was 1 extra saline diluent for YF-VAX, and so he has reason to believe that YF-VAX was administered to the patient with sterile water. He states that they will be in contact with the patient. He asks if YF-VAX reconstituted with sterile water would have provided any protection for the patient.  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.
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product storage error
Clinical narrative: four patients received pentacel that was not suitable for use due to the excursion with no reported adverse event; Initial information received on 28-Feb-2025 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare professional.  This case involves 4 patients of unknown demographics who received diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (VERO)] that was not suitable for use due to the excursion 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 in February 2025, the patients received a 0.5 ml dose of suspect Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(VERO)/HIB(PRP/T) Vaccine Suspension for injection (expiry date, lot number not reported) via unknown route in unknown administration site for Immunization that was not suitable for use due to the excursion with no reported adverse event (poor quality product administered) (latency: on same day).Information regarding batch number corresponding to the one at time of event occurrence is requested.  Action taken was not applicable.  Reportedly, there was a power outage with the unknown result of a lowering of the temperature. It happened on 12Feb2025. Max/low temperature reached: 31.4°F (<0°C) Duration: 41 minutes. Previous Excursion: NO, Human error: NO, Administered post-excursion: YES for pentacel (4 patients).   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: 4.0
Sex: M
Vaccine: DTAP, TDAP
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: 4yr old patient was given adacel instead of daptacel with no reported adverse event; Initial information received on 28-Feb-2025 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 4 years old male patient was given Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine [Adacel] instead of Diphtheria-15/Tetanus/5 Ac Pertussis Vaccine [Daptacel] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) ,concomitant medications and family history were not provided.  On an unknown date, 4 year old patient was given adacel (Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine ) instead of daptacel (Diphtheria-15/Tetanus/5 Ac Pertussis Vaccine ) with no reported adverse event (wrong product administered) (Suspension for injection) strength, expiry date, lot number not reported via unknown route in unknown administration site for Immunization (latency: same day). The information on batch number and expiration date corresponding to the one at time of event occurrence was requested.  Reportedly "This was to be his fifth dose on Daptacel schedule. "  Action taken was not applicable.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in 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.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Inappropriate schedule of product administration, Vaccination failure
Clinical narrative: Suspected vaccination failure; Shingles; 2n dose received late; This serious case was reported by a consumer and described the occurrence of vaccination failure in a 77-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included chronic lymphocytic leukemia (stable for 17 years), cholesterol and blood pressure. Concomitant products included atorvastatin calcium (Statin).   On 14-AUG-2023, the patient received the 2nd dose of Shingrix. On 14-JUL-2022, the patient received the 1st dose of Shingrix. On 14-AUG-2023, an unknown time after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: 2n dose received late). On an unknown date, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure was not reported and the outcome of the shingles was resolved and the outcome of the drug dose administration interval too long was not applicable.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.     The company considered the vaccination failure to be unrelated to Shingrix and Shingrix. It was unknown if the company considered the shingles to be related to Shingrix and Shingrix.   Additional Information: GSK Receipt Date: 23-FEB-2025 The patient reported 3 years after Shingrix vaccination sequence got shingles. The patient was wondering if there was value in repeating the dosage sequence more frequently given, decrease in immune functioning with the chronic lymphocytic leukemia along with age. The patient received 2nd dose at longer time interval then recommended, which led to lengthening of vaccination schedule. This case was considered as suspected vaccination failure as details regarding laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix (Dose 1 and Dose 2).
Sex: F
Vaccine: HEPA, MMR
Symptoms: Extra dose administered
Clinical narrative: extra dose given to the same patient) for PRIORIX and HAVRIX; This non-serious case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 3-year-old female patient who received HAV (Havrix) (batch number T5727, expiry date 06-MAY-2026) for prophylaxis.   Co-suspect products included MMR (Priorix) (batch number KH2BD, expiry date 01-JAN-2026) for prophylaxis.   On 29-JAN-2025, the patient received Havrix and Priorix. On 29-JAN-2025, an unknown time after receiving Havrix and Priorix, the patient experienced extra dose administered (Verbatim: extra dose given to the same patient) for PRIORIX and HAVRIX). The outcome of the extra dose administered was not applicable.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 28-FEB-2025 The health care professional reported that a patient received extra dose for Priorix and Havrix, which led to extra dose administered.
