chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Condition aggravated, Lymphoedema
Clinical narrative: lymphedema and other issues worse since getting covid shots; lymphedema and other issues worse since getting covid shots; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID: The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunization.   The patient's relevant medical history included: "Cancer" (unspecified if ongoing), notes: Living With Cancer 14 year cancer survivor.; "lymphedema" (ongoing), notes: Have been dealing with lymphedema. The patient's concomitant medications were not reported.  The following information was reported: LYMPHOEDEMA (non-serious), CONDITION AGGRAVATED (non-serious), outcome "not recovered" and all described as "lymphedema and other issues worse since getting covid shots".  Additional information: The patient never got or do blood pressure in left arm. Lymphedema and other issues worsened since getting covid shots. The patient would never do the shots and/or boosters again.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, COVID-19, Drug ineffective, Headache, Lethargy
Clinical narrative: Tested positive for COVID after receiving series and booster; Tested positive for COVID after receiving series and booster; Feeling lethargic; low energy; headache; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 23-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Tested positive for COVID after receiving series and booster"; LETHARGY (non-serious), outcome "unknown", described as "Feeling lethargic"; ASTHENIA (non-serious), outcome "unknown", described as "low energy"; HEADACHE (non-serious), outcome "unknown". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive.Clinical course included that "Patient tested positive for COVID after receiving series and booster. Feeling lethargic, low energy, headache".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: Tested positive for COVID after receiving series and booster; Tested positive for COVID after receiving series and booster; Feeling lethargic; low energy; headache; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 23-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Tested positive for COVID after receiving series and booster"; LETHARGY (non-serious), outcome "unknown", described as "Feeling lethargic"; ASTHENIA (non-serious), outcome "unknown", described as "low energy"; HEADACHE (non-serious), outcome "unknown". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive.Clinical course included that "Patient tested positive for COVID after receiving series and booster. Feeling lethargic, low energy, headache".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: Within an hour of getting booster, all the rashes and pain/itchiness went away; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID:  The reporter is the patient. A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history included: "horrible flare-up with eczema" (not ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (First booster dose, Unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunization. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "Within an hour of getting booster, all the rashes and pain/itchiness went away". Additional information: the patient wonder if it was a positive result from 2nd booster shot. The patient had been struggling with a horrible flare-up with eczema for more than a month. Within an hour of getting the booster, all the rashes and pain/itchiness went away. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: Patient has a 1st dose of the Johnson and Johnson on 24Apr2022 and 3 doses of the Pfizer covid vaccine.; This is a spontaneous report received from a contactable reporter(s) (Nurse), Program ID:   A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 2 (initial Pfizer dose), single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Johnson & Johnson (Dose 1), administration date: 24Apr2022, for COVID-19 Immunization. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (non-serious), outcome "unknown", described as "Patient has a 1st dose of the Johnson and Johnson on 24Apr2022 and 3 doses of the Pfizer COVID vaccine.". Additional information: The patient stated that she was not sure if the J and J vaccine was a booster dose or just the 1st dose. The patient also received dose 3 (booster), single and dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunization. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Mobility decreased
Clinical narrative: his wife is bedridden; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID:   A female patient received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunization, reaction(s): "COVID-19"; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE; UNKNOWN MANUFACTURER), for COVID-19 immunization, reaction(s): "COVID-19". The following information was reported: MOBILITY DECREASED (non-serious), outcome "unknown", described as "his wife is bedridden".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Antineutrophil cytoplasmic antibody positive, Cerebrovascular accident, Haemorrhagic stroke, Investigation, Magnetic resonance imaging
