chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: FLU3
Symptoms: Extra dose administered
Clinical narrative: potentially take 2 doses of the Fluzone Hd in a month apart with no reported adverse event; Initial information received on 17-Oct-2024 regarding an unsolicited valid non-serious case received from a nurse.  This case involves an unknown age female patient who potentially take 2 doses of the INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HD] in a month apart with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 17-Oct-2024, the patient received another dose of suspect Influenza USP Trival A-B High Dose Subvirion Vaccine and previously took dose On 17-Sep-2024 Suspension for injection in pre-filled syringe (strength, dose, expiry date, lot: not reported) via unknown route in unknown administration site for prophylactic vaccination (immunization) take 2 doses of the fluzone hd in a month apart with no reported adverse event (inappropriate schedule of product administration) (latency: on same day from last dose).  Information regarding batch number corresponding to the one at time of event occurrence is requested.  Reportedly, there is no safety or immunogenicity data to support multiple administrations of Fluzone High-Dose in a single season. It is not recommend the use of Fluzone High-Dose in a manner that is inconsistent with the approved product labeling.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.; Sender's Comments:  US-SA-2024SA314151:Patient 2
Age: 43.0
Sex: U
Vaccine: RAB
Symptoms: No adverse event, Off label use
Clinical narrative: Intentional Off Label Prescription by HCP: Imovax is prescribed with off label diagnosis of Bitten by cat, subsequent encounter with no reported adverse event; Initial information received on 23-Oct-2024 regarding an unsolicited valid  non-serious case received from a physician.  This case involves a 43 years old and unknown gender patient who received Rabies (HDC) Vaccine [Imovax Rabies] intentional off label prescription by hcp: imovax is prescribed with off label diagnosis of bitten by cat, subsequent encounter with no reported adverse event.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a  dose of suspect 1ml (once) Rabies (HDC) Vaccine Powder and solvent for suspension for injection (unknown dosage, expiry date and lot number) via intramuscular route in unknown administration site for Animal bite was prescribed with off label diagnosis of bitten by cat, subsequent encounter with no reported adverse event (off label use) (latency-same day).  There will be no information on batch number and expiration date corresponding to the one at time of event occurrence.  Reportedly, Imovax was prescribed with off label diagnosis Bitten by cat, subsequent. It was  intentional and  at the initiative of health care professional (HCP) for a therapeutic purpose.
Sex: U
Vaccine: FLU3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: given at least 3 doses of High Dose Fluzone to patients under 65 years of age, with no reported adverse event; Initial information received on 21-Oct-2024 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a Adult patient of an unknown age and gender and it was reported that at least 3 doses of influenza USP trival A-B high dose subvirion vaccine [Fluzone High Dose] to patients under 65 years of age, with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received influenza USP trival A-B high dose subvirion vaccine Suspension for injection in pre-filled syringe (lot number; strength; expiry date not reported) to patients under 65 years of age, with no reported adverse event (product administered to patient of inappropriate age) (latency: same day).  Information regarding batch number and expiration date corresponding to the one at time of event occurrence will not be available.  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: 83.0
Sex: F
Vaccine: FLUX
Symptoms: Diarrhoea
Clinical narrative: diarrhea; Initial information received on 29-Oct-2024 regarding an unsolicited valid  non-serious case received from a consumer/non-healthcare professional.  This case involves a 83 years old female patient who experienced diarrhea after receiving influenza vaccine and DUPILUMAB [DUPIXENT] via pre-filled pen.  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 influenza vaccine produced by unknown manufacturer (strength, expiry date and lot number not reported) via unknown route in unknown administration site as prophylactic vaccination (Immunization). On an unknown date, the patient started taking DUPIXENT (DUPILUMAB) Solution for injection 300 mg QOW (every other week) via subcutaneous route (strength: 300 mg/2ml) for Other atopic dermatitis.  On an unknown date the patient developed diarrhea (diarrhoea) (unknown latency) following the administration of influenza vaccine.  Information on the batch number was requested corresponding to the one at time of event occurrence.  Action taken was not applicable for event diarrhoea with influenza vaccine and no action taken with dupixent  It was not reported if the patient received a corrective treatment for the event (diarrhea).  At time of reporting, the outcome was Unknown for the event diarrhea.
