chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 22.0
Sex: F
Vaccine: RSV
Symptoms: Product administered to patient of inappropriate age, Product prescribing error, Product use issue
Clinical narrative: 23 year old patient recived Arexvy; Doctor prescribed Arexvy to a 23 year old; This non-serious case was reported by a physician via call center representative and described the occurrence of inappropriate age at vaccine administration in a 23-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   Concurrent medical conditions included asthma.   In JAN-2024, the patient received Arexvy. In JAN-2024, an unknown time after receiving Arexvy, the patient experienced inappropriate age at vaccine administration (Verbatim: 23 year old patient recived Arexvy) and drug prescribing error (Verbatim: Doctor prescribed Arexvy to a 23 year old). The outcome of the inappropriate age at vaccine administration and drug prescribing error were unknown.   Additional Information: GSK Receipt Date: 05-APR-2024 The doctor prescribed Arexvy to a 23 year old patient who was fine, which led to inappropriate age at vaccine administration and drug prescribing error. No data about lot number or exact administration date available. The reporter did not consent to follow up.
Sex: U
Vaccine: RSV
Symptoms: Intercepted product prescribing error
Clinical narrative: she is going to prescribe Arexvy to a 58 year old patient; This non-serious case was reported by a physician via call center representative and described the occurrence of intercepted drug prescribing error in a 58-year-old patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced intercepted drug prescribing error (Verbatim: she is going to prescribe Arexvy to a 58 year old patient). The outcome of the intercepted drug prescribing error was unknown.   Additional Information: GSK Receipt Date: 05-APR-2024 The doctor stated that she was going to prescribe Arexvy to a 58 year old patient not immunocompromised, which led to intercepted drug prescribing error. The reporter did not consent to follow-up.
Age: 9.0
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: patient over 7 years received Pediarix; 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 female patient who received DTPa-HBV-IPV (Pediarix) (batch number 2227K, expiry date 17-JAN-2026) for prophylaxis.   On 05-APR-2024, the patient received the 1st dose of Pediarix. On 05-APR-2024, an unknown time after receiving Pediarix, the patient experienced inappropriate age at vaccine administration (Verbatim: patient over 7 years received Pediarix). 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: 05-APR-2024 Medical Assistant reported that the patient over 7 years received Pediarix as a first Dtap, IPV and Hep B dose on their vaccination history, which led to inappropriate age at vaccine administration. The patient not had any Dtap or IPV record this was why they decided to administered a combo vaccine. The reporter consented to follow up.; Sender's Comments:  US-GSK-US2024043650:same reporter/ Different patient US-GSK-US2024043627:Same reporter / different patient
Age: 20.0
Sex: F
Vaccine: MENB
Symptoms: Expired product administered
Clinical narrative: Maladministration of Bexsero After the Expiration Date; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 20-year-old female patient who received Men B NVS (Bexsero) (batch number G7KX2, expiry date 31-MAR-2024) for prophylaxis.   On 05-APR-2024, the patient received Bexsero. On 05-APR-2024, an unknown time after receiving Bexsero, the patient experienced expired vaccine used (Verbatim: Maladministration of Bexsero After the Expiration Date). The outcome of the expired vaccine used 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: 05-APR-2024 The manager reported that the patient received Bexsero after the expiration date, which led to expired vaccine used. The reporter did not consent to follow-up.