Clinical narrative: absence seizure; we just saw a rheumatologist for followup after an expansive blood and urine test finding the Anca antibody; hemorrhagic stroke; stroke; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID: (005570).  A male patient received BNT162b2 (BNT162B2), on 17Dec2021 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization complete, Manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (1st booster, Manufacturer unknown), for COVID-19 immunization. The following information was reported: CEREBROVASCULAR ACCIDENT (medically significant) with onset 18Dec2021, outcome "unknown", described as "stroke"; HAEMORRHAGIC STROKE (medically significant) with onset 07Jan2022, outcome "unknown", described as "hemorrhagic stroke"; PETIT MAL EPILEPSY (medically significant), outcome "unknown", described as "absence seizure"; ANTINEUTROPHIL CYTOPLASMIC ANTIBODY POSITIVE (non-serious), outcome "unknown", described as "we just saw a rheumatologist for followup after an expansive blood and urine test finding the Anca antibody". The events "we just saw a rheumatologist for followup after an expansive blood and urine test finding the anca antibody" required physician office visit. The patient underwent the following laboratory tests and procedures: Blood Test: (unspecified date) Anca antibody; Magnetic resonance imaging: (03Jul2022) amyloid angiopathy; Urine analysis: (unspecified date) Anca antibody.  Clinical information: The reporter stated, regarding my Husband having a stroke the day after having the 2nd Pfizer booster shot 17Dec2021. Then 07Jan2022, it was a haemorrhagic stroke the following month after having the absence seizure. Today, we just saw a rheumatologist for follow up after an expansive blood and urine test finding the Anca antibody. Prior to today MRI 03Jul2022 results Radiology's impression saying possibly amyloid angiopathy until further test are done, which shortly after showed the ANCA antibody. Needs to be reported.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Petit mal epilepsy, Urine analysis
Clinical narrative: absence seizure; we just saw a rheumatologist for followup after an expansive blood and urine test finding the Anca antibody; hemorrhagic stroke; stroke; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID: (005570).  A male patient received BNT162b2 (BNT162B2), on 17Dec2021 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization complete, Manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (1st booster, Manufacturer unknown), for COVID-19 immunization. The following information was reported: CEREBROVASCULAR ACCIDENT (medically significant) with onset 18Dec2021, outcome "unknown", described as "stroke"; HAEMORRHAGIC STROKE (medically significant) with onset 07Jan2022, outcome "unknown", described as "hemorrhagic stroke"; PETIT MAL EPILEPSY (medically significant), outcome "unknown", described as "absence seizure"; ANTINEUTROPHIL CYTOPLASMIC ANTIBODY POSITIVE (non-serious), outcome "unknown", described as "we just saw a rheumatologist for followup after an expansive blood and urine test finding the Anca antibody". The events "we just saw a rheumatologist for followup after an expansive blood and urine test finding the anca antibody" required physician office visit. The patient underwent the following laboratory tests and procedures: Blood Test: (unspecified date) Anca antibody; Magnetic resonance imaging: (03Jul2022) amyloid angiopathy; Urine analysis: (unspecified date) Anca antibody.  Clinical information: The reporter stated, regarding my Husband having a stroke the day after having the 2nd Pfizer booster shot 17Dec2021. Then 07Jan2022, it was a haemorrhagic stroke the following month after having the absence seizure. Today, we just saw a rheumatologist for follow up after an expansive blood and urine test finding the Anca antibody. Prior to today MRI 03Jul2022 results Radiology's impression saying possibly amyloid angiopathy until further test are done, which shortly after showed the ANCA antibody. Needs to be reported.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: tested positive; tested positive; This is a spontaneous report received from contactable reporter (Pharmacist).  A 65-year-old male patient received BNT162b2 (BNT162B2), on 01Mar2021 as dose 1, single (Batch/Lot number: unknown), on 23Mar2021 as dose 2, single (Batch/Lot number: unknown) and on 23Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 64 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 08Jul2022, outcome "unknown" and all described as "tested positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (08Jul2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to vaccination failure cannot be ruled out.
Sex: U
Vaccine: COVID19
Symptoms: Myocardial infarction
Clinical narrative: Heart attack (episodes); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MYOCARDIAL INFARCTION (medically significant), outcome "unknown", described as "Heart attack (episodes)".  Clinical course: Sent this letter for information only. They live an Independent Living facility and had the Pfizer COVID-19 vaccine on schedule as recommended by the CDC. There have been five of them on one floor that have had heart issues after receiving the vaccine. Patient one had Heart attack (episodes), second had Procedure to get heart in Sync, third and fourth had Pacemaker, fifth patient had A-Fib that has worsened. They thought this might be information worth nothing.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Adenocarcinoma
Clinical narrative: found an adenocarcinoma in the gallbladder; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "immunocompromised" (unspecified if ongoing), notes: I am immunocompromised and so I had all 3 rounds of your, vaccine. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose number: 1, Manufacturer: unknown, Lot/ batch number: Unknown), for Covid-19 immunization; Covid-19 vaccine (Dose number: 2, Manufacturer: unknown, Lot/ batch number: Unknown), for Covid-19 immunization. The following information was reported: ADENOCARCINOMA (medically significant), outcome "unknown", described as "found an adenocarcinoma in the gallbladder". Therapeutic measures were taken as a result of adenocarcinoma.  Clinical course: The patient was immunocompromised and so had all 3 rounds of vaccine. Patient had been told, after having to have my gallbladder removed that they have found an adenocarcinoma in the gallbladder and it was a very unusual case and may not be isolated. Patient read online that some people experienced issues with their liver, bile ducts and gallbladder after the vaccine and I want to know from you how many cases of this you have had reported.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Nausea
