chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Chest X-ray, Drug ineffective, Investigation, SARS-CoV-2 test
Clinical narrative: tested positive for SARS-CoV-2 by reverse transcriptase polymerase; COVID-19; This is a literature report for the following literature source(s):  A 68-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3, (booster dose) single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "decompensated hepatitis C cirrhosis" (unspecified if ongoing); "hepatitis C" (unspecified if ongoing); "hepatocellular carcinoma" (unspecified if ongoing), notes: native MELD score 7; "hepatopulmonary syndrome" (unspecified if ongoing); "refractory hepatic hydrothorax" (unspecified if ongoing); "sarcopenia" (unspecified if ongoing); "frailty" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (hospitalization, medically significant), outcome "unknown", described as "tested positive for SARS-CoV-2 by reverse transcriptase polymerase"; COVID-19 (hospitalization, medically significant), outcome "unknown". The patient underwent the following laboratory tests and procedures: Chest X-ray: demonstrated chronic bilateral pleural effusions, notes: no other abnormalities; Model for End-Stage Liver Disease (MELD) score: 7; SARS-CoV-2 test: positive, notes: preoperative evaluation; Negative, notes: 1 week prior. Therapeutic measures were taken as a result of covid-19.; Sender's Comments: The efficacy of a vaccine varies individually and can be affected by different factors including product potency; however, a contributory role of BNT162B2 to the events COVID-19 and drug ineffective cannot be ruled out. Potential contributors include patient's advanced age and underlying decompensated hepatitis C, hepatic cirrhosis, hepatocellular carcinoma, hepatopulmonary syndrome and other co-morbidities.,Linked Report(s) : US-PFIZER INC-202201346497 Same Article/drug/event and different patient.;US-PFIZER INC-PV202200116532 Same Article and different patient/drug/event;
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: I got COVID after getting the vaccine and booster; I got COVID after getting the vaccine and booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, 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), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "I got COVID after getting the vaccine and booster".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: patient had COVID after taking Pfizer vaccine and booster; patient had COVID after taking Pfizer vaccine and booster; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; 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), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "patient had COVID after taking Pfizer vaccine and booster". Clinical course: A 64 (age unit unknown) male patient had COVID after taking Pfizer vaccine and booster, so the patient doesn't need any more vaccines.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy, CSF protein, Guillain-Barre syndrome, Physical examination
Clinical narrative: Post-vaccination Guillain-Barre Syndrome (GBS) and Bell's Palsy; Post-vaccination Guillain-Barre Syndrome (GBS) and Bell's Palsy; This is a literature report for the following literature source(s):   A 10-year-old boy with postvaccination Guillain-Barre Syndrome (GBS) and Bell's Palsy. A 10-year-old boy without significant past medical history presented to the emergency room (ER) with new right facial droop two weeks following his second dose of the Pfizer COVID-19 vaccine. He was diagnosed with Bell's Palsy and received a five-day course of steroids. He returned to the ER ten days later with a four-day history of bilateral lower extremity pain, weakness, and progressively worsening gait. His examination was notable for less than antigravity strength throughout the major muscle groups of both lower limbs, in which he also had impaired light touch sensation and areflexia. Setting: Pediatric unit of acute care hospital. Cerebrospinal fluid analysis was notable for elevated protein levels. In the setting of areflexia in the bilateral lower limbs, a presumptive diagnosis of GBS was made and a 5-day course of intravenous immunoglobulin (IVIg) was initiated, with improvement. At time of discharge, he was able to ambulate independently without use of an assistive device. Both GBS and Bell's palsy have been reported following vaccinations. This case is unique in that both occurred sequentially in a pediatric patient within 1 month of the second dose of the Pfizer COVID-19 vaccine. Neurological complications of the COVID-19 vaccine include both Bell's Palsy and GBS, which as in this case, may occur sequentially. Prompt initiation of IVIg, steroids, and rehabilitation may result in good recovery. Level of Evidence: Level V.; Sender's Comments: Based on the available information, the reported serious events cannot be excluded for the suspect product  BNT162B2. The impact of this report on the benefit/risk profile of the Pfizer product 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.