Age: 62.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site pain, Mobility decreased, Pain in extremity
Clinical narrative: Sore arm, limited range of motion of arm and shoulder where injection site is.
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; ended up getting shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: ended up getting shingles). The outcome of the vaccination failure was not reported and the outcome of the shingles was resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix.     The company considered the vaccination failure to be unrelated to Shingrix. It was unknown if the company considered the shingles to be related to Shingrix.   Additional Information: GSK Receipt Date: 17-FEB-2025 The case was received from the patient via interactive digital media. The reporter had several friends took the shingles vaccination and they ended up getting them.  This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix.
Vaccine: MENB
Symptoms: Product storage error
Clinical narrative: Vaccine stored outside recommended conditions and administered to patient; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a 14-year-old patient who received Men B NVS (Bexsero) (batch number 3L339, expiry date 30-SEP-2027) for prophylaxis.   On 25-FEB-2025, the patient received Bexsero. On an unknown date, an unknown time after receiving Bexsero, the patient experienced incorrect storage of drug (Verbatim: Vaccine stored outside recommended conditions and administered to patient). The outcome of the incorrect storage of drug was not applicable.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 26-FEB-2025 The patient was administered one Bexsero vaccine the day before reporting, after a below temperature excursion happened on February 7th, 2025, which led to incorrect storage of vaccine. The reporter was not aware of the excursion and reported it until at the time of reporting.  the reporter was not sure if he/she could provide patient's personal information. The conditions of the excursion were temperature, 0.44 degree C for 36 minutes. The reporter consented to follow up.
Age: 31.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Skin warm
Clinical narrative: Pt had local reaction 1 week warmth and her left shoulder hurt. Pt was started on cephalexin for possible cellulitis.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Local reaction including pain and redness surrounding injection sites
Age: 63.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Bronchiectasis, Bronchoscopy, Chest tube insertion, Pneumonia, Thoracotomy
Clinical narrative: onset of Bronchiectasis in Late 2022. None smoker ever. multiple lung infections, Hospital stays, Bronchoscopy's and a Thoracotomy with chest tubes for infection. Ongoing symptoms still.
Sex: M
Vaccine: TYP
Symptoms: Product storage error
Clinical narrative: Patient took entire course of Vivotif without refrigerating; Patient took entire course of Vivotif without refrigerating; Case reference number US-BN-2024-001945 is a spontaneous case report initially received from other health care professional via Med Communication (reference number: USBAV24-1146) on 24-May-2024 and concerns male patient of unspecified age.  The patient's relevant medical history and concomitant medications were not provided.  On 17-May-2024, Vivotif vaccine was dispensed.   As reported, patient was not aware that Vivotif should been kept in the fridge (explicitly coded as 'product storage error').  On unspecified dates, patient took entire course of Vivotif (brand name: unknown) without refrigerating, at unknown dose, route, or site of administration for unknown indication (explicitly coded as 'product administration error').  At the time of initial report, it was unknown if the patient experienced any adverse event due to Vivotif vaccine.  No further information provided.; Reporter's Comments: A male patient of unspecified age was not aware that Vivotif should been kept in the fridge which is considered as product storage error, and took entire course of Vivotif without refrigerating, at unknown dose, route, or site of administration for unknown indication which is considered as product administration error. Product storage error and product administration error are both considered listed per company conventions. At this point, it was unknown if the patient experienced any adverse event due to Vivotif vaccine. The patient's relevant medical history and concomitant medications were not provided. Product storage error and product administration error are both assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: A male patient of unspecified age was not aware that Vivotif should been kept in the fridge which is considered as product storage error, and took entire course of Vivotif without refrigerating, at unknown dose, route, or site of administration for unknown indication which is considered as product administration error. Product storage error and product administration error are both considered listed per company conventions. At this point, it was unknown if the patient experienced any adverse event due to Vivotif vaccine. The patient's relevant medical history and concomitant medications were not provided. Product storage error and product administration error are both assessed as not related to suspect product but to human factor. The case is non-serious.
