chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Activation syndrome, Agitation, Insomnia, Interchange of vaccine products
Clinical narrative: Dose 1, Dose 2, Dose 3 :Moderna / Dose 4: Covid19 Bivalent booster; agitation; activation; insomnia; This is a spontaneous report received from contactable reporter(s) (Other HCP) from a sales representative.  A 61-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "melanoma of the eye" (unspecified if ongoing); "hyperthyroidism" (unspecified if ongoing); "adrenal insufficiency" (unspecified if ongoing); "hypertension" (unspecified if ongoing); "asthma" (unspecified if ongoing); "blindness" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: moderna coviD-19 vaccine (DOSE 1, SINGLE), administration date: 03Mar2021, for COVID-19 Immunization; moderna coviD-19 vaccine (DOSE 2, SINGLE), administration date: 31Mar2021, for COVID-19 Immunization; moderna coviD-19 vaccine (DOSE 3, SINGLE), administration date: 24Aug2021, for COVID-19 Immunization. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (non-serious), outcome "unknown", described as "Dose 1, Dose 2, Dose 3 :Moderna / Dose 4: Covid19 Bivalent booster"; AGITATION (non-serious), outcome "recovered"; ACTIVATION SYNDROME (non-serious), outcome "recovered", described as "activation"; INSOMNIA (non-serious), outcome "recovered".  Additional information: It was reported that a 61 yo female experienced agitation/activation/insomnia for lasting 4 hours the same day after receiving her covid-19 booster. Patient did not seek physician care at office or hospital. Patient has fully recovered. Event took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: stroke; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 OMI ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 19Sep2022 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: CEREBROVASCULAR ACCIDENT (medically significant) with onset 24Sep2022, outcome "unknown", described as "stroke".  Clinical Course: Event took place after use of product. The patient felt the incidents were related.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Arthritis
Clinical narrative: Patient ended up with Arthritis in hands; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the parent. Other Case identifier(s): MOD-2022-461572 (Moderna).  A female 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 included: "Arthritis in lower back and Neck only" (unspecified if ongoing), notes: Arthritis in lower back and Neck only. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer.), for Covid-19 immunization. The following information was reported: ARTHRITIS (non-serious), outcome "unknown", described as "Patient ended up with Arthritis in hands".  Additional information: She states, her daughter received Pfizer Covid-19 booster and she also ended up with arthritis in hands. Nurse suggested to take turmeric for arthritis in hands, but she did not take.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: Pt had a strange feeling in head for the past year. Best way to describe it pt felt like pt was under water; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), in 2021 as dose 3 (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: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization, reaction(s): "Pt had a strange feeling in head for the past year. Best way to describe it pt felt like pt was under water"; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunization, reaction(s): "Pt had a strange feeling in head for the past year. Best way to describe it pt felt like pt was under water". The following information was reported: FEELING ABNORMAL (non-serious) with onset 2021, outcome "unknown", described as "Pt had a strange feeling in head for the past year. Best way to describe it pt felt like pt was under water".  Additional information: Pt received all 3 pfizer vaccines. Pt had a strange feeling in head for the past year. Best way to describe it was pt felt like pt was under water. Been to several doctors and could not explain why or gave pt a remedy. There were a lot of people online that had the same symptoms. All had their shots, all seem to thought like pt do that was the result of the vaccine. Pt know that there had not been enough studies, but with people being concerned that the probability of this feeling could be the result.  The information on the batch/lot number for [BNT162B2] has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Pain in extremity, Pyrexia
Clinical narrative: fever of 99.4 degrees F; arm soreness; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An adult 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: PYREXIA (non-serious), outcome "unknown", described as "fever of 99.4 degrees F"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "arm soreness". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: Patient details with age bracket provided as 20-39 years. No other details are known.  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.
