chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: M
Vaccine: COVID19-2
Symptoms: Intercepted medication error, No adverse event
Clinical narrative: Pharmacy was clearing him for another shot (Submitting AE with limited information - near miss), Patient was not eligible for a 3rd dose of the bivalent as he was not immunocompromised.; No adverse event; This spontaneous case was reported by a patient and describes the occurrence of INTERCEPTED MEDICATION ERROR (Pharmacy was clearing him for another shot (Submitting AE with limited information - near miss), Patient was not eligible for a 3rd dose of the bivalent as he was not immunocompromised.) and NO ADVERSE EVENT (No adverse event) in a 65-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.   On 30-Sep-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 13-Apr-2023, received sixth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INTERCEPTED MEDICATION ERROR (Pharmacy was clearing him for another shot (Submitting AE with limited information - near miss), Patient was not eligible for a 3rd dose of the bivalent as he was not immunocompromised.) and NO ADVERSE EVENT (No adverse event). At the time of the report, INTERCEPTED MEDICATION ERROR (Pharmacy was clearing him for another shot (Submitting AE with limited information - near miss), Patient was not eligible for a 3rd dose of the bivalent as he was not immunocompromised.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.            Patient was not immunocompromised.  Concomitant product use was not provided by the reporter.  Patient received his 1st dose on 07-Mar-2021, 2nd dose on 07-Apr-2021, 3rd dose on 29-Oct-2021, 4th dose on 16-Jun-2022. Patient was not eligible for a 3rd dose of the bivalent as he was not immunocompromised.  Treatment information was not provided.   Reporter did not allow further contact
Age: 2.0
Sex: M
Vaccine: UNK
Symptoms: COVID-19
Clinical narrative: He also contracted COVID-19 in JUL2023. Asymptomatic; This spontaneous case was reported by a patient family member or friend and describes the occurrence of COVID-19 (He also contracted COVID-19 in JUL2023. Asymptomatic) in a 24-month-old male patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Influenza vaccine. Past adverse reactions to the above products included No adverse event with Influenza vaccine.   In November 2022, the patient received first dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. In December 2022, received second dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form. In July 2023, the patient experienced COVID-19 (He also contracted COVID-19 in JUL2023. Asymptomatic). At the time of the report, COVID-19 (He also contracted COVID-19 in JUL2023. Asymptomatic) had resolved.        For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments.   Patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. Concomitant medication details not reported by the reporter. Patient did not took any medications or treatments.   This case was linked to US-MODERNATX, INC.-MOD-2023-737999 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-737999:1 Year old Child case
Age: 58.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Wrong product administered
Clinical narrative: No adverse event; Gave a Moderna Bivalent vaccine Friday 18-Aug-2023 and when they looked up the lot number it says it expired on 01-Jun-2023; 58 years old patient received Moderna Bivalent as first dose.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Gave a Moderna Bivalent vaccine Friday 18-Aug-2023 and when they looked up the lot number it says it expired on 01-Jun-2023), WRONG PRODUCT ADMINISTERED (58 years old patient received Moderna Bivalent as first dose.) and NO ADVERSE EVENT (No adverse event) in a 58-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 021H22A) for COVID-19 prophylaxis.     Patient had no relevant medical history or conditions, allergy, concomitant diseases and risk factor.     On 18-Aug-2023, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 18-Aug-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Gave a Moderna Bivalent vaccine Friday 18-Aug-2023 and when they looked up the lot number it says it expired on 01-Jun-2023) and WRONG PRODUCT ADMINISTERED (58 years old patient received Moderna Bivalent as first dose.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Gave a Moderna Bivalent vaccine Friday 18-Aug-2023 and when they looked up the lot number it says it expired on 01-Jun-2023), WRONG PRODUCT ADMINISTERED (58 years old patient received Moderna Bivalent as first dose.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Gave a Moderna Bivalent vaccine Friday 18-Aug-2023 and when they looked up the lot number it says it expired on 01-Jun-2023) and WRONG PRODUCT ADMINISTERED (58 years old patient received Moderna Bivalent as first dose.).    Concomitant product use was not provided by the reporter.  Individual vials size was 2.5 ml. Vial was initially stored in the refrigerator on 11-Aug-2023. Vial did not undergo any temperature excursions.  Treatment information was not provided.
