chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19-2
Symptoms: Abdominal pain upper, Chills, Dizziness, Fatigue, Headache
Clinical narrative: feeling faint and stomach pains after COVID booster; Chills; hot flashes; dizziness/feeling faint after COVID booster; headache; fatigue; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative. 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 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, Manufacturer: Unknown), for COVID-19 immunization. The following information was reported: ABDOMINAL PAIN UPPER (non-serious), outcome "unknown", described as "feeling faint and stomach pains after COVID booster"; CHILLS (non-serious), outcome "unknown"; HOT FLUSH (non-serious), outcome "unknown", described as "hot flashes"; DIZZINESS (non-serious), outcome "unknown", described as "dizziness/feeling faint after COVID booster"; HEADACHE (non-serious), outcome "unknown"; FATIGUE (non-serious), outcome "unknown".  Additional information: Event took place after use of product.  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: COVID19-2
Symptoms: Hot flush
Clinical narrative: feeling faint and stomach pains after COVID booster; Chills; hot flashes; dizziness/feeling faint after COVID booster; headache; fatigue; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative. 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 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, Manufacturer: Unknown), for COVID-19 immunization. The following information was reported: ABDOMINAL PAIN UPPER (non-serious), outcome "unknown", described as "feeling faint and stomach pains after COVID booster"; CHILLS (non-serious), outcome "unknown"; HOT FLUSH (non-serious), outcome "unknown", described as "hot flashes"; DIZZINESS (non-serious), outcome "unknown", described as "dizziness/feeling faint after COVID booster"; HEADACHE (non-serious), outcome "unknown"; FATIGUE (non-serious), outcome "unknown".  Additional information: Event took place after use of product.  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: Death, SARS-CoV-2 test
Clinical narrative: However her life ended on 19Oct2022 after getting your vaccines; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  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 included: "COVID-19" (unspecified if ongoing), notes: suffered complications. The patient's concomitant medications were not reported. The following information was reported: DEATH (death, medically significant) with onset 19Oct2022, outcome "fatal", described as "However her life ended on 19Oct2022 after getting your vaccines". Patient had COVID 19 in it before the vaccines and suffered complications however her life ended on 19Oct2022 after getting vaccines, her way of living was not at 100% due to complications was very thankful for your research and the ability that your vaccines her family was in better hands then her COVID. After so much health problems shes in peace withheld. She passed away on Monday unexpectedly from one day to another you could be gone. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown result. The patient date of death was 19Oct2022. The reported cause of death was unknown. It was not reported if an autopsy was performed.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Reported Cause(s) of Death: However her life ended on 19Oct2022 after getting your vaccines
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain
Clinical narrative: aches; headache; tired; This is a spontaneous report received from a 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), in 2022 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; Manufacturer unknown), for COVID-19 Immunization. The following information was reported: PAIN (non-serious) with onset 2022, 1 day after the suspect product(s) administration, outcome "unknown", described as "aches"; HEADACHE (non-serious) with onset 2022, 1 day after the suspect product(s) administration, outcome "unknown"; FATIGUE (non-serious) with onset 2022, 1 day after the suspect product(s) administration, outcome "unknown", described as "tired".  Additional information: The patient received COVID bivalent booster. The patient have aches, tired and headache on next day. The event took place after use of the product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Positive COVID-19 test; Positive COVID-19 test; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 52-year-old male patient received BNT162b2 (BNT162B2), on 25May2021 as dose 1, single (Batch/Lot number: unknown), on 14Jun2021 as dose 2, single (Batch/Lot number: unknown), on 04Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) and on 28Mar2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Refractory Multiple Myeloma" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant) with onset 18Jul2022, outcome "unknown", COVID-19 (medically significant) with onset 18Jul2022, outcome "recovered" (23Jul2022) and all described as "Positive COVID-19 test".  It was reported that the patient tested positive for COVID-19 on 18Jul2022 and started Paxlovid x5 days from 18Jul2022. On 22Jul2022, patient had chief complaint of fever and SOB, and intermittent coughing and was admitted on 23Jul2022. Viral/post-viral (COVID) bronchitis suspected - grade 3 (Pulmonary consult was obtained and COVID-19 related bronchitis was suspected). No evidence of bacterial PNA or other bacterial infection was found. Pt continued to improve clinically. COVID-19 test on 23Jul2022 negative. Patient with bronchitis related to covid-19 was given IV antibiotic cefepime and discharged on 25Jul2022 and was on augmentin x5 days. Patient was discharged home on 25Jul2022. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (18Jul2022) positive; (23Jul2022) Negative. Therapeutic measures were taken as a result of covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the available information, and considering the safety profile, there is a reasonable possibility of a  contributory role between the reported adverse events and the suspect  product BNT162b2 (BNT162B2).