Age: 43.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Swelling face
Clinical narrative: Swelling of upper lip and face; Initial information received on 24-Oct-2024 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare professional.  This case involves a 43 years old female patient (77.11 kg) who experienced swelling of upper lip and face, after receiving vaccines Influenza Usp Trival A-B Subvirion No Preservative Vaccine [Fluzone] and Covid-19 Vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 23-Oct-2024, the patient received (0.5 ml 1 dose every 1 Total) dose of suspect Influenza Usp Trival A-B Subvirion No Preservative Vaccine, Suspension for injection (strength: not reported) (lot: U8523DA, Expiry date: not reported) via intramuscular route in unknown administration site for prevention of flu (Antiviral prophylaxis), Also on the same day the patient also received (1 dosage form, once (1X) dose of suspect Covid-19 Vaccine (Novavax) not produced by Sanofi Pasteur, (form, strength: not reported) (lot: 6024MF016A, Expiry date: not reported) via intramuscular route in unknown administration site for For prevention of COVID (COVID-19 immunisation).  On 24-OCT-2024 the patient developed swelling of upper lip and face (swelling face) (latency: 1 day) following the administration of Influenza Usp Trival A-B Subvirion No Preservative Vaccine and of Covid-19 Vaccine.  Reportedly, Reporter guessing that side effect is a result of the Novavax vaccine and not Fluzone, but cannot determine for sure.  No lab data reported.  Action taken : not applicable.  The patient was treated with Diphenhydramine hydrochloride (Benadryl), two gelcaps for Swelling face.  At time of reporting, the outcome was Recovering / Resolving for the event.
Age: 1.25
Sex: F
Vaccine: DTAPIPVHIB, PNC20
Symptoms: Skin warm
Clinical narrative: Arm is bit warm to touch; Initial information received on 24-Oct-2024 regarding an unsolicited valid non-serious courtesy case received from a consumer/non-healthcare professional.  This case involves a 15 months old female patient (10.43 kg) who experienced arm is bit warm to touch after receiving vaccines Prevnar 20 and Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(VERO)/HIB(PRP/T) Vaccine [Pentacel (Vero)].  The patient's past vaccination(s) included PENTACEL in 2023. The patient's past medical history, medical treatment(s) and family history were not provided.   On 14-Oct-2024, the patient received a booster 0.5 ml dose of suspect Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(VERO)/HIB(PRP/T) Vaccine Suspension for injection (lot UK022AA, expiry: 30-Apr-2025 with unknown strength) via unknown route in the upper left arm as prophylactic vaccination. On 14-Oct-2024, the patient received a 0.5 ml dose of suspect Prevnar 20 not produced by Sanofi Pasteur (lot HN5980, expiry: 30-Sep-2025 with unknown strength and form) via unknown route in the upper left arm as Pneumococcal infection.  On an unknown date in OCT-2024 the patient arm is bit warm to touch (vaccination site warmth) (latency: few days approximately) following the administration of Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(VERO)/HIB(PRP/T) Vaccine and Prevnar 20.  It was reported "caller that was reporting a side effect. Her daughter got Prevnar 20 vaccine and another vaccine (later clarified as Pentacel) that was 'stuck' and she would like to know, the arm of her daughter is a bit warm to touch and vaccine was given last Monday. When paraphrased the concem, reporter stated, "yes past Monday." Reporter further stated, "I called her doctor and they said it probably is a localized reaction to one or both of the vaccines but I bring in her and they told me to follow up if there is no change."  Patient's details: Height: Reporter stated, "She is just under 3 feet. I believe 2 feet and 11 inches."  Vaccination details: Reporter stated, "Both were on her upper left arm." Vaccination facility details, reporter stated, "It was her doctor's office, Pediatrics and Adolescent medicine." Indication: Reporter stated, "Her 15 months checkup. It may have been boosters for both. The Prevnar was new but the Pentacel was a booster because she had it last year."  Action taken: as 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: M
Vaccine: FLUX
Symptoms: Nausea, Retching