Age: 74.0
Sex: F
Vaccine: UNK
Symptoms: COVID-19
Clinical narrative: covid 19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (covid 19) in a 74-year-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     Patient didn't receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.     On an unknown date, the patient received second dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On 01-Jun-2022, the patient experienced COVID-19 (covid 19). On 06-Jun-2022, COVID-19 (covid 19) had resolved.        For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. It was reported that patient had COVID twice. First time was before the booster and does not remember when the second time was. No treatment information was provided.
Age: 1.0
Sex: M
Vaccine: UNK
Symptoms: COVID-19, Pyrexia
Clinical narrative: covid 19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (covid 19) in a 12-month-old male patient who received SPIKEVAX NOS (SPIKEVAX NOS) (batch nos.) for COVID-19 prophylaxis.     No Medical History information was reported.   In February 2023, the patient received first dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. In March 2023, received second dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form. On 20-Jul-2023, the patient experienced COVID-19 (covid 19). At the time of the report, COVID-19 (covid 19) had resolved.        For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided. Patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. reporter's1 yr and 3 yrs old child patient received 2 doses of the Moderna COVID-19 vaccines and then contracted COVID-19. and reporter had questions  regarding booster doses, if recently diagnosed with COVID-19 then how long need to wait before receiving another booster. Infant received 2 doses of the Moderna COVID-19 vaccines in FEB2023 and MAR2023. He was diagnosed with COVID-19 on 20JUL2023. He had a fever for a day. He has taken all other disease control recommended vaccines. Toddler received 2 doses of the Moderna COVID-19 vaccines in NOV2022 and DEC2022 who also contracted Covid-19 in July-23 Asymptomatic. No medication or treatment.   This case was linked to US-MODERNATX, INC.-MOD-2023-738004 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 21-Aug-2023: Follow up received which contains significant information like patients details updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-738004:3 Year old Child case
Sex: M
Vaccine: COVID19-2
Symptoms: Arthralgia, Joint injury
Clinical narrative: He was doing some balancing exercises and tweaked his ankle. His right ankle and pain was ongoing to this point.; He was doing some balancing exercises and tweaked his ankle. His right ankle and pain was ongoing to this point.; This spontaneous case was reported by a patient family member or friend and describes the occurrence of JOINT INJURY (He was doing some balancing exercises and tweaked his ankle. His right ankle and pain was ongoing to this point.) and ARTHRALGIA (He was doing some balancing exercises and tweaked his ankle. His right ankle and pain was ongoing to this point.) in an elderly male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch nos. AS7144B and C23415) for COVID-19 prophylaxis.     Concurrent medical conditions included Gout. Concomitant products included IBUPROFEN (ADVIL [IBUPROFEN]) for Gout.   On 09-Sep-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 21-Aug-2023, received sixth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced JOINT INJURY (He was doing some balancing exercises and tweaked his ankle. His right ankle and pain was ongoing to this point.) and ARTHRALGIA (He was doing some balancing exercises and tweaked his ankle. His right ankle and pain was ongoing to this point.). At the time of the report, JOINT INJURY (He was doing some balancing exercises and tweaked his ankle. His right ankle and pain was ongoing to this point.) and ARTHRALGIA (He was doing some balancing exercises and tweaked his ankle. His right ankle and pain was ongoing to this point.) had not resolved.            Patient received his first dose of Moderna Covid-19 vaccine on 24-Jan-2021 (Lot number: 007M20A), second dose of Moderna Covid-19 vaccine on 27-Feb-2021 (lot number: 023M70A), third dose of Moderna Covid-19 vaccine on 23-Oct-2021 (lot number: 032F1A), Fourth dose of Moderna Covid-19 vaccine 13-Apr-2022 (lot number: 005M21A).  It was reported that Prior to his most recent dose yesterday he noticed his ankle did not feel great. He was doing some balancing exercises and tweaked his ankle. His right ankle and pain was ongoing to this point. He has not taken medications or treatments for his symptoms but would like to know if he could take Advil or Aloprim.