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Inappropriate schedule of product administration, Pain
Clinical narrative: 2nd Pfizer Covid 19 shot she had not a headache but achy and tired; 2nd Pfizer Covid 19 shot she had not a headache but achy and tired; dose 1: 28Feb2021, lot EL3248/dose 2: 08Mar2021, lot EL3302; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73-year-old female patient received BNT162b2 (BNT162B2), on 08Mar2021 as dose 2, single (Lot number: EL3302) at the age of 72 years for covid-19 immunisation. The patient's relevant medical history included: "she does have compromised immunity" (unspecified if ongoing), notes: she does have compromised immunity; "contrast dye" (unspecified if ongoing); "procedure with contrast dye" (unspecified if ongoing). Concomitant medication(s) included: HYDROXYCHLOROQUINE taken for immunosuppressant drug therapy. Past drug history included: Vancomycin, reaction(s): "Allergies: Vancomycin", notes: she is allergic to one or two antibiotics, Vancomycin and Levaquin; Levaquin, reaction(s): "Allergies: Levaquin", notes: she is allergic to one or two antibiotics, Vancomycin and Levaquin; Benadryl for burning sensation. Vaccination history included: BNT162b2 (Pfizer Covid-19 vaccines: dose #1 on 28Feb2021. lot EL3248 and expiry Apr2021), administration date: 28Feb2021, when the patient was 72-year-old, for COVID-19 immunization, reaction(s): "1st had no problem". The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 08Mar2021, outcome "unknown", described as "dose 1: 28Feb2021, lot EL3248/dose 2: 08Mar2021, lot EL3302"; PAIN (non-serious), FATIGUE (non-serious), outcome "unknown" and all described as "2nd Pfizer Covid 19 shot she had not a headache but achy and tired".  Additional Information: Reporter is a doctor but not medical. Patient did not had Prior Vaccinations (within 4 weeks). AE(s) following prior vaccinations: no, she had never had fever but with she thinks the 1st had no problem and the 2nd Pfizer Covid 19 shot she had not a headache but achy and tired. Patient's Medical History (including any illness at time of vaccination) was None. she does have compromised immunity and she takes low dose of immune suppressant Hydrochlorquine. Captured as stated. Spelling not confirmed. States she is allergic to one or two antibiotics, Vancomycin and Levaquin and allergic to contrast dye. She didn't have anaphylactic. She just felt a burning sensation and since then had a procedure with contrast dye and they gave her Benadryl and she seemed fine. The reporter does not have Manufacturer, dose, NDC, lot or expiry to provide for these products. Family Medical History Relevant to AE(s) was none. Relevant tests were None. Patient received booster #1 on 21Sep2021. It was reported that patient could not read the first digit of lot because of the fold it's either 3 or 8 and 01308A and booster #2 received on 11Apr2022 , lot FJ4991.
