chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Chest pain, Headache, Movement disorder, Myocardial infarction, Vomiting
Clinical narrative: pre heart attack; chest pain; painful headaches; vomiting; unable to move out of bed; 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 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 08Oct2022 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 completed; manufacturer unknown), for Covid-19 immunization. The following information was reported: MYOCARDIAL INFARCTION (hospitalization, medically significant), outcome "unknown", described as "pre heart attack"; CHEST PAIN (non-serious), outcome "unknown"; HEADACHE (non-serious), outcome "unknown", described as "painful headaches"; VOMITING (non-serious), outcome "unknown"; MOVEMENT DISORDER (non-serious), outcome "unknown", described as "unable to move out of bed". Patient became extremely ill. Patient could not take the pain anymore and went to the hospital where patient was told that he/she had a pre heart attack. Patient was concerned with his/her health and felt he/she needed to report what was really happening to a person of his/her age with this booster shot. Patient was told if he/she waited any longer, he/she would not be around to tell this story.  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: U
Vaccine: COVID19
Symptoms: Pain, Pruritus
Clinical narrative: severe generalized burning type pain; occasional pruritis in my feet, hands, extremities, & occasionally in the abdomen & back; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "I have an autoimmune disease" (unspecified if ongoing), notes: I have an autoimmune disease. Concomitant medication(s) included: CELLCEPT [MYCOPHENOLATE MOFETIL HYDROCHLORIDE] taken for autoimmune disorder; BENLYSTA subcutaneous taken for autoimmune disorder. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 Immunization, reaction(s): "severe generalized burning type pain/I have had this severe burning pain in my hands, feet, extremities and somewhat in my abdomen and in my back", "pruritus in my feet, hands, extremities, & occasionally in the abdomen & back"; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 Immunization, reaction(s): "had minimal symptoms with the 2nd, 3rd and 4th doses", "had minimal symptoms with the 2nd, 3rd and 4th doses"; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE), for COVID-19 Immunization, reaction(s): "had minimal symptoms with the 2nd, 3rd and 4th doses", "had minimal symptoms with the 2nd, 3rd and 4th doses"; Bnt162b2 (DOSE 4 (BOOSTER), SINGLE), for COVID-19 Immunization, reaction(s): "had minimal symptoms with the 2nd, 3rd and 4th doses", "had minimal symptoms with the 2nd, 3rd and 4th doses". The following information was reported: PAIN (non-serious), outcome "unknown", described as "severe generalized burning type pain"; PRURITUS (non-serious), outcome "unknown", described as "occasional pruritis in my feet, hands, extremities, & occasionally in the abdomen & back". Therapeutic measures were taken as a result of pain, pruritus.  Additional information: It was reported that patient had autoimmune disease currently prescribed cellcept 500mg b.i.d (two times a day) and Benlysta 200mg subcutaneous weekly. Patient had severe generalized burning type pain w/occasional pruritis in my feet, hands, extremities, & occasionally in the abdomen & back. These symptoms are unresponsive to OTC meds, partially responsive to oxycodone, & usually require short term use of prednisone.  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: M
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: Got very sick; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): 2022NVX-US-000004006 (Novavax).  A male patient received BNT162b2 (BNT162B2), in Dec2021 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 completed, Manufacturer unknown), for COVID-19 immunisation. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "Got very sick".  Additional information: It was also reported that patient received this vaccination as his first booster dose and got very sick.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19, FLUX
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: COVID; COVID; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): US2022AMR156058.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), in left arm and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation; influenza vaccine (FLU VACCINE VII), as single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history included: "COVID-19", start date: Jul2020 (unspecified if ongoing), notes: COVID 19 on Jul2020. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "COVID".  Clinical course: This report concern an individual patient or several patients was reported as Individual Patient. The patient also got vaccinated in left arm, and it did not hurt, in Sep, and after 2 months the 2nd dose. They just applied to patient, the new one from COVID and derivatives, from Pfizer, and the one from Flu, yes it hurt, and had the symptoms of both for 3 days. (COVID 19 on Jul2020).  The lot number for [BNT162b2], was not provided and will be requested during follow up.