Clinical narrative: dry heaving after influenza and covid shot; felt nauseous after the vaccine a week ago; Initial information received on 25-Oct-2024 regarding an unsolicited valid  non-serious case received from a consumer/non-health care professional.  The case is linked to US-SA-2024SA310685.  This case involves Elderly male patient (104.55 kg) who had dry heaving after Influenza Vaccine and covid shot and felt nauseous after the vaccine a week ago.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included COVID-19 vaccine for COVID-19 immunisation.  On an unknown date, the patient received a unknown dose of suspect Influenza Vaccine produced by unknown manufacturer formulation, strength, expiry date, lot number not reported via unknown route in unknown administration site for Prophylactic vaccination (Immunization).  On an unknown date the patient had dry heaving after influenza and covid shot (retching) and felt nauseous after the vaccine a week ago (nausea) (unknown latency) following the administration of Influenza Vaccine .  Reportedly "Pharmacist Advised That Nausea May Occur and Typically Resolves in A Few Days. Unknown If The Doctor Is Aware. "  Action taken was not applicable for all the events.  It was not reported if the patient received a corrective treatment for the events (dry heaving after influenza and covid shot, felt nauseous after the vaccine a week ago).  At time of reporting, the outcome was Unknown for both the events.; Sender's Comments:  US-SA-2024SA310685:IN-241029-159364
Age: 56.0
Sex: F
Vaccine: COVID19, FLUR4
Symptoms: Discomfort, Pruritus, Rash
Clinical narrative: Discomfort; Rash; Pruritus; Initial information received on 23-Oct-2024 regarding an unsolicited valid non-serious case received from a consumer/Non-Healthcare Professional.  This case involves a 56 years old female patient who had discomfort, rash and pruritus after receiving Novavax COVID-19 Vaccine and INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV].  The patient's past medical history included severe skin rash: known allergy to bactrim antibiotic (sulfa) (Rash). The patient's past medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing Food allergy in JUL-2024, Asthma, arthritis in knees (Arthritis) and severe skin rash: known allergy to bactrim antibiotic (sulfa) (Drug hypersensitivity).  Concomitant medications included Estradiol (Estrace); Metronidazole (Metrocream), Bupropion hydrochloride (Wellbutrin xl), Paroxetine hydrochloride (Paxil) and Fexofenadine hydrochloride (Fexofenadine HCL) for Product used for unknown indication; Gabapentin (Gabapentin) for Menopausal symptoms.  On 16-Sep-2024, the patient received INFLUENZA QUADRIVALENT RECOMBINANT VACCINE via intramuscular route in unknown administration site for Drug use for unknown indication (Product used for unknown indication) (strength, dose, batch and expiry date unknown) and on same day also received dose of suspect Novavax COVID-19 Vaccine not produced by Sanofi Pasteur injection strength 0.5 ml lot 6024MF012 via intramuscular route in unknown administration site for COVID-19 Immunization (dose, expiry date unknown). Information on batch number and expiry date corresponding to the one at time of event occurrence was requested.  On 19-SEP-2024 the patient had discomfort, rash and pruritus (latency 3 days).  Rash began behind Left knee, and inside Left elbow area, itching became more uncomfortable by Saturday, 21-Sep-2024. It has not resolved as of this report.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the events   At time of reporting, the outcome was Not Recovered / Not Resolved for all the events
Sex: U
Vaccine: FLU3
Symptoms: Device connection issue, Injury associated with device
Clinical narrative: when activating the needle safety device, the Luer skirt breaks, One needlestick occurred because of this failure; Initial information received on 24-Oct-2024 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp (non-healthcare professional).  This case involves an unknown age and unknown gender patient and reporter reported when activating the needle safety device for Influenza Usp Trival A-B High Dose Subvirion Vaccine [Fluzone High Dose], the luer skirt breaks, one needlestick occurred because of this failure.  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 0.5 mL of suspect Influenza Usp Trival A-B High Dose Subvirion Vaccine Suspension for injection in pre-filled syringe (lot UT8425BA, expiry date- 30-JUN-2025) via Intramuscular route in unknown administration site for Prophylactic vaccination (Immunisation), and when activating the needle safety device, the luer skirt breaks, one needlestick occurred because of this failure (injury associated with device) (latency- same day).  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 the event.