Sex: F
Vaccine: COVID19
Symptoms: Anxiety
Clinical narrative: she suffers from terrible anxiety/she has a terrible anxiety; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 30Nov2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Terrible anxiety" (unspecified if ongoing), notes: Past Medical History: Terrible anxiety. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer), for Covid-19 Immunization; Covid-19 vaccine (First Booster; Unknown manufacturer), for Covid-19 Immunization. The following information was reported: ANXIETY (non-serious), outcome "unknown", described as "she suffers from terrible anxiety/she has a terrible anxiety".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pyoderma gangrenosum
Clinical narrative: This is a literature report for the following literature source(s):  A 73-year-old female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "COVID-19 infection" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE), for COVID-19 immunisation. The following information was reported: PYODERMA GANGRENOSUM (medically significant), 14 days after the suspect product(s) administration, outcome "unknown". The location of lesions was left pretibial region. Therapeutic measures were taken as a result of pyoderma gangrenosum included infliximab injection, oral prednisone, cyclosporine, biweekly adalimumab injections. The clinical outcome was injection reaction to infliximab, unresponsive to all other treatments.; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the events and the use of suspect product BNT162B2 cannot be fully excluded. The impact of this report on the benefit/risk profile of the Pfizer product 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.
Sex: U
Vaccine: COVID19
Symptoms: Guillain-Barre syndrome
Clinical narrative: 2 covid vaccine shots last year of Apr ang I believed I got my GBS because of the vaccine reaction.and just this year last 18Oct2022 I had a recurrence of the illness.; 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), in Apr2021 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: Bnt162b2 (Dose:1), administration date: Apr2021, for Covid-19 immunization. The following information was reported: GUILLAIN-BARRE SYNDROME (medically significant) with onset 18Oct2022, outcome "not recovered", described as "2 covid vaccine shots last year of Apr ang I believed I got my GBS because of the vaccine reaction.and just this year last 18Oct2022 I had a recurrence of the illness.".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: my cousin died two days after getting his vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP), Program ID: (Unknown).   A male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEATH (death, medically significant), outcome "fatal", described as "my cousin died two days after getting his vaccine". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed.   Clinical Course: It reminded me of how my cousin died two days after getting his vaccine. Note: Unknown which vaccine the patient received.     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: my cousin died two days after getting his vaccine
Sex: U
Vaccine: UNK
Symptoms: Medication error, No adverse event, Vaccination error
Clinical narrative: Nurse forgot to reconstitute ipv/dtap with him in pentacel and used diligent instead with no reported adverse event; Initial information received on 30-Nov-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves Child and unknown gender patient who experienced nurse forgot to reconstitute ipv/dtap with him in pentacel and used diligent instead with no reported adverse event while receiving vaccine 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) and family history were not provided.   On 30-Nov-2022, the patient received a  dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE lot number not reported via intramuscular route in unknown administration site for Immunisation.  On 30-NOV-2022 the patient developed a non-serious nurse forgot to reconstitute ipv/dtap with him in pentacel and used diligent instead with no reported adverse event (vaccination error) (latency : same day) following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (Nurse forgot to reconstitute ipv/dtap with him in pentacel and used diligent instead with no reported adverse event).  At time of reporting, the outcome was Unknown for the event nurse forgot to reconstitute ipv/dtap with him in pentacel and used diligent instead 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 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: Influenza
Clinical narrative: Got my shot 10/20 woke up Sunday 11/20 with the worst case of flu; Initial information was received on 30-Nov-2022 regarding an unsolicited valid Social Media non-serious case received from a non-health-care professional.  This case involves an unknown age and unknown gender patient who had got my shot 10/20 woke up Sunday 11/20 with the worst case of flu 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 (strength, dose, formulation, frequency, lot number and expiry date: not reported) via unknown route in unknown administration site for Prophylactic vaccination (Immunisation).      On an unknown date the patient developed a non-serious event of got my shot 10/20 woke up sunday 11/20 with the worst case of flu (influenza) (unknown latency) following the administration of influenza vaccine.  No lab data was reported.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment.  Outcome: Unknown.
