chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.0
Sex: M
Vaccine: HIBV
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: received an ACT-HIB vaccine on 14Mar2023 that expired on 05Mar2023 with no reported adverse event; Initial information received on 16-Mar-2023 regarding an unsolicited valid non-serious case from a consumer/non-hcp.  This case involves a 1-year-old male patient who received HIB (PRP/T) VACCINE [ACT-HIB] on 14-Mar-2023 that expired on 05-Mar-2023 with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant: PCV 13.   On 14-Mar-2023, the patient received suspect HIB (PRP/T) VACCINE powder and solvent for solution for injection at an unknown dose (lot UJ649AAA, expiry date: 05-Mar-2023) via intramuscular route in the thigh nos for immunisation.  On 14-Mar-2023 the patient received an act-hib vaccine that expired on 05-Mar-2023 with no reported adverse event (expired product administered, same day latency). The caller asks if the dose is valid, if he should be revaccinated, and if so, when.  Action taken: Not applicable.  Outcome: Unknown.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 0.17
Sex: M
Vaccine: UNK
Symptoms: Medication error, No adverse event, Product preparation error
Clinical narrative: patient was administered the Hib portion of PENTACEL that was mixed with a sterile water diluent rather than the DTaP-IPV diluent,with no reported adverse event; Initial information received on 16-Mar-2023 regarding an unsolicited valid non-serious case received from an other health professional.  This case involves a 2 months old male patient and reporter reported that he was administered the hib portion of diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [pentacel (VERO)] was mixed with a sterile water diluent rather than the dtap-ipv diluent,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 hepatitis B vaccine for Immunisation; pneumococcal vaccine CONJ (pneumococcal conjugate vaccine) for Immunisation; and rotavirus vaccine (rotavirus vaccine) for Immunisation.  On 13-Mar-2023, the patient received 0.5 ml (milliliter) (dose 1) (once) of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine, suspension for injection, (strength: standard) (lot UJ678AA, expiry date: 09-Sep-2023) via intramuscular route in the right vastus lateralis for immunization.  On 13-Mar-2023, the patient was administered the hib portion of pentacel that was mixed with a sterile water diluent rather than the dtap-ipv diluent with no reported adverse event (product preparation error) (latency: same day).  No lab data were reported.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for an 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.
Age: 6.0
Sex: F
Vaccine: IPV
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: accidentally gave an expired IPOL vaccine to a patient with no reported adverse event; Initial information received on 16-Mar-2023 regarding an unsolicited valid non-serious case received from a healthcare professional.  This case involves 6 years old female patient who accidentally gave an expired poliomyelitis vaccine (inactivated) IPV (VERO) [IPOL] vaccine with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 16-Mar-2023, the patient received a standard dose 3 of suspect poliomyelitis vaccine (inactivated) IPV (VERO) Suspension for injection (lot U1A45, expiry date- 20-Feb-2023) at a dose of 0.5 ml total via intramuscular route in the left deltoid for Immunization.  On 16-Mar-2023, the patient developed a non-serious event of accidentally gave an expired poliomyelitis vaccine (inactivated) IPV (VERO) vaccine with no reported adverse event (expired product administered) (latency- same day).  It was reported, HCP who reported expired IPOL was administered to patient. She asks for appropriate follow-up. She asks is there a period of time before repeating. She asks where adverse events are listed.  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 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: 22.0
Sex: F
Vaccine: TD
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: patient received expired TENIVAC with no reported adverse event; Initial information received on 17-Mar-2023 regarding an unsolicited valid  non-serious case received from  Other Health Care Professional.  This case involves a 22 years old female patient who received expired DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [Tenivac] with no reported adverse event.  The patient's past medical history, medical treatment(s), concomitant medication(s), vaccination(s) and family history were not provided.   On 16-Mar-2023, the patient received 0.5 ml dose of suspect DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT, Suspension for injection (strength - standard, frequency - once, lot U6922AA, expiry date  - 22-Jn-2023) via intramuscular route in the deltoid NOS for prophylactic vaccination (Immunization) that was expired with no reported adverse event (expired product administered) (Latency: same day)  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 8.0
Sex: F
Vaccine: IPV
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: expired dose of IPOL was administered with no reported adverse event; Initial information was received on 17-Mar-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves 8 years old female patient who reported expired dose of ipol was administered 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 measles vaccine, MUMPS VACCINE, rubella vaccine (MMR VACCIN) for Prophylactic vaccination.  On 16-Mar-2023, the patient received 0.5 ml Total dose (once) of suspect ipv (VERO) (Suspension for Injection) (lot: U1A452M, expiry date: 20-Feb-2023) unknown strength via intramuscular route in left deltoid for Immunisation.  On 16-Mar-2023 the patient developed a non-serious event of expired dose of ipol was administered with no reported adverse event (expired product administered) same day following the administration of ipv (VERO).  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the 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: 1.08