Age: 65.0
Sex: M
Vaccine: COVID19, FLUX, UNK
Symptoms: Off label use, Pain in extremity, Product use issue
Clinical narrative: had Pfizer COVID-19 vaccine and flu shot to left arm and complained of left arm pain; had Pfizer COVID-19 vaccine and flu shot to left arm and complained of left arm pain; had Pfizer COVID-19 vaccine and flu shot to left arm and complained of left arm pain; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old male patient received BNT162b2 (BNT162B2), on 28Sep2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 65 years intramuscular, in left arm for covid-19 immunisation; influenza vaccine (INFLUENZA), on 28Sep2022 as dose number unknown, single (Batch/Lot number: unknown) intramuscular, in left arm; treprostinil sodium (TYVASO), since 13Jul2022 (Lot number: 2102217, Expiration Date: 31Dec2024) at 54 ug 4x/day for pulmonary arterial hypertension. The patient's relevant medical history included: "Pulmonary arterial hypertension" (ongoing). The patient's concomitant medications were not reported. The following information was reported: PRODUCT USE ISSUE (non-serious), OFF LABEL USE (non-serious), PAIN IN EXTREMITY (non-serious) all with onset 28Sep2022, outcome "unknown" and all described as "had Pfizer COVID-19 vaccine and flu shot to left arm and complained of left arm pain". The action taken for treprostinil sodium was unknown. Therapeutic measures were taken as a result of pain in extremity.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: the patient has Covid-19; the patient has Covid-19; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP).  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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "the patient has Covid-19".  Additional information: Reporter asked if the patient has Covid-19, how long before they would be able to get the booster shot.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on available information, a lack of efficacy with the suspect vaccine BNT162B2 in this patient cannot be completely excluded.
Sex: M
Vaccine: COVID19-2
Symptoms: Dizziness, Lethargy, Vertigo, Visual impairment
Clinical narrative: lethargy; problems with vision; visual vertigo; dizziness; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 73-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Sep2022 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: Covid-19 vaccine (DOSE: 1), for Covid-19 immunization; Bnt162b2 (DOSE: 2), administration date: Mar2021, for COVID-19 Immunization. The following information was reported: LETHARGY (non-serious), outcome "unknown"; VISUAL IMPAIRMENT (non-serious), outcome "unknown", described as "problems with vision"; VERTIGO (non-serious), outcome "unknown", described as "visual vertigo"; DIZZINESS (non-serious), outcome "unknown".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Blood pressure measurement, Fatigue, Feeling hot, Malaise, Pain
Clinical narrative: 2 days of being tired; achy; hot cheeks; felt crummy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): EC-2022-124484.  A 46-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Oct2022 as dose number unknown (booster), single (Batch/Lot number: unknown) at the age of 46 years for covid-19 immunisation; lenvatinib mesilate (LENVIMA), first regimen from 01Sep2022 (Batch/Lot number: unknown) to 15Sep2022 at 14 mg daily and second regimen since 08Oct2022 (ongoing) (Batch/Lot number: unknown) at 14 mg daily, all oral for endometrial cancer. The patient's relevant medical history included: "endometrial cancer" (unspecified if ongoing). Concomitant medication(s) included: KEYTRUDA taken for endometrial cancer, start date: 25Aug2022. Vaccination history included: Covid-19 vaccine (Primary immunization series complete, unknown manufacturer), for COVID-19 immunisation. The following information was reported: FATIGUE (non-serious) with onset 16Oct2022, outcome "recovered" (17Oct2022), described as "2 days of being tired"; PAIN (non-serious) with onset 16Oct2022, outcome "recovered" (17Oct2022), described as "achy"; MALAISE (non-serious) with onset 16Oct2022, outcome "recovered" (17Oct2022), described as "felt crummy"; FEELING HOT (non-serious) with onset 16Oct2022, outcome "recovered" (17Oct2022), described as "hot cheeks". Relevant laboratory tests and procedures are available in the appropriate section. The action taken for lenvatinib mesilate was unknown.  Additional Information: Patient had Covid booster 16Oct2022 and had 2 days of being tired, achy, had "hot cheeks and felt crummy" but much improved at the day of report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Weight