Sex: U
Vaccine: COVID19-2
Symptoms: Arthralgia, Body temperature, Chills, Headache, Pain
Clinical narrative: chills; Joint aches (specifically my hands/fingers); body aches; headache the first half of the morning; minor pain at the injection site; fever of 100.5F. This was its highest later in the day at 101.5F.; This is a spontaneous report received from a 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 25Oct2022 at 12:30 as dose number unknown (booster), single (Lot number: GJ6742, Expiration Date: 31Jul2023) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Series of primary immunization completed. Unknown manufacturer), for Covid-19 immunization. The following information was reported: PYREXIA (non-serious) with onset 26Oct2022, outcome "recovering", described as "fever of 100.5F. This was its highest later in the day at 101.5F."; CHILLS (non-serious), outcome "unknown"; ARTHRALGIA (non-serious), outcome "unknown", described as "Joint aches (specifically my hands/fingers)"; PAIN (non-serious), outcome "unknown", described as "body aches"; HEADACHE (non-serious), outcome "unknown", described as "headache the first half of the morning"; VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "minor pain at the injection site". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pyrexia.  Additional information: The fever was accompanied by chills, joint aches (specifically my hands/fingers), and body aches. Patient had a headache the first half of the morning. Patient also had minor pain at the injection site. For the fever patient took Tylenol every 5-6 hours. The fever seemed to subside by late evening around 10-11pm.
Sex: U
Vaccine: COVID19-2
Symptoms: Pyrexia, Vaccination site pain
Clinical narrative: chills; Joint aches (specifically my hands/fingers); body aches; headache the first half of the morning; minor pain at the injection site; fever of 100.5F. This was its highest later in the day at 101.5F.; This is a spontaneous report received from a 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 25Oct2022 at 12:30 as dose number unknown (booster), single (Lot number: GJ6742, Expiration Date: 31Jul2023) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Series of primary immunization completed. Unknown manufacturer), for Covid-19 immunization. The following information was reported: PYREXIA (non-serious) with onset 26Oct2022, outcome "recovering", described as "fever of 100.5F. This was its highest later in the day at 101.5F."; CHILLS (non-serious), outcome "unknown"; ARTHRALGIA (non-serious), outcome "unknown", described as "Joint aches (specifically my hands/fingers)"; PAIN (non-serious), outcome "unknown", described as "body aches"; HEADACHE (non-serious), outcome "unknown", described as "headache the first half of the morning"; VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "minor pain at the injection site". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pyrexia.  Additional information: The fever was accompanied by chills, joint aches (specifically my hands/fingers), and body aches. Patient had a headache the first half of the morning. Patient also had minor pain at the injection site. For the fever patient took Tylenol every 5-6 hours. The fever seemed to subside by late evening around 10-11pm.
Sex: M
Vaccine: COVID19-2
Symptoms: Fatigue, Heart rate, Heart rate increased
Clinical narrative: elevated ongoing heart rate; fatigue; This is a spontaneous report received from contactable reporter(s) (Physician) from a sales representative. The reporter is the patient.  A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 24Oct2022 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 (Series of primary immunization completed. Unknown manufacturer), for Covid-19 immunization. The following information was reported: HEART RATE INCREASED (non-serious), outcome "unknown", described as "elevated ongoing heart rate"; FATIGUE (non-serious), outcome "unknown". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Description of Event: Report of elevated ongoing heart rate and fatigue. Took vaccine two days ago.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202200091592 same drug/ae/reporter, different patient;
Sex: U
Vaccine: COVID19
Symptoms: Illness, Pain
Clinical narrative: I became seiously Ill; pain and hurt; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID: (005498). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 2, 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. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "I became seiously Ill"; PAIN (non-serious), outcome "unknown", described as "pain and hurt".  Additional information: Patient became seriously III after my second shot. I haven't caught Covid and it has given me nothing good except pain and hurt.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: FLUR4
Symptoms: Inappropriate schedule of product administration
Clinical narrative: getting a second influenza vaccine this season as it was being offered, despite having gotten an influenza vaccine approximately one month ago, with no reported adverse event; Initial information received  on 18-Oct-2022 regarding an unsolicited valid non-serious case received from a physician.  This case involves an unknown age male patient who was getting a second INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] vaccine this season as it was being offered, despite having gotten an influenza vaccine approximately one month ago, with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 18-Oct-2022, the patient received suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (strength, formulation, dose; unknown) (lot number and expiry date: not reported) via intramuscular route in unknown administration site for Prophylactic vaccination (Immunisation).  On an unknown date, a non-serious event reported, patient was getting a second influenza vaccine this season as it was being offered, despite having gotten an influenza vaccine approximately one month ago, with no reported adverse event (inappropriate schedule of product administration) (unknown latency).  It was unknown if the patient experienced any additional symptoms/events. There were no lab data/results available.  Action taken with QUADRIVALENT RECOMBINANT INFLUENZA VACCINE (FLUBLOK QIV) 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.