Sex: F
Vaccine: HIBV
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: expired dose of ACTHIB was administered to a patient with no reported adverse event; Initial information received on 17-Mar-2023 regarding an unsolicited valid non-serious case received from a healthcare professional.  This case involves a 13-month-old female, to whom an expired dose of HIB (PRP/T) VACCINE [ACT-HIB] was administered 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 PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13); VARICELLA ZOSTER VACCINE (VARICELLA VACCINE); and MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) for Immunisation.  On 06-Mar-2023, the patient received a Booster dose at 0.5ml total of suspect HIB (PRP/T) VACCINE Powder and solvent for solution for injection, Strength: standard (lot number: UJ646AA, expiry date: 05-Mar-2023) via intramuscular route in Left Quad for Immunization and on the same day expired dose of acthib was administered to a patient with no reported adverse event (expired product administered).  It was reported, requesting validity information.   Action taken with HAEMOPHILUS TYPE B (HIB) VACCINE (ACT-HIB) was not applicable.  At time of reporting, the outcome was Unknown.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: MNQ
Symptoms: Immune thrombocytopenia
Clinical narrative: itp; Initial information received on 17-Mar-2023 regarding an unsolicited valid serious case from a physician.  This case involves child and unknown gender patient who experienced ITP after receiving meningococcal A-C-Y-W135 (D CONJ) vaccine [Menactra].  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.   On 10-Dec-2019, the patient received suspect meningococcal A-C-Y-W135 (D CONJ) vaccine for solution for injection at an unknown dose (lot number, expiry date: not reported) via unknown route in unknown administration site for immunization.  On 29-Dec-2019 the patient developed a serious ITP (immune thrombocytopenia) 19 days latency following the administration of meningococcal A-C-Y-W135 (D CONJ) vaccine.   Action taken: Not applicable.  Corrective treatment: Not reported.  Outcome: Unknown for the event ITP.  Seriousness criteria: Medically significant. The patient was hospitalized on the same day this event occurred.; Sender's Comments: Sanofi company comment dated 21-Mar-2023: This case involves child and unknown gender patient who experienced ITP after receiving meningococcal A-C-Y-W135 (D CONJ) vaccine [Menactra]. Additional information regarding condition at the time of vaccination, concomitant disease or risk factor excluding other predisposing etiologies, temporal association, data on individual patient would be needed for complete assessment of the case. Based upon the reported information, the role of vaccine cannot be assessed.
Age: 2.0
Sex: F
Vaccine: HIBV
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: received an expired dose of ACT-HIB with no reported adverse event; Initial information received on 17-Mar-2023 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 2-year-old female patient who received an expired dose of HIB (PRP/T) VACCINE [ACT-HIB] 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; and HEPATITIS A VACCINE INACT (HAVRIX) for Prophylactic vaccination.  On 17-Mar-2023, the patient received dose 4 at 0.5ml total of suspect HIB (PRP/T) VACCINE Powder and solvent for solution for injection (strength: standard) (lot number: UJ648ABA, expiry date: 16-Mar-2023) in unknown administration site for Immunization an expired dose of act-hib with no reported adverse event (expired product administered) (latency: same day).  It was reported, asks what the next steps are. Refunds/Credits will not be issued due to adverse events. The Patient waited 15 Minutes in the office, and nothing Happened; However, The patient had left the building before the healthcare professional (Hcp) Office Realized They Had Administered Expired.   Action taken with HAEMOPHILUS TYPE B (HIB) VACCINE (ACT-HIB) was not applicable.  At time of reporting, the outcome was Unknown.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the 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: 74.0
Sex: M
Vaccine: RAB
Symptoms: Fatigue
Clinical narrative: little tired; Initial information received on 20-Mar-2023 regarding an unsolicited valid non-serious case from a consumer/non-hcp.  This case involves a 74-year-old male patient who was little tired after receiving vaccine rabies (HDC) vaccine [Imovax Rabies].  The patient's past medical history included Rabies immunisation in 2011. The patient's past medical treatment(s), vaccination(s), concomitant medication and family history were not provided.   On 17-Mar-2023, the patient received suspect rabies (HDC) vaccine powder and solvent for suspension for injection at a dose of 1 dosage form (DF) once (lot V1D643M, expiry date: 06-Sep-2024) via unknown route in the right arm for bitten by a dog (immunisation).  On an unknown date the patient developed a non-serious little tired (fatigue) (unknown latency) following the administration of rabies (HDC) vaccine.  It was reported consumer says he had the vaccine in 2011 and wants to know if he needs to get the next dose today or can he wait until tomorrow and what happens if he doesn't get it? He has talked with an epidemiologist who said he is low risk but suggest the vaccine which is due to today. He felt a little tired but wants to know if he gets the other symptoms listed in the information provided to him how long would those symptoms last and would they be chronic? When did the vaccine come out? Is the vaccine dangerous?  Action taken: Not applicable.  Corrective treatment: Not reported.  Outcome: Unknown.