Clinical narrative: 2 days of being tired; achy; hot cheeks; felt crummy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): EC-2022-124484.  A 46-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Oct2022 as dose number unknown (booster), single (Batch/Lot number: unknown) at the age of 46 years for covid-19 immunisation; lenvatinib mesilate (LENVIMA), first regimen from 01Sep2022 (Batch/Lot number: unknown) to 15Sep2022 at 14 mg daily and second regimen since 08Oct2022 (ongoing) (Batch/Lot number: unknown) at 14 mg daily, all oral for endometrial cancer. The patient's relevant medical history included: "endometrial cancer" (unspecified if ongoing). Concomitant medication(s) included: KEYTRUDA taken for endometrial cancer, start date: 25Aug2022. Vaccination history included: Covid-19 vaccine (Primary immunization series complete, unknown manufacturer), for COVID-19 immunisation. The following information was reported: FATIGUE (non-serious) with onset 16Oct2022, outcome "recovered" (17Oct2022), described as "2 days of being tired"; PAIN (non-serious) with onset 16Oct2022, outcome "recovered" (17Oct2022), described as "achy"; MALAISE (non-serious) with onset 16Oct2022, outcome "recovered" (17Oct2022), described as "felt crummy"; FEELING HOT (non-serious) with onset 16Oct2022, outcome "recovered" (17Oct2022), described as "hot cheeks". Relevant laboratory tests and procedures are available in the appropriate section. The action taken for lenvatinib mesilate was unknown.  Additional Information: Patient had Covid booster 16Oct2022 and had 2 days of being tired, achy, had "hot cheeks and felt crummy" but much improved at the day of report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19-2
Symptoms: Death, Pleural effusion
Clinical narrative: Developed bilateral PE. Then died; Developed bilateral PE. Then died; This is a spontaneous report received from contactable reporter(s) (Physician) from a sales representative.  An 80-year-old 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: "Hypertension" (unspecified if ongoing). The patient's 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), outcome "fatal", PLEURAL EFFUSION (medically significant), outcome "unknown" and all described as "Developed bilateral PE. Then died". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed.  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. Sender's Comments: The event indicating an unknown cause of death is assessed as related by the company until sufficient information is available to confirm an unrelated cause of death   The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: Died.
Age: 3.0
Sex: U
Vaccine: UNK
Symptoms: Extra dose administered, Medication error, No adverse event
Clinical narrative: received an extra dose, with no reported adverse event; Initial information received on 01-Nov-2022 regarding an unsolicited valid non-serious case from other health professional.  This case involves a 3-year-old and unknown gender patient who received an extra dose, with no reported adverse event of diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (Vero)].  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.  Concomitant medications included pneumococcal vaccine CONJ 13V (CRM197) (PREVNAR 13) and Hepatitis B Vaccine both for Immunisation.  On 22-Jul-2020, 13-Oct-2020, 24-Oct-2019 and 25-Mar-2021 the patient received suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine Suspension for injection at an unknown doses (lot number, expiry date: not reported) via unknown route in unknown administration site for prophylactic vaccination.   On 25-Mar-2021 the patient received an extra dose, with no reported adverse event (extra dose administered, same day) following the administration of diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) 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 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.
