chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 47.0
Sex: F
Vaccine: RSV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: A dose of Arexvy was given to an immunocompromised patient under 60 years old.; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate age at vaccine administration in a 47-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 7X243, expiry date 21-AUG-2025) for prophylaxis.   Concurrent medical conditions included immunocompromised.   On 30-APR-2024, the patient received Arexvy. On 30-APR-2024, an unknown time after receiving Arexvy, the patient experienced inappropriate age at vaccine administration (Verbatim: A dose of Arexvy was given to an immunocompromised patient under 60 years old.). The outcome of the inappropriate age at vaccine administration was unknown.   Additional Information: GSK Receipt Date: 01-MAY-2024 A dose of Arexvy was given to a patient under 60 years old, which led to inappropriate age at vaccine administration. The consented to follow up.
Sex: F
Vaccine: TTOX, VARZOS
Symptoms: Chills, Extra dose administered, Fatigue, Headache, Pain
Clinical narrative: headache; chills; achy; tired; received 3rd dose of Shingrix; This non-serious case was reported by a consumer via call center representative and described the occurrence of headache in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included TETANUS VACCINE for prophylaxis.   On 30-APR-2024, the patient received the 3rd dose of Shingrix and TETANUS VACCINE. On 30-APR-2024, less than a day after receiving Shingrix, the patient experienced headache (Verbatim: headache), chills (Verbatim: chills), pain (Verbatim: achy), tiredness (Verbatim: tired) and extra dose administered (Verbatim: received 3rd dose of Shingrix). The outcome of the headache, chills and pain were resolved and the outcome of the tiredness was not resolved and the outcome of the extra dose administered was unknown.   It was unknown if the reporter considered the headache, chills, pain and tiredness to be related to Shingrix.     It was unknown if the company considered the headache, chills, pain and tiredness to be related to Shingrix.   Additional Information: GSK Receipt date: 01-MAY-2024 The caller reported that she received Shingrix in right arm and a Tetanus shot in the left on 30 April 2024. She stated that 5 hours after the vaccines she experienced headache, chills and was achy. She was feeling better but still tired. She stated that she had already gotten the 2-dose series of Shingrix and yesterday's shot was dose 3 of Shingrix which led to extra dose administered. She asked what she should do. It was unknown if the reporter considered the headache, chills, pain and tiredness to be related to Tetanus vaccine.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Patient had forgotten to take the 2nd dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received about 1 year ago prior to the reporting).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: Patient had forgotten to take the 2nd dose). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 02-May-2024 The reporter called to inform that the patient had forgotten to receive the 2nd dose on time and went to the pharmacy to ask if they should just take the 2nd dose or restart the series.  According to the reporter the patient had taken the 1st dose about a year ago.  The vaccine administration facility was the same as primary reporter. The reporter consented to follow up. This US2024056378 case has been linked to the case reported by the same reporter for different patient.; Sender's Comments:  US-GSK-US2024056378:same reporter
Age: 12.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Expired product administered, Inappropriate schedule of product administration, Product administered to patient of inappropriate age
Clinical narrative: administration of Kinrix to an 11 years old patient; It was the 2nd DTap & Polio for patient; Expired vaccine used; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 12-year-old male patient who received DTPa-IPV (Kinrix) (batch number 5H95B, expiry date 04-JUN-2011) for prophylaxis.   On 02-MAY-2024, the patient received Kinrix. On 02-MAY-2024, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: administration of Kinrix to an 11 years old patient), inappropriate schedule of vaccine administered (Verbatim: It was the 2nd DTap & Polio for patient) and expired vaccine used (Verbatim: Expired vaccine used). The outcome of the inappropriate age at vaccine administration, inappropriate schedule of vaccine administered and expired vaccine used were unknown.   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: 02-May-2024 The reporter was a medical assistant. The reporter reported that the 11 years old patient received Kinrix vaccine, which led to inappropriate age at vaccine administration. The reporter stated that it was the 2nd dose DTap & Polio for the patient, which led to inappropriate schedule of vaccine administered. The reporter stated that they were in need of the combo vaccine for DTap & Polio which was why she thought Kinrix was best option until she realized the age group for Kinrix. The patient received Kinrix vaccine which was already expired, which led to expired vaccine used. The reporter requested data on how to proceed if they are covered and if they need to come in for separate vaccines. The reporter consented to follow up. This US2024056398 case has been linked to the case reported by the same reporter for different patient.; Sender's Comments:  US-GSK-US2024056398:same reporter different patient