Age: 6.0
Sex: U
Vaccine: MEN
Symptoms: Medication error, No adverse event, Wrong product administered
Clinical narrative: mistakenly administered Menquadfi to a 6 year old with no reported adverse event; Initial information received on 20-Mar-2023 regarding an unsolicited valid non-serious case received from a nurse practitioner.  This case involves a 6 years old and unknown gender patient to whom meningococcal A-C-Y-W135 (T CONJ) vaccine [Menquadfi] was administered mistakenly with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant(s) and family history were not provided.   On 10-Mar-2023, the patient received an 0.5 ml (milliliter) of suspect meningococcal A-C-Y-W135 (T CONJ) vaccine, solution for injection (Strength = standard) (With unknown route, lot number, expiration and at unknown administration site) for immunization.  On 10-Mar-2023, reporter reported that mistakenly, menquadfi was administered to a 6-year-old with no reported adverse event (wrong product administered) (latency: same day).  It was also reported that Nurse practitioner reports that the 6-year-old patient has no special indications to receive MENQUADFI.  No lab data were reported.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for an 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.
Age: 68.0
Sex: F
Vaccine: FLU4
Symptoms: Dysgeusia, Pruritus, Skin swelling
Clinical narrative: having a sour taste in mouth the next day; bumps on lower extremities; itching on lower extremities; Initial information was received on 20-Mar-2023 regarding an unsolicited valid non-serious case received from a Patient.  This case involves 68 years old female patient who experienced itching on lower extremities, having a sour taste in mouth the next day and bumps on lower extremities while receiving vaccine influenza quadrival a-b high dose hv vaccine [Fluzone HIGH-DOSE QUADRIVALENT].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 16-Mar-2023, the patient received a dose of suspect influenza quadrival a-b high dose hv vaccine at dose of 0.7 ml lot number not reported via intramuscular route in the left deltoid for Immunisation.  On 16-Mar-2023 the patient developed a non-serious event of itching on lower extremities (pruritus) and bumps on lower extremities (skin swelling) following the administration of influenza quadrival a-b high dose hv vaccine.  On 17-Mar-2023 the patient developed a non-serious event of having a sour taste in mouth the next day (dysgeusia) 1 day following the administration of influenza quadrival a-b high dose hv vaccine.  Action taken with QUADRIVALENT influenza vaccine (Fluzone HIGH-DOSE QUADRIVALENT) was not applicable.  It was not reported if the patient received a corrective treatment for the events (itching on lower extremities, having a sour taste in mouth the next day, bumps on lower extremities).  At time of reporting, the outcome was Not Recovered for the event itching on lower extremities, having a sour taste in mouth the next day and bumps on lower extremities.