Sex: U
Vaccine: FLUX
Symptoms: Cough, Malaise, Pain, Pyrexia
Clinical narrative: fever; hurting; so sick; cough; Initial information received on 06-Nov-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp.  This case involves an unknown age/gender patient who experienced fever, hurting, so sick and cough after receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a  dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (dose, route, site,lot number and expiry date unknown) for immunization.  On an unknown date ( 5 days later),  the patient developed a non-serious events fever (pyrexia), hurting (pain),  so sick (illness)  and cough (unknown latency) following the administration of INFLUENZA VACCINE.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the events (pyrexia, pain, illness, cough).  At time of reporting, the outcome was Unknown for all the events.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: flu terrible; Initial information received on 07-Nov-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-healthcare professional (hcp).  This case involves an unknown age and unknown gender patient who experienced flu terrible after receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date in Oct-2022, the patient received suspect INFLUENZA VACCINE produced by unknown manufacturer (strength, formulation, dose: unknown) (lot number and expiry date: not reported) via unknown route in unknown administration site for Prophylactic vaccination (Immunisation).  On an unknown date, the patient got Influenza Vaccine a month ago and developed a non-serious event of flu terrible (influenza) right now (unknown latency) following the administration of INFLUENZA VACCINE.  It is unknown if the patient experienced any additional symptoms/events. It is unknown if there were lab data/results available.  Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the event (flu terrible).  At time of reporting, the outcome was Unknown for the event flu terrible.
Sex: U
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: arm pain weeks after administration; Initial information received on 07-Nov-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves an unknown age and unknown gender patient who experienced arm pain weeks after administration while receiving vaccine influenza quadrival a-b multidose vaccine preserved [fluzone].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a  dose of suspect influenza quadrival a-b multidose vaccine preserved  Suspension for injection lot UT7695JA via intramuscular route in unknown administration site Prophylactic vaccination.  On an unknown date the patient developed a non-serious arm pain weeks after administration (pain in extremity) (unknown latency) following the administration of influenza quadrival a-b multidose vaccine preserved.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event (arm pain weeks after administration).  At time of reporting, the outcome was Unknown for the event arm pain weeks after administration.
Age: 72.0
Sex: M
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: got the worst flu that he has ever had; Initial information received on 04-Nov-2022 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves a 72 years old male patient who got the worst flu that he has ever had while receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing Latex allergy and allergic reactions to Thimerosal and Sulfa in the past.  On an unknown date, the patient received a unknown dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number, expiry date, formulation, strength was unknown) via unknown route in unknown administration site as prophylactic vaccination.  On an unknown date the patient got the worst flu that he has ever had (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event.
Age: 5.0
Sex: U
Vaccine: FLU4
Symptoms: Medication error, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: accidentally given a 5 year old child with no adverse event; Initial information received on 05-Nov-2022 regarding an unsolicited valid non-serious case received from a pharmacist via e-mail.  This case involves a 5 year old patient of an unknown gender who was accidentally given INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] with no 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 0.7 ml of suspect of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot number: UJ925AA, expiry date: 30-June-2023, formulation, and strength not reported) via unknown route in unknown administration site for prophylactic vaccination and accidentally given a 5 year old child with no adverse event (product administered to patient of inappropriate age) (unknown latency).  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event.  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: 23.0
Sex: F
Vaccine: TDAP
Symptoms: Joint swelling
Clinical narrative: ankle swelling; Initial information received on 07-Nov-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 23 years old female patient who experienced ankle swelling after receiving vaccine Diphtheria-2/tetanus/5 AC pertussis vaccine [Adacel].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 27-Oct-2022, the patient received dose 0.5 ml Once (1x) (total) Diphtheria-2/tetanus/5 AC pertussis vaccine suspension for injection with strength: Unknown (lot- U7461AA, expiry date- 12-JUL-2024) via intramuscular route in the right deltoid for immunization.  On 31-OCT-2022 the patient developed ankle swelling (joint swelling) latency: 4 days following the administration of Diphtheria-2/tetanus/5 ac pertussis vaccine.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event (ankle swelling).  Outcome : Not Recovered / Not Resolved.
