chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 52.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash, Rash erythematous
Clinical narrative: pt developed erythematous rash under L axilla (received vaccine in LUE) several days after vaccination, which over the course of the last week, has been spreading to other parts of body including R axilla, chest, waist
Age: 80.0
Sex: M
Vaccine: RSV
Symptoms: Blood test, Chest X-ray, Dehydration, Electrocardiogram, Incontinence
Clinical narrative: Total incontinence (2 minutes), nausea (2 hours), vomiting (2twice), low oxygen (2 days), dehydration (8
Age: 80.0
Sex: M
Vaccine: RSV
Symptoms: Nausea, Oxygen saturation decreased, Vomiting
Clinical narrative: Total incontinence (2 minutes), nausea (2 hours), vomiting (2twice), low oxygen (2 days), dehydration (8
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Patient developed redness, warmth, swelling, and pain in her left arm starting  around 2:00 AM on 2/4/24 after receiving the vaccine around 1:00PM on 2/3/24.  The symptoms have remained pretty constant (no worsening or improvement) as of 7:30 PM on 2/4/24.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Induration, Rash erythematous, Skin warm
Clinical narrative: Hot, red, hard rash on skin, 5 inch diameter
Age: 80.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site rash
Clinical narrative: Patient reported rash at the site of injection
Age: 18.0
Sex: F
Vaccine: HEP
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: Patient is 18 years old. Engerix-B is indicated for 20 years of age & older.  She received 1st dose of Engerix-B on 1/2/24. She returned to our pharmacy for 2nd dose on 2/3/24- Error was caught. I researched interchangeability with Heplisav-B. According to guidelines, patient should received 2nd dose at 4 weeks, then 3rd dose 8 weeks from original dose. Explained error to patient & inquired if she had experienced any adverse effects. She verbalized that she has been doing fine. Adminstered 2nd dose on 2/3/24 & patient will return for 3rd dose on 3/2/24
Age: 1.0
Sex: M
Vaccine: PNC20
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: Swollen and red leg, painful
Age: 57.0
Sex: M
Vaccine: RSV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Arexy vaccine administered to 57 year old patient. This vaccine is indicated for patients 60 and over.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Immediate post-injection reaction, Impaired quality of life, Myelitis transverse, Paralysis
Clinical narrative: paralyzed from the chest down; contracted Transverse Myelitis; the way your vaccine killed my life; This serious case was reported by a consumer via sales rep and described the occurrence of paralysis in a 60-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Additional patient notes included the patient was extremely healthy and fit. The patient still swam competitively and was more active than the normal 60 year old.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced paralysis (Verbatim: paralyzed from the chest down) (serious criteria GSK medically significant), myelitis transverse (Verbatim: contracted Transverse Myelitis) (serious criteria GSK medically significant) and quality of life decreased (Verbatim: the way your vaccine killed my life). The outcome of the paralysis, myelitis transverse and quality of life decreased were not reported.   The reporter considered the paralysis, myelitis transverse and quality of life decreased to be possibly related to Shingrix.     The company considered the paralysis, myelitis transverse and quality of life decreased to be possibly related to Shingrix.   Additional Information: GSK Receipt Date:30-JAN-2024 The reporter was a GSK/ViiV field staff employee. The patient had a Shingrix vaccination in 2019 during a routine doctors exam. Immediately after the vaccine, the patient contracted Transverse Myelitis and have been paralyzed from the chest down ever since. Doctors correctly identified Shingrix as the reason and the patient had an attorney talking to GlaxoSmithKline for years and years. GlaxoSmithKline's attorneys admit liability, but it was more important to them to make the patient go away than to make up for the way. The patient stated that GlaxoSmithKline's vaccine killed their life, so the patient have been on the merry-go-round of attorney back and forth while living as best as they could.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Bladder catheterisation, Demyelination, Diplegia, Hypoaesthesia, Loss of personal independence in daily activities