Sex: M
Vaccine: FLU3, RSV
Symptoms: Chills, Cough, Diarrhoea, Myalgia, Pyrexia
Clinical narrative: 104 degree fever; shakes; chills to the point where he was violently shaking; massive diarrhea; vomiting; muscle aches; cough; Initial information received on 28-OCT-2024 regarding an unsolicited valid  non-serious case received from a consumer.  This case involves an unknown age male patient who had 104 degree fever, shakes, chills to the point where he was violently shaking, massive diarrhea, vomiting, muscle aches and cough after receiving  Abrysvo and INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [FLUZONE].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 19-SEP-2023, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED Suspension for injection in unknown administration site and Abrysvo not produced by Sanofi Pasteur in the right deltoid (unknown strength, dosage, formulation, expiry, lot number and route)for prophylactic vaccination.  On 19-SEP-2023 the patient developed 104 degree fever (pyrexia) , shakes (tremor), chills to the point where he was violently shaking (chills),massive diarrhea (diarrhoea), vomiting , muscle aches (myalgia) and cough following the administration of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED and Abrysvo.  Information on the batch number was requested corresponding to the one at time of event occurrence.  Action taken was not applicable.  The patient was treated with Paracetamol (Tylenol) for Product used for unknown indication.  At time of reporting, the outcome was Recovered / Resolved on an unknown date for the event 104 degree fever. At time of reporting, the outcome was unknown for the event muscle aches, chills to the point where he was violently shaking,  vomiting, cough, shakes and massive diarrhea.
Sex: M
Vaccine: FLU3, RSV
Symptoms: Tremor, Vomiting
Clinical narrative: 104 degree fever; shakes; chills to the point where he was violently shaking; massive diarrhea; vomiting; muscle aches; cough; Initial information received on 28-OCT-2024 regarding an unsolicited valid  non-serious case received from a consumer.  This case involves an unknown age male patient who had 104 degree fever, shakes, chills to the point where he was violently shaking, massive diarrhea, vomiting, muscle aches and cough after receiving  Abrysvo and INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [FLUZONE].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 19-SEP-2023, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED Suspension for injection in unknown administration site and Abrysvo not produced by Sanofi Pasteur in the right deltoid (unknown strength, dosage, formulation, expiry, lot number and route)for prophylactic vaccination.  On 19-SEP-2023 the patient developed 104 degree fever (pyrexia) , shakes (tremor), chills to the point where he was violently shaking (chills),massive diarrhea (diarrhoea), vomiting , muscle aches (myalgia) and cough following the administration of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED and Abrysvo.  Information on the batch number was requested corresponding to the one at time of event occurrence.  Action taken was not applicable.  The patient was treated with Paracetamol (Tylenol) for Product used for unknown indication.  At time of reporting, the outcome was Recovered / Resolved on an unknown date for the event 104 degree fever. At time of reporting, the outcome was unknown for the event muscle aches, chills to the point where he was violently shaking,  vomiting, cough, shakes and massive diarrhea.