Sex: F
Vaccine: COVID19
Symptoms: Bone scan, Periarthritis
Clinical narrative: Frozen Shoulder from the Vaccine injection; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): NVSC2022US228671_NS.  A 71-year-old female patient received BNT162b2 (BNT162B2), in 2021 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: RECLAST. The following information was reported: PERIARTHRITIS (non-serious), outcome "unknown", described as "Frozen Shoulder from the Vaccine injection". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Her last Reclast infusion was in Oct2021, and then 10 days later had the Covid Vaccine injection. Consumer stated has gotten Frozen Shoulder from the Vaccine injection. Consumer's latest bone scan was lower then in the past. Consumer thinks the COVID-19 Vaccine injection was given too soon after having her Reclast Infusion.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Myalgia, Vaccination site pain
Clinical narrative: moderate chills; fatigue; headache; injection site soreness; arm muscle pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Oct2022 as dose number unknown (booster), single (Batch/Lot number: unknown) at the age of 31 years 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 but unknown manufacturer.), for Covid-19 immunization. The following information was reported: MYALGIA (non-serious) with onset Oct2022, outcome "unknown", described as "arm muscle pain"; FATIGUE (non-serious) with onset Oct2022, outcome "unknown"; HEADACHE (non-serious) with onset Oct2022, outcome "unknown"; VACCINATION SITE PAIN (non-serious) with onset Oct2022, outcome "unknown", described as "injection site soreness"; CHILLS (non-serious) with onset Oct2022, outcome "unknown", described as "moderate chills".  Additional information: Description of event: Received bivalent Covid booster on 12Oct. Within 12 hours experienced moderate chills, fatigue, and headache as well as injection site soreness and arm muscle pain. No fever. Event took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Menstrual disorder
Clinical narrative: having lots of problems with her menstrual cycle; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID.  A female patient received BNT162b2 (BNT162B2), 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: MENSTRUAL DISORDER (non-serious), outcome "unknown", described as "having lots of problems with her menstrual cycle". Additional information: his daughter had lots of problems with her menstrual cycle. He stated as well that it's been going for a year.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Brain injury, Chronic obstructive pulmonary disease
Clinical narrative: brain injuries; COPD; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (159558). The reporter is the patient.  A male patient received BNT162b2 (BNT162B2), on 24Mar2022 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: CHRONIC OBSTRUCTIVE PULMONARY DISEASE (non-serious) with onset 2022, outcome "unknown", described as "COPD"; BRAIN INJURY (medically significant) with onset 2022, outcome "unknown", described as "brain injuries".  Clinical course: The reporter who had brain injuries and COPD would like to know if he can take the Bivalent vaccine. His last shot was 24Mar2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Feeling abnormal, Hypoaesthesia, Impaired quality of life, Trigger finger
Clinical narrative: I get the Covid jab, now 1 yr later life has changed dramatically; I can not feel the back of my neck and have numbness is both arms and hands, fingers, combined with trigger fingers; I can not feel the back of my neck and have numbness is both arms and hands, fingers, combined with trigger fingers; I can not feel the back of my neck and have numbness is both arms and hands, fingers, combined with trigger fingers; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), 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: IMPAIRED QUALITY OF LIFE (non-serious), outcome "unknown", described as "I get the Covid jab, now 1 yr later life has changed dramatically"; FEELING ABNORMAL (non-serious), TRIGGER FINGER (non-serious), HYPOAESTHESIA (non-serious), outcome "unknown" and all described as "I can not feel the back of my neck and have numbness is both arms and hands, fingers, combined with trigger fingers". The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: TYP
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: gave a patient typhim that expired 3 weeks ago,with no reported adverse event; Initial information received on 07-Oct-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves Adult male patient who was administered typhim that expired 3 weeks ago and experienced no adverse event after receiving vaccine Typhoid VI Polysaccharide Vaccine (Typhim VI).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Hepatitis A Vaccine (Hepatitis A Vaccine); Hepatitis B Vaccine (Hepatitis B Vaccine), Tetanus Vaccine (Tetanus Vaccine) and yellow fever vaccine live (Yellow fever vaccine live) for prophylactic vaccination.  On 07-Oct-2022, the patient received a dose of suspect typhoid VI polysaccharide vaccine (lot T1E371M, expiry date 14-Sep-2022, administration site unknown) via intramuscular route for immunization.  On 07-Oct-2022 the patient experienced a non-serious gave a patient typhim that expired 3 weeks ago, with no reported adverse event (expired product administered)(latency same day) following the administration of typhoid VI polysaccharide vaccine.  Action taken: Not Applicable.  Outcome : Unknown.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.; Sender's Comments:  01312671:
Age: 84.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity
Clinical narrative: arms began to hurt; Initial information regarding an unsolicited valid non-serious case received via patient on 07-Oct-2022. Agency number: 01312669   This case involves an 84-year-old female patient who experienced arms began to hurt while receiving vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. This case is linked to case 2022SA416023(husband case).   On 28-Sep-2022, the patient received of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE at (unknown: formulation, strength, dose, lot number, route in unknown administration site) for prophylactic vaccination. Information regarding batch and expiry date requested.  On an unknown date in 2022, 3-days after getting the fluzone high dose quadrivalent the arms began to hurt (pain in extremity) and has continued to hurt since then. The patient reported that her arm hurts worse than her husbands and that the provider told them to use ice (corrective treatment).  Action taken: Not applicable.  At time of reporting, the outcome was Not Recovered for the event.