Clinical narrative: She felt tired after receiving her first dose of Comirnaty; She felt nauseas after receiving her first dose of Comirnaty; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID:  A female patient received BNT162b2 (COMIRNATY), in Aug2021 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "She felt tired after receiving her first dose of Comirnaty"; NAUSEA (non-serious), outcome "unknown", described as "She felt nauseas after receiving her first dose of Comirnaty". Additional information: In Aug2021, respondent received first dose of Comirnaty, when she returned for her second dose she was given a choice of brand for her second dose of the vaccine and selected Moderna because she felt nauseas and tired after receiving her first dose of Comirnaty. Reporter considered event caused by suspect product. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Contusion, Diarrhoea, Malaise, Menstruation delayed
Clinical narrative: Menstruation was delayed for 3 weeks; extreme swelling in arm; bruising; felt sick "10x worse than the flu"; diarrhea; a temperature of 103; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP), Program ID: (181379). The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for 1 day for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, Manufacturer unknown), for Covid-19 immunization.  The following information was reported: MENSTRUATION DELAYED (medically significant), outcome "not recovered", described as "Menstruation was delayed for 3 weeks"; PERIPHERAL SWELLING (non-serious), outcome "recovered", described as "extreme swelling in arm"; CONTUSION (non-serious), outcome "recovered", described as "bruising"; MALAISE (non-serious), outcome "recovered", described as "felt sick "10x worse than the flu""; DIARRHOEA (non-serious), outcome "recovered", described as "diarrhea"; PYREXIA (non-serious), outcome "recovered", described as "a temperature of 103". The patient underwent the following laboratory tests and procedures: Body temperature: 103.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Pyrexia
Clinical narrative: Menstruation was delayed for 3 weeks; extreme swelling in arm; bruising; felt sick "10x worse than the flu"; diarrhea; a temperature of 103; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP), Program ID: (181379). The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for 1 day for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, Manufacturer unknown), for Covid-19 immunization.  The following information was reported: MENSTRUATION DELAYED (medically significant), outcome "not recovered", described as "Menstruation was delayed for 3 weeks"; PERIPHERAL SWELLING (non-serious), outcome "recovered", described as "extreme swelling in arm"; CONTUSION (non-serious), outcome "recovered", described as "bruising"; MALAISE (non-serious), outcome "recovered", described as "felt sick "10x worse than the flu""; DIARRHOEA (non-serious), outcome "recovered", described as "diarrhea"; PYREXIA (non-serious), outcome "recovered", described as "a temperature of 103". The patient underwent the following laboratory tests and procedures: Body temperature: 103.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Chronic obstructive pulmonary disease
Clinical narrative: has COPD a Chronic Breathing Lung Disorder; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: The reporter is the patient.  An 89-year-old male patient received BNT162b2 (BNT162B2), in Feb2022 as dose number unknown (second booster), single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for Covid-19 Immunization; Covid-19 vaccine (First booster, unknown manufacturer), for Covid-19 Immunization. The following information was reported: CHRONIC OBSTRUCTIVE PULMONARY DISEASE (non-serious), outcome "unknown", described as "has COPD a Chronic Breathing Lung Disorder".  Additional information: Caller had COPD a Chronic Breathing Lung Disorder and had his Pfizer Covid-19 second Booster 5 months before (Feb2022). He wanted to know if he still needs to get another booster shot because if he gets covid, he will probably die.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 53.0
Sex: F
Vaccine: TTOX
Symptoms: Dizziness
Clinical narrative: Dizzy spell Saturday lasting 2 seconds. Again on Monday while driving.; Initial information received on 14-Jul-2022 regarding an unsolicited valid  courtesy non-serious case received from a consumer/non-hcp.  This case involves a 53 years old female patient who had dizzy spell Saturday lasting 2 seconds. again, on Monday while driving while receiving vaccine TETANUS TOXOID.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect TETANUS TOXOID produced by unknown manufacturer (formulation, strength: unknown) lot number not reported via unknown route in unknown administration site for Tetanus.Lot number was requested.  On an unknown date the patient had dizzy spell Saturday lasting 2 seconds. Again, on Monday while driving. (dizziness) (unknown latency) following the administration of TETANUS TOXOID.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (Dizzy spell Saturday lasting 2 seconds. Again, on Monday while driving.).  At time of reporting, the outcome was Unknown for the event .