Age: 16.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Administration of Kinrix to an 16 years old patient; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 16-year-old female patient who received DTPa-IPV (Kinrix) (batch number 5H95B, expiry date 16-FEB-2026) for prophylaxis.   On 02-MAY-2024, the patient received Kinrix. On 02-MAY-2024, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Administration of Kinrix to an 16 years old patient). The outcome of the inappropriate age at vaccine administration was unknown.   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: 02-May-2024 The reporter was a medical assistant. The reporter reported that the 16 years old patient received Kinrix vaccine, which led to inappropriate age at vaccine administration. The reporter stated that it was the first dose of Polio vaccine for patient. The reporter stated that they were in need of the combo vaccine for DTap & Polio which was why she thought Kinrix was best option until she realized the age group for Kinrix. The reporter requested data on how to proceed if they are covered and if they need to come in for separate vaccines. The reporter consented to follow up. This US2024056395 case has been linked to the case reported by the same reporter for different patient.; Sender's Comments:  US-GSK-US2024056395:same reporter different patient
Age: 17.0
Sex: M
Vaccine: DTAP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: administered the Infanrix vaccine to a 17 year old patient; inadvertently administered the Infanrix; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 17-year-old male patient who received DTPa (Infanrix) (batch number 7HM5J, expiry date 13-SEP-2024) for prophylaxis.   On 02-MAY-2024, the patient received Infanrix. On 02-MAY-2024, an unknown time after receiving Infanrix, the patient experienced inappropriate age at vaccine administration (Verbatim: administered the Infanrix vaccine to a 17 year old patient) and wrong vaccine administered (Verbatim: inadvertently administered the Infanrix). The outcome of the inappropriate age at vaccine administration and wrong vaccine administered were unknown.   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: 02-MAY-2024 Office supervisor called to inquired that was any information available and how to proceed. Supervisor reported that they inadvertently administered the Infanrix vaccine to 17-year-old patient on reporting day. Health care professional stated that the patient should had receive the Boostrix vaccine, but received In Infanrix, which led to wrong vaccine administered. The reporter did not consent to follow-up. The patient received Infanrix above the age recommended, which led to inappropriate age at vaccine administration.
Sex: F
Vaccine: HEP
Symptoms: Incomplete course of vaccination
Clinical narrative: first dose of Engerix-B on 6/28/2023, asks do we need to continue with the Engerix-B; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a 42-year-old female patient who received HBV (Engerix B) for prophylaxis.   Previously administered products included Engerix B (1st dose received on 28th June 2023).   On an unknown date, the patient did not receive the 2nd dose of Engerix B. On an unknown date, an unknown time after receiving Engerix B, the patient experienced incomplete course of vaccination (Verbatim: first dose of Engerix-B on 6/28/2023, asks do we need to continue with the Engerix-B). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 02-May-2024 The reporter reported that the patient received first dose of Engerix-B on 28th June 2023 and wanted to know do they need to continue with the Engerix-B Or switch to another vaccine as the patient now needs Hep A and B. The vaccine administration facility was the same as primary reporter. Till the time of reporting, the patient did not receive the 2nd dose, which led to incomplete course of vaccination. The reporter consented to follow up via postal.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: patient missed the second dose of shingrix; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 54-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose 2 years ago on an unknown date).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: patient missed the second dose of shingrix). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 02-MAY-2024 The reporter wanted to know if patient missed the second dose of Shingrix had to get 2 doses again or just one. Till the time of reporting the patient did not receive 2nd dose of Shingrix, which led to an incomplete course of vaccination. The vaccine administration facility was the same as primary reporter. The chat was disconnected by healthcare professional (HCP) so no additional information available. Unknown if follow up was permissible.