Clinical narrative: paralyzed from the chest down; contracted Transverse Myelitis; the way your vaccine killed my life; This serious case was reported by a consumer via sales rep and described the occurrence of paralysis in a 60-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Additional patient notes included the patient was extremely healthy and fit. The patient still swam competitively and was more active than the normal 60 year old.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced paralysis (Verbatim: paralyzed from the chest down) (serious criteria GSK medically significant), myelitis transverse (Verbatim: contracted Transverse Myelitis) (serious criteria GSK medically significant) and quality of life decreased (Verbatim: the way your vaccine killed my life). The outcome of the paralysis, myelitis transverse and quality of life decreased were not reported.   The reporter considered the paralysis, myelitis transverse and quality of life decreased to be possibly related to Shingrix.     The company considered the paralysis, myelitis transverse and quality of life decreased to be possibly related to Shingrix.   Additional Information: GSK Receipt Date:30-JAN-2024 The reporter was a GSK/ViiV field staff employee. The patient had a Shingrix vaccination in 2019 during a routine doctors exam. Immediately after the vaccine, the patient contracted Transverse Myelitis and have been paralyzed from the chest down ever since. Doctors correctly identified Shingrix as the reason and the patient had an attorney talking to GlaxoSmithKline for years and years. GlaxoSmithKline's attorneys admit liability, but it was more important to them to make the patient go away than to make up for the way. The patient stated that GlaxoSmithKline's vaccine killed their life, so the patient have been on the merry-go-round of attorney back and forth while living as best as they could.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Monoplegia, Multi-organ disorder, Musculoskeletal disorder
Clinical narrative: paralyzed from the chest down; contracted Transverse Myelitis; the way your vaccine killed my life; This serious case was reported by a consumer via sales rep and described the occurrence of paralysis in a 60-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Additional patient notes included the patient was extremely healthy and fit. The patient still swam competitively and was more active than the normal 60 year old.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced paralysis (Verbatim: paralyzed from the chest down) (serious criteria GSK medically significant), myelitis transverse (Verbatim: contracted Transverse Myelitis) (serious criteria GSK medically significant) and quality of life decreased (Verbatim: the way your vaccine killed my life). The outcome of the paralysis, myelitis transverse and quality of life decreased were not reported.   The reporter considered the paralysis, myelitis transverse and quality of life decreased to be possibly related to Shingrix.     The company considered the paralysis, myelitis transverse and quality of life decreased to be possibly related to Shingrix.   Additional Information: GSK Receipt Date:30-JAN-2024 The reporter was a GSK/ViiV field staff employee. The patient had a Shingrix vaccination in 2019 during a routine doctors exam. Immediately after the vaccine, the patient contracted Transverse Myelitis and have been paralyzed from the chest down ever since. Doctors correctly identified Shingrix as the reason and the patient had an attorney talking to GlaxoSmithKline for years and years. GlaxoSmithKline's attorneys admit liability, but it was more important to them to make the patient go away than to make up for the way. The patient stated that GlaxoSmithKline's vaccine killed their life, so the patient have been on the merry-go-round of attorney back and forth while living as best as they could.
Age: 84.0
Sex: M
Vaccine: COVID19-2
Symptoms: Rash, Swelling, Tongue disorder, Urticaria
Clinical narrative: Patient developed rash hives, swelling and thick tongue hours after vaccine received. Sought care adn received prescription for prednisone as a result
Sex: F
Vaccine: RSV
Symptoms: Exposure during pregnancy, Product use issue
Clinical narrative: Pharmacist gave Arexvy outside of indication; Pharmacist gave Arexvy outside of indication.; This non-serious prospective pregnancy case was reported by a pharmacist via sales rep and described the occurrence of vaccine exposure during pregnancy in a female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 28-SEP-2023, the patient received the 1st dose of Arexvy (unknown arm). On 28-SEP-2023, an unknown time after receiving Arexvy, the patient experienced vaccine exposure during pregnancy (Verbatim: Pharmacist gave Arexvy outside of indication) and off label use (Verbatim: Pharmacist gave Arexvy outside of indication.). The outcome of the vaccine exposure during pregnancy and off label use were unknown.   Pregnancy exposure: Pregnancy Exposure (Arexvy): Trimester unknown Pregnancy Outcome: Pregnancy was ongoing   Additional Information: GSK Receipt Date: 26-JAN-2024 The reporter reported that the health safety information was a medical error. Reporter gave Arexvy outside of indication, which led to off label use. Vaccine was given for maternal purposes, which led to vaccine exposure during pregnancy. The reporter consented to follow-up.