Sex: M
Vaccine: HPV4
Symptoms: Cardiomyopathy, Myocarditis, Pericarditis, Sudden cardiac death
Clinical narrative: Cardiomiopathy; Noninfections myocarditis/pericarditis; Noninfections myocarditis/pericarditis; Died of sudden cardiac death; Information has been received from a nurse practitioner concerning a patient's nephew, a 17-year-old male patient.  The patient's medical history, concurrent conditions, and concomitant medications were not reported.  On an unspecified day in November 2010, the patient was vaccinated with a dose of HPV rL1 6 11 16 18 VLP vaccine (yeast) (GARDASIL) intramuscular Injection (strength, dose, route of administration, anatomical location, lot number, and expiry date were not provided) (also reported as the nurse "thought" he was vaccinated with a dose of HPV rL1 6 11 16 18 VLP vaccine (yeast) [GARDASIL] in November 2010).   The nurse practitioner stated that two weeks after the patient received the dose of HPV rL1 6 11 16 18 VLP vaccine (yeast) (GARDASIL), approximately in November 2010 (also reported as "two weeks ago" on approximately 01-APR-2011), the patient died of sudden cardiac death on the lacrosse field. Unspecified medical treatment was given. It was unspecified if any lab diagnostic test were performed. The cause of death was sudden cardiac death. It was unknown if an autopsy was performed.  The causal relationship between the event and the suspect vaccine was not provided.  Upon internal review the event of sudden cardiac death was considered to be medically significant. Moreover. the event was also considered to be immediately life-threatening and disabling by the reporting nurse practitioner.   Follow up information has been received from a physician via social media on 03-APR-2024.  It was mentioned that the patient had no any birth defect. On 01-NOV-2010, the patient was vaccinated with a dose of quadrivalent human papillomavirus (types 6,11,16,18) Recomb. Vaccine (GARDASIL) intramuscular Injection (strength, dose, route of administration, anatomical location, lot number, and expiry date were not provided). On unknown day, the patient developed cardiomyopathy and noninfections myocarditis/pericarditis. In addition, it was confirmed that on 01-APR-2011, 5 months after the patient was vaccinated, he died. At the time of reporting the outcome of the events of cardiomyopathy, myocarditis and pericarditis was reported as fatal.  The action taken with the suspect vaccine regarding the events was not applicable.  The causal relationship between quadrivalent human papillomavirus (types 6,11,16,18) Recomb. Vaccine (GARDASIL) and the events of cardiomyopathy, myocarditis and pericarditis was not provided.  Upon internal review the events of cardiomyopathy, myocarditis and pericarditis were considered to be medically significant. Moreover, the reporter considered those events as disability and life-threatening evens.  This is one of the cases received from the same reporter.; Sender's Comments: , MERCK1104USA02226:Mfr number; Reported Cause(s) of Death: Died of sudden cardiac death
Sex: U
Vaccine: COVID19, MNQ
Symptoms: Urticaria
Clinical narrative: Urticaria (hives); This spontaneous case was reported by a pharmacist and describes the occurrence of URTICARIA (Urticaria (hives)) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.    Co-suspect product included non-company product MENINGOCOCCAL VACCINE A/C/Y/W CONJ (DIP TOX) (MENACTRA) for Prophylactic vaccination.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form and dose of MENINGOCOCCAL VACCINE A/C/Y/W CONJ (DIP TOX) (MENACTRA) (unknown route) 1 dosage form. On an unknown date, the patient experienced URTICARIA (Urticaria (hives)). At the time of the report, URTICARIA (Urticaria (hives)) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Treatment information was not reported.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: COVID-19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (COVID-19) in a 54-year-old male patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.   In February 2021, the patient received first dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received fifth dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, received fourth dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form, third dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form and second dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form. In 2023, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: Positive.     For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not reported.  Since Feb-2021, patient had received 6 doses of Moderna vaccine. Patient had received 6th dose (last dose) of Moderna vaccine in Sep-2023 (batch no: 3030371).  It was reported that patient got COVID last year and tested positive, got it before September. Right around the time that he got his vaccine, 10 months past his previous dose. Patient feels like he was needed vaccine every 6 months, or to start wearing a mask at the 6-month mark. Treatment medication was not reported. Patient did not have any of the high-risk conditions but had exposure to his parents/mom.   Reporter did not allow further contact.   Most recent FOLLOW-UP information incorporated above includes: On 05-Apr-2024: Live non-significant follow-up received. Quality complaint number added.