Age: 60.0
Sex: F
Vaccine: FLUX
Symptoms: Arthralgia, Asthma, Condition aggravated, Inappropriate schedule of product administration, Medication error
Clinical narrative: joint pain; asthma flare up because she did not get her medication on time; did not get her medication on time; Initial information received on 30-Nov-2022 regarding an unsolicited valid non-serious case received from a consumer.  This case involves an adult female patient who experienced joint pain, asthma flare up because she did not get her medication on time while receiving vaccine influenza vaccine and while treated with dupilumab [Dupixent] via Prefilled pen.  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 Asthma.  On 11-Nov-2022, the patient started taking Dupixent (dupilumab) solution pen-injector at a dosage of 300 mg every other week subcutaneously (strength: 150 mg/mL) (with an unknown batch number and expiry date) for Moderate persistent asthma.  On an unknown date, the patient received a dose of suspect influenza vaccine produced by unknown manufacturer (formulation, strength, dose and lot number not reported) via unknown route in unknown administration site for prophylactic immunization.  On an unknown date, the patient developed a non-serious event of joint pain (arthralgia) (unknown latency) following the first dose intake of dupilumab and (unknown latency) following the administration of influenza vaccine.  On an unknown date, the patient developed a non-serious event of asthma flare up because she did not get her medication on time (asthma) and (inappropriate schedule of product administration) (unknown latency) following the first dose intake dupilumab.  It was reported, patient reported experiencing an asthma flare up because she did not get her medication on time. Patient also reports an ER visit. Uses rescue inhaler 3 or more days per week. 2 courses of oral corticosteroids. Asthma symptoms affect quality of life alot. Missed doses. joint pain but could be from the flu vaccine. Patient states asthma attacks could be from all the stress related to trying to get medication.   Dupilumab was continued. Action taken with influenza vaccine was not applicable.  It was not reported if the patient received a corrective treatment for the events.  At time of reporting, the outcome was Unknown for all the events.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: I also got the flu; Initial information was received on 30-Nov-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-health-care professional.  This case involves Adult and unknown gender patient who reported i also got the flu after receiving 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 an unknown dose of suspect influenza vaccine produced by unknown manufacturer (unknown formulation) (lot number, expiry date, strength, frequency was unknown) via unknown route in unknown administration site for Influenza immunization.  On an unknown date the patient had a non-serious event i also got the flu (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.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: I did and got the Flu anyway; Initial information was received on 01-Dec-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-health-care professional.  This case involves unknown age and unknown gender patient who stated that, "i did and got the flu anyway" while 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 (lot number: not reported) via unknown route in unknown administration site (strength, dose, frequency: unknown). for prophylactic vaccination.  On an unknown date the patient developed a non-serious event of "i did and got the flu anyway" (influenza) (latency: unknown) following the administration of influenza vaccine.  Action taken with influenza vaccine was unknown.  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.
Sex: U
Vaccine: FLUX
Symptoms: Oropharyngeal pain, Respiratory disorder
Clinical narrative: sore throat; Initial information received on 30-Nov-2022 regarding an unsolicited valid social media non-serious case received via consumer/non-hcp.  This case involves patient of unspecified demographics who experienced sore throat while receiving vaccine Influenza Vaccine (Flu shot).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received suspect INFLUENZA VACCINE produced by unknown manufacturer at (unknown: formulation, strength, dose, lot number, route in unknown administration site) for prophylactic vaccination. Information regarding batch number requested.  On an unknown date, the patient developed a non-serious sore throat (oropharyngeal pain) at third day latency following the administration of INFLUENZA VACCINE.  It was reported on by patient that "Got my shot and on the third day had that respiratory virus that's going around, which started with a sore throat and lasted 2 weeks."   Action taken: Not applicable.  It was not reported if the patient received a corrective treatment for the event (sore throat).  At time of reporting, the outcome was recovered for the event sore throat in 2 weeks.