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Interchange of vaccine products, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; Dose 1: Pfizer/ Dose 2: Pfizer/ Dose 3: Pfizer/ Dose 4: UNKNOWN/ Dose 5: Pfizer.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 63-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 19Sep2022 at 12:00 as dose 5 (booster), single (Lot number: GH9702) at the age of 62 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 13Mar2021 at 12:00 as dose 1, single (Lot number: EN6208), in left arm, on 05Apr2021 at 12:00 as dose 2, single (Lot number: ER8733), in left arm and on 10Oct2021 at 12:00 as dose 3 (booster), single (Lot number: FE3590), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), on 20Feb2022 at 12:00 as dose 4 (booster), single (Lot number: FM698) for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing); "thyroid" (unspecified if ongoing); "cholesterol" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 20Feb2022 at 12:00, outcome "unknown", described as "Dose 1: Pfizer/ Dose 2: Pfizer/ Dose 3: Pfizer/ Dose 4: UNKNOWN/ Dose 5: Pfizer."; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old female patient (not pregnant) received BNT162b2 (BNT162B2 NOS), on 15Sep2022 at 13:15 as dose number unknown, single (Batch/Lot number: unknown) at the age of 70 , 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) all with onset 2023, outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Tested positive on 22Aug2023. Cold-like symptoms started on 20Aug2023; Tested positive on 22Aug2023. Cold-like symptoms started on 20Aug2023; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5, lot unknown reason: Unable to locate or read the details), on 22Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "known allergies: sulfa" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 20Aug2023, outcome "not recovered" and all described as "Tested positive on 22Aug2023. Cold-like symptoms started on 20Aug2023". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (22Aug2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 59.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 26Sep2022 at 18:00 as dose 5 (booster), single (Lot number: GH9693) at the age of 59 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 03May2023 at 15:00 as dose 4 (booster), single (Lot number: 049621A), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 22Aug2023 at 10:00, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (22Aug2023) Positive, notes: Positive COVID 19 Antigen Test. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Passed away a few days ago; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete, unknown manufacturer), for COVID-19 Immunization. The following information was reported: DEATH (death, medically significant) with onset Aug2023, outcome "fatal", described as "Passed away a few days ago". The patient date of death was Aug2023. The reported cause of death was unknown. It was not reported if an autopsy was performed. Caller on behalf of his father, who passed away a few days ago (Aug2023). He wanted to report an adverse reaction to the Pfizer-BioNTech COVID-19 Vaccine.   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Reported Cause(s) of Death: Passed away a few days ago
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Sep2022 as dose 4 (booster), single (Lot number: GH9702) at the age of 45 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19". Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid received from 12Aug2023 to 16Aug2023.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old female patient (not pregnant) received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "P.E. x2" (unspecified if ongoing); "Asthma" (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 which included Paxlovid received from 22Aug2023.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 28Jan2023 as dose 4 (booster), single (Lot number: GL0447) at the age of 46 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 26Feb2021 as dose 1, single (Lot number: EL9266), in left arm, on 17Mar2021 as dose 2, single (Lot number: EN6206), in left arm and on 23Nov2021 as dose 3 (booster), single (Lot number: 32030BD), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Chronic Back Pain" (unspecified if ongoing); "known allergies: Penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Percocet, reaction(s): "known allergies: Percocet"; Vicodin, reaction(s): "known allergies: Vicodin". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19 including Paxlovid from 16Aug2023 to 20Aug2023.