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Pruritus
Clinical narrative: itching; he was feeling dizzy and tired; he was feeling dizzy and tired; This spontaneous case was reported by a patient and describes the occurrence of PRURITUS (itching), DIZZINESS (he was feeling dizzy and tired) and FATIGUE (he was feeling dizzy and tired) in a male patient of an unknown age who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.   On 07-Oct-2023, the patient received third dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 03-Apr-2024, received fourth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) dosage was changed to 1 dosage form. In December 2023, the patient experienced PRURITUS (itching) (seriousness criterion hospitalization), DIZZINESS (he was feeling dizzy and tired) (seriousness criterion hospitalization) and FATIGUE (he was feeling dizzy and tired) (seriousness criterion hospitalization). The patient was hospitalized on sometime in December 2023 due to DIZZINESS, FATIGUE and PRURITUS. At the time of the report, PRURITUS (itching), DIZZINESS (he was feeling dizzy and tired) and FATIGUE (he was feeling dizzy and tired) had resolved.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   It was reported that the patient's allergy, concomitant diseases and risk factor were reported as unknown. It was reported that the patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine. No concomitant medication was reported. It was reported that in December the patient had to go to the hospital because he was feeling dizzy and tired. He also experienced some itching. He received treatment in the hospital and after 4 or 5 days the recovered. The patient did not share exact date he started to feel those symptoms. The patient was also reported that now on 3rd of April he went to the drugstore and by accident he got a new shot of Spikevax (this was his fourth shot ever of Covid-19 vaccine). The patient had experienced any signs or symptoms, and he manifests that he was feeling very well. The patient had a very long 12 hours sleep after returning back home. Company Comment: This is a spontaneous case concerning a male patient of an unknown age with no reported medical history, who experienced the serious (due to hospitalization) unexpected, events of PRURITUS, DIZZINESS and FATIGUE, which occurred approximately 2 months after a dose of mRNA-1273.815 (SPIKEVAX 2023-2024) vaccine, received as the third dose of COVID-19 vaccination schedule. It was reported that in December the patient had to go to the hospital because he was feeling dizzy and tired. He also experienced some itching. He received treatment in the hospital and after 4 or 5 days he recovered. The benefit-risk relationship of mRNA-1273.815 (SPIKEVAX 2023-2024)  vaccine is not affected by this report.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: low grade headache; This spontaneous case was reported by a patient and describes the occurrence of HEADACHE (low grade headache) in a 59-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On 09-Mar-2024, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 11-Mar-2024,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024), the patient experienced HEADACHE (low grade headache). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency; PARACETAMOL (TYLENOL) at an unspecified dose and frequency and FLUTICASONE at a dose of 4 days. At the time of the report, HEADACHE (low grade headache) had not resolved.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.   For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  The headache developed 36 hours or so after the shot. It was typically felt on top of the head, like someone resting hand on head with gentle pressure. Patient had no other symptoms - no cognitive issues, brain fog, no dizziness, blurry vision. Patient had no history of headaches - very rarely have them. 59 years old and otherwise was good health.  It was stated that she has been seeing an HCP for her headaches who was treating them "like an ENT issue with anti-inflammatories." However, she felt her HCP has "Very little experience with this and has been unable to discuss any potential mechanism for the cause of her headaches." It was stated she was "Living with it" and would "Like to get it resolved" but stated it was "not urgent.   This case was linked to MOD-2024-764961 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 05-Apr-2024: Live non-significant follow-up received. Reporter, references added, and narrative was updated.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a Consumer or other non HCP.  A 43-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 11Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 41 years for covid-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose 1, single) and as dose 2, single) for covid-19 immunisation. The patient's relevant medical history included: "known allergies: Penicillin" (unspecified if ongoing); "Anemia" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19". Therapeutic measures were taken as a result of drug ineffective, covid-19 from 26Mar2024 to 01Apr2024.