Vaccine: HPV9
Symptoms: No adverse event, Syringe issue
Clinical narrative: No additional AE; leaking; syringe popped out; patient received partial dose of GARDASIL 9; This spontaneous report was received from a Physician via a company representative and refers to a patient of unknown age and gender.   The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.   On 10-Feb-2025, the patient was vaccinated with partial dose (about half dose) (Accidental underdose) of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) 0.5 mL (lot #Y000206, expiration date: 23-Sep-2026, dose number 1) for prophylaxis.  During the vaccination, the syringe popped out (Device connection issue) and about half of it leaked out (Device leakage). The reporter confirmed syringe was not cracked or broken and needle was locked in place at time of vaccination and only leak was at the syringe hub/luer lock. The vaccine was not available for retrieval as it was discarded. No additional adverse event (no adverse event).
Sex: F
Vaccine: PNC21
Symptoms: Injection site erythema, Injection site pain, Injection site reaction, Injection site swelling, Pruritus
Clinical narrative: injection site reaction: developed extreme itching; aching at injection site; injection site reaction: developed swelling; injection site reaction: developed redness; This spontaneous report was received from a physician and refers to an 88-year-old female patient. The patient's concomitant medication included "flue shot". No information regarding the patient's medical history, concurrent conditions, drug reactions or allergies was provided. On 03-FEB-2025, the patient was vaccinated with Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) injection, intramuscularly in unspecified arm (dose, lot #, expiration date and site of administration was not reported) for prophylaxis. On the same day, she experienced injection site reaction described as aching and then developed swelling, redness, and extreme itching. It was reported that the patient sought medical attention, however no details was reported. She was using cool, wet compress at the site, however no treatment was given. On an unknown date in February 2025, the patient recovered from the pain at the vaccination site. The outcome of the rest of the events was reported as not recovered.  The causality assessment was not provided.
Vaccine: MMRV
Symptoms: Expired product administered
Clinical narrative: no additional AE/No PQC; patient received an expired dose of PROQUAD; This invalid spontaneous report was received from an other health professional (nurse) and refers to a patient of unknown age and gender.  The patient's pertinent medical history, concomitant medications and drug reaction/allergies were not reported.  On 26-MAR-2024, the patient was vaccinated with an expired dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), dose unknown, lot #W024967, expiration date: 05-FEB-2024 (route of administration and anatomical location were not provided) for prophylaxis (expired product administered) and with sterile diluent (BAXTER Sterile Diluent) (dose, lot #, expiration date, route of administration and indication were not reported). No symptoms or side effects were reported (also reported as "no AE/no PQC"). This case is invalid due to lack of patient identifiers.
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; Medical Assistant calling with a report of an adverse event regarding improperly stored and administered VARIVAX; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender.   No information regarding the patient's medical history, previous drug reactions or allergies and concomitant medications was provided. Medical Assistant stated that the Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) was involved in multiple temperature excursions beginning on 05-DEC-2024, and the product was administered to the patient involved on 06-DEC-2024, with Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX), (lot #Y015108 who had been verified to be a valid lot number, expiration date: 06-SEP-2026) 0.5 mL / Two dose series), for prophylaxis; and sterile diluent (BAXTER STERILE DILUENT) (improper storage of product in use).  No additional adverse event.