Age: 68.0
Sex: M
Vaccine: FLUA4
Symptoms: Injection site pain, Myalgia, Product administered at inappropriate site
Clinical narrative: The shot was given in the upper back part of my arm (unusual place to give a shot ) I know it would be sore awhile , but when it went past 2 weeks I was concerned. I was told to go to my Doctor I did he prescribe Inflammatory meds. after a week still hurting then Doctor sent me to Orthopedic Doctor were I received Cortisone shot and still hurting in my muscle and bicep.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vision blurred
Clinical narrative: I received my 6th Covid vaccine on 01/27/24, @ 3:45 PM. And, @ 4:05 PM, I had bilateral blurred vision for 20-minutes, which then alternated w/ normal vision until 5:00 PM, when my vision became normal again. There were no other SXS.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cardiac pacemaker evaluation, Echocardiogram, Ophthalmic scan, Ultrasound Doppler, Vision blurred
Clinical narrative: I received my 6th Covid vaccine on 01/27/24, @ 3:45 PM. And, @ 4:05 PM, I had bilateral blurred vision for 20-minutes, which then alternated w/ normal vision until 5:00 PM, when my vision became normal again. There were no other SXS.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Abdominal distension, Peripheral swelling
Clinical narrative: my legs swollen; my abdominal swollen/swelling of the lower body plus the abdomen; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PERIPHERAL SWELLING (non-serious), outcome "unknown", described as "my legs swollen"; ABDOMINAL DISTENSION (non-serious), outcome "unknown", described as "my abdominal swollen/swelling of the lower body plus the abdomen".  Additional information: Caller advised he has had the very 1st Pfizer Covid-19 vaccine and the booster. He would like to know what the side effects are, was specifically asking for swelling of the lower body plus the abdomen as he experienced these months after getting vaccinated. Consumer stated, "I have been having effects and I do not know if the effects are from the Pfizer vaccine or not, my legs swollen, my abdominal swollen and stuff like that, is that any of the side effects of it?"  Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400027643 same patient, different doses, same event;
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: My hair has begun to be thinning; 3pills in the morning and 3 pills at night for 5 days; This is a spontaneous report received from a Nurse.  An 80-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Sep2023 as dose 1, single (Lot number: Unknown) for covid-19 immunisation; nirmatrelvir, ritonavir (PAXLOVID), (Lot number: Unknown) at 3pills in the morning and 3 pills at night for 5 days, oral for covid-19; pneumococcal vaccine (PNEUMOCOCCAL VACCINE), in Sep2023 as dose number unknown, single (Lot number: Unknown) for immunisation; rsv vaccine (RSV VACCINE), in Sep2023 as dose number unknown, single (vacuna gripe) beginning of september (Lot number: Unknown) and in Sep2023 as dose number unknown, single (vacuna gripe) end of september (Lot number: Unknown) for immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: FARXIGA. The following information was reported: ALOPECIA (non-serious), outcome "unknown", described as "My hair has begun to be thinning"; INCORRECT DOSE ADMINISTERED (non-serious), outcome "unknown", described as "3pills in the morning and 3 pills at night for 5 days". The action taken for nirmatrelvir, ritonavir was unknown.  Additional information: Patient was finishing her last bout with COVID and Paxlovid and her hair has begun to be thinning. She was wondering if it could be from the Paxlovid or could be from the COVID virus itself or if it could be from the vaccine.   Batch/lot number is not provided, and it cannot be obtained.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Alopecia, Incorrect dose administered
Clinical narrative: My hair has begun to be thinning; 3pills in the morning and 3 pills at night for 5 days; This is a spontaneous report received from a Nurse.  An 80-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Sep2023 as dose 1, single (Lot number: Unknown) for covid-19 immunisation; nirmatrelvir, ritonavir (PAXLOVID), (Lot number: Unknown) at 3pills in the morning and 3 pills at night for 5 days, oral for covid-19; pneumococcal vaccine (PNEUMOCOCCAL VACCINE), in Sep2023 as dose number unknown, single (Lot number: Unknown) for immunisation; rsv vaccine (RSV VACCINE), in Sep2023 as dose number unknown, single (vacuna gripe) beginning of september (Lot number: Unknown) and in Sep2023 as dose number unknown, single (vacuna gripe) end of september (Lot number: Unknown) for immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: FARXIGA. The following information was reported: ALOPECIA (non-serious), outcome "unknown", described as "My hair has begun to be thinning"; INCORRECT DOSE ADMINISTERED (non-serious), outcome "unknown", described as "3pills in the morning and 3 pills at night for 5 days". The action taken for nirmatrelvir, ritonavir was unknown.  