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: she has had several COVID-19 infections, despite being vaccinated/she had Pfizer vaccines; she has had several COVID-19 infections, despite being vaccinated/she had Pfizer vaccines; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  An elderly female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "she has had several COVID-19 infections, despite being vaccinated/she had Pfizer vaccines". Patient is over the age of 65 years and wants to wait to "get next booster", referring to additional dose of most updated Pfizer COVID-19 vaccines, as recommended by the CDC. Patient said she has a schedule to get an additional COVID booster in about another two weeks, and she has a spinal steriod injection for pain. She was trying to read up on medical information because she knows that steriod treatment can reduce the efficacy of COVID-19 vaccines, and she wants to make sure that when she gets it, the steriod shot is not going to affect her vaccine. She mentioned that she had Pfizer vaccines, and since they approved it for over 65 people to get an additional dose, she is going to get the dose of Pfizer, so she wanted to see if there was any time frame that she would weigh in between her shots because she wanted to make sure it wouldn't affect her vaccine. She has had several COVID-19 infections, despite being vaccinated.  "People aged 65 years and older who received 1 dose of any updated 2023-2024 COVID-19 vaccine (Pfizer-BioNTech, Moderna or Novavax). should receive 1 additional dose of an updated COVID-19 vaccine at least 4 months after the previous updated dose."  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a Consumer or other non HCP.  A 60-year-old female patient (not pregnant) received BNT162b2 (BNT162B2 NOS), in Nov2022 as dose number unknown, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 05Apr2024 to 07Apr2024. The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Sex: U
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: Administrational error with expired hib with no reported adverse event; Initial information received on 01-Apr-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a patient of an unknown age and gender who had administrational error with expired HIB (PRP/T) VACCINE [ACT-HIB] 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 unknown expired dose of suspect HIB (PRP/T) VACCINE (strength, expiry date and lot number not reported) Powder and solvent for solution for injection via unknown route in unknown administration site as Prophylactic vaccination (immunization) (expired product administered) (same day latency). Information on the batch number was requested.   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: 16.0
Sex: F
Vaccine: IPV
Symptoms: No adverse event, Product storage error
Clinical narrative: punctured IPV (VERO) [Ipol] which was reached at max/lowest temperature:47.8 f/ duration out of labelled range: 20 mins, due to human error with no reported adverse event; vaccine given after temp excursion with no reported adverse event; Initial information received on 19-Mar-2024 regarding an unsolicited non-valid non-serious case received from a other health professional.  This case involves 16 years old female patient (158 cm and 72.8 kg) where reporter reported punctured IPV (VERO) [Ipol] which was reached at max/lowest temperature:47.8 f/ duration out of labelled range: 20 mins, due to human error with no reported adverse event and vaccine given after temp excursion with no reported adverse event.  On an unknown date, a dose of 0.5 ml punctured IPV (VERO) [Ipol] which was reached at max/lowest temperature:47.8 f/ duration out of labelled range: 20 mins, due to human error with no reported adverse event (product storage error) (Latency: Unknown) (poor quality product administered) (latency- same day) (Suspension for injection) (lot W1A101M) (expiry: 10-Feb-2025)  It was reported that the door opened too long due to fixing of broken shelves.Vaccine given after temp excursion.pt (patient)is fine no issues. Pt will be re-vaccinated after 4/13/24   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.  Additional information was received on 02-Apr-2024 from Other health professional: Patient details (Age, height and weight), dose of suspect and event (poor quality product administered) added, text amended accordingly.
Age: 0.17
Sex: F
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: 2 doses of ACT-HIB were administered after the expiration date with no reported adverse event; Initial information received on 02-Apr-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 2 months old female patient who was administered a dose of HIB (PRP/T) Vaccine [ACT-HIB] after the expiration date 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 had received (dose and units unknown) of suspect  HIB (PRP/T) Vaccine (Powder and solvent for solution for injection) (lot UJ863AA; expiry date: 25-Mar-2024 via unknown route in unknown administration site for immunization with no reported adverse event (expired product administered) (latency: same day)  Reportedly, 2 doses of ACT-HIB were administered after the expiration date with no reported adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 4.0
Sex: M
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired dose of acthib was administered to a patient with no reported adverse event; Initial information received on 02-Apr-2024 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 4-year-old male patient and expired dose of HIB (PRP/T) VACCINE [ACT-HIB] was 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 measles vaccine live (ENDERS-EDMONSTON), mumps vaccine live (JERYL LYNN), rubella vaccine live (WISTAR RA 27/3), varicella zoster vaccine live (OKA/MERCK) (PROQUAD) for Prophylactic vaccination; and diphtheria vaccine toxoid, pertussis vaccine acellular 3-component, polio vaccine INACT 3V (VERO), tetanus vaccine toxoid (KINRIX) for Prophylactic vaccination.  On 02-Apr-2024, the patient received a 0.5 ml dose of suspect HIB (PRP/T) vaccine, Powder and solvent for solution for injection (strength: unknown) (lot: UJ854AA, expiry date: 15-Mar-2024) via intramuscular route in the left thigh for immunization and expired dose of acthib was administered to a patient with no reported adverse event (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.