Sex: F
Vaccine: FLUX
Symptoms: Bronchitis chronic, Depression, Dry skin, Fatigue, Hyperphagia
Clinical narrative: skin cancer; Flu vaccine causes chronic bronchitis; Initial information received on 29-Apr-2024 regarding an unsolicited valid  serious case received from a consumer/non-healthcare professional.  This case involves Elderly female patient who experienced skin cancer and chronic bronchitis after receiving vaccine Influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included SALBUTAMOL SULFATE (ALBUTEROL SULFATE); AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE (ADDERALL); DULOXETINE HYDROCHLORIDE (CYMBALTA); PRAVASTATIN (PRAVASTATIN); VITAMIN D NOS (VITAMIN D [VITAMIN D NOS]); and UBIDECARENONE (COQ 10).  On an unknown date, the patient received a dose of suspect Influenza vaccine produced by unknown manufacturer (lot number, strength, dose, form and expiry not reported) via unknown route in unknown administration site as prophylactic vaccination.  On an unknown date the patient developed a skin cancer and chronic bronchitis (bronchitis chronic) (unknown latency) following the administration of Influenza vaccine.   Reportedly, Patient reports dry skin- Feels fatigues and is overeating- Has depression but states it is well controlled with medication.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the events.  At time of reporting, the outcome was Unknown for the events.  Seriousness: Skin cancer was assessed as medically significant.  Consent given by reporter to contact for follow-up: No; Sender's Comments: Sanofi company comment for information received on 07-May-2024: This case involves Elderly female patient who experienced skin cancer and chronic bronchitis after receiving vaccine Influenza vaccine. Further information regarding medical history, concurrent condition during vaccination and tolerance, allergic history, laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of the individual suspect vaccine cannot be assessed.
Sex: F
Vaccine: FLUX
Symptoms: Skin cancer
Clinical narrative: skin cancer; Flu vaccine causes chronic bronchitis; Initial information received on 29-Apr-2024 regarding an unsolicited valid  serious case received from a consumer/non-healthcare professional.  This case involves Elderly female patient who experienced skin cancer and chronic bronchitis after receiving vaccine Influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included SALBUTAMOL SULFATE (ALBUTEROL SULFATE); AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE (ADDERALL); DULOXETINE HYDROCHLORIDE (CYMBALTA); PRAVASTATIN (PRAVASTATIN); VITAMIN D NOS (VITAMIN D [VITAMIN D NOS]); and UBIDECARENONE (COQ 10).  On an unknown date, the patient received a dose of suspect Influenza vaccine produced by unknown manufacturer (lot number, strength, dose, form and expiry not reported) via unknown route in unknown administration site as prophylactic vaccination.  On an unknown date the patient developed a skin cancer and chronic bronchitis (bronchitis chronic) (unknown latency) following the administration of Influenza vaccine.   Reportedly, Patient reports dry skin- Feels fatigues and is overeating- Has depression but states it is well controlled with medication.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the events.  At time of reporting, the outcome was Unknown for the events.  Seriousness: Skin cancer was assessed as medically significant.  Consent given by reporter to contact for follow-up: No; Sender's Comments: Sanofi company comment for information received on 07-May-2024: This case involves Elderly female patient who experienced skin cancer and chronic bronchitis after receiving vaccine Influenza vaccine. Further information regarding medical history, concurrent condition during vaccination and tolerance, allergic history, laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of the individual suspect vaccine cannot be assessed.