Additional information: Patient was finishing her last bout with COVID and Paxlovid and her hair has begun to be thinning. She was wondering if it could be from the Paxlovid or could be from the COVID virus itself or if it could be from the vaccine.   Batch/lot number is not provided, and it cannot be obtained.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE; HCP stated that MMR II was administered on 12/11/2023 and the expiration date was 10/2023; This spontaneous report has been received from a nurse, regarding a patient with unknown age and gender. The patient's concurrent condition, pertinent medical history, previous drug reactions or allergies and concomitant medications were not reported.  On 11-DEC-2023, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant human albumin [rHA]) (M-M-R II) injection (lot number was reported as w034714, expiration date was reported as October 2023, but upon internal validation was 18-OCT-2023, dose, frequency, anatomical location and route of administration were not reported) for prophylaxis (expired product administered). No reported signs/symptoms of adverse effects. No reported adverse effects. No additional adverse event (AE) (no adverse event).
Sex: U
Vaccine: HEP
Symptoms: Circumstance or information capable of leading to medication error, No adverse event, Product leakage, Underdose
Clinical narrative: No additional AEs; leakage of vaccine; leakage of vaccine; This spontaneous report has been received from a medical assistant, regarding a patient with unknown age and gender. The patient's concurrent condition, pertinent medical history, previous drug reactions or allergies and concomitant medications were not reported.  On 31-JAN-2024, the patient was vaccinated with hepatitis b vaccine (recombinant) (thimerosal free) (RECOMBIVAX HB) intramuscular injection (0.5 milliliter (ml), lot number X021477 has been verified to be a valid lot number and expiration date was 18-MAY-2026, frequency and anatomical location were not reported) intramuscularly for prophylaxis.   On 31-JAN-2024, the patient moved during administration of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) resulting in leakage of vaccine (product leakage, incorrect dose administered). No additional adverse event (AE) (no adverse event).
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE; ROTATEQ with expiration date of 12/10/2023 was administered on 01/18/2024; This spontaneous report has been received from a medical assistant, regarding a patient with unknown age and gender. The patient's concurrent condition, pertinent medical history, previous drug reactions or allergies and concomitant medications were not reported.  On 18-JAN-2024, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid (lot number 1912561 has been verified to be a valid lot number and expiration date was 10-DEC-2023, dose, frequency and anatomical location were not reported) orally for prophylaxis (expired product administered). No reported signs/symptoms of adverse effects. No additional adverse event (AE) (no adverse event).
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Circumstance or information capable of leading to medication error, Underdose
Clinical narrative: was fighting off the nurse who was administering it; she did not even get half of the dose; This spontaneous report was received from a nurse referring to a 4-year-old male patient (conflicting information, also reported as female). The patient's medical history, historical drugs, past drug reactions or allergies, concurrent conditions, and concomitant drugs were not reported.   On 30-JAN-2024, the patient was vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) injection (strength, dose, route of administration, lot#, and expiration date were not reported) in the patient's arm by a nurse for prophylaxis.  During the administration, the patient was fighting off the nurse who administered it, and the needles slipped from the patient's arm, so the patient did not even get half of the dose (incorrect dose administered). The patient was not injured. The outcome of the events above was not reported. The action taken with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) regarding the event was not applicable. The causal relationship between the event and Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) was unknown.