Sex: M
Vaccine: MNQ
Symptoms: Medication error, No adverse event, Product use issue
Clinical narrative: 9 month old patient receiving menquadfi with no reported adverse event; Initial information received on 07-Nov-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case involves a 9 months old male patient who reported a medication error due to a 9 month old patient receiving menquadfi with no reported adverse event while 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 an unknown date, the patient received a  dose of suspect Meningococcal A-C-Y-W135 (T Conj) Vaccine [Menquadfi] 0.5 ml 1 DF (dosage form) lot U7299AC in  (strength, formulation, frequency, administration site unknown) (expiry date: 04-AUG-2024) for prophylactic vaccination.  On 07-Nov-2022 the patient developed a non-serious event "9 month old patient receiving menquadfi with no reported adverse event" (product use issue) (unknown latency) following the administration of Meningococcal A-C-Y-W135 (T Conj) Vaccine [Menquadfi].  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event product use issue.     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: 1.0
Sex: M
Vaccine: HIBV
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: the diluent for the product was expired with no reported adverse event; Initial information was received on 08-Nov-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves 1 years old male patient who was reported with diluent for the product was expired with no reported adverse event while receiving vaccine hib (prp/t) vaccine [ACT-HIB].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 31-Oct-2022, the patient received suspect standard hib (prp/t) vaccine powder and solvent for solution for injection at a dose of 0.5 ml once (lot UJ594AA, expiry date - 30-Jan-2023) (diluent - Lot Number:U7171AB, Expiration Date: 26-Oct-2022) via intramuscular route in unknown administration site for Immunization.  On 31-Oct-2022 the patient reported a non-serious event of the diluent for the product was expired with no reported adverse event (expired product administered) (latency: same day) following the administration of hib (prp/t) vaccine.  Action taken with haemophilus type b (hib) vaccine (ACT-HIB) 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: 66.0
Sex: M
Vaccine: FLU4
Symptoms: Extra dose administered, Medication error, No adverse event
Clinical narrative: a dose of FLUZONE HIGH DOSE QIV was given in error after patient had already received a dose this season with no reported adverse event; Initial information received from on 08-Nov-2022 regarding an unsolicited valid  non-serious case received from a nurse.  This case involves a 66-year-old male patient to whom a dose of influenza quadrival A-B high dose HV vaccine [Fluzone High-Dose Quadrivalent] was given in error after patient had already received a dose this season with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.  Concomitant medications included elasomeran (Moderna COVID-19 Vaccine) for COVID-19 immunisation.  On 11-Oct-2022, patient received influenza quadrival A-B high dose HV vaccine at an unknown dosing (lot number and expiry date: not reported) and on 08-Nov-2022, the patient received a suspect influenza quadrival A-B high dose HV vaccine at a dose of 0.7 ml (lot UJ904AC, expiry date: 30-Jun-2023) via intramuscular route in the left deltoid for Immunization.   On 08-Nov-2022 the a dose of fluzone high dose qiv was given in error after patient had already received a dose this season with no reported adverse event (extra dose administered, 28 days latency from the first therapy and same day latency from second therapy).  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: 89.0
Sex: M
Vaccine: RAB
Symptoms: Expired product administered
Clinical narrative: patient received an expired IMOVAX RABIES vaccine with no reported adverse event; Initial information received on 08-Nov-2022 regarding an unsolicited valid non-serious case received via pharmacist. GMI number: 01358059.  This case involves an 89-year-old male patient to whom expired Rabies (HDC) Vaccine [Imovax Rabies] vaccine 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 Immunoglobulins Nos for Immunization.  On 08-Nov-2022, the patient received a 2nd dose of an expired suspect RABIES (HDC) VACCINE at (unknown: formulation, strength) at dose 1ml once (lot: T1E943M, expiry date: 14-Oct-2022) via intramuscular route in the right deltoid for immunization with no reported adverse event (expired product administered) at same day latency.  It was reported that "Pharmacist reporting that a patient received an expired IMOVAX RABIES vaccines and was calling for further guidance. Pharmacist asked if patient needs to repeat the dose. The Pharmacist wanted to know if the vaccine was live. This situation is reported as a medication error due to giving an expired dose."   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.