Age: 12.0
Sex: M
Vaccine: DTAP, TDAP
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: accidentally administered DAPTACEL (DTaP) instead of Tdap with no reported adverse event; Initial information received on 04-Apr-2024 and follow up information received on 05-Apr-2024 both were processed together 04-Apr-2024 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 12 years old male patient who was accidentally administered Diphtheria-15/Tetanus/5 AC Pertussis Vaccine [Daptacel] instead of Diphtheria-2/Tetanus/5 AC Pertussis Vaccine [Adacel]  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 HPV Vaccine for Prophylactic vaccination.  On 07-Mar-2024, the patient received 0.5 ml dose of suspect Diphtheria-15/Tetanus/5 AC Pertussis Vaccine (Suspension for injection )(lot 2CA54C3) instead of tdap with no reported adverse event (wrong product administered) (Latency: same day) (Suspension for injection) (lot, expiry not reported) via intramuscular route in the right deltoid for prophylactic vaccination (Immunisation). Information regarding batch number will be requested in this case.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 1.67
Sex: F
Vaccine: TDAP
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: 20 month old patient received adacel instead of daptacel with no reported adverse event; 20 month old patient received adacel with no reported adverse event; Initial information received on 08-Apr-2024 regarding an unsolicited valid non-serious case received from an other health professional.  This case involves a 20 month old female patient received diphtheria-2/tetanus/5 ac pertussis vaccine [Adacel] instead of daptacel with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included hepatitis a vaccine for Prophylactic vaccination.  On 04-Mar-2024, the patient received 0.5 ml TOTAL dose of suspect diphtheria-2/tetanus/5 ac pertussis vaccine Suspension for injection (lot- U7961AA and expiration date- 06-Dec-2025) via intramuscular route in the right thigh (strength: not provided) for Immunisation (wrong product administered) and (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.
Age: 0.17
Sex: F
Vaccine: DTPPVHBHPB, PNC20, RV5
Symptoms: Influenza virus test negative, Laboratory test normal, Pyrexia, Respiratory pathogen panel, Respiratory syncytial virus test negative
Clinical narrative: Fever (temp max of 103.2)
Age: 0.17
Sex: F
Vaccine: DTPPVHBHPB, PNC20, RV5
Symptoms: SARS-CoV-2 test negative
Clinical narrative: Fever (temp max of 103.2)
Age: 22.0
Sex: F
Vaccine: HPV9
Symptoms: Abdominal pain, Chills, Chromaturia, Decreased appetite, Dizziness
Clinical narrative: 2 hours after vaccination patient developed chills, leg pain, and noticed dark urine. 24 hours after vaccination patient noticed yellow skin/eyes, and developed nausea/loss of appetite, abdominal pain, congestion,  lightheadedness and severe headache. Symptoms continued until 4/9/24 (3 days post vaccination). Patient is symptom free on 4/10/24.
Age: 22.0
Sex: F
Vaccine: HPV9
Symptoms: Headache, Nausea, Ocular icterus, Pain in extremity, Respiratory tract congestion
Clinical narrative: 2 hours after vaccination patient developed chills, leg pain, and noticed dark urine. 24 hours after vaccination patient noticed yellow skin/eyes, and developed nausea/loss of appetite, abdominal pain, congestion,  lightheadedness and severe headache. Symptoms continued until 4/9/24 (3 days post vaccination). Patient is symptom free on 4/10/24.
Age: 22.0
Sex: F
Vaccine: HPV9
Symptoms: Yellow skin
Clinical narrative: 2 hours after vaccination patient developed chills, leg pain, and noticed dark urine. 24 hours after vaccination patient noticed yellow skin/eyes, and developed nausea/loss of appetite, abdominal pain, congestion,  lightheadedness and severe headache. Symptoms continued until 4/9/24 (3 days post vaccination). Patient is symptom free on 4/10/24.
Age: 70.0
Sex: F
Vaccine: RSV
Symptoms: Eye swelling, Feeling hot
Clinical narrative: Swollen eyes, felt warm on the face
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site cellulitis, Injection site discolouration, Injection site erythema, Injection site swelling
Clinical narrative: patient had redness and swelling around the injection site that worsened over the next few days after vaccination on 4/5/24. By monday 4/8/24 patient claimed arm was turning more purplish in color and swollen to "the size of a grapefruit." patient is immunocompromised so she went to ER and they diagnosed her with cellulitis and sent her home with 10 day course of oral antibiotics.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site swelling, Pain
Clinical narrative: redness, swelling on left lateral thigh since yesterday.  Patient received 2 vaccines for 4-year-old well-child check.  Received 1 on left, and 1 on right thigh.  Patient does not have any reaction to the right buttock.  Dad denies fevers, changes in activity levels.  He feels that patient has been acting normal until his left thigh is bumped on an object and he complains of pain.