Age: 0.33
Sex: F
Vaccine: IPV
Symptoms: Medication error, No adverse event, Poor quality product administered, Product storage error
Clinical narrative: patient received IPOL from a punctured vial after it was exposed to a temperature excursion with no reported adverse event; Initial information received on 07-Oct-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 4 years old female patient received IPV (VERO) [IPOL] from a punctured vial after it was exposed to a temperature excursion with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 06-Sep-2022, the patient received 0.5 ml dose of suspect IPV (VERO), suspension for injection from a punctured vial (lot V1B901M; Expiration Date :22-Jun-2024) via unknown route in unknown administration site for immunization after it was exposed to a temperature excursion with no reported adverse event (poor quality product administered) (latency; same day).  This situation occurred due to fridge malfunction Max/Low Temperature reached 16.6C, 8.9C, +9.6C, +8.6C, +12.8C for 1st excursion 6 HOURS and 17 MINUTES 2nd excursion 23 MINUTES 3rd excursion 15 MINUTES 4th excursion 8 MINUTES 5th excursion 6HOURS and 16 MINUTES. Human error was not involved.  Action taken: not applicable.  Outcome: Unknown.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the 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: 1.5
Sex: M
Vaccine: MMR, MMRV, PPV, UNK
Symptoms: Medication error, No adverse event, Product preparation error
Clinical narrative: patient was administered pentacel DTAP-IPV component was administered, not the ACT-HIB portion with no reported adverse event; Initial information received on 10-Oct-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 18 months old male patient was administered diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (Vero)] onlyl DTAP-IPV component was administered, 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.  Concomitant medications included measles vaccine live (enders-edmonston), mumps vaccine live, rubella vaccine live (wistar ra 27/3), varicella zoster vaccine live (oka/merck) (Proquad); measles vaccine, mumps vaccine, rubella vaccine (MMR) and pneumococcal for Immunisation.  On 10-Oct-2022, the patient received 0.5ml (dose 3) of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine, suspension for injection (lot UJ668AAA; Expiry date: 13-May-2023)via intramuscular route in the right leg (right thigh) for Immunization.  On 10-OCT-2022 the patient was administered only dtap-ipv component was administered, not the act-hib portion with no reported adverse event (product preparation error) (latency; on same day). This situation is reported as a medication error due to the incorrect administration of PENTACEL. Only the liquid DTAP-IPV portion was administered to the patient  Action taken : not applicable.  Outcome: Unknown.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: MNQ
Symptoms: Inappropriate schedule of product administration, Medication error, No adverse event
Clinical narrative: first dose of MENACTRA at 11 years old and has given the second dose at 5 weeks before the patient turned 16 with  no reported adverse event; Initial information received on 10-Oct-2022 regarding an unsolicited valid  non-serious case received from a physician.  This case a patient of an unknown age and gender and reported that patient received first dose of Menactra at 11 years old and has given the second dose at 5 weeks before the patient turned 16 with  no reported adverse event, and it involved vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose 1 of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE,  wit an unknown formulation and strength, 1 dosage form (DF) once, ( lot number  and expiry date: not reported) via unknown route in unknown administration site for immunization. The patient received the same vaccine with an unknown formulation, strength, dose frequency, route, indication, batch number and expiry date). The information regarding batch number has been requested  The reporter stated that she has given a patient first dose of Menactra at 11 years old and has given the second dose at 5 weeks before the patient turned 16 with  no reported adverse event (inappropriate schedule of product administration) (latency: unknown)  The reporter  to know if she can give another dose as the school required the vaccine before school admission   Action taken : not applicable.  Outcome: unknown   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the 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: U
Vaccine: MNQ
Symptoms: Seizure like phenomena