Age: 12.0
Sex: F
Vaccine: MEN
Symptoms: Product storage error
Clinical narrative: temperature excursion product adminitered with no reported adverse event; Initial information was received on 30-Apr-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 12 years old female patient to whom  temperature excursion meningococcal A-C-Y-W135 (T CONJ) vaccine [Menquadfi] was administered with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 25-Apr-2024, the patient received an unknown dose (total) of suspect meningococcal A-C-Y-W135 (T CONJ) vaccine (Solution for injection) (lot number, expiry date, strength was unknown) via unknown route in unknown administration site for Immunization (poor quality product administered) (Latency: same day). The information on the batch number was requested.  This situation was not due to human error. Reason: Wire was not completely attached to the data logger  Max/Lowest Temp reached: 10.76F -13hrs 50minutes 10.69F - 8hrs 21 mins.   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: U
Vaccine: YF
Symptoms: No adverse event, Product preparation error
Clinical narrative: YF-VAX incorrect diluent was used, with no reported adverse event; Initial information received on 06-May-2024 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves an unknown age and unknown gender patient and yellow fever vaccine [YF-VAX] incorrect diluent was used, with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant(s) and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect yellow fever vaccine, Solution for injection (strength, lot number, expiry date: unknown) via unknown route in unknown administration site for prophylactic vaccination (immunization) and yf-vax incorrect diluent was used, with no reported adverse event (product preparation error) (latency: same day).   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: 2.0
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Expired product administered, No adverse event
Clinical narrative: administered pentacel which was out of date for about a month with no reported adverse event; Initial information received on 06-May-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 2 years old female patient who was administered DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] which was out of date for about a month with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 06-May-2024, the patient received 1X, total 0.5 ml expired suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE, Suspension for injection (lot UJ868AA and expiry 20-03-24) (expired product administered, latency same day) (route and strength: unknown)  in the left thigh for immunization.  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: 9.0
Sex: M
Vaccine: TD
Symptoms: Expired product administered, No adverse event
Clinical narrative: patient was inadvertently administered an expired dose of Tenivac with no adverse event; Initial information was received on 06-May-2024 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 9 years old male patient who was inadvertently administered an expired dose of diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult [Tenivac] with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Patient received no concomitant vaccines.    On 06-May-2024, the patient received a 0.5 ml, (total) dose of suspect diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult, (Suspension for injection) (lot: U7183AA, expiry date: 24-Sep-2023, unknown strength) via intramuscular route in the left deltoid for Immunisation and patient was inadvertently administered an expired dose of tenivac today intramuscularly into the left deltoid (expired product administered) (Latency: same day).  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: U
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired product being administered with no reported adverse event; Initial information received on 07-May-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves patient (unknown age and gender) to whom expired HIB (PRP/T) VACCINE [ACT-HIB] being administered with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 09-Apr-2024, the patient was administered expired dose of suspect HIB (PRP/T) VACCINE, Powder and solvent for solution for injection (strength not reported) (lot number; UJ862AA; Expiration Date: 24-Mar-2024) via unknown route in unknown administration site for Immunization with no reported adverse event (expired product administered) (latency: on same day).  LPN clarified that one patient received a dose on 9Apr2024 and two patients received a dose on 11Apr2024.   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: 0.83
Sex: M
Vaccine: HIBV
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: dose of Hib vaccine given too early, at 10 months rather than 12-15 months with no reported adverse event; Initial information was received on 07-May-2024 regarding an unsolicited valid  non-serious case received from a Nurse.  This case involves a 10 months old male patient to whom 4th dose of HIB (PRP/T) vaccine [ACT-HIB] given too early, rather than 12-15 months 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 20v (crm197) (prevenar 20) and influenza vaccine inact split 3v (fluarix) for prophylactic vaccination.  On 24-Apr-2024, the patient received a 0.5 ml (dose 4) of suspect HIB (PRP/T) vaccine, Powder and solvent for solution for injection (lot UJ977AA, expiry date: 08-Nov-2024, strength: unknown) via intramuscular route in left thigh for Immunization and 4th dose of hib vaccine given too early, at 10 months rather than 12-15 months with no reported adverse event (inappropriate schedule of product administration) (Latency: same day).  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: 11.0
Sex: U
Vaccine: DTAP