Age: 7.0
Sex: M
Vaccine: TDAP
Symptoms: Medication error, No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: ADACEL was administered mistakenly to the patient, with no reported adverse event; ADACEL was administered mistakenly to the patient to 7 year old child, with no reported adverse event; Initial information was received on 22-Aug-2023 regarding an unsolicited valid  non-serious case received from a physician.  This case involves a 7 years old male patient to whom diphtheria-2/tetanus/5 AC pertussis vaccine [Adacel] was administered mistakenly 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, measles vaccine, mumps vaccine, rubella vaccine (MMR), polio vaccine (polio) and varicella zoster vaccine (varicella vaccine) for Prophylactic vaccination.  On 25-Jul-2023, the patient received a 0.5 ml , once (Dose 1) of suspect diphtheria-2/tetanus/5 AC pertussis vaccine (Suspension for injection) (lot: U7549AA, expiry date: 04-Nov-2024, strength: standard) via unknown route in the right thigh for Prophylactic vaccination (Immunisation) and was mistakenly administered Adacel, with no reported adverse event (wrong product administered) and (product administered to patient of inappropriate age) (Latency: same day).  It was reported " Physician said he's calling to confirm if it will not count for tetanus vaccine or is it counted as a tetanus dose? He also said that ADACEL was administered mistakenly to the patient, since they thought DTaP can't be given after 7 years of age. Physician said that the patient was supposed to get his DTaP but he never got his DTaP at age 5 so he received Tdap at 7 years old as the 5th dose in his DTaP series."  At time of reporting, the outcome was Unknown for the event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the 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: M
Vaccine: HIBV
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: administered ActHIB 13 days after expiry with no reported adverse event; Initial information was received on 23-Aug-2023 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 2 months old male patient who was administered HIB (PRP/T) vaccine [ACT-HIB] 13 days after expiry with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included diphtheria vaccine toxoid, hepatitis B vaccine RHBSAG (YEAST), pertussis vaccine acellular 3-component, polio vaccine inact 3V (VERO), tetanus vaccine toxoid (PEDIARIX), pneumococcal vaccine conj 7V (CRM197) (PREVNAR) and rotavirus vaccine live reassort oral 5V (ROTATEQ) for Prophylactic vaccination.  On 23-Aug-2023, the patient received a 0.5 ml dose (dose 1) (once) of suspect HIB (PRP/T) vaccine (Powder and solvent for solution for injection) (lot:UJ739AB, expiry date: 10-Aug-2023, strength: standard) via intramuscular route in the right thigh for Immunisation and was administered acthib 13 days after expiry with no reported adverse event (expired product administered) (Latency: same day).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 1.0
Sex: F
Vaccine: UNK
Symptoms: Medication error, No adverse event, Single component of a two-component product administered
Clinical narrative: patient was administered the PENTACEL however only the DTAP/IPV component, not the ACT-HIB portion (with no reported adverse event); Initial information received on 23-Aug-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 1 years old female patient who was administered the Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(VERO)/HIB(PRP/T) Vaccine [Pentacel (VERO)] however only the dtap/ipv component, not the act-hib portion (with no reported adverse event).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 22-Aug-2023, the patient received a 0.5 ml dose of suspect Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(VERO)/HIB(PRP/T) Vaccine Suspension for injection (lot U7311A, expiry date: 09-Sep-2023 with unknown strength) via intramuscular route in left thigh as Immunization.  On 22-Aug-2023 (Latency: same day) the patient was administered the Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(VERO)/HIB(PRP/T) Vaccine  however only the dtap/ipv component, not the act-hib portion (with no reported adverse event) (single component of a two-component product administered) (unknown latency).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 36.0
Sex: F
Vaccine: YF
Symptoms: Incorrect route of product administration
Clinical narrative: administered YF-Vax to a patient intramuscularly instead of subcutaneously with no reported adverse event; Initial information was received on 23-Aug-2023 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves 36 years old female patient who reported that administered yellow fever vaccine - [YF-VAX] to a patient intramuscularly instead of subcutaneously with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 22-Aug-2023, the patient received a dose 1 of 0.5 ml of suspect yellow fever vaccine - (Solution for injection) (Frequency : Once, lot UJ818AA, strength, expiry date unknown) via intramuscular route in unknown administration site for Immunization and administered yellow fever vaccine - (YF-VAX) to a patient intramuscularly instead of subcutaneously with no reported adverse event (incorrect route of product administration) (latency : same day).  It was reported that "Caller also inquired whether the vaccine needs to be readministered using the correct route."  Action taken with yellow fever vaccine (YF-VAX) was not applicable.  At time of reporting, the outcome was Unknown for the event administered YF-VAX to a patient intramuscularly instead of subcutaneously 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: 2.0