Vaccine: HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE; GARDASIL-9 expired on 1/6/2025 and was administered on 2/11/2025; This spontaneous report was received from an Office Manager and referred to a patient of unknown age and gender.   The patient's medical history, concurrent conditions, concomitant therapies, drug reactions and allergies were not reported.  On 11-FEB-2025, the patient was vaccinated with Human Papillomavirus 9-valent Vaccine, Recombinant (lot #W028573, expiration date: 06-JAN-2025) for prophylaxis (strength, formulation, dose, and route of administration were not provided) (Expired product administered). No additional AE.
Age: 60.0
Sex: F
Vaccine: PNC21
Symptoms: Rash
Clinical narrative: rash; Information has been received from Business Partner/CRO on 12-Feb-2025.  This spontaneous report was received from a/an Pharmacist and refers to a(n) 60-year-old female patient.   The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.   On 03-Feb-2025, the patient started therapy with Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE), Solution for injection (lot #Y011819, expiration date: 01-Oct-2025) 0.5 mL (0.5ml/dose), administered by Intramuscular route. On an unknown date, the patient started therapy with . The patient started therapy with Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE), for the treatment of Age over 50 years old.  On 03-Feb-2025, the patient experienced rash.   At the reporting time, the patient was recovering from rash.   The action taken with Pneumococcal 21-valent Conjugate Vaccine was reported as not applicable.   The causal relationship between the event of rash and Pneumococcal 21-valent Conjugate Vaccine was unknown/not reported/not provided.
Sex: M
Vaccine: PNC21
Symptoms: Chills, Fatigue, Malaise, Tremor
Clinical narrative: Physician reported he has been sick all day and had to cancel his patient appointments; severe reaction to include chills with shaking, and fatigue.; severe reaction to include chills with shaking, and fatigue.; severe reaction to include chills with shaking, and fatigue; This spontaneous report has been received from a physician and refers to himself, a male patient of unknown age.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.   On 06-Feb-2025, the patient was vaccinated with Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) for prophylaxis (dose, vaccination scheme, frequency, route of administration, anatomical site of injection, lot number, and expiration date were not reported/unknown by the reporter).  On that same date, the patient experienced severe reaction to include chills with shaking (tremor), and fatigue. On an unknown date, the patient experienced he has been sick all day and had to cancel his patient appointments.   At the reporting time, the patient had not recovered from all the events.   The causal relationship between the events and Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) was not reported.   No additional information is expected.
Vaccine: HPV9
Symptoms: Product storage error
Clinical narrative: No additional EAE/PQC; 3 doses of GARDASIL-9 were administered to a patient after a temperature excursion; This spontaneous report was received from a nurse regarding to a patient of unknown age and gender. The patient's pertinent medical history, previous drug reactions or allergies and concomitant medications were not provided.  On an unspecified date, the patient was vaccinated with 3 doses series of human papilloma virus (HPV) rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection, lot number X019862 (lot number X019862 had been verified to be valid lot number for HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine [yeast], expiration date was not provided, but upon an internal validation, established as 14-FEB-2025) (strength, dose, frequency, route of administration and anatomical injection site were not provided) for prophylaxis.   The nurse stated that the 3 doses of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) were administered to a patient after a temperature excursion (temperature: unknown, only knows it was above 46 F with time frame for longer than 1600 hours. There was previous temperature excursion, details unknown). No further information was available from the HCP. Consent to contact the physician was provided. No additional adverse event (AE)/product quality complaint (PQC).