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: intended to administer a Tdap injection to a patient, however, daptacel was mistakenly administered instead with no reported adverse event; 11 yr old was given a dose of daptacel inappropriately with no reported adverse event; Initial information received on 07-May-2024 regarding an unsolicited valid non-serious case received from an other health professional.  This case involves a 11 years old and unknown gender patient who experienced intended to administer a tdap injection to a patient, however diphtheria-15/tetanus/5 ac pertussis vaccine [Daptacel] was mistakenly administered instead 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 of suspect diphtheria-15/tetanus/5 ac pertussis vaccine Suspension for injection lot number not reported via unknown route in unknown administration site (dose, frequency, route, formulation, strength, lot/batch number and expiration date: not provided) for Immunisation (wrong product administered) (product administered to patient of inappropriate age) (latency- same day).  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: U
Vaccine: HIBV
Symptoms: No adverse event, Product preparation error
Clinical narrative: act-hib vaccine was given to with wrong diluent with no reported adverse event; Initial information received on 08-May-2024 regarding an unsolicited valid non-serious case received via other health professional.  This case involves an unknown age and unknown gender patient and HIB (PRP/T) VACCINE [ACT-HIB] vaccine was given to with wrong diluent with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant(s) and family history were not provided.  On an unknown date, the patient received an unknown dose of suspect HIB (PRP/T) vaccine, Powder and solvent for solution for injection (strength: unknown) (lot: UK007AB, expiry date: unknown) via unknown route in unknown administration site for immunization and act-hib vaccine was given to with wrong diluent with no reported adverse event (product preparation error) (latency: same day)     This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cough, Headache, Nasal congestion, Rhinorrhoea
Clinical narrative: Chills,headache, runny/stuffy nose, cough . Cannot remember if reacted to 1st 2 doses. If she did would have been mild.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Chills, Decreased appetite, Diarrhoea, Nausea
Clinical narrative: Felt a lot of gastrointestinal discomfort and nausea around 11pm. Vomited around 1 am the following day, and twice more. Could not keep any food or water down. Diarrhea at the same time, happened around 2 times. Did not eat much the following day due to no appetite. Fever, aches, and chills all occurred at the same time and continued for just over 24 hours after.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Vomiting
Clinical narrative: Felt a lot of gastrointestinal discomfort and nausea around 11pm. Vomited around 1 am the following day, and twice more. Could not keep any food or water down. Diarrhea at the same time, happened around 2 times. Did not eat much the following day due to no appetite. Fever, aches, and chills all occurred at the same time and continued for just over 24 hours after.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PPV, RV1
Symptoms: Ocular hyperaemia, Rash, Rash erythematous, Scab, Skin infection
Clinical narrative: Broke out in red bumps all over scalp that scabbed over and then broke out again and eventually (a few days later) caused her eyes to become very red and one to swell closed.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PPV, RV1
Symptoms: Swelling of eyelid
Clinical narrative: Broke out in red bumps all over scalp that scabbed over and then broke out again and eventually (a few days later) caused her eyes to become very red and one to swell closed.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: The HCP had reached out to them to ask what to do about "several patients" who had received only the first SHINGRIX dose; This non-serious case was reported by a pharmacist via sales rep and described the occurrence of incomplete course of vaccination in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (on an unknown date received 1st dose).   On an unknown date, the patients did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: The HCP had reached out to them to ask what to do about "several patients" who had received only the first SHINGRIX dose). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 02-MAY-2024 The health care professional (HCP) had reached out to them to ask what to do about several patients who had received only the first Shingrix dose.   He stated that he has noticed this over a few months. Till the time of reporting the several patient received only one dose, which led to incomplete course of vaccination. Consented to follow up. The case is link with US2024056377, by same reporter.; Sender's Comments:  US-GSK-US2024056377:same reporter
Sex: U
Vaccine: HEPAB
Symptoms: Incomplete course of vaccination
Clinical narrative: wanted to get a late second dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received HAB (Twinrix) for prophylaxis.   Previously administered products included Twinrix (1st dose received on 22nd April 2022).   On an unknown date, the patient did not receive the 2nd dose of Twinrix. On an unknown date, an unknown time after receiving Twinrix, the patient experienced incomplete course of vaccination (Verbatim: wanted to get a late second dose). The outcome of the incomplete course of vaccination was unknown.   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: 01-May-2024 The reporter explained that the patient received a first dose of Twinrix on 22nd April 2022 and now they wanted to receive a late second dose. The patient demographics and lot number or expiration date were unknown by the reporter. Till the time of reporting, the patient did not receive the 2nd dose, which led to incomplete course of vaccination. The reporter consented to follow up.