Age: 56.0
Sex: M
Vaccine: FLUX
Symptoms: Chills, Eye movement disorder, Feeling abnormal, Sleep disorder
Clinical narrative: daze; chills; could not sleep; eyeballs did not work; Initial information received on 21-Oct-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case involves a 56 years old male patient who was having daze, chills, could not sleep and eyeballs did not work while receiving vaccine INFLUENZA VACCINE.  The patient's past medical treatment(s), vaccination(s) and family history were not provided. It was unknown if the patient had any medical history, concomitant disease or risk factor.   On an unknown date, the patient received an unknown dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (formulation, strength, route: unknown) lot number not reported in unknown administration site as prophylactic vaccination.  On an unknown date the patient developed a non-serious events daze (feeling abnormal), chills the patient went to bed early but could not sleep (sleep disorder) eyeballs did not work (eye disorder) (unknown latency) following the administration of INFLUENZA VACCINE.  It was unknown if there were lab data/results available. It was unknown if the company suspect product inappropriately used as per local Marketing authorization.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the events (daze, chills, could not sleep, eyeballs did not work).  At time of reporting, the outcome was Unknown for all.
Age: 5.0
Sex: F
Vaccine: IPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired Ipol was administered with no reported adverse event; Initial information received on 17-Oct-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 5 years old female patient to whom expired IPV (VERO) [IPOL] was administered 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 23-Sep-2022, the patient received 0.5ml dose of suspect IPV (VERO) (strength was unknown, lot T1D482M and expiry date: 25-Jul-2022) via intramuscular route in the right deltoid for Immunization.  On 23-Sep-2022 the patient developed a non-serious event of expired ipol was administered with no reported adverse event (expired product administered) (Latency: same day) following the administration of IPV (VERO).  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: 1.0
Sex: F
Vaccine: HIBV
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: expired dose of acthib was administered with no reported adverse event; Initial information received on 17-Oct-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 1 years old female patient to whom experienced expired dose of acthib was administered with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included MEASLES VACCINE LIVE (ENDERS-EDMONSTON), MUMPS VACCINE LIVE (JERYL LYNN), RUBELLA VACCINE LIVE (WISTAR RA 27/3), VARICELLA ZOSTER VACCINE LIVE (OKA/MERCK) (PROQUAD) for Immunisation; HEPATITIS A VACCINE (HEPATITIS A) for Immunisation; and VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) for Immunisation.  On 17-Oct-2022, the patient received 0.5 ml of suspect HIB (PRP/T) VACCINE (lot UJ583AB and expiry-15-10-22) (strength and formulation: unknown) via intramuscular route in the left thigh for immunization.  On 17-OCT-2022 the patient developed a non-serious expired dose of acthib was administered with no reported adverse event (expired product administered) (latency same day).   Action taken with HAEMOPHILUS TYPE B (HIB) VACCINE (ACT-HIB) was not applicable.  At time of reporting, the outcome was Unknown for the event expired dose of acthib was administered with no reported adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 7.0
Sex: F
Vaccine: HIBV, UNK
Symptoms: Injection site erythema, Injection site pain, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Left arm is red and sore near injection site (3 inches round); Left arm is red and sore near injection site (3 inches round); 7 year old being administered PENTACEL; She states that the hib was expired so they decided to give her PENTACEL since it has hib in it; Initial information was received on 18-Oct-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case involves a 7 years old female patient to whom pentacel being administered, she states that the hib was expired so they decided to give her pentacel since it has hib in it and left arm is red and sore near injection site (3 inches round) while receiving vaccines HIB (PRP/T) VACCINE and DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)].  The patient's past vaccination(s) included pentacel with patient had already received 4 doses of vaccine. The patient's past medical history, medical treatment(s) and family history were not provided.   