Age: 3.0
Sex: F
Vaccine: DTAP
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: administered an expired dose of Daptacel with no reported adverse event; Initial information received on 20-Mar-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 3 years old female patient and it was reported that administered an expired dose of diphtheria-15/tetanus/5 AC pertussis vaccine [Daptacel] 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 hepatitis A vaccine (hepatitis A) for prophylactic vaccination; HIB vaccine (HIB) for prophylactic vaccination; and measles vaccine, mumps vaccine, rubella vaccine (MMR) for prophylactic vaccination.  On 16-Mar-2023, patient was administered an expired dose of diphtheria-15/tetanus/5 AC pertussis vaccine [Daptacel] suspension for injection (batch/lot number: C5829BA and expiry date: 01-Mar-2023; strength: standard; dose: 0.5 mL) via intramuscular route in the left deltoid for immunization with no reported adverse event (expired product administered) (latency: same day).  Action taken: Not applicable.  At time of reporting, the outcome was Unknown for the event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: F
Vaccine: MNQ
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: expired dose of MENACTRA was inadvertently administered with no reported AE; Initial information was received  on 20-Mar-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves an adult female patient who stated expired dose of menactra was inadvertently administered with no reported ae after receiving meningococcal A-C-Y-W135 (D CONJ) vaccine [Menactra].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 20-Mar-2023, the patient received 0.5 ml Total (once) dose of suspect meningococcal A-C-Y-W135 (D CONJ) vaccine (Solution for injection) (lot: U7191AA, expiry date: 18-Jan-23), (unknown strength) via intramuscular route in unknown administration site for Immunisation.  On 20-Mar-2023 the patient developed a non-serious event of expired dose of menactra was inadvertently administered with no reported ae (expired product administered) same day following the administration of meningococcal A-C-Y-W135 (D CONJ) 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.  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: 1.0
Sex: M
Vaccine: HIBV
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: acthib was administered with an expired diluent with no reported adverse event; Initial information received on 20-Mar-2023 regarding an unsolicited valid non-serious case received from nurse.  This case involves a 1 years old male patient who was administered HIB (PRP/T) VACCINE [ACT-HIB] with an expired diluent 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, TETANUS VACCINE TOXOID (DTAP) and PNEUMOCOCCAL VACCINE CONJ (PNEUMOCOCCAL CONJUGATE VACCINE) both for Prophylactic vaccination.  On 14-Mar-2023, the patient received a dose of 0.5 ml dose 3 of suspect ACT-HIB (Powder and solvent for solution for injection) (Lot: HIB: UJ646AA, DILUENT: U7251AA, Expiry date: HIB: 01APR2023, DILUENT: 05MAR2023) (strength: standard; frequency: once) via intramuscular route in the right thigh for immunization.  On 14-Mar-2023 the patient was administered ACT-HIB with an expired diluent with no reported adverse event (expired product administered) (latency: same day).  It was reported that Caller with question on whether dose needs repeating.  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.   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: 1.25
Sex: M
Vaccine: UNK
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: the PENTACEL dose was given yesterday 20Mar2023, but it expired on 25Feb2023 with no reported adverse event; Initial information received on 22-Mar-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 15 months old male patient and reporter reported the Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine [Pentacel (Vero)]  dose was given yesterday 20mar2023, but it expired on 25feb2023 with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 20-Mar-2023, the patient received 0.5 ml dose of suspect Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine Suspension for injection (Expiry date: 25-Feb-2023) (Frequency-Once) (Strength- Standard) (with an unknown lot number) via intramuscular route in the right thigh for Immunisation.  On 20-Mar-2023, the patient received Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine dose was given yesterday 20mar2023, but it expired on 25feb2023 with no reported adverse event (expired product administered) (Latency: same day).  It was reported, This situation is reported as a medication error due to patient receiving an expired dose of PENTACEL.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event the pentacel dose was given yesterday 20mar2023, but it expired on 25feb2023 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.
Age: 11.0
Sex: F
Vaccine: HEPA
Symptoms: Asthenia, Blood glucose normal, Dizziness, Injection site pain, Syncope
Clinical narrative: Site: Pain at Injection Site-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: PT FELT DIZZY AND WEAK, DENIES ANY PAIN AT THE INJECTION SITE OR REDNESS OR SWELLING.-Mild, Systemic: Weakness-Mild, Additional Details: PATIENT FELT DIZZY AFTER 5 MINUTES OF VACCINATION AND SHE ALMOST MADE HERSELF SLIDE DOWN THE FLOOR, NO HEAD INJURY, SHE REMAINED CONCIOUS FELT WEAK, HELPED HER TO SIT ON THE BED, WITHIN FEW SECONDS SHE FELT BETTER, HER VITAL SINS WERE STABLE BP -89/60 PULSE- 77 O2 SAT -98, SHE STATED SHE WAS GOO TO GO, FELT BETTER DENIES ANY DIZZINESS ABLE TO STAND UP BY HER SELF, PT FELT DIZZY AGAIN ON THE ENTRANCE BACK TO CLINIC, EMS ACTIVATED, VS STABLE BS -125 EMS EVALUATED HER AND SENT HER HOME.