Age: 0.08
Sex: F
Vaccine: RV1
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: a 4 week old patient received Rotarix today at 10:09am.; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 4-week-old female patient who received Rota (Rotarix liquid formulation) (batch number Y4NG3, expiry date 03-OCT-2025) for prophylaxis.   On 02-MAY-2024 10:09, the patient received Rotarix liquid formulation. On 02-MAY-2024 10:09, an unknown time after receiving Rotarix liquid formulation, the patient experienced inappropriate age at vaccine administration (Verbatim: a 4 week old patient received Rotarix today at 10:09am.). The outcome of the inappropriate age at vaccine administration was unknown.   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: 02-MAY-2024 The regular nurse reported that a 4 week old patient received Rotarix, which led to inappropriate age at vaccine administration. Consented to follow up.
Sex: F
Vaccine: HEPAB
Symptoms: Incomplete course of vaccination
Clinical narrative: patient that got her first shot in February 19th and then have her  back for the second dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 56-year-old female patient who received HAB (Twinrix adult) for prophylaxis.   Previously administered products included twinrix (received 1st dose on 19th February 2023, with batch 2PG39 and expiration date 19th September 2025.).   On an unknown date, the patient did not receive the 2nd dose of Twinrix adult. On an unknown date, an unknown time after receiving Twinrix adult, the patient experienced incomplete course of vaccination (Verbatim: patient that got her first shot in February 19th and then have her  back for the second dose). The outcome of the incomplete course of vaccination was unknown.   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: 02-MAY-2024 The pharmacist called and questioned about the twinrix vaccine. The  patient that got her first shot in February 19th and then have her back for the second dose, and asked if have to start the series over again  or could give the second shot and just continue on, what was the protocol for that. Till the reporting the patient did not received 2nd dose, which led to incomplete course of vaccination Consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: patient received his first dose of Shingrix 2 years ago and hasn't yet received dose 2.; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 72-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose 2 years ago, batch number:7BC47, expiry date:09-JUN-2023).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: patient received his first dose of Shingrix 2 years ago and hasn't yet received dose 2.). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 03-MAY-2024 Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination. The case had been linked to US2024056885, reported by the same reporter, for a different patient.