Age: 5.0
Sex: F
Vaccine: DTAP, TDAP
Symptoms: Wrong product administered
Clinical narrative: received Adacel, but should have received DTAP and Polio combination with no reported adverse event; Initial information received on 07-Oct-2024 regarding an unsolicited valid  non-serious case received from a nurse.  This case involves a 5 years old female patient who received diphtheria-2/tetanus/5 AC pertussis vaccine [Adacel], but should have received diphtheria, tetanus, AC pertussis and IPV vaccine with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included 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.  On an unknown date, the patient received an unknown dose 1 of  diphtheria, tetanus, AC pertussis and IPV vaccine produced by unknown manufacturer (strength, expiry date and lot number not reported) via unknown route in unknown administration site as prophylactic vaccination (Immunization). 3 other doses were administered on unknown dates of the same vaccine. On 04-Sep-2024, the patient received 0.5 ml of diphtheria-2/tetanus/5 AC pertussis vaccine Suspension for injection with standard strength (lot U8232AA and expiry date- 31-May-2026) once via intramuscular route in the right deltoid for Immunization, but should have received dtap and polio combination with no reported adverse event (wrong product administered) (latency- same day).  Reportedly, they don't give it until the patient is above 7 years old. The patient received 4 doses of DTAP already prior to the administration of ADACEL. So far, they were not contacted by the parents for any reports of adverse event of the patient. There was no ER (emergency)/Dr (Doctor) visit.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 16.0
Sex: M
Vaccine: UNK
Symptoms: No adverse event, Wrong product administered
Clinical narrative: 16-year-old patient was inadvertently administered Flublok with no reported adverse event; Initial information received on 07-Oct-2024 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 16 years old male patient to whom was inadvertently administered Influenza Trivalent Recombinant Vaccine [Flublok Tiv] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Diphtheria vaccine toxoid, Pertussis vaccine acellular 3-component, Tetanus vaccine toxoid (Boostrix) for Immunisation.  On 05-Oct-2024, the 16 years old male patient received a 0.5 ml dose of suspect Influenza Trivalent Recombinant Vaccine Solution for injection (strength: standard, frequency: once, expiry date: Jun-2025 and lot TFAA2435) via intramuscular route in the right deltoid as immunization (product administered to patient of inappropriate age) (latency: same day)   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: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Back pain, Dyspnoea, Pulmonary pain
Clinical narrative: their lungs seemed to hurt/ sharp pain in the upper left lung for 1 and half to 2 days; pain was on the left back side; having trouble catching her breath, and had unable to breathe deeply/breathing problem; Initial information received on 07-Oct-2024 (with live follow up processed together on 07-Oct-2024) regarding an unsolicited valid non-serious case received from a consumer/non-hcp (non-healthcare professional).  This case was linked to US-SA-2024SA307598.  This case involves 65 years old female patient who had her lungs seemed to hurt/ sharp pain in the upper left lung for 1 and half to 2 days, pain was on the left back side and having trouble catching her breath, and had unable to breathe deeply/breathing problem after receiving Influenza Quadrivalent Recombinant Vaccine [Flublok].  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 was Underweight. List concomitant: no other vaccines  On 04-Oct-2024, the patient received a standard dose of suspect influenza quadrivalent recombinant vaccine (once) (strength, formulation, expiry date, lot number- not reported) via intramuscular route in the left upper arm for Immunization. Information on the batch number was requested corresponding to the one at time of event occurrence.  On an unknown date in OCT-2024 the patient had her lungs seemed to hurt/ sharp pain in the upper left lung for 1 and half to 2 days (pulmonary pain), pain was on the left back side (back pain) and having trouble catching her breath, and had unable to breathe deeply/breathing problem (dyspnoea) (latency- few days approximately) following the administration of influenza quadrivalent recombinant vaccine.  Reportedly, patient was tall, skinny, and underweight. Caller noted that they had never difficulty with flu products in the past.   Relevant laboratory test results included: Oxygen saturation - On an unknown date In Oct-2024: 97 %  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the events.  At time of reporting, the outcome was Recovered / Resolved on an unknown date in Oct-2024 for the event pulmonary pain and back pain; and was Not Recovered / Not Resolved for the event (dyspnoea).; Sender's Comments:  US-SA-2024SA307598:02252896 (husband case)
Age: 63.0
Sex: M
Vaccine: UNK
Symptoms: Back pain, Dysphonia, Pulmonary pain