On 17-Oct-2022, the patient received a dose 5th dose of 0.5 ml suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE (lot number not reported) (formulation, strength and expiry;unknown) instead of hib was expired so they decided to give her pentacel (wrong product administered) (latency same day) via unknown route in the left arm for immunization.   On 17-OCT-2022 the patient developed a non-serious 7 year old being administered pentacel (product administered to patient of inappropriate age) (latency same day)  On an unknown date the patient developed a non-serious left arm is red and sore near injection site (3 inches round) (injection site erythema and injection site pain) (unknown latency)   Action taken:not applicable.  Corrective: unknown for (injection site erythema and injection site pain)   Outcome- unknown for all 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.
Sex: U
Vaccine: FLU4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: patient received a FLUZONE HIGH-DOSE QUADRIVALENT VACCINE twice within a one-month period with no reported adverse event; Initial information received on 18-Oct-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves an unknown age/gender patient who experienced patient received a fluzone high-dose quadrivalent vaccine twice within a one-month period with no reported adverse event 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.    On 16-Sep-2022, the patient received a  dose 1 of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE lot number not reported via unknown route in unknown administration site. On 17-Oct-2022 also received a  dose 2 of the same vaccine with an (strength, dose, formulation route,batch number: unknown)  in unknown administration site for immunization.  On 17-OCT-2022 the patient reported a non-serious event patient received a fluzone high-dose quadrivalent vaccine twice within a one-month period with no reported adverse event (inappropriate schedule of product administration) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  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.
Sex: U
Vaccine: FLU4
Symptoms: Expired product administered, No adverse event
Clinical narrative: after giving the first dose it was noticed that we used an expired vial with no reported adverse event; Initial information received on 18-Oct-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a patient of an unknown age and gender patient and it was reported that "after giving the first dose it was noticed that we used an expired vial with no reported adverse event " and it involved vaccine INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [FLUZONE QUADRIVALENT MULTIDOSE].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 17-Oct-2022, the patient received a  dose of suspect INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED , (lot number: not reported  ; expiry date: 30-Jun-2021) via unknown route in unknown administration site for immunization.  It was reported by healthcare provider and their site was administering flu vaccines on 17-Oct-2022, after giving the first dose it was noticed that we used an expired vial with no reported adverse event (expired product administered) (latency: same day)  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: 32.0
Sex: F
Vaccine: TD
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: she pulled TENIVAC out of the refrigerator and accidentally gave a patient, TENIVAC today, 20-Oct-2022 that expired on 07-Oct-2022 with no reported adverse event; Initial information received on 20-Oct-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 32 years old female patient who experienced she pulled tenivac out of the refrigerator and accidentally gave a patient, tenivac today, 20-oct-2022 that expired on 07-oct-2022 with no reported adverse event while receiving vaccine DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) for Immunisation; HEPATITIS B VACCINE (HEPATITIS B VACCINE) for Immunisation; VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) for Immunisation; and INFLUENZA VACCINE (INFLUENZA VACCINE) for Immunisation.  On 20-Oct-2022, the patient received 0.5 ml of suspect DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT (lot U6852AA expiry date-07-Oct-2022) (expired product administered, latency same day) (formulation and strength: unknown) via intramuscular route in the right deltoid for prophylaxis vaccination.   Action taken with DIPHTHERIA AND TETANUS TOXOIDS (TENIVAC) was 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.