Sex: U
Vaccine: FLUX
Symptoms: Illness
Clinical narrative: sick for over a week; Initial information received on 02-Dec-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-HCP.  This case involves an unknown age and unknown gender patient who was sick for over a week after receiving 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 (form, strength, dose, frequency, lot number, expiry date: unknown) via unknown route in unknown administration site for Prophylactic vaccination.  On an unknown date the patient was sick for over a week (illness) (unknown latency) following the administration of influenza vaccine.  Action taken  was not applicable.  It was not reported if the patient received a corrective treatment for the event (sick for over a week).  At time of reporting, the outcome was Unknown for the event sick for over a week.
Sex: F
Vaccine: RAB
Symptoms: Extra dose administered, Medication error, No adverse event, Product preparation error
Clinical narrative: received 8 doses in the past 4.5 months and was told there was a concern for error in her prep series with no reported adverse event; received 8 doses in the past 4.5 months and was told there was a concern for error in her prep series with no reported adverse event; Initial information received on 30-Nov-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves an unknown age female patient who received 8 doses in the past 4.5 months and was told there was a concern for error in her prep series with no reported adverse event. (Rabies (HDC) vaccine) [imovax rabies].  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 Rabies (HDC) vaccine (form, strength, dose, frequency, lot number, expiry date: unknown) via intramuscular route in unknown administration site for Immunization    On an unknown date the patient received 8 doses in the past 4.5 months and was told there was a concern for error in her prep series with no reported adverse event (extra dose administered) and (product preparation error) (unknown latency).  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 67.0
Sex: F
Vaccine: FLU4
Symptoms: Blood glucose increased, Chills, Dehydration, Diarrhoea, Headache
Clinical narrative: the vaccine did not work as had this very bad flu disease; bout of flu; dehydration; high blood sugar; headache; diarrhea; chills; high fever of 103.5 f; Initial information was received on 01-Dec-2022 regarding an unsolicited valid  serious case received from a patient.  This case involves a 67 years old female patient and reporter reported that the vaccine did not work as had this very bad flu disease, and had bout of flu with 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 an unknown date in Oct-2022, the patient received 0.7 ml dose of suspect Influenza quadrival A-B high dose HV vaccine (with unknown strength, lot number and expiration date) via unknown route in the left arm for prophylactic vaccination.   On an unknown date in 2022, the patient had serious event the vaccine did not work as had this very bad flu disease (vaccination failure) (latency: 6 weeks) following the administration of Influenza quadrival A-B high dose HV vaccine. This event was assessed as medically significant. On an unknown date in 2022, the patient had non serious events bout of flu (influenza) wherein she experienced high blood sugar (blood glucose abnormal), dehydration, headache, diarrhea (diarrhoea), chills and high fever of 103.5 f (pyrexia) (latency: 6 weeks) following the administration of Influenza quadrival A-B high dose HV vaccine.  Relevant laboratory test results included: Blood glucose - On an unknown date: [high] Body temperature - On an unknown date: 103.5 F  Action taken: Not applicable.  Corrective treatment: The patient was treated with Paracetamol (Tylenol) for Influenza.  Outcome: Unknown for the events.; Sender's Comments: Sanofi company comment dated 06-Dec-2022: This case involves a 67 years old female patient and reporter reported that the vaccine did not work as had this very bad flu disease, and had bout of flu after being vaccinated with Influenza quadrival A-B high dose HV vaccine [Fluzone high-dose quadrivalent]. Case will be reevaluated post further update on concurrent condition during vaccination, past medical history, concomitant medications and risk factors underlying diseases excluding alternative etiologies for the reported events, which will preclude a comprehensive assessment of this case. Based upon the reported information, the role of the suspect vaccine cannot be assessed.