Sex: M
Vaccine: DTPPVHBHPB, HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; Medical assistant calling to report a patient was inadvertently administered both the RECOMBIVAX HB and VAXELIS Vaccines on the same day on 12/20/2024.  No symptoms reported as of now, however caller states they have not followed up with the parents; This spontaneous report was received from a medical assistant concerning a 2-month-old male patient.   The patient's pertinent medical history, past drug reactions or allergies, concurrent conditions and concomitant therapies were not provided.  On 20-DEC-2024, the patient was inadvertently administered both the  Hepatitis B Vaccine (Recombinant) (lot #X027728, expiration date: 16-Oct-2026) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed (+) Inactivated Poliovirus (+) Haemophilus b Conjugate [Meningococcal Protein Conjugate] and Hepatitis B Vaccine (VAXELIS), Unknown (lot #U7899AA, expiration date: 31-Aug-2026). Both administered as prophylaxis (route, dose, anatomical site were not reported) (vaccine overdose). No symptoms reported as of now, however the reporter stated that they have not followed up with the parents to confirm. The patient's next appointment would be on 20-FEB-2025. No additional details were provided. The operator of device was healthcare professional.; Reporter's Comments: Keywords : BP
Sex: F
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: not experienced any ill effects; Expired Pneumovax 23 was administered; This spontaneous report was received from an other healthcare profession via vendor and refers to a 72-year-old female patient. No information regarding the patient's medical history, concurrent conditions, concomitant medications, drug reactions or allergies was provided.  On 12-FEB-2025, the patient was vaccinated with an expired dose of Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX 23) lot # X018278 was confirmed to be valid, expiration date 24-NOV-2024, for prophylaxis (dose, route and site of administration were not reported). The patient had no ill effects.
Vaccine: HPV9
Symptoms: No adverse event, Syringe issue
Clinical narrative: No  additional AEs/PQC reported; Caller reports GARDASIL 9 PFS leaked during administration and patient did not receive full dose.; GARDASIL 9 PFS leaked during administration and patient did not receive full dose.; Caller reports GARDASIL 9 PFS leaked during administration and patient did not receive full dose.; This spontaneous report was received from a nurse practitioner and refers to a patient of unknown age and gender.   The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On 18-FEB-2025, the patient was vaccinated with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) (valid lot number Y007322, expiration date: 18-AUG-2026) intramuscular injection for prophylaxis (dose, dose number, anatomical location, route of administration was not provided) and was leaked during administration and patient did not receive full dose ( product leakage, poor quality device used, accidental underdose). No other information provided.  No additional adverse event (AE) reported.
Age: 77.0
Sex: M
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: the patients have not experienced any ill effects; This office manager reports that expired PNEUMOVAX 23 was administered to two patients on 12Feb2025.; This spontaneous report has been received from a regarding a health professional regarding a 77-year-old male patient. Information regarding medical history, concurrent conditions and concomitant therapies was not reported. On 12-FEB-2025, the patient received Pneumococcal Vaccine, Polyvalent (23-valent) Solution for injection (PNEUMOVAX 23) for prophylaxis, lot number X018278 which has been verified to be valid, expiration date reported and validated as 24-NOV-2024 (scheme, dose, strength, anatomical site, route of administration not provided) (expired vaccine used). The patient have not experienced any ill effects (no adverse event).
Vaccine: HEP
Symptoms: No adverse event, Underdose
Clinical narrative: No symptoms reported. No additional adverse event reported.; adult patient who was inadvertently administered a pediatric dose of RECOMBIVAXHB; This spontaneous report was received from a certified medical assistant and refers to an adult patient of an unknown gender. No information regarding the patient's medical history, concurrent conditions, concomitant medications, drug reactions or allergies. On 19-FEB-2025, the patient was inadvertently administered a pediatric dose of hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB) injection, 0.5 ml for prophylaxis (lot #, expiration date, route and site of administration were not provided). No symptoms reported. No additional adverse event reported.
Vaccine: TYP
Symptoms: Product dose omission issue
Clinical narrative: The patient took the three doses of Vivotif, and missed the fourth dose; Case reference number US-BN-2024-001983 is a spontaneous case initially received from a pharmacist via Med Communications (reference number: USBAV23-1245) on 03-Jun-2024 and concerns a patient of unspecified demographics.  The patient's relevant medical history and concomitant medication details were not provided.  On unspecified dates, the patient took three doses of Vivotif (batch number: unknown), at unknown doses, or routes of administration, for an unknown indication.   On an unspecified date, as reported it was one week since last dose of Vivotif, the patient missed fourth dose of Vivotif (explicitly coded as 'missed dose').  At the time of the initial report, it was unknown if the patient experienced any adverse event due to Vivotif.  Additional information received from Bavarian Nordic on 04-Jun-2024 included reporter name updated.; Reporter's Comments: A patient of unspecified demographics missed fourth dose of Vivotif. Product dose omission issue is considered listed per company convention. At this point, it was unknown if the patient experienced any adverse event due to Vivotif. The patient's relevant medical history and concomitant medication details were not provided. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: A patient of unspecified demographics missed fourth dose of Vivotif. Product dose omission issue is considered listed per company convention. At this point, it was unknown if the patient experienced any adverse event due to Vivotif. The patient's relevant medical history and concomitant medication details were not provided. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.