Age: 10.0
Sex: F
Vaccine: FLU4, HPV9
Symptoms: Dizziness, Fatigue, Injection site pain, Malaise
Clinical narrative: 10yr old patient came in with mother requesting child immunizations. Patient was screened for contraindications and had no contraindications to the vaccines. Mother declined any allergies and any previous reaction to vaccines for the patient. Influenza vaccine was administered on her left deltoid, and HPV was administered on her right deltoid. About 10 minutes after patient received the vaccines, the patient stated "not feeling well, tired, pain at injection site, and a little dizzy". Patient remained alert and oriented and no respiratory distress was observed. Vital signs were obtained at 12:00pm, blood pressure 110/72, O2 99%, heart rate 71. Indicated patient to take deep slow breaths and a bottle of water was provided to the patient. Mother stated that patient had ate breakfast that morning. Patient was observed for an additional 10 minutes. At 12:10pm patient stated "feeling better" and "dizziness went away", and vital signs were taken, blood pressure 112/80, O2 98%, heart rate 86. Educated mother to seek emergency medical care if patient's symptoms return or worsen. Patient's mother verbalized understanding. Patient was released at 12:13pm. Provider was notified.
Age: 1.25
Sex: M
Vaccine: HEPA, PNC20
Symptoms: Influenza virus test negative, Pruritus, Respiratory syncytial virus test negative, SARS-CoV-2 test negative, Skin abrasion
Clinical narrative: Large confluent urticaria over buttocks, thighs and lower extremities, and distal arms. Diffuse itching. patient treated with oral zyrtec once daily and benadryl as needed. Topical hydrocortisone to large area of excoriation.
Age: 1.25
Sex: M
Vaccine: HEPA, PNC20
Symptoms: Urine analysis normal, Urticaria
Clinical narrative: Large confluent urticaria over buttocks, thighs and lower extremities, and distal arms. Diffuse itching. patient treated with oral zyrtec once daily and benadryl as needed. Topical hydrocortisone to large area of excoriation.
Age: 77.0
Sex: F
Vaccine: RSV
Symptoms: Erythema, Inflammation, Pain
Clinical narrative: patient expressed concerns of soreness, redness, inflammation, and pain  that took 2 days after the administration of the RSV vaccine. patient has expressed that she feels like the symptoms are slowly subsiding now. Patient did not do anything to treat the symptoms
Age: 10.0
Sex: M
Vaccine: HEPA, HEPA
Symptoms: Abdominal pain upper, Chest pain, Dizziness, Dyspnoea, Fatigue
Clinical narrative: Patient was diagnosed with an alpha gal allergy in May 2023. On 4/5/24 around 1:15pm he was given the second dose of the Hep A Vaqta vaccine per recommendations from our pediatrician. On 4/7/24 around 7:00am patient woke up with stomach pain. An hour or so later he began having trouble breathing and complained of chest pain. He also complained of weakness in his legs. Around 12:00pm he starting experiencing dizziness and extreme fatigue. His other symptoms were still present as well. I had him take a Pepcid and 10mg of liquid Xyzol. Around 4:00pm he was still experiencing symptoms so I had him take 25mg of a Unisom Sleep Melt (the equivalent of a Benadryl but without the mammal coating). Patient went to bed with the same symptoms but woke up on Monday morning feeling better. As of 4/10/24 Patient is still experiencing leg pain as a result of the reaction.
Age: 10.0
Sex: M
Vaccine: HEPA, HEPA
Symptoms: Muscular weakness, Pain in extremity
Clinical narrative: Patient was diagnosed with an alpha gal allergy in May 2023. On 4/5/24 around 1:15pm he was given the second dose of the Hep A Vaqta vaccine per recommendations from our pediatrician. On 4/7/24 around 7:00am patient woke up with stomach pain. An hour or so later he began having trouble breathing and complained of chest pain. He also complained of weakness in his legs. Around 12:00pm he starting experiencing dizziness and extreme fatigue. His other symptoms were still present as well. I had him take a Pepcid and 10mg of liquid Xyzol. Around 4:00pm he was still experiencing symptoms so I had him take 25mg of a Unisom Sleep Melt (the equivalent of a Benadryl but without the mammal coating). Patient went to bed with the same symptoms but woke up on Monday morning feeling better. As of 4/10/24 Patient is still experiencing leg pain as a result of the reaction.