Sex: U
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, COVID-19 immunisation, SARS-CoV-2 test, Vaccination failure
Clinical narrative: CONFIRMED CLINICAL VACCINATION FAILURE; REVACCINATION WITH DIFFERENT COVID 19 VACCINE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a consumer by a Business partner (Pfizer Inc.) on 24-JAN-2024 was received on 24-JAN-2024 and concerned a patient of unspecified age and sex. Initial information was processed along with additional information received on 24-JAN-2024 01-FEB-2024 and 02-FEB-2024. The patient's height, and weight were not reported. The patient's concurrent conditions included: hypothyroidism, and allergy. The patient t received vaccination with covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, intramuscular, batch number was not reported) dose was not reported, administered on 11-APR-2021 for covid-19 prophylaxis. Non-company suspect vaccine included: tozinameran (Dose number in series 1) (form of admin, route of admin, and batch number were not reported) dose was not reported, administered on 17-NOV-2023 to Left Arm, and dose was not reported, administered on 01-OCT-2022 to Left Arm for covid-19 prophylaxis. ; and elasomeran (Dose number in series 1)(form of admin, route of admin, and batch number were not reported) dose was not reported, administered on 28-OCT-2021 for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Concomitant medications included levothyroxine, and vitamins nos.  On JAN-2024, Laboratory data included: COVID-19 virus test Tested positive again with onset of new symptoms. On 19-JAN-2024, following vaccination with covid-19 vaccine ad26.cov2.s, the patient experienced  confirmed clinical vaccination failure and revaccination with different covid 19 vaccine, confirmed covid-19 infection. Treatment medications (dates unspecified) included: nirmatrelvir/ritonavir. The action taken with covid-19 vaccine ad26.cov2.s, tozinameran, and elasomeran was not applicable. The outcome of the revaccination with different covid 19 vaccine, confirmed covid-19 infection and confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). The suspected product quality complaint has been confirmed to be 90000312188- the reported allegation could not be determined. a manufacturing related root cause could not be identified. based on the PQC evaluation/investigation performed.; Sender's Comments: V0: Vaccination failure. The event has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event. Specifically: SPECIAL SITUATIONS. Therefore, this event is considered inconsistent with vaccine administration.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Fatigue, Malaise, Pyrexia
Clinical narrative: DID NOT FEEL WELL; HAD FEVER; CHILLS; FATIGUE; This spontaneous report received from a pharmacist concerned a 38 year old female. The patient's weight, height, and medical history were not reported. The patient received vaccination with covid-19 vaccine ad26.cov2.s  (Dose number in series 1) (suspension for injection, intramuscular, batch number was not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. On an unspecified date in 2021, following vaccination with covid-19 vaccine ad26.cov2.s, the patient experienced did not feel well, had fever, chills, and fatigue (Dose number in series 1).  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from did not feel well, had fever, chills, and fatigue. On an unspecified date in 2021, the patient received additional non-company suspect vaccine included: (Dose number in series 2) elasomeran ( form of admin, route of admin, and batch number were not reported), dose, start therapy date were not reported for covid-19 prophylaxis.  On an unspecified date 2021, following vaccination with elasomeran, the patient experienced did not feel well, had fever, chills, and fatigue (Dose number in series 2). The action taken with elasomeran was not applicable. The patient recovered from did not feel well, had fever, chills, and fatigue. This report was non-serious.