Sex: M
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient took third dose of Vivotif 12 hours later (on day six instead on day five); Case reference number US-BN-2024-001980 is a spontaneous case initially received from a pharmacist via Med Communications (reference number: USBAV23-1229) on 03-Jun-2024 and concerns a male patient of unspecified age.  The patient's relevant medical history and concomitant medications were not provided.  On unspecified date, reported as day one, the patient took first dose of Vivotif (batch number: unknown), at an unknown dose, orally, for typhoid immunisation.  On unspecified date, reported as day three, the patient took second dose of Vivotif (batch number: unknown), at an unknown dose, orally.  On unspecified date, reported as day six and as 12 hours late, the patient took third dose of Vivotif instead on day five (batch number: Unknown), at an unknown dose, orally (explicitly coded as 'inappropriate schedule of vaccine administered').  At the time of the initial report, it was unknown if the patient experienced any adverse event due to Vivotif.  No further information was provided.; Reporter's Comments: A male patient of unspecified age took third dose of Vivotif six and as 12 hours late, at an unknown dose, orally which is considered as inappropriate schedule of vaccine administered. Inappropriate schedule of product administration is considered listed per company convention. At this point, it was unknown if the patient experienced any adverse event due to Vivotif. The patient's relevant medical history and concomitant medications were not provided. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: A male patient of unspecified age took third dose of Vivotif six and as 12 hours late, at an unknown dose, orally which is considered as inappropriate schedule of vaccine administered. Inappropriate schedule of product administration is considered listed per company convention. At this point, it was unknown if the patient experienced any adverse event due to Vivotif. The patient's relevant medical history and concomitant medications were not provided. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.
Sex: F
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: The patient took first two doses of Vivotif, two days in row; Case reference number US-BN-2024-001982 is a spontaneous case initially received from pharmacist via Med Communications (reference number: USBAV23-1231) on 03-Jun-2024 and concerns female patient of unspecified age.  The patient's relevant medical history and concomitant medication details were not provided.  On unspecified days, as reported two days in a row, the patient took the first and the second dose of Vivotif (batch number: unknown), at unknown dose, orally, for typhoid immunization (explicitly coded as 'inappropriate schedule of vaccine administered').  At the time of the initial report, it was unknown if the patient experienced any adverse event due to Vivotif.  Additional information received from Med Communications on 03-Jun-2024 included Vivotif indication and new reference number (USBAV23-1227).; Reporter's Comments: A female patient of unspecified age took the first and the second dose of Vivotif, two days in a row, at unknown dose, orally, for typhoid immunization which is considered as inappropriate schedule of vaccine administered. Inappropriate schedule of product administration is considered listed per company convention. At this point, it was unknown if the patient experienced any adverse event due to Vivotif. The patient's relevant medical history and concomitant medication details were not provided. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: A female patient of unspecified age took the first and the second dose of Vivotif, two days in a row, at unknown dose, orally, for typhoid immunization which is considered as inappropriate schedule of vaccine administered. Inappropriate schedule of product administration is considered listed per company convention. At this point, it was unknown if the patient experienced any adverse event due to Vivotif. The patient's relevant medical history and concomitant medication details were not provided. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.