Age: 11.0
Sex: F
Vaccine: HEPA
Symptoms: Unresponsive to stimuli
Clinical narrative: Site: Pain at Injection Site-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: PT FELT DIZZY AND WEAK, DENIES ANY PAIN AT THE INJECTION SITE OR REDNESS OR SWELLING.-Mild, Systemic: Weakness-Mild, Additional Details: PATIENT FELT DIZZY AFTER 5 MINUTES OF VACCINATION AND SHE ALMOST MADE HERSELF SLIDE DOWN THE FLOOR, NO HEAD INJURY, SHE REMAINED CONCIOUS FELT WEAK, HELPED HER TO SIT ON THE BED, WITHIN FEW SECONDS SHE FELT BETTER, HER VITAL SINS WERE STABLE BP -89/60 PULSE- 77 O2 SAT -98, SHE STATED SHE WAS GOO TO GO, FELT BETTER DENIES ANY DIZZINESS ABLE TO STAND UP BY HER SELF, PT FELT DIZZY AGAIN ON THE ENTRANCE BACK TO CLINIC, EMS ACTIVATED, VS STABLE BS -125 EMS EVALUATED HER AND SENT HER HOME.
Sex: F
Vaccine: COVID19
Symptoms: Bradycardia, Cardiac monitoring abnormal, Chest discomfort, Dizziness, Electrocardiogram abnormal
Clinical narrative: About a week or 2 after receiving the 2nd Moderna COVID-19 vaccine, I began having episodes of bradycardia with lightheadedness and heaviness/pressure in my chest and bilateral sides of my neck followed by tachycardia with multi focal PVCs. My heart rate has been as low as 36 bpm and as high as 170-180 bpm. I was seen by a provider a couple of weeks later when the symptoms had not resolved. I have been seen by my provider on several occasions, a cardiologist, have had labs drawn, and worn a cardiac monitor. I continue to have these same episodes without resolution and the symptoms are occurring more frequently.
Sex: F
Vaccine: COVID19
Symptoms: Heart rate decreased, Heart rate increased, Laboratory test, Musculoskeletal discomfort, Tachycardia
Clinical narrative: About a week or 2 after receiving the 2nd Moderna COVID-19 vaccine, I began having episodes of bradycardia with lightheadedness and heaviness/pressure in my chest and bilateral sides of my neck followed by tachycardia with multi focal PVCs. My heart rate has been as low as 36 bpm and as high as 170-180 bpm. I was seen by a provider a couple of weeks later when the symptoms had not resolved. I have been seen by my provider on several occasions, a cardiologist, have had labs drawn, and worn a cardiac monitor. I continue to have these same episodes without resolution and the symptoms are occurring more frequently.
Sex: F
Vaccine: COVID19
Symptoms: Ventricular extrasystoles
Clinical narrative: About a week or 2 after receiving the 2nd Moderna COVID-19 vaccine, I began having episodes of bradycardia with lightheadedness and heaviness/pressure in my chest and bilateral sides of my neck followed by tachycardia with multi focal PVCs. My heart rate has been as low as 36 bpm and as high as 170-180 bpm. I was seen by a provider a couple of weeks later when the symptoms had not resolved. I have been seen by my provider on several occasions, a cardiologist, have had labs drawn, and worn a cardiac monitor. I continue to have these same episodes without resolution and the symptoms are occurring more frequently.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Dermatitis atopic, Rash
Clinical narrative: Patient reports her atopic dermatitis symptoms started "a few weeks" after her Moderna COVID-19 booster, which was administered on 11/11/2021. Pt states symptoms started under her armpits and face then spread to her hands.