Age: 10.0
Sex: M
Vaccine: HEPA, HEPA
Symptoms: Abdominal pain upper, Chest pain, Dyspnoea, Fatigue, Leg amputation
Clinical narrative: Patient was diagnosed with an alpha gal allergy in May 2023. On 4/5/24 around 1:15pm he was given the second dose of the Hep A Vaqta vaccine per recommendations from our pediatrician. On 4/7/24 around 7:00am patient woke up with stomach pain. An hour or so later he began having trouble breathing and complained of chest pain. He also complained of weakness in his legs. Around 12:00pm he starting experiencing dizziness and extreme fatigue. His other symptoms were still present as well. I had him take a Pepcid and 10mg of liquid Xyzol. Around 4:00pm he was still experiencing symptoms so I had him take 25mg of a Unisom Sleep Melt (the equivalent of a Benadryl but without the mammal coating). Patient went to bed with the same symptoms but woke up on Monday morning feeling better. As of 4/10/24 Patient is still experiencing leg pain as a result of the reaction.
Age: 10.0
Sex: M
Vaccine: HEPA, HEPA
Symptoms: Muscular weakness
Clinical narrative: Patient was diagnosed with an alpha gal allergy in May 2023. On 4/5/24 around 1:15pm he was given the second dose of the Hep A Vaqta vaccine per recommendations from our pediatrician. On 4/7/24 around 7:00am patient woke up with stomach pain. An hour or so later he began having trouble breathing and complained of chest pain. He also complained of weakness in his legs. Around 12:00pm he starting experiencing dizziness and extreme fatigue. His other symptoms were still present as well. I had him take a Pepcid and 10mg of liquid Xyzol. Around 4:00pm he was still experiencing symptoms so I had him take 25mg of a Unisom Sleep Melt (the equivalent of a Benadryl but without the mammal coating). Patient went to bed with the same symptoms but woke up on Monday morning feeling better. As of 4/10/24 Patient is still experiencing leg pain as a result of the reaction.
Age: 79.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Diarrhoea, Headache, Pyrexia, Vomiting
Clinical narrative: Shivering, headache, fever, throwing up, diarrhea.
Age: 14.0
Sex: M
Vaccine: COVID19, FLU4, HPV9
Symptoms: Fatigue, Malaise, Musculoskeletal stiffness, Nasopharyngitis, Pallor
Clinical narrative: 14 year old male came to receive 3 vaccines (Pfizer 23-24 form IM RD / Fluarix IM LD / HPV#2 IM LD). After receiving his last vaccine (HPV) at 12:12pm, patient stated that he felt "sick, tired and I don't feel good." A few seconds later with his head down, patient starts to lean forward to the left and flexes a stiff right arm with a semi-balled fist inward towards his body. This episode last for less than 10-15 seconds while patient looked pale with eyes closed.  Afterwards, patient  opened his eyes and asked "what happened?" Patient alert and oriented afterwards and stated that "I just remembered feeling tired, sleepy and cold after the last vaccine." Patient talkative, engaged and answering questions appropriately.  Patient stated that he had breakfast this morning. Elevated patient's feet on chair and noted patient's strong hand grip when asked to squeeze my hands. Vital signs at 12:15pm: Temperature 97.3; Blood pressure 66/42 ; Heart rate 52 ; Respiratory rate 16 ; Oxygen Saturation 99% Vital signs 10 minutes later at 12:25pm Blood pressure 80/53 ; Heart rate 67 ; Respiratory rate 20 ; Oxygen Saturation  99%. Patient stated that he felt better and tolerated water and a snack well without nausea or vomiting. Patient remained alert and oriented without further complaints of feeling tire or sick. No prior history of reactions to any vaccines reported by mother. Patient observed for an additional 30 to 45 minutes. Last set of vital signs at 1:00pm : Temp 97.8 ; Blood pressure 92/58 ; Heart rate 82 ; Respiratory rate 16 ; Oxygen Saturation at 99%. NP Provider notified. Patient walking around with a steady gait and  in no apparent distress prior to being released with mother at 1:15pm. Mother given instructions to seek medical attention if symptoms return or if patient shows any signs of distress. Understanding verbalized by mother.