Sex: U
Vaccine: UNK
Symptoms: Breath holding, Seizure
Clinical narrative: afebrile seizures; breath holding spell; Initial information received on 15-Jul-2022 regarding an unsolicited valid serious case received from a physician.This is a courtesy case received from partner Pfizer (GPE).   This case involves 6 months old child with unknown  gender who experienced afebrile seizures and breath holding spell while receiving vaccine Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine [Pentacel (Vero)].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a 2 doses of suspect Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine(lot number not reported) at an unknown dose via unknown route in unknown administration site as prophylactic vaccination.  On an unknown date (latency: unknown),the patient developed a serious events of afebrile seizures (seizure) and breath holding spell (breath holding) following the administration of Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine  Action taken :not applicable.  It was not reported if the patient received a corrective treatment for the events (breath holding spell, afebrile seizures).  At time of reporting, the outcome was Not Recovered / Not Resolved for both events; Sender's Comments: Sanofi company comment dated 21-Jul-2022: This case involves 6 months old child patient with unknown gender who was vaccinated with Pentacel (vero) and experienced afebrile seizures and breath holding spell . The time to onset is unknown with the role of the vaccine. The clinical course was not provided. Furthermore, information regarding condition at the time of vaccination, the role of medical history, concomitants, and laboratory data excluding other predisposing etiologies would be needed for a complete assessment of the case. Based upon the reported information, the role of an individual vaccine cannot be assessed.
Age: 8.0
Sex: F
Vaccine: TDAP
Symptoms: Accidental exposure to product, Product administered to patient of inappropriate age
Clinical narrative: an 8 year old was inadvertently administered a dose of adacel with no reported Adverse event; an 8 year old was inadvertently administered a dose of adacel with no reported Adverse event; the patient is behind in her vaccinations with no reported Adverse event; Initial information received on 12-Jul-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 8 years old female patient who was inadvertently administered a dose of diphtheria-2/tetanus/5 AC pertussis vaccine [Adacel] with no reported adverse event and reported the patient is behind in her vaccinations with no reported adverse event.  The patient's past vaccination(s) included DTAP on 10-JAN-2014  at age of 2 months, DTAP on 16-MAY-2014 at age of 7 months and DTAP on 01-MAR-2018  at age of 4 Years. The patient's past medical history, medical treatment(s) and family history were not provided.  Concomitant medications included hepatitis B vaccine, hepatitis A vaccine ,  measles vaccine, mumps vaccine, rubella vaccine (MMR) ,  varicella zoster vaccine (varicella vaccine) for immunisation.  On 30-Jun-2022, the patient received 0.5ml  dose of suspect diphtheria-2/tetanus/5 AC pertussis vaccine, suspension for injection (unknown strength) (lot C5828AA; Expiry date 30-Mar-2023) via intramuscular route in the left deltoid for immunization.  On 30-Jun-2022 It was reported that 8 year old was inadvertently administered a dose of adacel with no reported adverse event (accidental exposure to product) (product administered to patient of inappropriate age) and patient was behind in her vaccinations with no reported adverse event (inappropriate schedule of product administration) (latency; Same day). It was asked that this dose will count as a valid dose for her DTAP series  Action taken : not applicable.  Outcome : Unknown.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 12.0
Sex: F
Vaccine: MNQ
Symptoms: Booster dose missed, No adverse event
Clinical narrative: received his routine doses of MENACTRA but declined to receive a booster in high school prior to college, with no reported adverse event; Initial information received on 12-Jul-2022 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 12 years old female patient who received his routine doses of Meningococcal A-C-Y-W135 (D Conj) Vaccine [Menactra] but declined to receive a booster in high school prior to college, with no reported adverse event.  The patient's past medical history included Cancer (Neoplasm malignant) in 2018, underwent radiation (Exposure to radiation) and stem cell transplant. The patient's past medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received his routine doses of menactra but declined to receive a booster dose of suspect Meningococcal A-C-Y-W135 (D Conj) Vaccine (Solution for injection) (dose; frequency; lot; strength and expiry date not reported) via unknown route in unknown administration site for Prophylactic vaccination (Immunisation).  On an unknown date the patient received his routine doses of Meningococcal A-C-Y-W135 (D Conj) Vaccine but declined to receive a booster in high school prior to college, with no reported adverse event (Booster dose missed).  It was reported that patient's oncologist is recommending revaccinations due to her immunity being "wiped out" due to cancer treatments.  Action taken with Meningococcal Vaccine (Menactra) was not applicable.  At time of reporting, the outcome was Unknown for the event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 20.0
Sex: M
Vaccine: MNQ