Clinical narrative: seizure like activity; Initial information received on 10-Oct-2022 regarding an unsolicited valid serious case received from a healthcare professional.  This case involves a 16-year-old patient (unknown gender), who experienced seizure like activity after receiving vaccine MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE [MENQUADFI].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 07-Oct-2022, the patient received 0.5ml total dose of suspect MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE (strength, formulation, route: unknown) (lot number: U7249AA and expiry date: 11-Mar-2024) in unknown administration site for Immunization.  On 07-Oct-2022, on the same day, the patient developed a serious event of seizure like activity (Seizure like phenomena) following the administration of MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE.   It was reported, Office has since removed all MENQUADFI with that particular LOT# from refrigerator and has ordered more. No additional patient information at the time of call.   Action taken with MENINGOCOCCAL VACCINE (MENQUADFI) was not applicable.  It was not reported if the patient received a corrective treatment for the event (seizure like activity).  At time of reporting, the outcome was Unknown for the event seizure like activity.  Seriousness Criteria: Medically significant for seizure like activity.; Sender's Comments: Sanofi company comment dated on 14-Oct-2022: This case involves a 16 years old and unknown gender patient who experienced seizure like activity while receiving vaccine MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE [MENQUADFI].  The time to onset is compatible with the role of the product. However, information regarding medical history, past medical treatment, vaccinations, condition at the time of vaccination and laboratory data excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of vaccine will be assessed completely after receiving follow up information.
Age: 5.0
Sex: F
Vaccine: FLU4
Symptoms: Expired product administered
Clinical narrative: inadvertently given expired product, with no reported adverse event; Initial information received on 10-Oct-2022 regarding an unsolicited valid non-serious case received from a healthcare professional.  This case involves a 5-year-old female patient to whom inadvertently given expired vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV], with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 07-Oct-2022, the patient received 0.5ml total dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (strength; standard; formulation: unknown) (lot number: UT7378MA and expiry date: 30-Jun-2022) Drug Treatment Duration: not applicable (NA)  via intramuscular route in the left deltoid for Immunization and on the same day to the patient inadvertently given expired product, with no reported adverse event (expired product administered).  This situation is reported as a medication error.  Action taken was not applicable.  At time of reporting, the outcome was Unknown.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.; Sender's Comments:  01314490:
Age: 8.0
Sex: M
Vaccine: FLU4
Symptoms: Expired product administered, No adverse event
Clinical narrative: FLUZONE PFS, that were expired was administered with no reported Adverse Event; Initial information received on 10-Oct-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 8 years old male patient who was administered expired influenza quadrival A-B vaccine [Fluzone QIV] 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 suspect influenza quadrival A-B vaccine suspension for injection standard at a dose of 0.5 ml once (lot UT7378MA, expiry date- 30-Jun-2022) via intramuscular route in the right deltoid for immunization.  On 07-Oct-2022 the patient was administered expired influenza quadrival A-B vaccine with no reported adverse event (expired product administered) (unknown latency) following the administration of vaccine.  Action taken with influenza quadrival A-B vaccine was 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 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: FLU4
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired Fluzone vaccine was administered with no reported adverse event; Initial information received on 10-Oct-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked to case 2022SA418873(CLUSTER).  This case involves a 2 years old female patient to whom expired INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV] was administered with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 07-OCT-2022, the patient received 0.5 ml of expired INFLUENZA QUADRIVAL A-B VACCINE with no reported adverse event (expired product administered) (lot UT7378MA and expiry date- 30-Jun-2022) via intramuscular route in unknown administration site for immunization or TB test.  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 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: F
Vaccine: FLU4
Symptoms: Expired product administered
Clinical narrative: Fluzone PFS, that were expired was administered to patient with no reported adverse event.; Initial information received on 10-Oct-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 12 years old female patient who was administered expired Influenza Quadrival A-B Vaccine (Fluzone Quadrivalent) with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 07-Oct-2022, the patient received a dose of 0.5 mL frequency: once of suspect influenza quadrival A-B vaccine (with lot UT7378MA, expiry date: 30-Jun-2022) via intramuscular route in the left deltoid for prophylaxis.  On 07-Oct-2022 (latency: same day) the patient was administered Fluzone PFS, that were expired with no reported adverse event (expired product administered).   No lab data was reported.  Action taken : Not Applicable.  Outcome: Unknown.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the 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: FLUR3