Sex: F
Vaccine: HIBV
Symptoms: Expired product administered, Medication error
Clinical narrative: expired ACTHIB was administered to a patient with no reported adverse event; Initial information received on 24-Aug-2023 regarding an unsolicited valid non-serious case received from an other health professional.  This case involves a 2 years old female patient who got expired 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), concomitant medication(s) and family history were not provided.   On 24-Aug-2023, the patient received (TOTAL) dose of suspect HIB (PRP/T) VACCINE Powder and solvent for solution for injection (lot- UJ739ABA and expiration date- 10-Aug-2023) via unknown route in right thigh (dose and strength: not provided) for Immunization (expired product administered) (latency- same day).  Action taken- not applicable.  At time of reporting, the outcome was Unknown for the event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 37.0
Sex: M
Vaccine: DTAP, DTAP
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: patient was administered with DAPTACEL instead of Tdap with no reported adverse event; 37 YEARS OLD patient was administered with DAPTACEL instead of Tdap with no adverse event; Initial information received on 24-Aug-2023 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 37-year-old male patient who was administered with diphtheria-15/ tetanus/ 5 AC pertussis vaccine [Daptacel] instead of Tdap (diphtheria, tetanus and acellular pertussis vaccine) with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 18-Aug-2023, 37-year-old patient received unknown dose of suspect diphtheria-15/tetanus/5 AC pertussis vaccine, suspension for injection (batch number: C6013AA; expiry date: 05-Jun-2024) via unknown route in unknown administration site for Immunization instead of diphtheria, tetanus and acellular pertussis vaccine produced by unknown manufacturer (unknown formulation, batch number, expiry date) with no reported adverse event (wrong product administered) (product administered to patient of inappropriate age) (same day latency).   Action taken: not applicable.  At time of reporting, the outcome was Unknown for both the events.   No additional information at the time of the report.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 3.0
Sex: M
Vaccine: DTAP
Symptoms: Erythema, Injection site cellulitis
Clinical narrative: CELLULITIS OF L LEG, REDNESS
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine stored in unapproved storage unit
Age: 63.0
Sex: F
Vaccine: UNK
Symptoms: Injection site rash, Injection site swelling, Peripheral swelling
Clinical narrative: Swollen arm (not just at site of injection), elevated large bump at site of injection, 3x3? rash five inches away from injection site on inside of arm   Lasting one week in duration
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Pt  received first dose on 07/20/2023. Pt  asked for second dose on 08/24/2023 and was given . It was given before the full two month wait  for second dose Shingrix.
Age: 60.0
Sex: F
Vaccine: RSV
Symptoms: Feeling hot, Myalgia, Pain in extremity, Vaccination site erythema
Clinical narrative: Vaccine was administered 8/24/2023. Patient reports muscle pain in the arm of the vaccine injection on 8/28/2023. Patient also complains of redness and feeling warm sensation in that arm. Redness is around the vaccine injection site. Patient will go to urgent care to be evaluated for potential soft and tissue infection.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Dizziness, Feeling hot, Hyperhidrosis, Pallor, Pyrexia
Clinical narrative: This was dose #2 but pt received Menactra as her 1st dose years ago so this was her first dose of MENVEO. Pt was sweating, light headed, felt warm/feverish, pale in color, blurry vision. We gave patient a glass of water and after 15-20 minutes of resting and sipping water she slowly began to feel like her normal self. Mom was told her monitor her for the rest of the night and let us know if she has any more issues over the next couple of days.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Vision blurred
Clinical narrative: This was dose #2 but pt received Menactra as her 1st dose years ago so this was her first dose of MENVEO. Pt was sweating, light headed, felt warm/feverish, pale in color, blurry vision. We gave patient a glass of water and after 15-20 minutes of resting and sipping water she slowly began to feel like her normal self. Mom was told her monitor her for the rest of the night and let us know if she has any more issues over the next couple of days.