Sex: U
Vaccine: HIBV
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: administered acthib that was reconstituted with expired diluent with no reported adverse event; Initial information was received on 09-Nov-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves an unknown age and unknown gender patient who was administered hib (prp/t) vaccine [ACT-HIB] that was reconstituted with expired diluent 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 hib (prp/t) vaccine powder and solvent for solution for injection (expiry date - 30-Nov-2022, Diluent - 29-Oct-2022) lot number not reported via unknown route in unknown administration site (strength, dosage, frequency: unknown) for Immunization.  On 08-Nov-2022 the patient was administered hib (prp/t) vaccine that was reconstituted with expired diluent with no reported adverse event (expired product administered) (unknown latency) following the administration of vaccine.  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.
Sex: F
Vaccine: UNK
Symptoms: Feeling abnormal, Pain in extremity
Clinical narrative: Normal sore arms; Might have had a funny feeling; This spontaneous case was received on 04-Nov-2022 from a consumer via Communications (reference number: SEQW22-05431) and concerned a female patient of an unreported age.   The patient's medical history and concomitant medications were not reported. The patient's historical vaccines included unspecified flu vaccines received in the last 40 years, after which the patient experienced sore arm, reported as 'normal sore arms'.  On an unspecified date, the patient was vaccinated with the Fluad Quadrivalent (influenza vaccine inact sag 4v; dose reported as 0.5, route of administration and anatomical location: not reported), against influenza caused by influenza virus subtypes A and B contained in the vaccine.  On an unspecified date, an unknown amount of time after receiving the Fluad Quadrivalent vaccine, the patient experienced sore arms and said she 'might have had funny feeling'.  The outcome of the event was not reported.  The reporter did not provide a causality assessment. The patient described her experience with the vaccine- and with flu vaccines in general for the last 40 years- as positive apart from the 'normal sore arms'.  This case was assessed as non-serious.  Company comment: The events of pain in arm and feeling strange are considered as possible related to Fluad Quadrivalent due to temporal relationship.; Reporter's Comments: The patient described her experience with the vaccine- and with flu vaccines in general for the last 40 years- as positive apart from the 'normal sore arms'.; Sender's Comments: The events of pain in arm and feeling strange are considered as possible related to Fluad Quadrivalent due to temporal relationship.
Age: 71.0
Sex: M
Vaccine: UNK
Symptoms: Headache, Loss of consciousness, Nausea, Unresponsive to stimuli, Vomiting
Clinical narrative: Unresponsive for 1 minute; Took about 4 steps and passed out; Nauseated/Felt like vomiting; Headache; This spontaneous case was received on 04-Nov-2022 from a pharmacist via Agency (reference number: SEQW22-05419) and concerned a 71-year-old, male patient.  The patient's concurrent conditions included a prostate problem. The patient's health care practician (HCP) was told the patient did not have a medical history and that she had measured his blood pressure and that it was fine. He was healthy, having a heart rate of 60 bpm and a normal blood pressure. The patient's concomitant medications included Cialis (tadalafil) for a prostate problem and Synthroid (levothyroxine sodium) used for an unreported indication.   On 03-Nov-2022, at 3:40 pm, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine inact sag 4v; dose: 0.5 ml, route of administration and anatomical location: not reported) for active immunization of persons 65 years of age and older against influenza caused by influenza virus subtypes A and B contained in the vaccine. The batch number reported was 346346, and expiration date 21-Apr-2023. It was reported the patient was okay with it and fine on that day.   On 04-Nov-2022, 14 hours after receiving Fluad Quadrivalent, the patient was asleep. The patient felt like vomiting/ nauseated and got up, took about four steps and passed out. The patient called the pharmacy saying he was vomiting and became unresponsive for one minute. In a later call, he denied having actually vomited and added that he had never passed out in his life. The patient reported having suffered a mild headache as well.  On the same day, the patient recovered from the events. The reporter claims that the patient is fine now.    The reporter did not provide causality assessment.  The events of passed out and 'unresponsive to stimuli' were considered to be medically significant by Physician within Seqirus' Pharmacovigilance and Risk Management Department.  Company comment: A 71-year-old, male patient was vaccinated with Fluad Quadrivalent. Fourteen hours following vaccination, the patient felt nauseated and passed out. Reportedly, the patient was unresponsive for one minute and reported headache as well. The patient did not have a medical history, he was healthy, having a heart rate of 60 bpm and a normal blood pressure. Causal role of the suspect vaccine is assessed as possibly related, with the currently available information and plausible temporal relationship.; Sender's Comments: A 71-year-old, male patient was vaccinated with Fluad Quadrivalent. Fourteen hours following vaccination, the patient felt nauseated and passed out. Reportedly, the patient was unresponsive for one minute and reported headache as well. The patient did not have a medical history, he was healthy, having a heart rate of 60 bpm and a normal blood pressure. Causal role of the suspect vaccine is assessed as possibly related, with the currently available information and plausible temporal relationship.