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram abnormal, Condition aggravated, Dyspnoea, Pulmonary thrombosis, Thrombosis
Clinical narrative: I couldn't breathe. I went to the Er. I was diagnosed with massive blood clots in my lungs and legs. I had no health issues for blood clots prior to this diagnosis. I was told later by the hospital doctor that this was a life threatening event. I am still recovering 03/22/23 and have not regained my total health.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Incorrect product formulation administered, Pain in extremity
Clinical narrative: Patient was administered Moderna monovalent 1st dose for the primary series on X/XX/2023 with lot# 015b22a. Patient was administered in the left arm 0.5 ml IM. The lot expired on XX/XX/2023 and hadn't been removed from inventory and was administered to the patient. This was discovered on XX/XX/2023 and follow up with patient reported only normal injection site reactions such as sore arm and fatigue for a few days. There were no major adverse events related to the vaccine administration. There were no major adverse events related to the vaccine administration. This was discovered on XX/XX/2023 and follow up with patient reported only normal injection site reactions such a sore arm and fatigue for a few days.
Sex: U
Vaccine: RV1
Symptoms: Infant irritability, Pyrexia, Vomiting, Wrong product administered
Clinical narrative: I had taken my child to her 4 month well baby appointment at a new pediatrician. The nurse was supposed to carefully examine the immunization records. However, it appears she did not. My baby had taken the RotaTeq vaccine on January 06 and was told to be sure she took RotaTeq again on February 8. I had this schedule to be done and to my dismay an error was made. The nurse gave my baby Rotarix instead. The doctor and the nurse have not called me back to explain how this occurred and the did have Rota Teq in the office. my baby has been fussy, running a fever and very irritable. They have her scheduled for 6 moths shots but she will not even be 6 months at that time. (March 31).She also requires and additional rotavirus vaccine by 24 weeks which was not accounted for nor schedule for, I am quite disturbed as my baby has vomited all day and this vaccine did not agree as well with her as the Rota Teq did. I do not trust this nurse anymore as she tried to downplay this event and never called me back nor did the main provider. I checked the state immunization registry prior to her appointment and afterwards as I noticed a variance (which I mentioned in office) in the two oral vaccines. The nurse should have paid more attention to which vaccine was to be used and she should have used the correct vaccine.
Age: 69.0
Sex: M
Vaccine: COVID19-2
Symptoms: Biopsy skin abnormal, Laboratory test, Malignant melanoma, Neck mass
Clinical narrative: On 4 October 2022 I received a Pfizer Omicron COVID booster vaccine. On 10 November 2022, I noticed a lump under the skin at the frontal base of my neck. The tissue was removed surgically on 20 January 2023. The tissue was identified as a Melanoma by lab using Next Generation sequencing. Of note is that the tissue location was just under where I had a skin Melanoma removed in April 2013. I receive regular examinations from my Dermatologist every six months since 2013 and until the recurrence appeared after my COVID booster, I had been cancer free. I believe there may be a link between the Pfizer Omicron COVID booster vaccine received on 4 October 2022 and the recurrence of Melanoma observed on 10 November 2022.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Toe amputation, Wheelchair user
Clinical narrative: Patient was admitted to their local hospital on 3/9/2023 for concern of a toe infection. Patient previously had part of his second toe, left, amputated on 2/4/2023. During this admission on 3/9/2023, patient had the rest of his second toe, left, surgically removed on 3/10/2023. Patient was discharged on 3/12/2023. Patient was discharged with antibiotics for two weeks: Doxycycline Hyclate 100 mg BID and Cefadroxil 1000 mg BID. Patient is recovering at home, and reported feeling well from the surgery. Patient uses a scooter to help him move around. Patient was vaccinated with the Janssen Ad26.CoV2.S vaccine on 2/21/2023. At the time of Day 28 call, patient denied any symptoms of fever, cough, sore throat, headache, and no change in taste and/or smell. External medical records have not yet been received at time of event reporting--no labs to report.
Age: 52.0
Sex: F
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: no additional AEs; PROQUAD given instead of MMR II on 2/22/2023 to 52 year old patient. Caller reports that this was supposed to be patient's 2nd dose of MMR II.; PROQUAD given instead of MMR II on 2/22/2023 to 52 year old patient.; This spontaneous report was received from registered nurse and refers to a 52-year-old female patient. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On an unknown date, the patient was vaccinated with 1st dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection, administered for prophylaxis (anatomical location, lot #, expiry date, and route of administration were not provided).  On 22-FEB-2023, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant human albumin (rHA) (PROQUAD) subcutaneous injection, 0.5 milliliter/once, lot #W028567, expiration date: 06-MAR-2024, administered for prophylaxis (anatomical location, and route of administration were not provided) instead of 2nd dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (wrong product administered). The measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant human albumin (rHA) (PROQUAD) was given to 52-year-old patient (product administered to patient of inappropriate age).  There were no adverse events reported (no adverse event).