Age: 12.0
Sex: F
Vaccine: MENB
Symptoms: Wrong product administered
Clinical narrative: Patient due for MCV4, patient inadvertently administered MenB.  Patient called no answer, left a voicemail.
Age: 62.0
Sex: F
Vaccine: COVID19-2, COVID19
Symptoms: Blood pressure systolic increased, C-reactive protein normal, Eye haemorrhage, Headache, Hypertension
Clinical narrative: 1. STRONG HEADACHE 2. HIGH BLOOD PRESSURE: 160/68 ( I NEVER HAD HIGH BLOOD PRESSURE UNTIL THE DAY AFTER THE COVID VACCINE) 3. BLOOD IN MY LEFT EYE 4. CONSTANT HEADACHE AFTER THE DAY OF THE COVID VACCINE 5. CONSTANT HIGH BLOOD PRESSURE ONE DAY TO ANOTHER SINCE THE COVID VACCINE WITHOUT NEVER HAVING BEFORE ANY EVENT OF HIGH BLOOD PRESSURE 6. SYSTOLIC BLOOD PRESSURE HIGH BUT DIASTOLIC STAY NORMAL LOW. HEART RATE ALSO STAY NORMAL LOW. BUT SYSTOLIC BLOOD PRESSURE DIDN'T WENT AWAY NEITHER AFTER SEVERAL DAYS
Age: 62.0
Sex: F
Vaccine: COVID19-2, COVID19
Symptoms: Red blood cell sedimentation rate normal
Clinical narrative: 1. STRONG HEADACHE 2. HIGH BLOOD PRESSURE: 160/68 ( I NEVER HAD HIGH BLOOD PRESSURE UNTIL THE DAY AFTER THE COVID VACCINE) 3. BLOOD IN MY LEFT EYE 4. CONSTANT HEADACHE AFTER THE DAY OF THE COVID VACCINE 5. CONSTANT HIGH BLOOD PRESSURE ONE DAY TO ANOTHER SINCE THE COVID VACCINE WITHOUT NEVER HAVING BEFORE ANY EVENT OF HIGH BLOOD PRESSURE 6. SYSTOLIC BLOOD PRESSURE HIGH BUT DIASTOLIC STAY NORMAL LOW. HEART RATE ALSO STAY NORMAL LOW. BUT SYSTOLIC BLOOD PRESSURE DIDN'T WENT AWAY NEITHER AFTER SEVERAL DAYS
Age: 62.0
Sex: F
Vaccine: COVID19-2, COVID19
Symptoms: Blood pressure measurement, Blood pressure systolic increased, Eye haemorrhage, Headache
Clinical narrative: 1. STRONG HEADACHE 2. HIGH BLOOD PRESSURE: 160/68 ( I NEVER HAD HIGH BLOOD PRESSURE UNTIL THE DAY AFTER THE COVID VACCINE) 3. BLOOD IN MY LEFT EYE 4. CONSTANT HEADACHE AFTER THE DAY OF THE COVID VACCINE 5. CONSTANT HIGH BLOOD PRESSURE ONE DAY TO ANOTHER SINCE THE COVID VACCINE WITHOUT NEVER HAVING BEFORE ANY EVENT OF HIGH BLOOD PRESSURE 6. SYSTOLIC BLOOD PRESSURE HIGH BUT DIASTOLIC STAY NORMAL LOW. HEART RATE ALSO STAY NORMAL LOW. BUT SYSTOLIC BLOOD PRESSURE DIDN'T WENT AWAY NEITHER AFTER SEVERAL DAYS
Age: 45.0
Sex: F
Vaccine: MMRV
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Patient came to receive her second dose of MMR, MMRV administered inadvertently IM in patient's left deltoid, Patient appeared to tolerate immunization well.  no obvious S/SX of ASE r/t inadvertent vaccine administration observed while patient remained in the clinic.