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Cough, Influenza, Nasal congestion, Oropharyngeal pain, SARS-CoV-2 test negative
Clinical narrative: Caught the flu; Nasal congestion; Sore throat; Coughing; This spontaneous case was received on 04-Nov-2022 from other non-healthcare professional (consumer) via Agency (reference number: SEQW22-05445) and concerned a 63-year-old, female patient.  The patient had no relevant medical history and was not taking any concomitant medications. The patient described herself as healthy and added she was not immunocompromised in any way.  On 17-Oct-2022, the patient was vaccinated with Afluria Quadrivalent (influenza vaccine inact split 4v dose: 0.5 ml, route of administration and anatomical location: not reported) for active immunization against influenza disease caused by influenza virus subtypes A and B present in the vaccine. The batch number was not reported.  On an unspecified date in 2022, an unknown amount of time after receiving Afluria Quadrivalent, the patient claimed to have caught the flu. The patient stated her husband and a neighbour (reported as 'neighbor') had it and that she must have caught it from them. The patient reported sore throat, coughing and nasal congestion and knew for a fact that was it not Covid 19 considering her test came out negative.  The outcome of the events was not reported.   The reporter did not provide causality assessment.  The event of 'flu' was considered to be medically significant by Physician within Seqirus' Pharmacovigilance and Risk Management Department.  Company comment: A 63-year-old, female patient was vaccinated with Afluria Quadrivalent. An unknown amount of time following vaccination, the patient caught the flu. Reportedly the patient developed sore throat, coughing and nasal congestion. As reported, Covid 19 test came out negative. The patient had no relevant medical history and was not taking any concomitant medications. Information regarding the additional diagnostic findings was not provided. Causal role of the suspect vaccine is unassessable, with the currently available information and unclear temporal relationship.; Sender's Comments: A 63-year-old, female patient was vaccinated with Afluria Quadrivalent. An unknown amount of time following vaccination, the patient caught the flu. Reportedly the patient developed sore throat, coughing and nasal congestion. As reported, Covid 19 test came out negative. The patient had no relevant medical history and was not taking any concomitant medications. Information regarding the additional diagnostic findings was not provided. Causal role of the suspect vaccine is unassessable, with the currently available information and unclear temporal relationship.