Age: 14.0
Sex: M
Vaccine: COVID19, FLU4, HPV9
Symptoms: Somnolence
Clinical narrative: 14 year old male came to receive 3 vaccines (Pfizer 23-24 form IM RD / Fluarix IM LD / HPV#2 IM LD). After receiving his last vaccine (HPV) at 12:12pm, patient stated that he felt "sick, tired and I don't feel good." A few seconds later with his head down, patient starts to lean forward to the left and flexes a stiff right arm with a semi-balled fist inward towards his body. This episode last for less than 10-15 seconds while patient looked pale with eyes closed.  Afterwards, patient  opened his eyes and asked "what happened?" Patient alert and oriented afterwards and stated that "I just remembered feeling tired, sleepy and cold after the last vaccine." Patient talkative, engaged and answering questions appropriately.  Patient stated that he had breakfast this morning. Elevated patient's feet on chair and noted patient's strong hand grip when asked to squeeze my hands. Vital signs at 12:15pm: Temperature 97.3; Blood pressure 66/42 ; Heart rate 52 ; Respiratory rate 16 ; Oxygen Saturation 99% Vital signs 10 minutes later at 12:25pm Blood pressure 80/53 ; Heart rate 67 ; Respiratory rate 20 ; Oxygen Saturation  99%. Patient stated that he felt better and tolerated water and a snack well without nausea or vomiting. Patient remained alert and oriented without further complaints of feeling tire or sick. No prior history of reactions to any vaccines reported by mother. Patient observed for an additional 30 to 45 minutes. Last set of vital signs at 1:00pm : Temp 97.8 ; Blood pressure 92/58 ; Heart rate 82 ; Respiratory rate 16 ; Oxygen Saturation at 99%. NP Provider notified. Patient walking around with a steady gait and  in no apparent distress prior to being released with mother at 1:15pm. Mother given instructions to seek medical attention if symptoms return or if patient shows any signs of distress. Understanding verbalized by mother.
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse event; 1st Moderna on 3Nov2021/2nd Moderna on 22May2022/the patient received her second primary dose more than 35 days after the first primary dose; This spontaneous case was reported by a medical assistant and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st Moderna on 3Nov2021/2nd Moderna on 22May2022/the patient received her second primary dose more than 35 days after the first primary dose) and NO ADVERSE EVENT (No adverse event) in a 65-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.   On 03-Nov-2021, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 22-May-2022, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On 22-May-2022, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st Moderna on 3Nov2021/2nd Moderna on 22May2022/the patient received her second primary dose more than 35 days after the first primary dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st Moderna on 3Nov2021/2nd Moderna on 22May2022/the patient received her second primary dose more than 35 days after the first primary dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st Moderna on 3Nov2021/2nd Moderna on 22May2022/the patient received her second primary dose more than 35 days after the first primary dose).    Concomitant medication details not reported by the reporter. Patient did not received any other vaccines in the 4 weeks prior to COVID-19 vaccine. Treatment details was not reported by the reporter.   This case was linked to MOD-2023-726229 (Patient Link).
Sex: F
Vaccine: RSV
Symptoms: Abnormal cord insertion, Premature delivery, Preterm premature rupture of membranes
Clinical narrative: PPROM at 36 weeks and 4 days - 3 days after vaccine; PPROM at 36 weeks and 4 days - 3 days after vaccine; High risk pregnancy due to a marginal cord insertion; This is a spontaneous report received from an Other HCP from Regulatory Authority. Regulatory number: 2714330-1 (VAERS ID), 2733027-1 (VAERS ID).  A 28-year-old female patient (pregnant) received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 20Oct2023 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient had no relevant medical history. The patient was 3 trimester pregnant at the event onset. The patient is expected to deliver a baby(s) on 16Nov2023. The patient took concomitant medications. The following information was reported: ABNORMAL CORD INSERTION (hospitalization) with onset, outcome "recovered", described as "High risk pregnancy due to a marginal cord insertion"; PRETERM PREMATURE RUPTURE OF MEMBRANES (hospitalization), PREMATURE DELIVERY (hospitalization) all with onset outcome "recovered" and all described as "PPROM at 36 weeks and 4 days - 3 days after vaccine". The baby was delivered premature, delivery date. The baby weighed 2550.937 grams.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.  Follow-up (05Feb2024): This is a spontaneous follow-up report received from the same Other HCP from Regulatory Authority. Updated Information included: retrospective was checked and additional reference number.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.  Follow (04Mar2024): No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.  Amendment: This follow-up report is being submitted to amend previously reported information: Premature delivery and Abnormal cord insertion added.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400003735 baby case;