Clinical narrative: had a sharp pain in the upper left lung for 1 and half to 2 days/pain was on the left back side; still have the breathing; Initial information received on 07-OCT-2024 regarding (live follow up received on CSD : 07-OCT-2024) an unsolicited valid  non-serious case received from Non-Healthcare Professional.  This case is linked to 2024SA306923.  This case involves a 63 years old male patient who had had a sharp pain in the upper left lung for 1 and half to 2 days/pain was on the left back side and still have the breathing after receiving Influenza Trivalent Recombinant Vaccine [Flublok Tiv].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  List concomitant: no other vaccine.   On 04-OCT-2024, the patient received a dose of suspect (Standard) Influenza Trivalent Recombinant Vaccine Solution for injection (once) (unknown dosage, expiry date and lot number) via intramuscular route in the left arm for immunization.  On 04-OCT-2024 the patient had a sharp pain in the upper left lung for 1 and half to 2 days/pain was on the left back side (pulmonary pain) and still had the breathing (dysphonia) (latency-same day)following the administration of Influenza Trivalent Recombinant Vaccine.  Information on the batch number was requested corresponding to the one at time of event occurrence.  Reportedly, caller reported that wife was tall, skinny, and underweight, while her husband was kind of round. Caller was not sure if their body builds were the reason for why her husband was feeling better, but she was not and also noted that they have never had difficulty with flu products in the past.   Relevant laboratory test results included: Oxygen saturation - On an unknown date in OCT-2024: 97 % O2 (oxygen)  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for both the events.  At time of reporting, the outcome was Recovered / Resolved on an unknown date for the event (pulmonary pain) and was Not Recovered / Not Resolved for the event (dysphonia).; Sender's Comments:  US-SA-2024SA306923:02252896 (husband case)
Age: 5.0
Sex: M
Vaccine: DTAPIPV, DTAPIPVHIB
Symptoms: No adverse event, Wrong product administered
Clinical narrative: 5 year old was administered Pentacel instead of Quadracel with no reported adverse event; Initial information received on 07-Oct-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 5 years old male patient to whom had administered Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(Vero)/HIB(PRP/T) Vaccine [Pentacel (Vero)] instead of Diphtheria-15/Tetanus/5 Hybrid AC Pertussis/Ipv (Mrc5) Vaccine [Quadracel] 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, Mumps vaccine, Rubella vaccine (Mmr); Hepatitis a vaccine (Hepatitis A) and Varicella zoster vaccine (Varicella vaccine) for Immunisation.  On 12-Aug-2024, the patient received a 0,5 ml (dose 2) dose of suspect Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(Vero)/HIB(PRP/T) Vaccine Suspension for injection (strength: standard, frequency: once, expiry date: 30-Jun-20lot UK036AB via intramuscular route in the right arm as Immunization instead of Diphtheria-15/Tetanus/5 Hybrid AC Pertussis/Ipv (Mrc5) Vaccine with no reported adverse event  (wrong product administered) (latency: same day).   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: 71.0
Sex: M
Vaccine: FLU3
Symptoms: Influenza
Clinical narrative: diagnosed with Influenza A; Initial information received on 07-Oct-2024 regarding an unsolicited valid  serious case received from a physician.  This case involves a 71 years old male patient who had diagnosed with influenza A after receiving Influenza Usp Trival A-B High Dose Subvirion Vaccine [Fluzone Hd].  The patient's past medical history included Pulmonary fibrosis, Vaccination site pain, Vaccination site erythema and Vaccination site swelling with Caller reported soreness, redness, and mild swelling around injection site for previous flu vaccines in past years. Caller did not specify which previous flu products he received. The patient's past medical treatment(s), vaccination(s) and family history were not provided.   On 02-Sep-2024, the patient received a 0.5 ml dose of suspect Influenza Usp Trival A-B High Dose Subvirion Vaccine Suspension for injection in pre-filled syringe (strength: standard, expiry date: 30-JUN-2025, frequency: once and lot UT8454TA) via intramuscular route in the left deltoid as immunization.  On 26-SEP-2024 the patient diagnosed with influenza a (influenza) (latency; 24 days).  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for both events..  At time of reporting, the outcome was Unknown for both events.  This event (vaccination failure) was assessed as medically significant.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Peripheral swelling, Tenderness, Wheezing
Clinical narrative: arms are very red and swollen from her shoulders down to her wrists; arms are very red and swollen from her shoulders down to her wrists; arms are very red and swollen from her shoulders down to her wrists and very tender; wheezing; Initial information received on 07-Oct-2024 regarding an unsolicited valid  non-serious case received from a patient.  This case involves a 71 years old female patient who experienced arms are very red and swollen from her shoulders down to her wrists and very tender and wheezing after receiving influenza USP trival A-B subvirion vaccine [Fluzone].  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 Polymers allergy and Drug hypersensitivity.   On an unknown date in 2021, the patient received an unknown dose of influenza USP trival A-B subvirion vaccine Suspension for injection with standard strength (expiry date and lot number not reported) via unknown route in unknown administration site for Influenza.  On an unknown date the patient developed arms are very red and swollen from her shoulders down to her wrists and very tender (peripheral swelling) (erythema) (tenderness) and wheezing (unknown latency) following the administration of influenza USP trival A-B subvirion vaccine.  Information on the batch number was requested corresponding to the one at time of event occurrence.   Reportedly, reporter stated she might had taken the FLUZONE T about 3 years ago and had an allergic reaction to it. It was her understanding that the FLUZONE T might have thimerosal in it. Caller said she was hoping to get her vaccine this week. Patient was allergic to propylene glycol, polyethylene glycol, polysorbate 80 and thimerosal.  Action taken was not applicable.  The patient was treated with Salbutamol (Albuterol) for all the events.  At time of reporting, the outcome was Recovering / Resolving for all the events.