Sex: F
Vaccine: FLUC3
Symptoms: Influenza
Clinical narrative: Confirmed with a case of Flu A; This spontaneous case was received on 04-Nov-2022 from other non-healthcare professional (patient's father) via Communications (reference number: SEQW22-05437) and concerned a female patient of unreported age.  The patient's medical history and concomitant medications were not reported.  On an unspecified date in Sep-2022, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine inact sag 4v; dose: 0.5 ml; route of administration, and anatomical location: not reported) for prevention of influenza disease caused by influenza virus subtypes A and B. The batch number reported was 348368 and the expiry date was 30-Jun-2023.  On 01-Nov-2022, an unknown amount of time after receiving Flucelvax Quadrivalent, the patient was confirmed with a case of flu A.  The outcome of the event 'influenza A virus infection' was not reported.   The event of 'influenza A virus infection' was considered medically significant by a Physician within Seqirus's Pharmacovigilance and Risk Management Department.  Company comment: A female patient of unreported age was vaccinated with the suspect product Flucelvax Quadrivalent in on an unknown date in September. On 01-Nov-2022 of the same year the patient developed as reported confirmed flu type A. Information regarding the underlying medical history, related diagnostic findings and concomitant medications has not been provided. Based on plausible temporal relationship, causality for the reported event is assessed as possibly related.; Sender's Comments: A female patient of unreported age was vaccinated with the suspect product Flucelvax Quadrivalent in on an unknown date in September. On 01-Nov-2022 of the same year the patient developed as reported confirmed flu type A. Information regarding the underlying medical history, related diagnostic findings and concomitant medications has not been provided. Based on plausible temporal relationship, causality for the reported event is assessed as possibly related.
Age: 1.83
Sex: F
Vaccine: PNC13, UNK
Symptoms: Adrenal haemorrhage, Autopsy, Cyanosis, Death, Decreased appetite
Clinical narrative: -low grade fever the same evening / 7h  after vaccination -vomiting in the morning -high fever (40degC/104degF) next day 23h after vaccination, tachycardia, tachypnea, sleepiness, no appetite -pediatrician was called, parents were told that this might be normal the day after immunization and that there is no need for an appointment and check up -episode of centralization, cold and blue hands and lips in the evening -parents went to hospital to check oxygenation  -in hospital, centralization was resolved, parents were told that centralization happens sometimes with high fevers, O2 (finger) was 98%, child was 'warm' and tachycard. Parents decided to take child home in accordance with nurse and give antipyretic suppository -child died at 2 p.m.the next day, reanimation was unsuccessful -autopsy showed bacterial meningitis and septicamia, haemophilus influenza serotype A (HIA), bilateral adrenal haemorrhage
Age: 1.83
Sex: F
Vaccine: PNC13, UNK
Symptoms: Haemophilus infection, Haemophilus test positive, Meningitis bacterial, Peripheral coldness, Pyrexia
Clinical narrative: -low grade fever the same evening / 7h  after vaccination -vomiting in the morning -high fever (40degC/104degF) next day 23h after vaccination, tachycardia, tachypnea, sleepiness, no appetite -pediatrician was called, parents were told that this might be normal the day after immunization and that there is no need for an appointment and check up -episode of centralization, cold and blue hands and lips in the evening -parents went to hospital to check oxygenation  -in hospital, centralization was resolved, parents were told that centralization happens sometimes with high fevers, O2 (finger) was 98%, child was 'warm' and tachycard. Parents decided to take child home in accordance with nurse and give antipyretic suppository -child died at 2 p.m.the next day, reanimation was unsuccessful -autopsy showed bacterial meningitis and septicamia, haemophilus influenza serotype A (HIA), bilateral adrenal haemorrhage
Age: 1.83
Sex: F
Vaccine: PNC13, UNK
Symptoms: Sepsis, Skin warm, Somnolence, Tachycardia, Tachypnoea
Clinical narrative: -low grade fever the same evening / 7h  after vaccination -vomiting in the morning -high fever (40degC/104degF) next day 23h after vaccination, tachycardia, tachypnea, sleepiness, no appetite -pediatrician was called, parents were told that this might be normal the day after immunization and that there is no need for an appointment and check up -episode of centralization, cold and blue hands and lips in the evening -parents went to hospital to check oxygenation  -in hospital, centralization was resolved, parents were told that centralization happens sometimes with high fevers, O2 (finger) was 98%, child was 'warm' and tachycard. Parents decided to take child home in accordance with nurse and give antipyretic suppository -child died at 2 p.m.the next day, reanimation was unsuccessful -autopsy showed bacterial meningitis and septicamia, haemophilus influenza serotype A (HIA), bilateral adrenal haemorrhage