Sex: F
Vaccine: PNC15
Symptoms: Needle issue, No adverse event, Poor quality device used, Syringe issue
Clinical narrative: No additional AE; syringe broke off at the base where you screw on the needle/ the entire luer lock snapped off.; Poor quality device used; This spontaneous report was received from a medical assistant and refers to a female patient of unknown age. The patient's medical history, concurrent conditions and concomitant medications were not reported.   On 28-FEB-2023, the patient was vaccinated with pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) injection, 0.5 ml, lot #W027250, expiration date: 09-JUL-2024, administered for prophylaxis (strength and route of administration were not provided). After administration the nurse attempted to put the safety on the needle and the entire luer lock snapped off (reported also as when I was giving a child one it broke off) (syringe issue) (poor quality device used). No adverse event reported (no adverse event).  This is one of several reports from the same reporter. ; Sender's Comments:  US-009507513-2303USA000534:
Sex: F
Vaccine: PNC15
Symptoms: Accidental exposure to product, No adverse event
Clinical narrative: No additional AE; Inadvertent exposure to vaccine; Accidental needle stick; This spontaneous report was received from a medical assistant and refers to a female patient of unknown age. The patient's medical history, concurrent conditions and concomitant medications were not reported.   On 28-FEB-2023, the patient's daughter was vaccinated with pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) injection, 0.5 ml, lot #W027250, expiration date: 09-JUL-2024, administered for prophylaxis (strength and route of administration were not provided), after administration the nurse attempted to put the safety on the needle and the entire luer lock snapped off. The needle that was still attached to the luer lock punctured the patient, who was holding her child who had just received the vaccine, in the leg (accidental exposure to product) (injury associated with device). No additional adverse event reported (no adverse event).  This is one of several reports from the same reporter. ; Sender's Comments:  US-009507513-2303USA000493:
Age: 31.0
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE; VAQTA was administered to a patient 8 hours after expiration; This spontaneous report as received from a medical assistant and refers to a patient of unknown age and gender. No medical history, concurrent conditions nor concomitant medications were reported.  On 03-MAR-2023, the patient was vaccinated with Hepatitis A Vaccine, Inactivated (VAQTA) (1 mL, lot # W004865, which was verified as valid upon internal review, expiration date 02-MAR-2023, route of administration and anatomical location were not provided) for prophylaxis. A dose of Hepatitis A Vaccine, Inactivated (VAQTA) was administered to a patient one day after expiration (Expired vaccine used). Dose did not undergo any temperature excursions. No additional adverse event (AE). No product quality complaint (PQC).  Follow-up information was received from medical assistant on 21-MAR-2023.  Reporter refers to a 31-year-old female, therefore this is no longer non-valid case.   On 03-MAR-2023, Hepatitis A Vaccine, Inactivated (VAQTA) was administered intramuscularly to a patient 8 hours after expiration. The patient was fine.