Age: 54.0
Sex: F
Vaccine: RSV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Wrong age; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate age at vaccine administration in a 54-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   Concurrent medical conditions included chronic obstructive pulmonary disease and respiratory disorder.   On 02-MAY-2024, the patient received Arexvy. On 02-MAY-2024, an unknown time after receiving Arexvy, the patient experienced inappropriate age at vaccine administration (Verbatim: Wrong age). The outcome of the inappropriate age at vaccine administration was unknown.   Additional Information: GSK receipt date: 03-MAY-2024 Pharmacist explained they administered Arexvy to a 54 year old patient, which led to inappropriate age at vaccine administration.  The caller clarified this was a mistake but also because the patient has some respiratory issues, and mentioned Chronic Obstructive Pulmonary Disease. Did not consent to follow-up.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Chest pain, Erythema, Facial pain, Pruritus
Clinical narrative: Shingrix #1 given 04-26-24 - seen at clinic 5-4-24 due to slight face, redness & itchiness Right external cheek - appeared 4-30-24. follow up visit 5-8-24 with blister on right cheek, swollen face, redness. Rx of acyclovir cream and tablet prescribed. Spoked with pt. 5/10/24 - getting better - blisters dry - with slight itchiness & pain on (R) cheek
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Swelling face
Clinical narrative: Shingrix #1 given 04-26-24 - seen at clinic 5-4-24 due to slight face, redness & itchiness Right external cheek - appeared 4-30-24. follow up visit 5-8-24 with blister on right cheek, swollen face, redness. Rx of acyclovir cream and tablet prescribed. Spoked with pt. 5/10/24 - getting better - blisters dry - with slight itchiness & pain on (R) cheek
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PNC20, RV5
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: 24 hrs after injection she had a red area 1.25 cm with small amt .5 cm of induration under
Age: 2.5
Sex: F
Vaccine: DTAP
Symptoms: Gait disturbance, Pyrexia, Swelling
Clinical narrative: Fevering, swelling, limping on leg
Age: 17.0
Sex: F
Vaccine: HPV9
Symptoms: Fall, Pallor, Syncope, Unresponsive to stimuli
Clinical narrative: shortly after vaccine (seconds), pt fell off the exam table, skin was pale, unresponsive for several seconds, dx with vasovagal syncope with fall.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation, Cardiac stress test, Catheterisation cardiac, Dyspnoea, Echocardiogram
Clinical narrative: Heart Palpitations, AFIB, Shortness of breath, fatigue.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Magnetic resonance imaging heart, Palpitations
Clinical narrative: Heart Palpitations, AFIB, Shortness of breath, fatigue.
Age: 0.42
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC20, RV1
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Upon further review of chart and record, the error truly stems from the 1/4/24 well child appt. Pt received 2-month vaccines late. Given on 12/25/23 (3 months of age). Pediarix, Hib, Prevnar, and Rota.  Pt returned for 4-month appt on 1/4/24, and again was given Pediarix, Hib, Prevnar, and Rota. Due to the fact, not enough time had passed, since the previous vaccines, they were considered given too early per record (does not meet minimum interval from last dose). Thus, they needed to be repeated.   Vaccines were given again (repeated) at 2/29/24.   The vaccines given on 2/29/24 were correctly given. It was the vaccines given on 1/4/24 that was not in the recommended range.
Age: 19.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site urticaria
Clinical narrative: Localized redness, swelling, and hives around injection site.
Age: 0.58
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: vaccine given was expired, no symptoms
Age: 0.75
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine given was expired, no symptoms
Age: 0.75
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine given was expired, no symptoms
Age: 13.0
Sex: F
Vaccine: HEP, IPV, MMR, MNQ, TDAP, VARCEL
Symptoms: Cold sweat, Dizziness, Immediate post-injection reaction, Nausea, Pallor
Clinical narrative: Patient experienced vasovagal syncope immediately after receiving vaccinations.  Symptoms: Pale, clammy, lightheaded, nauseated.  Moved to reclining position, provided with water.  After about half an hour patient was able to eat and drink.  Mother of patient reported that she had not eaten anything at all prior to clinic visit.
Age: 13.0
Sex: F
Vaccine: HEP, IPV, MMR, MNQ, TDAP, VARCEL
Symptoms: Syncope
Clinical narrative: Patient experienced vasovagal syncope immediately after receiving vaccinations.  Symptoms: Pale, clammy, lightheaded, nauseated.  Moved to reclining position, provided with water.  After about half an hour patient was able to eat and drink.  Mother of patient reported that she had not eaten anything at all prior to clinic visit.