Age: 8.0
Sex: M
Vaccine: TDAP
Symptoms: Inappropriate schedule of product administration, Medication error, Pain in extremity, Poor quality product administered
Clinical narrative: sore arm post injection; ADACEL looks yellowish brown in the syringe; two dose of ADACEL vaccines within 3 months; Initial information  was received on 20-Oct-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case involves a 8 years old male patient who experienced adacel looks yellowish brown in the syringe, two dose of adacel vaccines within 3 months and sore arm post injection while 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 an unknown date, the patient received a 1 dose  dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (dose, formulation, strength, lot and expiry date: unknown) via unknown route in unknown administration site for prophylaxis vaccination.  On 14-Oct-2022, the patient received 2nd dose (lot-C5788CA)  unknown route in the left arm.  On 14-OCT-2022 the patient developed a non-serious adacel looks yellowish brown in the syringe (Poor quality product administered) and two dose of adacel vaccines within 3 months (inappropriate schedule of product administration) (latency same day) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE.  On an unknown date the patient developed a non-serious sore arm post injection (pain in extremity) (unknown latency) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE.  It was reported that "ADACEL can be administered the day of the expiration date listed on the bottle, if the ADACEL looks yellowish brown in the syringe if it was safe to administer, and if it was okay for her previously unvaccinated son to receive two ADACEL vaccines with in 3 months.The patient had received his initial ADACEL vaccine 3 months prior and the mother was advised by an alternate pediatrician that he should have received the 'TD' instead of the ADACEL moving forward".  Action taken with DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE (ADACEL) was not applicable.  Corrective- Unknown for pain in extremity  At time of reporting, the outcome was Unknown for all 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: 12.0
Sex: F
Vaccine: FLU4
Symptoms: Expired product administered
Clinical narrative: received the expired fluzone dose with no reported adverse event; Initial information received on 21-Oct-2022 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 12 years old female patient to whom expired fluzone dose with no reported adverse event while receiving vaccine influenza quadrival A-B vaccine [Fluzone Quadrivalent].  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.  On 20-Oct-2022, the patient received suspect INFLUENZA QUADRIVAL A-B VACCINE at a dose of 0.5 ml (lot UJ776AA, expiry date: 30-Jun-2022) via intramuscular route in the left deltoid for immunization.  On 20-Oct-2022 the patient developed a non-serious received the expired fluzone dose with no reported adverse event (expired product administered) (same day latency) following the administration of INFLUENZA QUADRIVAL A-B 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.
Age: 45.0
Sex: M
Vaccine: FLUX
Symptoms: Fatigue, Nausea, Pyrexia
Clinical narrative: Tired; Nauseated/feeling some nauseas; Fever of 102; This spontaneous case from the United States was received on 12-Oct-2022 from other non-healthcare professional (consumer) via Communications (reference number: SEQW22-04395) and concerned a 45-year-old, male patient.  The patient's had no relevant medical history and was not taking concomitant medications.   On 11-Oct-2022, the patient was vaccinated with influenza vaccine (brand not specified; dose, route of administration, anatomical location, and indication: not reported). The batch number was not reported.  On the same date, in the evening after receiving influenza vaccine, the patient was nauseated/feeling some nausea and was tired. The patient woke up that evening with a fever of 102. The patient took Motrin (ibuprofen) to alleviate the symptoms.   At the time of initial reporting on 12-Oct-2022, the patient had not recovered from the events.   The reporter did not provide a causality assessment.  The case was assessed as non-serious.  Company comment: A 45-year-old patient was administered with influenza vaccine. On the same date, in the evening after receiving influenza vaccine, the patient developed nausea, fever and fatigue. The patient took Motrin (ibuprofen) to alleviate the symptoms. At the time of initial reporting on 12-Oct-2022, the patient had not recovered from the events. Causal role of the suspect vaccine is assessed as possibly related, due to plausible chronology and no alternative aetiology provided.; Sender's Comments: A 45-year-old patient was administered with influenza vaccine. On the same date, in the evening after receiving influenza vaccine, the patient developed nausea, fever and fatigue. The patient took Motrin (ibuprofen) to alleviate the symptoms. At the time of initial reporting on 12-Oct-2022, the patient had not recovered from the events. Causal role of the suspect vaccine is assessed as possibly related, due to plausible chronology and no alternative aetiology provided.