Age: 14.0
Sex: M
Vaccine: IPV
Symptoms: No adverse event, Poor quality product administered, Product storage error
Clinical narrative: Administered of punctured IPOL that had reached Max/low temperature reached: 9.3 C for 13 mins 10 C which was not suitable for use with no adverse event; Initial information received from Regulatory Authority on 29-Jan-2024 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 14 years old male patient who was administered punctured IPV (VERO) [IPOL] that had reached max/low temperature reached: 9.3 Celsius for 13 minutes 10 Celsius which was not suitable for use with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HPV VACCINE (HUMAN PAPILLOMA VACCINE) and MENINGOCOCCAL VACCINE A/C/Y/W CONJ (TET TOX) (MENQUADFI) for Prophylactic vaccination.  On 08-Dec-2023, the patient received 0.5 mL dose of punctured IPV (VERO) [IPOL] that had reached max/low temperature reached: 9.3 Celsius for 13 minutes 10 Celsius which was not suitable for use with no adverse event (poor quality product administered) (latency: same day) (Suspension for injection) (Frequency: once) (Strength: standard) (lot W1C751M and expiry date: 18-Nov-2025) via intramuscular route in the left deltoid for Immunization.   "Reportedly: Nurse called back and added that the punctured IPOL she reported previously was administered to 49 patients.Human error: Unknown Administered: Yes."  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: 0.33
Sex: F
Vaccine: UNK
Symptoms: No adverse event, Product preparation error
Clinical narrative: administration of PENTACEL to a patient using the liquid (DTaP-IPV) component without reconstituting it with the powder (Hib) component with no adverse event; Initial information received on 29-Jan-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves administration of diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (Vero)] to a 4 months old female patient using the liquid (dtap-ipv) component without reconstituting it with the powder (hib) component with no 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 7V (CRM197) (Prevnar) for Prophylactic vaccination.  On 26-Jan-2024, the patient received 0.5 ml (dose 1) of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine, Suspension for injection (strength not reported) (lot UJ970AA and Expiration Date :23-Nov-2024)  via intramuscular route in the left thigh for Immunization using the liquid (dtap-ipv) component without reconstituting it with the powder (hib) component with no adverse event (single component of a two-component product administered) (latency: on 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: 13.0
Sex: M
Vaccine: IPV
Symptoms: Medication error, No adverse event, Poor quality product administered, Product storage error
Clinical narrative: administration of punctured IPOL with no reported adverse event; Initial information received from Regulatory Authority on 29-Jan-2024 regarding an unsolicited valid non-serious case received from a nurse.  This case involves 13 years old male patient who had administration of punctured IPV (VERO) [IPOL] 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 Prophylactic vaccination; Measles Vaccine, Mumps Vaccine, Rubella Vaccine (MMR) for prophylactic vaccination; and Varicella Zoster Vaccine (Varicella Vaccine) for Prophylactic vaccination.  On 12-Dec-2023, the patient had administration of punctured standard dose of 0.5 mL total of suspect IPV (VERO) Suspension for injection (lot W1C751M, expiry date- 18-NOV-2025) via intramuscular route in left deltoid for Immunization with no reported adverse event (poor quality product administered) (latency- same day).    Nurse called back and added that the punctured IPOL she reported previously was administered to 50 patients. Nurse also asked for recommendations if the patients need revaccination. Product/s: Punctured IPOL Reason: Unknown Max/low temperature reached: 9.3 C for 13 mins 10 C for 10 C. Human error was Unknown Administered- Yes, it was administered to 50 patients. No treatment was received.   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: 13.0
Sex: F
Vaccine: IPV
Symptoms: Medication error, No adverse event, Poor quality product administered, Product storage error
Clinical narrative: administration of punctured IPOL with no reported adverse event; Initial information received on 29-Jan-2024 regarding an unsolicited valid non-serious case received from a nurse.  This case involves 13 years old female patient who had administration of punctured IPV (VERO) [IPOL] 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; HPV vaccine; and varicella zoster vaccine (Varicella Vaccine) for immunization.  On 19-Dec-2023, the patient had administration of punctured standard dose of 0.5 mL total of suspect IPV (VERO) Suspension for injection (lot W1C751M, expiry date- 18-NOV-2025) via intramuscular route in the right deltoid for Immunization with no reported adverse event (poor quality product administered) (latency- same day).    Nurse called back and added that the punctured IPOL she reported previously was administered to 50 patients. Nurse also asked for recommendations if the patients need revaccination. Product/s: Punctured IPOL Reason: Unknown Max/low temperature reached: 9.3 C for 13 mins 10 C for 10 C. Human error was Unknown Administered- Yes, it was administered to 50 patients. No treatment was received.   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: 10.0