Vaccine: TYP
Symptoms: Product storage error
Clinical narrative: Patient took their first Vivotif dose on Tuesday, but the product was not refrigerated, and it's been for more than 24 hours out of refrigeration; Patient took their first Vivotif dose on Tuesday, but the product was not refrigerated, and it's been for more than 24 hours out of refrigeration; Case reference number US-BN-2024-002001 is a spontaneous case initially received from a pharmacist via Med Communication (reference number: USBAV24-1292) on 06-Jun-2024 and concerns a patient of unknown age and gender.  The patient's medical history and concomitant medication was not reported.  On an unspecified date, the patient took the first dose of Vivotif (batch number: unknown) at an unknown dose, via oral use for unknown indication. As reported, patient took their first Vivotif dose on Tuesday, but the product was not refrigerated, and it's been for more than 24 hours out of refrigeration (explicitly coded as 'product storage error' and 'product administration error').  At the time of the initial report, it was unknown if the patient experienced any adverse event due to Vivotif.  No further information was provided.; Reporter's Comments: A patient of unknown age and gender took the first dose of Vivotif, at an unknown dose, via oral use for unknown indication. Reportedly, patient took their first Vivotif dose which has been for more than 24 hours out of refrigeration which is considered as product storage error and product administration error. Product storage error and product administration error are both considered listed per company conventions. At this point, it was unknown if the patient experienced any adverse event due to Vivotif. The patient's medical history and concomitant medication was not reported. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: A patient of unknown age and gender took the first dose of Vivotif, at an unknown dose, via oral use for unknown indication. Reportedly, patient took their first Vivotif dose which has been for more than 24 hours out of refrigeration which is considered as product storage error and product administration error. Product storage error and product administration error are both considered listed per company conventions. At this point, it was unknown if the patient experienced any adverse event due to Vivotif. The patient's medical history and concomitant medication was not reported. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient took two doses of Vivotif consecutively, instead of taking the first two doses every other day; Case reference number US-BN-2024-002019 is a spontaneous case initially received from a pharmacist via Med Communication (reference number: USBAV24-1309) on 07-Jun-2024 and concerns a patient of unknown age and gender.  The patient's medical history and concomitant medication were not provided.  On 06-Jun-2024, the patient took the first dose of Vivotif (batch number: unknown) at an unknown dose, via oral use for unknown indication.  On 07-Jun-2024, one day after the first dose the patient took the second dose of Vivotif (batch number: unknown) at an unknown dose, via oral use (explicitly coded as 'inappropriate schedule of vaccine administered').  At the time of initial report, it was unknown if the patient experienced any adverse event due to Vivotif.  No further information was provided.; Reporter's Comments: A patient of unknown age and gender took the second dose of Vivotif, one day after the first dose, at an unknown dose, via oral use which is considered as inappropriate schedule of vaccine administered. Inappropriate schedule of product administration is considered listed per company convention. At this point, it was unknown if the patient experienced any adverse event due to Vivotif. The patient's relevant medical history and concomitant medications were not provided. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: A patient of unknown age and gender took the second dose of Vivotif, one day after the first dose, at an unknown dose, via oral use which is considered as inappropriate schedule of vaccine administered. Inappropriate schedule of product administration is considered listed per company convention. At this point, it was unknown if the patient experienced any adverse event due to Vivotif. The patient's relevant medical history and concomitant medications were not provided. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.
Age: 0.58
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received an expired dose of covid.   The Date of expiration written on the box 2/26/25,    Dose was given on 2/28/25,     After speaking with Immunization,  TIme out was taken and addressed.  Plan was discussed to make sure that the expiration dates are looked at more thoroughly to make sure they are removed from inventory.   We discussed getting "expire first" stickers to make it more noticeable to staff.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Face and mouth X-ray, Headache, Impaired quality of life, Pulmonary function test
Clinical narrative: Nothing at first then I developed a strong sense of smell and cough. I smell things no one else smells. I can get a headache from this but not always. It can make me cough, but not always. I get a burning in my throat from some smells. It has affected my life completely. Ongoing!