Symptoms: Medication error, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: FLUBLOK was administered to 9 pediatric patients with no reported adverse event; Initial information was received on 10-Oct-2022 regarding an unsolicited valid  non-serious case received from a healthcare professional.  This case is linked to cases 2022SA418226(CLUSTER), 2022SA419186(CLUSTER), 2022SA419213(CLUSTER), 2022SA420021(CLUSTER), 2022SA420094(CLUSTER), 2022SA420025(CLUSTER) and 2022SA420021(CLUSTER).  This case involves a 2 years old female patient and reporter reported Influenza quadrivalent recombinant vaccine [Flublok] was administered to 9 pediatric patients with no reported adverse event .  No other vaccines. The patient's past medical history, medical treatment(s) and family history were not provided.   On 10-Oct-2022, the pediatric patient received a total dose of suspect Influenza quadrivalent recombinant vaccine 0.5 ml (with unknown strength and formulation) (lot: QFAA223, expiration date: 30-Jun-2023) via intramuscular route in the left deltoid for immunization with no reported adverse event (product administered to patient of inappropriate age) (latency: same day).  Action taken: Not applicable.  Corrective treatment: Not reported.  Outcome: Unknown.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: F
Vaccine: FLU4
Symptoms: Expired product administered
Clinical narrative: administered an expired dose of fluzone quadrivalent single dose vials with no reported adverse event; Initial information received on 11-Oct-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves an unknown age female patient who was administered an expired dose of Influenza Quadrival A-B Vaccine [FLUZONE QIV].and experienced no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 04-Oct-2022, the patient received a dose of 0.5 mL once of suspect influenza quadrival A-B vaccine with (lot 33D9L, expiry date: 30 Jun 2022) (strength and formulation: unknown) via intramuscular route in unknown administration site for prophylaxis.  On 04-Oct-2022, (latency: same day) the patient was administered an expired dose of influenza quadrival A-B vaccine single dose vials with no reported adverse event (expired product administered).   No lab data was reported.  Action taken : Not Applicable.  Outcome : Unknown.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the 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: 1.08
Sex: F
Vaccine: HIBV, PNC13, VARCEL
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: administrated to a child earlier than recommended in the prescribing information, with no reported adverse event; Initial information received on 11-Oct-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case involves a 13 months and 20 days old female patient  to whom  HIB (PRP/T) VACCINE [ACT-HIB] was administrated to a child earlier than recommended in the prescribing information, with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) and VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) for Prophylactic vaccination.  On 11-Oct-2022, the patient received a 0.5 ml (dose 4) of suspect HIB (PRP/T) VACCINE, powder and solvent for solution for injection (lot UJ648ABA; expiry date; 16-Mar-2023) via intramuscular route in the left thigh for Immunization to a child earlier than recommended in the prescribing information, with no reported adverse event  (product administered to patient of inappropriate age).  Action taken : not applicable.  Outcome: Unknown.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Medication error, No adverse event, Poor quality product administered, Product storage error
Clinical narrative: administered IPOL post excursion with no reported adverse event; temperature excursion at 47 Fahrenheit for 20 minutes due to the refrigerator door being left opened with no reported adverse event; Initial information received from on 11-Oct-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case involves a 5 years old male patient who was administered ipol post temperature excursion at 47 Fahrenheit for 20 minutes due to the refrigerator door being left opened with no reported adverse event while receiving vaccine IPV (VERO) [IPOL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, TETANUS VACCINE TOXOID (INFANRIX) for Immunisation.  On 21-Sep-2022, the suspect IPV (VERO) was exposed to a temperature excursion at 47 Fahrenheit for 20 minutes due to the refrigerator door being left opened with no reported adverse event (product storage error).  On 23-Sep-2022, the patient received 0.5 mL total dose of suspect IPV (VERO) once (lot V1A022M and expiry date: 17-Feb-2024) via intramuscular route in the left deltoid for prophylactic vaccination.  On 23-Sep-2022, (latency: same day) the patient was administered ipol post excursion with no reported adverse event (poor quality product administered) following the administration of IPV (VERO).  Action taken with POLIOMYELITIS VACCINE (INACTIVATED) (IPOL) was not applicable.  At time of reporting, the outcome was Unknown for both the events.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 4.0
Sex: F
Vaccine: IPV
Symptoms: Medication error, No adverse event, Poor quality product administered, Product storage error