Age: 67.0
Sex: F
Vaccine: FLU4
Symptoms: Influenza, Pyrexia, Vaccination failure
Clinical narrative: the vaccine did not work as had this very bad flu disease; bout of flu; dehydration; high blood sugar; headache; diarrhea; chills; high fever of 103.5 f; Initial information was received on 01-Dec-2022 regarding an unsolicited valid  serious case received from a patient.  This case involves a 67 years old female patient and reporter reported that the vaccine did not work as had this very bad flu disease, and had bout of flu with 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 an unknown date in Oct-2022, the patient received 0.7 ml dose of suspect Influenza quadrival A-B high dose HV vaccine (with unknown strength, lot number and expiration date) via unknown route in the left arm for prophylactic vaccination.   On an unknown date in 2022, the patient had serious event the vaccine did not work as had this very bad flu disease (vaccination failure) (latency: 6 weeks) following the administration of Influenza quadrival A-B high dose HV vaccine. This event was assessed as medically significant. On an unknown date in 2022, the patient had non serious events bout of flu (influenza) wherein she experienced high blood sugar (blood glucose abnormal), dehydration, headache, diarrhea (diarrhoea), chills and high fever of 103.5 f (pyrexia) (latency: 6 weeks) following the administration of Influenza quadrival A-B high dose HV vaccine.  Relevant laboratory test results included: Blood glucose - On an unknown date: [high] Body temperature - On an unknown date: 103.5 F  Action taken: Not applicable.  Corrective treatment: The patient was treated with Paracetamol (Tylenol) for Influenza.  Outcome: Unknown for the events.; Sender's Comments: Sanofi company comment dated 06-Dec-2022: This case involves a 67 years old female patient and reporter reported that the vaccine did not work as had this very bad flu disease, and had bout of flu after being vaccinated with Influenza quadrival A-B high dose HV vaccine [Fluzone high-dose quadrivalent]. Case will be reevaluated post further update on concurrent condition during vaccination, past medical history, concomitant medications and risk factors underlying diseases excluding alternative etiologies for the reported events, which will preclude a comprehensive assessment of this case. Based upon the reported information, the role of the suspect vaccine cannot be assessed.
Age: 0.92
Sex: M
Vaccine: FLUR4
Symptoms: No adverse event, Off label use, Product administered to patient of inappropriate age
Clinical narrative: flublok quadrivalent administered to an 11 month old patient with no reported adverse event; Initial information was received on 01-Dec-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves 11 months old male patient who stated flublok quadrivalent administered to an 11 month old patient with no reported adverse event after receiving influenza quadrivalent recombinant vaccine [Flublok QIV].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 27-Oct-2022, the patient received an 0.5 ml dose of suspect influenza quadrivalent recombinant vaccine (unknown formulation) (lot: QFAA2235, expiry date: 30-Jun-2023) Frequency: Once (strength: standard) via intramuscular route in left leg for Immunization.  On an unknown date the patient had a non-serious event flublok quadrivalent administered to an 11 month old patient with no reported adverse event (off label use) (unknown latency) following the administration of influenza quadrivalent recombinant 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.