Sex: F
Vaccine: IPV
Symptoms: Product storage error
Clinical narrative: administration of punctured IPOL  with no reported adverse event; Initial information received from Regulatory Authority on 29-Jan-2024 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 10 years old female patient who had administration of punctured IPV (VERO) [IPOL] 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 HPV vaccine for Prophylactic vaccination; and COVID-19 vaccine for Prophylactic vaccination.  On 21-Dec-2023, the patient had administration of punctured dose (standard) of 0.5 mL total of suspect IPV (VERO) Suspension for injection (lot W1C751M, expiry date- 18-NOV-2025) via intramuscular route in the right deltoid for Immunization with no reported adverse event (poor quality product administered) (latency- same day).    Nurse called back and added that the punctured IPOL she reported previously was administered to 50 patients. Nurse also asked for recommendations if the patients need revaccination. Product/s: Punctured IPOL Reason: Unknown Max/low temperature reached: 9.3 C for 13 mins 10 C for 10 C. Human error was Unknown Administered- Yes, it was administered to 50 patients.   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: 15.0
Sex: M
Vaccine: IPV
Symptoms: Medication error, No adverse event, Poor quality product administered, Product storage error
Clinical narrative: Max/low temperature reached: 9.3 C for 13 mins 10 C for 10 C with no adverse event; puctured ipol was administered to patient post excursion with no reported adverse event; Initial information received on 29-Jan-2024 regarding an unsolicited valid  non-serious case received from a health professional.  This case involves a 15 years old female patient who was administered with puctured Ipv (Vero) [Ipol] which was exposed to max/low temperature reached: 9.3 c for 13 mins, 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 HPV VACCINE for Prophylactic vaccination.  On 18-Jan-2024, the patient received (0.5 ml once) dose of suspect Ipv (Vero), Suspension for injection, which was exposed to max/low temperature reached: 9.3 c for 13 mins, with no reported adverse event (product storage error) and (poor quality product administered) (strength: unknown) (lot: W1C751M, Expiry date: 18-Nov-2025) via intramuscular route in unknown administration site for prophylactic vaccination (immunization).  No lab data reported.  Action taken : not applicable.  At time of reporting, the outcome was Unknown for both the events.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 9.0
Sex: M
Vaccine: IPV
Symptoms: Medication error, No adverse event, Poor quality product administered, Product storage error
Clinical narrative: administration of punctured IPOL that was exposed to temperature excursion with max/low temperature reached: 9.3 c for 13 mins 10 c for 10 mins due to unknown reason with no reported adverse event; Initial information received on 29-Jan-2024 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 9 years old male patient who had administration of punctured IPV (VERO) [IPOL] that was exposed to temperature excursion with max/low temperature reached: 9.3 c for 13 mins 10 c for 10 mins due to unknown reason 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 for Prophylactic vaccination.  On 05-Jan-2024, the patient received a dose of 0.5 ml of suspect IPV (VERO) (Suspension for injection) (lot: W1C751M; expiry date: 18-Nov-2025) via intramuscular route in the left deltoid for Immunization.  On 05-Jan-2024 the patient had administration of punctured ipol that was exposed to temperature excursion with max/low temperature reached: 9.3 c for 13 mins 10 c for 10 mins due to unknown reason with no reported adverse event (poor quality 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: 13.0
Sex: F
Vaccine: IPV
Symptoms: Medication error, No adverse event, Poor quality product administered, Product storage error