Age: 72.0
Sex: M
Vaccine: FLUC3
Symptoms: Tinnitus
Clinical narrative: Ringing on the ear; This spontaneous case was received on 13-Oct-2022 from other non-healthcare professional (consumer) via Communications (reference number: SEQW22-04476) and concerned a 72-year-old, male patient.  The patient's concurrent conditions included heart bypass. Concomitant medications included clopidogrel, metoprolol, vitamin B3 and pantoprazol, all used for an unreported indication.  On 13-Oct-2022, in the morning, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine, subunit influenza virus vaccine polyvalent; dose: 0.5 ml, indication, route of administration and anatomical location: not reported). The batch number was not reported.  On the same day, after receiving Flucelvax Quadrivalent, the patient experienced ringing in the ears.  On 13-Oct-2022, the patient recovered from the event.   The reporter did not provide a causality assessment. However, the reporter was wondering is ringing in ears a rare side effect of the Flucelvax.  This case was assessed as non-serious.  Company comment: A 72-year-old, male patient was vaccinated with the suspect product Flucelvax Quadrivalent. On the same day after vaccination the patient developed tinnitus. Information regarding the related diagnostic findings was not provided. Based on plausible time relationship, causality is assessed as possibly related.; Reporter's Comments: The reporter did not provide a causality assessment. However, the reporter was wondering is ringing in ears a rare side effect of the Flucelvax.; Sender's Comments: A 72-year-old, male patient was vaccinated with the suspect product Flucelvax Quadrivalent. On the same day after vaccination the patient developed tinnitus. Information regarding the related diagnostic findings was not provided. Based on plausible time relationship, causality is assessed as possibly related.
Sex: M
Vaccine: COVID19, FLUC3
Symptoms: Dry mouth, Nasopharyngeal swab, Oropharyngeal pain
Clinical narrative: Sore throat; Dry mouth; This spontaneous case from the Regulatory Authority was received on 12-Oct-2022 from a physician via Pfizer (reference number: 202201191501), with additional information received via Med Communications on 13-Oct-2022 (reference number: SEQW22-04455) and on 17-Oct-2022 (reference number: SEQW22-04582) and retrieved on 14-Oct-2022 from Vaccine Adverse Event Reporting System (VAERS) (reference number: 2465271-1) (being processed together), and concerned an adult male patient of an unspecified age.  The patient's medical history and concomitant medications were not reported. The patient's historical vaccine included three doses of Covid-19 vaccine (brand not specified), two doses received on an unspecified date and  third dose (booster) received on an unspecified date in Oct-2021, all used for Covid-19 immunisation.  On 23-Sep-2022, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine inact sag 4v; dose: 0.5 ml; anatomical location: deltoid; route of administration: not reported) for immunisation and prevention of Influenza disease. The batch number was not reported. The patient has not experienced COVID prior to the vaccination.  On the same date, the patient was vaccinated with non-company co-suspect Pfizer-BioNTech COVID-19 Vaccine (tozinameran; dose: reported as '4 (booster)'; route of administration: intramuscular; anatomical location and indication: not reported). The batch number was not reported.  On 24-Sep-2022, 24 hours after receiving Flucelvax Quadrivalent and co-suspect Pfizer-BioNTech COVID-19 Vaccine, the patient experienced persistent and severe sore throat associated with dry mouth. No fever or exudates. The patient was taking ibuprofen with minimal relief.  On an unspecified date in 2022, the patient underwent COVID-19 antigen test two times and nasal swab, and the results were negative.  On an unspecified date in Sep-2022, the patient recovered from the events. As reported, they lasted about six days and resolved.  