Age: 0.5
Sex: M
Vaccine: FLU3
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: patient received the first dose then after 10 days, another dose of fluzone np with no reported adverse event; Initial information received on 10-Oct-2024 regarding an unsolicited valid non-serious case received from an other health professional.  This case involves a 6 months old male patient where patient received the first dose then after 10 days, another dose of influenza USP TRIVAL A-B subvirion no preservative vaccine [Fluzone] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 09-Oct-2024, the patient received 0.5 ml dose 1 (once) of suspect influenza usp trival a-b subvirion no preservative vaccine Suspension for injection (strength- standard) (lot UT8434NA and expiration date- 30-JUN-2025) via intramuscular route in the thigh nos (not specified) for Influenza immunization and On 19-Oct-2024 he also received a dose 2 of vaccine with an unknown batch number via unknown route in unknown administration site and patient received the first dose then after 10 days, another dose of fluzone np with no reported adverse event (inappropriate schedule of product administration) (latency- same day).  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: 1.25
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation issue
Clinical narrative: DTaP-IPV liquid component of PENTACEL was mixed with a sterile water diluent and given to a patient with no reported adverse event; Initial information received on 11-Oct-2024 regarding an unsolicited valid non-serious case received from an other health professional.  This case involves a 15 months old female patient who reported reported dtap-ipv liquid component of diphtheria/tetanus/5 hybrid ac pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (VERO)] was mixed with a sterile water diluent and given to a patient 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 Influenza vaccine for Immunisation.  On 09-Oct-2024, the patient received 0.5 ml dose 4 of suspect diphtheria/tetanus/5 hybrid ac pertussis/IPV(VERO)/HIB(PRP/T) vaccine Suspension for injection (strength- standard) (lot- UK045AA and expiration date- 31-AUG-2025) via intramuscular route in the left thigh and dtap-ipv liquid component of pentacel with sterile water and administering it to a patient with no ae (product preparation error) (latency- same day).  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: F
Vaccine: FLU3
Symptoms: Exposure via skin contact, No adverse event, Syringe issue
Clinical narrative: the vaccine ran down the patient's arm as she was administering it with no adverse event; vaccine ran down the patient's arm as she was administering it with no adverse event; Initial information received on 11-Oct-2024 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves Elderly female patient who was administering the vaccine Influenza Usp Trival A-B High Dose Subvirion Vaccine [Fluzone Hd] which ran down the patient's arm, with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect Influenza Usp Trival A-B High Dose Subvirion Vaccine, Suspension for injection in pre-filled syringe (strength: not reported) and while administering the vaccine which ran down the patient's arm, with no reported adverse event (accidental exposure to product) and (exposure via skin contact) (latency: same day) (lot: UT8409CA, Expiry date: 30-Jun-2025) via unknown route in unknown administration site for prophylactic vaccination (immunization).  Reportedly, While administering the vaccine started coming out of somewhere near the top of the prefilled syringe.  The vaccine ran down the patient's arm and onto the arm of the chair.  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: 60.0
Sex: U
Vaccine: FLU3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: FLUZONE HD was administered to a 60-year-old patient, with no reported adverse event; Initial information received on 11-Oct-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 60 years old and unknown gender patient who was administered Influenza Usp Trival A-B High Dose Subvirion Vaccine [Fluzone Hd], with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the 60 year old patient received a dose of suspect Influenza Usp Trival A-B High Dose Subvirion Vaccine Suspension for injection in pre-filled syringe (lot number, strength, dose and expiry not reported) via unknown route in unknown administration site, with no reported adverse event (product administered to patient of inappropriate age) (latency: same day). Information regarding batch number and expiration date corresponding to the one at time of event occurrence was requested.    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: UNK