Age: 68.0
Sex: F
Vaccine: COVID19-2
Symptoms: Blood magnesium, Blood potassium decreased, Cold sweat, Dizziness, Mobility decreased
Clinical narrative: On 08/07/2023, as I was finishing a yoga class and was supine on the yoga mat resting, I suddenly felt overwhelming nausea and dizziness. I could not sit up. I vomited twice and began to shake violently, and my skin got clammy.  EMS was called, and I had projectile vomiting in the ambulance on the way to the hospital.
Age: 68.0
Sex: F
Vaccine: COVID19-2
Symptoms: Nausea, Tremor, Vomiting, Vomiting projectile
Clinical narrative: On 08/07/2023, as I was finishing a yoga class and was supine on the yoga mat resting, I suddenly felt overwhelming nausea and dizziness. I could not sit up. I vomited twice and began to shake violently, and my skin got clammy.  EMS was called, and I had projectile vomiting in the ambulance on the way to the hospital.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Burning sensation, Immediate post-injection reaction, Injected limb mobility decreased, Pain
Clinical narrative: Immediate pain when given the vaccine, a burning sharp sensation shot through the arm and up into the neck. Extreme pain for 3 days after, then symptoms became a bit milder. 11 days later and right arm still can?t move in certain directions without pain, and can?t lift heavy objects either.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Technician administer 8/24. Patient presented 8/28 complaining of sore shoulder and rash. Patient could move arm and extremities but motion at shoulder limited to pain. Patient reported a "rash". A raised, red area approx. 1 1/2" in diameter about 6" proximal to the injection site. Area was more tender than injection site to the touch and did not radiate warmth, though patient reported it felt warmer. Patient reported no change in temperature between visit dates. Patient had only taken tylenol for the pain. Instructed patient to take benadryl and ibuprofen (reported no contraindications), attempt to ice area and see if any improvement. Also instructed to draw a line with a pen around the area. If no improvement the following day or rash moved beyond the line instructed patient to seek immediate medical attention.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Joint range of motion decreased, Pain
Clinical narrative: Technician administer 8/24. Patient presented 8/28 complaining of sore shoulder and rash. Patient could move arm and extremities but motion at shoulder limited to pain. Patient reported a "rash". A raised, red area approx. 1 1/2" in diameter about 6" proximal to the injection site. Area was more tender than injection site to the touch and did not radiate warmth, though patient reported it felt warmer. Patient reported no change in temperature between visit dates. Patient had only taken tylenol for the pain. Instructed patient to take benadryl and ibuprofen (reported no contraindications), attempt to ice area and see if any improvement. Also instructed to draw a line with a pen around the area. If no improvement the following day or rash moved beyond the line instructed patient to seek immediate medical attention.
Age: 14.0
Sex: F
Vaccine: MMR
Symptoms: Disorientation, Fall, Hyperhidrosis, Pallor, Syncope
Clinical narrative: Post Vaccination Syncopal Episode, occurred during 15 minute waiting period, while standing.  The patient fell to the floor. No head injury occurred per patient and none was observed witnessing the event.  Client laid on the floor for a few minutes until she said she felt better.  We assisted her up to a chair to sit for the remainder of the time and then she had another syncopal episode.  After that, we attempted to get her back to the floor to lay down again and she had another syncopal episode. The patient was pale skin, sweaty and was disoriented for short bursts of time.  During this event, Emergency medical services were called.  Emergency services assessed and determined based on continued disorientation, transporting to the local hospital for follow up was highly recommended.  Patients family accompanied her to the hospital.
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Essential tremor, Fatigue, Feeling abnormal, Tremor
Clinical narrative: On 09/15/2022, I had gotten my 6th Covid vaccine booster and my yearly flu vaccine. (Details below,)  Felt very tired. I went to bed and as I was sitting in bed, reading, my hands started shaking violently. It wasn't like an essential tremor. I sat there in shock, trying to control my hands, but they kept shaking for about 5 minutes. The shaking stopped, and has not returned.  I'm hesitant to get a booster for Covid.