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Smoke sensitivity, Throat irritation
Clinical narrative: Nothing at first then I developed a strong sense of smell and cough. I smell things no one else smells. I can get a headache from this but not always. It can make me cough, but not always. I get a burning in my throat from some smells. It has affected my life completely. Ongoing!
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac operation, Chest discomfort, Coronary artery bypass, Fatigue
Clinical narrative: tightness in the chest, fatigue
Age: 61.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Patient was intended to receive the standard flu vaccine but instead was administered the fluad high dose vaccine. No adverse effects reported.
Age: 12.0
Sex: F
Vaccine: HEP
Symptoms: Extra dose administered
Clinical narrative: Pt given Hep B as the 3rd dose but it was an extra 4th dose 4 weeks after dose#3.  Dose#3 given at another facility.
Age: 8.0
Sex: M
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Pt given Hep A dose without realizing that dose was given 1 mo prior.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Urticaria
Clinical narrative: Redness, warmth and swelling down the majority of her upper left arm that is still there after 1 week. Mom stated it looked like hives. Denies fever.
Sex: F
Vaccine: TYP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient took two doses of Vivotif and missed to receive third dose; Case reference number US-BN-2024-002043 is a spontaneous case initially received from a consumer via Med Communication (reference number: USBAV24-1342) on 11-Jun-2024 and concerns a female patient of unknown age.  The patient's medical history and concomitant medication were not provided.  On 06-Jun-2024, the patient took the first dose of Vivotif (batch number: unknown) at unknown dose, via oral use, prior to travel on 27 Jun 2024.   On 08-Jun-2024, two days after the first dose, the patient took the second dose of Vivotif (batch number: unknown) at unknown dose, via oral use. As reported, patient took two doses of Vivotif and missed to receive third dose (explicitly coded as 'Inappropriate schedule of vaccine administered').  At the time of the initial report, it was unknown if the patient experienced any adverse event Vivotif.  No further information was provided.; Reporter's Comments: A female patient of unknown age took two doses of Vivotif and missed to receive third dose, which is considered as inappropriate schedule of vaccine administered. It was unknown if the patient experienced any adverse event Vivotif. Inappropriate schedule of product administration is considered as listed per company convention. The patient's medical history and concomitant medication were not provided. Inappropriate schedule of product administration has been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: A female patient of unknown age took two doses of Vivotif and missed to receive third dose, which is considered as inappropriate schedule of vaccine administered. It was unknown if the patient experienced any adverse event Vivotif. Inappropriate schedule of product administration is considered as listed per company convention. The patient's medical history and concomitant medication were not provided. Inappropriate schedule of product administration has been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Alopecia, Condition aggravated, Dry skin, Eczema, Immunodeficiency
Clinical narrative: Cause eczema which was only on small section of arm and calf?s of both legs, to take up 85% of my entire body.  Severely dry and damaged skin that resulted in loss of massive amounts of skin from touch alone. Loss of hair across entire body. Insomnia, restless leg syndrome, compromised immune system. The treatment and medications I?m currently on are triamcinolone and Dupixent, which I cannot afford and my doctor states I will most likely be on this medication for the rest of my life
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Insomnia, Restless legs syndrome, Skin exfoliation, Skin injury
Clinical narrative: Cause eczema which was only on small section of arm and calf?s of both legs, to take up 85% of my entire body.  Severely dry and damaged skin that resulted in loss of massive amounts of skin from touch alone. Loss of hair across entire body. Insomnia, restless leg syndrome, compromised immune system. The treatment and medications I?m currently on are triamcinolone and Dupixent, which I cannot afford and my doctor states I will most likely be on this medication for the rest of my life
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Erythema, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Tdap and Menquadfi vaccines were given on the afternoon of 02/21/25.  The next day, the spot around the vaccines were red and swollen.  Tender to touch.  Redness spreading down the arm some.  No wheezing, respiratory distress or lip/tongue swelling.  Denies fevers.
Age: 7.0
Sex: F
Vaccine: DTAP
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse reactions noted