Sex: F
Vaccine: HIBV, PPV, PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: PATIENT WAS GIVEN THE VACCINE DUE TO A LOW TITER TO IT BUT WE REALIZED AFTER THE FACT THAT IT EXPIRED 01/22/2023 / SHOULD WE ADMINISTER AGAIN / PATIENT IS FINE NO ISSUES; PATIENT WAS GIVEN THE VACCINE DUE TO A LOW TITER TO IT BUT WE REALIZED AFTER THE FACT THAT IT EXPIRED 01/22/2023 / SHOULD WE ADMINISTER AGAIN / PATIENT IS FINE NO ISSUES; This spontaneous report has been received from healthcare professional via Pfizer and Genaes, referring to a 9-year-old White hispanic or latino female patient.  The patient's medical history was not reported. The patient's concurrent conditions included down's syndrome. Concomitant therapies were not reported. The patient had no known allergies.  On unknown dates, the patient was administered patient started therapy with pneumococcal vaccine and Haemophilus b (hib) vaccine vaccine (formulation, strength, dose, vaccination scheme, route of administration and anatomical location, indication, lot number and expiration date were not provided)  On 16-MAR-2023 09:45, the patient was vaccinated with an expire dose pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) syringe injection, administered for prophylaxis in the thigh (lot #U018632 confirmed to be valid, expiration date not reported but stablished as 11-JAN-2023; strength, and route of administration were not provided) (ex); and at an unknown hour, hib vaccine conj (tet tox) (ACTHIB), dose number 6, lot# UJ756AA, administered in the right leg (strength, formulation, expiry date, route of administration, and indication were not provided). The patient was administered those vaccines as experienced on an unspecified date a low titer (antibody test negative). As the pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) vaccines was administered after expire date the reported inquired if the vaccine should administer again. It was reported also that the patient was fine, no issues. The outcome of the event was not reported.  The causality assessment between the suspect therapies and the event was not provided.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AEs; an expired dose of MMR-II was given to a 12 month old; This spontaneous report as received from a Nurse prescriber via a Company representative refers to a 12 month old patient of unknown gender.     No pertinent medical history, concurrent conditions, drug reactions, allergies or concomitant therapies were provided.  On an unknown date  in 2023, the patient was vaccinated with an  expired dose of  measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) expiration date: 26-FEB-2023 (expired product administered) for prophylaxis (dosage schedule, route, anatomical location and lot number and were not reported).  No additional adverse events were reported.
Sex: F
Vaccine: HPV9
Symptoms: No adverse event, Therapeutic response unexpected
Clinical narrative: Patient who had presented with 'HPV infection, warts on face and hands' was administered GARDASIL 9 on unknown date with, following Corresponding GARDASIL 9 administration, Corresponding Patient's 'warts cleared up' / 'infection cleared up with; This spontaneous report was received from a medical doctor and refers to a female.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On unknown date, the patient had presented human papillomavirus infection (HPV), warts on face and hands. Then on unknown date, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection(strength, lot #, expiry date, and route of administration were not provided) administered for prophylaxis. Following hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) administration, patient warts cleared up and infection cleared up within 3 months. On unknown date, the patient expirienced unexpected therapeutic benefit. At the time of the report, the patient had the human papillomavirus infection (HPV), warts on face and hands lested for 3 years. Caller was unable to further clarify these statements at current call time. No additional adverse event (AE) was reported and no further information provided.
Sex: U
Vaccine: MMR, TTOX, VARZOS
Symptoms: Brain stem syndrome, Immunisation reaction, Immunoglobulin therapy, Myelin oligodendrocyte glycoprotein antibody-associated disease, Plasmapheresis
Clinical narrative: Vaccine induced Myelin oligodendrocyte glycoprotein antibody-associated disease; Literature Report:   This literature marketed report has been received from the authors of the published literature article entitled as above regarding a late 30's patient of unknown gender, who was part of a study that evaluate the prevalence and clinical characteristics iatrogenic central nervous system (CNS) inflammatory events of a total of 27 patients in a tertiary neuroimmunology clinic over five years from January 2017 and December 2021. The patient's pertinent medical history, previous drug reactions or allergies and concomitant medications were not provided. The patient did not have any other autoimmune disease, nor cancer history.  On an unknown date, the patient was vaccinated with tetanus vaccine; measles, mumps, and rubella (manufacturer unknown) and varicella-zoster vaccine (manufacturer unknown) (doses, vaccine schemes, routes, lot numbers and expiration dates were not provided).   After 2. 5 weeks of the last dose of pembrolizumab, the patient experienced vaccine- induced myelin oligodendrocyte glycoprotein antibody-associated disease (MOGAD) with concomitant brainstem and spinal motor attack. The Naranjo Adverse Drug Reaction Probability Scale result was 7 and was used to score the probability of iatrogenicity. Treatment with plasma exchange (PLEX) and Intravenous Immunoglobulin (IVIg) had full response. The final disease course was reported as monophasic. The outcome was not provided.  The causality assessment between the event and the suspect vaccines was considered to be related.  Upon internal review, the event vaccine- induced myelin oligodendrocyte glycoprotein antibody-associated disease (MOGAD) was determined to be medically significant.   A copy of the published article is attached as further documentation of the patient's experience.  This is one of several reports derived from the same literature article.; Sender's Comments:  US-009507513-2303USA007194:MSD