Sex: U
Vaccine: FLU4
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 2nd shot of FLUZONE HIGH DOSE QIV was given today, the last one being in September with no reported AE; Initial information received on 01-Dec-2022 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves an unknown age and unknown gender patient who had 2nd shot of fluzone high dose qiv was given today, the last one being in september with no reported ae 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 01-Dec-2022, the patient received a dose of suspect influenza quadrival a-b high dose hv vaccine (Lot number: UJ917AD and Expiration Date :  Expiration Date)(strength, dose, formulation, frequency: not reported) via unknown route in unknown administration site for Immunization (Immunisation).  On 01-Dec-2022 the patient developed a non-serious event of 2nd shot of fluzone high dose qiv was given today, the last one being in september with no reported ae (inappropriate schedule of product administration) 1 day following the administration of influenza quadrival a-b high dose hv 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: 17.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain
Clinical narrative: Injection site tenderness; Injection site pain; Initial information was received on 01-Dec-2022 regarding an unsolicited valid non-serious case received from a health care professional.  This case involves 17 years old female patient who experienced injection site tenderness and injection site pain after receiving vaccine influenza quadrival a-b vaccine [Fluzone QIV].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included diphenhydramine hydrochloride (MENNA).  On 28-Nov-2022, the patient received a dose of 05 ml suspect influenza quadrival a-b vaccine Suspension for injection with frequency: Total (lot: U7684BB and expiry date: 30-Jun-2023) via intramuscular route in the left arm for Immunization (Immunisation).  On 29-Nov-2022 the patient developed a non-serious event of injection site pain and injection site tenderness (injection site pain) 1 day following the administration of influenza quadrival a-b vaccine.  It was reported, "MA reporting that a patient received the product FLUZONE QIV NP 2 days ago and is now back today at the clinic complaining of pain and tenderness in the area. MA said the patient was provided a splint for their arm and was advised to apply an ice pack but the patient is still in pain."  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the events (Injection site tenderness, Injection site pain).  At time of reporting, the outcome was Not Recovered for the event injection site tenderness and injection site pain.
Age: 1.33
Sex: F
Vaccine: HIBV
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: administered ACTHIB to a patient wherein the diluent is expired by one day with no reported adverse event; Initial information received on 01-Dec-2022 regarding an unsolicited valid non-serious case via other health professional.  This case involves a 16-month-old female patient who was administered ACTHIB to a patient wherein the diluent is expired by one day with no reported adverse event after receiving vaccine HIB (PRP/T) vaccine [ACT-HIB].  The patient's past medical history, medical treatment(s), vaccination(s), concomitant(s) and family history were not provided.  Concomitant medications included diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (DTAP).  On an unknown date, the patient received a 0.5 ml dose of suspect HIB (PRP/T) vaccine (batch lot number: UJ637AA) (strength, form: unknown) (expiry date: 27-Feb-2022) via unknown route in unknown administration site for Immunization.  On an unknown date the patient had a non-serious event of administered ACTHIB to a patient wherein the diluent is expired by one day 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.  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: 0.17
Sex: M
Vaccine: IPV
Symptoms: Incorrect dose administered, Medication error, No adverse event
Clinical narrative: stated a 2 month old patient received 2 doses of IPOL with no reported adverse event; Initial information was received on 01-Dec-2022 regarding an unsolicited valid non-serious case received from a non-health-care professional.  This case involves 2 months old male patient who had stated a 2 month old patient received 2 doses of ipol with no reported adverse event after receiving vaccine ipv (VERO) [Ipol].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, hepatitis b vaccine RHBSAG (YEAST), PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, POLIO VACCINE INACT 3V (VERO), TETANUS VACCINE TOXOID (Pediarix).  On an 1-Dec-2022, the patient received 2nd  dose of 0.5 ml suspect ipv (VERO) Suspension for injection (frequency: total) (lot: VIB901M and expiry date: 02-Jul-2024) (strength,: not reported) via intramuscular route in Left Thigh for Immunization (Immunisation).  On 01-Dec-2022 the patient had a non-serious event of stated a 2 month old patient received 2 doses of ipol with no reported adverse event (incorrect dose administered) (same day  latency) 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: 61.0
Sex: M
Vaccine: TDAP