Age: 3.0
Sex: M
Vaccine: COVID19-2, DTAPIPV, HEPA, MMRV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Kinrix was given to a patient who was 3 years old which is outside of the licensed ages.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Electrocardiogram, Full blood count, Head injury, Immunoglobulins
Clinical narrative: Patient seen at emergency dept after c/o syncopal episode while at work. Patient felt dizzy, lost consciousness & hit top of head. (no fall certain)
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Laboratory test, Loss of consciousness, Metabolic function test, Syncope, Troponin
Clinical narrative: Patient seen at emergency dept after c/o syncopal episode while at work. Patient felt dizzy, lost consciousness & hit top of head. (no fall certain)
Age: 0.17
Sex: U
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: given a vaccine on 8/23/23 that had expored on 8/10/23 No complications at this time
Age: 0.5
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC13, RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccines Hib was expired. expiration date was 8/10/26 lot # UJ739AB  Patient was notified per mom patient had no reaction.
Age: 24.0
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B surface antibody positive, Hepatitis B surface antigen negative
Clinical narrative: The client had a Hepatits B titer dram in May, 2023, but it was noted after the Hepatitis B vaccine was given that it was a Hepatits B surface ANTIGEN and not a Hepatitis B surface ANTIBODY titer. Thus, not a valid Hep B titer to determine antibodies and need for any further vaccine.
Age: 20.0
Sex: F
Vaccine: HEP
Symptoms: Back pain, Chills, Headache, Pain, Pyrexia
Clinical narrative: 8/24/23 Received a call from client. Client states at approx 2 am on 8/23/23 she experienced fever, body aches, chills and a headache that lasted until approx 5 pm on 8/23/23. Client states at approx 1 am on 8/24/23 she experienced severe back pain that ran up and down her spine and was "almost unbearable". Client reports no other sx but reports she has had this pain for 12 hours and continues to have this severe back pain. Client states she has not taken any medication for relief. Advised client to seek medical evaluation from a provider. Client states she is on her way to a walk in clinic for an evaluation of her back pain sx. Will contact client in a few days to assess her health status. See continuation page
Age: 20.0
Sex: F
Vaccine: HEP
Symptoms: Spinal X-ray, Spinal pain
Clinical narrative: 8/24/23 Received a call from client. Client states at approx 2 am on 8/23/23 she experienced fever, body aches, chills and a headache that lasted until approx 5 pm on 8/23/23. Client states at approx 1 am on 8/24/23 she experienced severe back pain that ran up and down her spine and was "almost unbearable". Client reports no other sx but reports she has had this pain for 12 hours and continues to have this severe back pain. Client states she has not taken any medication for relief. Advised client to seek medical evaluation from a provider. Client states she is on her way to a walk in clinic for an evaluation of her back pain sx. Will contact client in a few days to assess her health status. See continuation page
Age: 65.0
Sex: F
Vaccine: FLU4
Symptoms: Syringe issue, Underdose
Clinical narrative: WHILE ADMINISTERING INFLUENZA VACCINE, THERE WAS LEAKAGE FROM THE PREFILLED SYRING. PATIENT DID NOT GET THE ADEQUATE DOSE
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Immediate post-injection reaction, Pain in extremity, Pruritus, Urticaria
Clinical narrative: 8/23/23 Pt received Shingrix - 1st dose at 10:50AM. Only sore arm and burning sensation upon administration. Right Deltoid. 8/27/23 Pt woke up @ 8am with welts that began on each side of back along spine and spread to stomach, arms, legs, and back. No change in vision, no significant pain, only pruritus - large visible welts. MD gave pt 40mg loratadine, Benadryl 50mg & hydroxyzine.  No sxn between these dates. 8/28/23 MD sent in high dose Prednisone as per 18 days use.