The reporter did not provide a causality assessment.  The case was assessed as non-serious.  Company comment: A patient of unreported age experienced oropharyngeal pain and dry mouth one day after receiving the suspect product Flucelvax Quadrivalent and co-suspect Pfizer-BioNTech COVID-19 Vaccine. Despite confounding by co-suspect vaccine, causal role of the suspect product cannot be excluded. Therefore, causality for the reported events is assessed as possibly related due to plausible temporal relationship.; Sender's Comments: A patient of unreported age experienced oropharyngeal pain and dry mouth one day after receiving the suspect product Flucelvax Quadrivalent and co-suspect Pfizer-BioNTech COVID-19 Vaccine. Despite confounding by co-suspect vaccine, causal role of the suspect product cannot be excluded. Therefore, causality for the reported events is assessed as possibly related due to plausible temporal relationship.
Age: 38.0
Sex: F
Vaccine: FLUC4
Symptoms: Dizziness, Immediate post-injection reaction, Injection site bruising, Injection site haemorrhage, Injection site induration
Clinical narrative: Immediately following injection, injection site began bruising/bleeding and swelling with significant pain to the area. About a tennis sized area of swelling with a quarter sized induration on top of that. Experienced hives and dizziness. Joint has since become stiff with large dark bruise but hives and dizziness resolved.
Age: 38.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site pain, Injection site swelling, Joint stiffness, Urticaria
Clinical narrative: Immediately following injection, injection site began bruising/bleeding and swelling with significant pain to the area. About a tennis sized area of swelling with a quarter sized induration on top of that. Experienced hives and dizziness. Joint has since become stiff with large dark bruise but hives and dizziness resolved.
Age: 40.0
Sex: M
Vaccine: COVID19-2
Symptoms: Tinnitus
Clinical narrative: Ear ringing-  tinnitus
Age: 34.0
Sex: M
Vaccine: COVID19-2
Symptoms: Chest pain, Chills, Decreased activity, Decreased appetite, Fatigue
Clinical narrative: Injection site pain within 5 minutes. Minor pain grew to bothersome soreness within an hour prompting the first Tylenol which dulled the pain. Around 12 hours later pain returned at bed time and a second Tylenol was taken. However that night had chills, sweats, and extreme shivering/tremors in jaw and in abdominal muscles. The muscles were left painfully sore that night due to the contractions.  Sweating and extreme fatigue for two days. Fatigue tapering off over two days after that as activity level grew to normal along with normalizing food intake. Chest pain a persisting symptom that takes longer to dull but seemingly everything back to normal after a week.  However chest pain, sweats and minor fatigue returning unexpectedly in the middle of the night a full week later as this report is being typed.
Age: 34.0
Sex: M
Vaccine: COVID19-2
Symptoms: Hyperhidrosis, Immediate post-injection reaction, Injection site pain, Muscle contractions involuntary, Myalgia
Clinical narrative: Injection site pain within 5 minutes. Minor pain grew to bothersome soreness within an hour prompting the first Tylenol which dulled the pain. Around 12 hours later pain returned at bed time and a second Tylenol was taken. However that night had chills, sweats, and extreme shivering/tremors in jaw and in abdominal muscles. The muscles were left painfully sore that night due to the contractions.  Sweating and extreme fatigue for two days. Fatigue tapering off over two days after that as activity level grew to normal along with normalizing food intake. Chest pain a persisting symptom that takes longer to dull but seemingly everything back to normal after a week.  However chest pain, sweats and minor fatigue returning unexpectedly in the middle of the night a full week later as this report is being typed.