Age: 1.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine given was expired, no symptoms
Age: 2.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine given was expired, no symptoms
Age: 2.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine given was expired, no symptoms
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity
Clinical narrative: Pt reports dull pain in vaccine arm that is lasting month after vaccination.
Age: 4.0
Sex: F
Vaccine: DTPPVHBHPB, HEPA, MMRV, PNC20
Symptoms: Injection site cellulitis, Injection site pain, Injection site swelling
Clinical narrative: Patient received vaccines on 5/7/2024 and came back into the office on 5/9/2024 with localized swelling and tenderness on palpitation to the left thigh. Patient was prescribed Keflex for a diagnosis of cellulitis and will follow up on 5/16/2024 or sooner if not improving.
Age: 0.58
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine given was expired, no symptoms
Age: 18.0
Sex: M
Vaccine: FLU4, TYP
Symptoms: Oropharyngeal pain, Pharyngeal exudate, Platelet count decreased, Skin disorder, Streptococcus test negative
Clinical narrative: Vaccinated on 4/29/24, came to clinic on 5/25/24 with complaint of sore throat "for about 4 days". Returned to clinic on 4/29/24 with complaint of "random spots" on his body for about 2 days; spots were noted on both arms, both thighs and the back. Throat with exudate, but negative strep test.  Patient was sent to ER and diagnosed with thrombocytopenia: platelet count 23,000.
Age: 18.0
Sex: M
Vaccine: FLU4, TYP
Symptoms: Thrombocytopenia
Clinical narrative: Vaccinated on 4/29/24, came to clinic on 5/25/24 with complaint of sore throat "for about 4 days". Returned to clinic on 4/29/24 with complaint of "random spots" on his body for about 2 days; spots were noted on both arms, both thighs and the back. Throat with exudate, but negative strep test.  Patient was sent to ER and diagnosed with thrombocytopenia: platelet count 23,000.
Age: 4.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccines given was expired, no symptoms
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Computerised tomogram thorax, Condition aggravated, Electrocardiogram, Hypertension, Laboratory test
Clinical narrative: JANSSEN 9/16/2021 THREE DAYS LATER DEVELOPED SYNCOPE, UNCONTROLLED HTN, PERICARDITIS.  REQUIRED HOSPITAL ED VISIT AND MULTIPLE CLINIC VISITS.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Pericarditis, Syncope, Ultrasound scan
Clinical narrative: JANSSEN 9/16/2021 THREE DAYS LATER DEVELOPED SYNCOPE, UNCONTROLLED HTN, PERICARDITIS.  REQUIRED HOSPITAL ED VISIT AND MULTIPLE CLINIC VISITS.
Age: 3.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine given was expired, no symptoms
Age: 3.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: vaccine given was expired, no symptoms
Age: 2.0
Sex: F
Vaccine: VARCEL
Symptoms: Inappropriate schedule of product administration
Clinical narrative: I had administered the patient's second dose of Varicella earlier than recommended. Her first dose was on 05/08/2023, her second dose was administered 05/10/2024, one year after the first dose. I called patient's parent/guardian to obtain information on how patient was doing, but it went to voicemail. I left voicemail to give me a call back.
Age: 62.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Vaccine expired 4/30/2024 was inadvertently administered on 5/13/2024
Age: 1.5
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine given was expired, no symptoms
Age: 43.0
Sex: M
Vaccine: HEPA, MNQ, RAB, TYP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient arrived in clinic to receive vaccines due for upcoming travel: Rabies #1, Meningococcal, and typhoid injection. Patient had received Hepatitis A #1 on 12/7/2023 and the second dose is required 6 months after the first dose. We were short staffed due to a staff member calling out, so staff did not have the usual amount of time to prepare for the appointment that morning. The LPN providing the vaccines did a quick count of the months since the first dose, and miscounted, believing that he was due on that day.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: vaccine was frozen instead of refrigerated