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: a patient received an expired product Adacel with no adverse event; Initial information was received on 02-Dec-2022 regarding an unsolicited valid non-serious case received from a health care professional.  This case involves 61 years old male patient received an expired product adacel with no adverse event 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 02-Dec-2022, the patient received a dose of 0.5 ml suspect diphtheria-2/tetanus/5 ac pertussis vaccine Suspension for injection frequency: total (lot number: C5757AA and expiry date: 21-Jul-2022) via intramuscular route in the left deltoid for .  On 02-Dec-2022 the patient developed a non-serious event of a patient received an expired product adacel with no adverse event (expired product administered) following the administration of diphtheria-2/tetanus/5 ac pertussis vaccine.  It was reported, "Agency reporting that a patient received expired ADACEL. Caller also would like to know does the patient need to wait to be revaccinated if they are on chemotherapy."  Action taken: not applicable.  Outcome: Unknown.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: M
Vaccine: TDAP
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: expired ADACEL vaccine being administered with no reported adverse event; Initial information received on 02-Dec-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves an unknown age male patient who had administered with expired DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (ADACEL) with no reported adverse event   The patient's past vaccination(s) included TDAP with Caller states that it has been more than 10 years since the patient received a Tdap vaccine. The patient's past medical history, medical treatment(s) and family history were not provided.   On 30-Nov-2022, the patient received a  dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE Suspension for injection lot U6855AA via intramuscular route in Left Arm, Dosage text  0.5 ml (milliliter) 1X  (Total) , expiry date: 25-NOV-2022 ( strength, : unknown) for Immunisation  On 30-NOV-2022 the patient who had administered ADACEL with expired with no reported adverse event (expired product administered) (latency : same day)  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: M
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: SICK NOW; This spontaneous report received from a consumer via a company representative concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced sick now. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from sick now. This report was non-serious. This case was associated with a product quality complaint: 90000261952 This case, from the same reporter is linked to 20221210446, 20221210598, 20221210980 and 20221211116.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: flu; Initial information was received on 30-Nov-2022 regarding an unsolicited valid Social Media non-serious case received from a patient.  This case involves a patient with unknown demographics who had flu after being vaccinated with 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 a dose of suspect Influenza vaccine (produced by unknown manufacturer) (with unknown strength, dose, route, administration site, lot number and expiration date) for influenza. Got higher dose because of patient's age.  On an unknown date in Oct-2022 the patient got flu (influenza) (unknown latency) following the administration of Influenza vaccine.  Action taken: Not applicable.  Corrective treatment: Not reported.  Outcome: Unknown.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: flu; Initial information received on 01-Dec-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-healthcare professional.  This case involves a patient of unknown age and demographics who experienced flu 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 (strength, dose, formulation, frequency, lot number and expiry date: not reported) via unknown route in unknown administration site as prophylactic vaccination (Immunisation).  On an unknown date, the patient developed a non-serious event of flu (influenza) (unknown latency) following the administration of influenza vaccine.  No lab data was reported.  Action taken: Not applicable.  It was not reported if the patient received a corrective treatment for the event (flu).  At time of reporting, the outcome was Unknown for the event flu.
Sex: U
Vaccine: FLUX
Symptoms: Drug ineffective, Influenza
Clinical narrative: Still got the flu; Still got the flu; Initial information received on 03-Dec-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp.  This case involves Adult and unknown gender patient who still got the flu 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 suspect influenza vaccine produced by unknown manufacturer (dose, strength, frequency, formulation, route, batch number, expiry date: unknown) in unknown administration site for Flu (influenza)  On an unknown date the patient diagnosed with non-serious events still got the flu (influenza), (drug ineffective) (unknown latency) following the administration of influenza vaccine.  No lab data was reported.  Action taken was 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 both the events
Age: 0.25
Sex: M
Vaccine: HIBV
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: ACTHIB that was given after expiration with no reported adverse event; Initial information received on 02-Dec-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 3 months old male patient who was given HIB (PRP/T) vaccine [ACT-HIB] after expiration with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included pneumococcal vaccine CONJ 13V (CRM197) (PREVNAR 13); AND ROTAVIRUS VACCINE LIVE reassort oral 5V (Rotateq).  On 01-Dec-2022, the patient received 0.5 ml total dose of suspect HIB (PRP/T) vaccine with standard strength (lot UJ611AAB and expiry date 30-Nov-2022) (form: unknown)  via intramuscular route in the left thigh for Immunization.  On 01-DEC-2022 the patient was given HIB (PRP/T) vaccine after expiration with no reported adverse event (expired product administered) (latency: same day).  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Error: Wrong Vaccine Formulation (ex. Prevnar 13 v. Prevnar 23)-