Symptoms: Hepatic enzyme increased
Clinical narrative: elevated liver enzymes about a week; Initial information received on 11-Oct-2024 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves an unknown age male patient who experienced elevated liver enzymes about a week after receiving Influenza Trivalent Recombinant Vaccine [Flublok TIV].  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 Trivalent Recombinant Solution for injection (lot number, strength, dose and expiry not reported) via unknown route in unknown administration site as immunization. Information regarding batch number and expiration date corresponding to the one at time of event occurrence was requested.   On an unknown date the patient had elevated liver enzymes about a week (hepatic enzyme increased) (unknown latency) following the administration of Influenza Trivalent Recombinant.  It was reported "Asked if this has been reported as side effect of Flublok vaccine or reported as interfering with liver enzyme lab results. Patient will have liver biopsy done."  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event.
Age: 62.0
Sex: M
Vaccine: FLU3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: inappropriate use due to administering FLUZONE HD to 62-year-old patients with no adverse event; Initial information received on 11-Oct-2024 regarding an unsolicited valid  non-serious case received from a pharmacist.  The case is linked to US-SA-2024SA308562.  This case involves a 62 years old male patient who had inappropriate use due to administering Influenza Usp Trival A-B High Dose Subvirion Vaccine [Fluzone HD] with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included COVID-19 Vaccine for COVID-19 immunisation.  On 08-Oct-2024, the patient received a dose of 0.5 ml 1x of suspect Influenza Usp Trival A-B High Dose Subvirion Vaccine (Suspension for injection in pre-filled syringe) lot U8519DA, Expiry date: 30-Jun-2025, strength was unknown via intramuscular route in the left deltoid for Immunization and inappropriate use due to administering fluzone hd to 62-year-old patients with no adverse event (product administered to patient of inappropriate age) (latency : same day).  Reportedly "This situation is pre-assessed as a medication error/an inappropriate use due to administering FLUZONE HD to 62-year-old patients.Pharmacist requesting information regarding FLUZONE HD.Caller stated that they had a few patients who were under the age of 65, but given the FLUZONE HD. Caller wants to make sure these patients are still considered to be fully vaccinated or do they need to be revaccinated."  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.; Sender's Comments:  US-SA-2024SA308562:02261463
Age: 62.0
Sex: M
Vaccine: FLU3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: administering FLUZONE HD to 62-year-old patient, with no reported adverse event; Initial information received on 11-Oct-2024 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves a 62 years old male patient who experienced administering fluzone hd to 62-year-old patient, with no reported adverse event while receiving vaccine Influenza Usp Trival A-B High Dose Subvirion Vaccine [Fluzone High Dose].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included COVID-19 vaccine (COVID-19 vaccine) for Immunisation.  On an unknown date, the patient received a dose of suspect Influenza Usp Trival A-B High Dose Subvirion Vaccine Suspension for injection in pre-filled syringe at a dose of 0.5v ml (lot number: U8519DA and expiry date: 30-JUN-2025 )  via intramuscular route in the left deltoid. administering fluzone hd to 62-year-old patient, with no reported adverse event (product administered to patient of inappropriate age) following the administration of influenza usp trival a-b high dose subvirion vaccine (latency same day) for prophylactic vaccination.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.; Sender's Comments:  US-SA-2024SA308755:02261463