Clinical narrative: administered IPOL post excursion with no reported adverse event; temperature excursion at 47 Fahrenheit for 20 minutes due to the refrigerator door being left opened with no reported adverse event; Initial information received from  on 11-Oct-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case is linked to cases 2022SA422655(CLUSTER), 2022SA422419(CLUSTER) and 2022SA422653(CLUSTER).  This case involves a 4 years old female patient who was administered ipol post temperature excursion at 47 fahrenheit for 20 minutes due to the refrigerator door being left opened with no reported adverse event while receiving vaccine IPV (VERO) [IPOL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 21-Sep-2022, the suspect IPV (VERO) was exposed to a temperature excursion at 47 fahrenheit for 20 minutes due to the refrigerator door being left opened with no reported adverse event (product storage error).  On 23-Sep-2022, the patient received 0.5 mL toatl dose of suspect IPV (VERO) once (lot V1A022M and expiry date: 17-Feb-2024) via intramuscular route in the left thigh for prophylactic vaccination.  On 23-Sep-2022, (latency: same day) the patient was administered ipol post excursion with no reported adverse event (poor quality product administered) following the administration of IPV (VERO).  Action taken was not applicable.  At time of reporting, the outcome was Unknown for both the events.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 10.0
Sex: M
Vaccine: IPV
Symptoms: Medication error, No adverse event, Poor quality product administered, Product storage error
Clinical narrative: temperature excursion due to the refrigerator door being left opened on 21SEP2022. Caller reporting PENTACEL, ACTHIB, IPOL, MENQUADFI, and TENIVAC at a high of 47F out of range for 20 minutes with no reported adverse event; administered IPOL post excursion with no reported adverse event; Initial information received on 11-Oct-2022 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare professional (hcp).  This case is linked to cases 2022SA422151(CLUSTER), 2022SA421782(CLUSTER), 2022SA422546(CLUSTER), 2022SA422846(CLUSTER), 2022SA419841(CLUSTER), 2022SA422655(CLUSTER) and 2022SA422419(CLUSTER).  This case involves a 10 years old male patient who received IPV (VERO) [IPOL] after temperature excursion at a high of 47 F (Fahrenheit) out of range for 20 minutes with no reported adverse event .  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   A temperature excursion due to the refrigerator door being left opened on 21-Sep-2022. Pentacel, Acthib, Ipol, Menquadfi, and Tenivac at a high of 47F out of range for 20 minutes with no reported adverse Event  (product storage error) (unknown latency).  On 26-Sep-2022, patient received 0.5 ml total dose of suspect IPV (VERO) (lot V1A022M, exp date: 17-Feb-2024, strength: standard ) via intramuscular route in the right deltoid for immunization post excursion with no reported adverse event (poor quality product administered).   Action taken: not applicable.  At time of reporting, the outcome was Unknown for the events.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 81.0
Sex: M
Vaccine: TD
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: TENIVAC vaccine expired on 08Oct2022 and it was given today 12Oct2022 with no reported adverse event; Initial information received on 12-Oct-2022 regarding an unsolicited non-valid non-serious case received from a other health professional.  This case involves a 81 years old male patient and reporter reported tenivac vaccine expired on 08oct2022 and vaccine diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult [Tenivac] was given today 12oct2022 with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 12-Oct-2022, the patient received a dose of suspect diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult Suspension for injection (Lot: U6831AA, expiry date 08-Oct-2022) (unknown administration site)(strength:standard) 0.5 ml total at once via intramuscular route for immunization    On 12-Oct-2022 the patient was administered with tenivac vaccine expired on 08oct2022 with no reported adverse event (expired product administered) following the administration of vaccine.  No lab data reported.  Action taken was 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 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: MNQ
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: patient was administered MENACTRA after the expiration date with no reported adverse event; Initial information received on 13-Oct-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 16 years old female patient who was administered MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] after the expiration date with no reported adverse event.   The patient's past medical history, medical treatment(s), concomitant medication, vaccination(s) and family history were not provided.   On 04-Oct-2022, the patient received a 0.5ml dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (strength, formulation was unknown, lot ABXB34AA and expiry date: 31-Jul-2022) via intramuscular route in the right deltoid for Immunization.  On 04-Oct-2022 the patient developed a non-serious event of patient was administered menactra after the expiration date with no reported adverse event (expired product administered)(Latency: same day) following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE.  Action taken : not applicable.  Outcome: Unknown  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the 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.