Clinical narrative: Max/low temperature reached 9.3 C for 13 mins 10 C for 10 C was administered to patient with no reported adverse event; Initial information was received from Regulatory Authority on 29-Jan-2024 regarding an unsolicited valid  non-serious case received from a Nurse.  This case involves a 13 years old female patient to whom max/low temperature reached: 9.3 c for 13 mins 10 c for 10 c was administered with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   Concomitant medications included diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (TDAP) for Prophylactic vaccination.  On 11-Jan-2024, the patient received a 0.5 ml, once dose of suspect IPV (VERO) (Suspension for injection) (lot W1C751M, expiry date: 18-Nov-2025, Strength: standard) via intramuscular route in the right deltoid for Immunisation and max/low temperature reached: 9.3 c for 13 mins 10 c for 10 c was administered to patients with no reported adverse event (poor quality 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: 7.0
Sex: M
Vaccine: IPV
Symptoms: Medication error, No adverse event, Poor quality product administered, Product storage error
Clinical narrative: Administered punctured IPV (VERO) [IPOL] that had reached max/low temperature reached: 9.3 Celsius for 13 minutes 10 Celsius which was not suitable for use with no adverse event; Initial information received from Regulatory Authority on 29-Jan-2024 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 7-year-old male patient who was administered punctured IPV (VERO) [IPOL] that had reached max/low temperature reached: 9.3 Celsius for 13 minutes 10 Celsius which was not suitable for use with no 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 (TDAP) for Prophylactic vaccination.  On 13-Jan-2024, the patient received 0.5 mL dose of punctured IPV (VERO) [IPOL] that had reached max/low temperature reached: 9.3 Celsius for 13 minutes 10 Celsius which was not suitable for use with no adverse event (poor quality product administered) (latency: same day) (Suspension for injection) (Frequency: once) (Strength: standard) (lot W1C751M and expiry date: 18-Nov-2025) via intramuscular route in the left deltoid for Immunization.   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: 2.0
Sex: M
Vaccine: IPV
Symptoms: Medication error, No adverse event, Poor quality product administered, Product storage error
Clinical narrative: punctured IPOL reached temperature reached of  9.3 C for 13 mins was administered with no reported adverse event.; punctured IPOL reached temperature reached of  9.3 C for 13 mins was administered with no reported adverse event.; Initial information received on 29-Jan-2024 regarding an unsolicited valid  non-serious case received from a nurse.  This case involves a 2 years old male patient to whom punctured IPV (VERO) [IPOL] reached temperature reached of  9.3 c for 13 mins was administered with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Hepatitis A Vaccine for Prophylactic vaccination.  On an unknown date the punctured (IPOL) IPV (VERO) which reached temperature reached of  9.3 c for 13 mins (product storage error) (unknown latency)  On 16-Jan-2024, the patient administered 0.5 ml dose of punctured IPV (VERO), Suspension for injection (strength: not reported) (lot W1C751M; Expiry  date: 18-Nov-2025) via intramuscular route in the right vastus lateralis for Immunization which reached temperature reached of  9.3 c for 13 mins with no reported adverse event (poor quality product administered) (latency: same day).  This situation is unknown if had Human error.   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 and Regulatory Authority 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: 10.0
Sex: M
Vaccine: IPV
Symptoms: Medication error, No adverse event, Poor quality product administered, Product storage error
Clinical narrative: open ipol max/low temperature reached: 9.3 C for 13 mins with no reported adverse event; administration of punctured IPOL with no reported adverse event; Initial information received on 29-Jan-2024 regarding an unsolicited valid  non-serious case received from a health professional.  This case involves a 10 years old female patient who was administered with puctured Ipv (Vero) [Ipol] which was exposed to max/low temperature reached: 9.3 c for 13 mins, 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 Vaccine), Measles Vaccine, Mumps Vaccine, Rubella Vaccine (Mmr), Covid-19 Vaccine (Covid-19 Vaccine), Diphtheria Vaccine Toxoid, Pertussis Vaccine Acellular, Tetanus Vaccine Toxoid (Tdap), and Varicella Zoster Vaccine (Varicella Vaccine) for Immunisation.  On 16-Jan-2024, the patient received (0.5 ml once) dose of suspect Ipv (Vero), Suspension for injection, which was exposed to max/low temperature reached: 9.3 c for 13 mins, with no reported adverse event (product storage error) and (poor quality product administered) (latency: same day) (strength: unknown) (lot: W1C751M, Expiry date: 18-Nov-2025) via intramuscular route in unknown administration site for prophylactic vaccination (immunization).  No lab data reported.  Action taken : not applicable.  At time of reporting, the outcome was Unknown for both the events.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.