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired MENACTRA being administered to a patient, with no adverse event; Initial information received on 13-Jul-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 20 years old male patient who was administered expired Meningococcal A-C-Y-W135 (D CONJ) Vaccine [Menactra], with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 13-Jul-2022, the patient received (0.5 mL 1X) dose of suspect Meningococcal A-C-Y-W135 (D CONJ) Vaccine (lot U6952AA; expiry date; 09-Jun-2022, strength, formulation not reported) via intramuscular route in the left deltoid for immunization.  On 13-Jul-2022  (latency: same day) the patient developed a non-serious expired menactra being administered to a patient, with no adverse event (expired product administered).  Action taken: Not applicable.  Outcome: Unknown   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: M
Vaccine: DTAP
Symptoms: Inappropriate schedule of product administration, Medication error
Clinical narrative: received 4 doses of DTaP before the age of 2 years, with no reported adevrse event; Initial information received from on 13-Jul-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case involves a 2  years old patient who received 4 doses of DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE (DTaP) before the age of 2 years, with no reported adevrse event  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.    On an unknown date, the patient received an unknown  dose of suspect DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE produced by unknown manufacturer lot number not reported in unknown administration site for immunization.  It was reported that the patient had received 4 doses of DTaP before the age of 2 years, with no reported adevrse event (inappropriate schedule of product administration) (unknown latency)   Action taken : not applicable.  Outcome: unknown   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.; Sender's Comments:  01188572:
Sex: U
Vaccine: RAB
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient got 1 injection more than a week ago with no reported adverse event; Initial information received on 13-Jul-2022 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves an unknown age and gender patient who got 1 injection more than a week ago with no reported adverse event while receiving vaccine RABIES (HDC) VACCINE [IMOVAX RABIES].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date of July 2022, the patient received a  dose of suspect RABIES VACCINE (lot number not reported) at an unknown dose via unknown route at an unknown administration site as immunization.  On an unknown date of 2022,  the patient states that he/she got 1 injection more than a week ago with no reported adverse event (incorrect product administration duration) (unknown latency) and wanted to confirm how to proceed with the other 3 injections.  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, No adverse event
Clinical narrative: expired ACT-HIB was inadvertently given to a child with no reported adverse event; Initial information received on 13-Jul-2022 regarding an unsolicited valid non-serious case from a healthcare professional.  This case involves a 1-year-old male patient to whom expired HIB (PRP/T) VACCINE [ACT-HIB] was inadvertently given to a child with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) for Immunisation; VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) for Immunisation; PNEUMOCOCCAL VACCINE 13V (PNEUMOCOCCAL 13 VALENT VACCINE) for Immunisation; and HEPATITIS A VACCINE (HEPATITIS A VACCINE) for Immunisation.  On 13-Jul-2022, the patient received 0.5ml total dose of suspect HIB (PRP/T) VACCINE strength: standard (lot: UJ525AAB; Expiration Date: 11-Jul-2022), Drug Treatment Duration: not applicable, via intramuscular route in the right thigh for Immunization and on the same day expired HIB (PRP/T) VACCINE was inadvertently given to a child with no reported adverse event (expired product administered).  It was reported, the caller is wanting to know what to do.  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: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Medication error, No adverse event, Vaccination error
Clinical narrative: co-administering Menactra with Covid-19 (with no reported adverse event); use of Menactra instead of the intended vaccine against meningococcal B (with no reported adverse event); Initial information received on 13-Jul-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 18 years old female patient who was co-administering menactra with covid-19 (with no reported adverse event) and use of menactra instead of the intended vaccine against meningococcal b (with no reported adverse event) while receiving vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA].  The patient's past vaccination(s) included MENVEO on 17-JUN-2015  with first dose and MENVEO on 29-JAN-2020 with second dose. The patient's past medical history, medical treatment(s) and family history were not provided.  Concomitant medications included COVID-19 VACCINE (COVID-19 VACCINE) for Immunisation.  On 13-Jul-2022, the patient received an unknown dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (formulation, strength, route: unknown) lot U7207AA, expiration date:08-Feb-2023, in the right arm as immunization.  On 13-JUL-2022 the patient was co-administering menactra with covid-19 (with no reported adverse event) (vaccine coadministration) and there was use of menactra instead of the intended vaccine against meningococcal b (with no reported adverse event) (vaccination error) same day following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for all the events.  At time of reporting, the outcome was Unknown for 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 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: Inappropriate schedule of product administration, No adverse event
Clinical narrative: MENACTRA has been used every 5 years for patient's that are asplenic or are immunodeficient with no reported adverse event; Initial information received on 14-Jul-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves an unknown age female patient who was administered menactra has been used every 5 years  that are asplenic or are immunodeficient with no reported adverse event ,while receiving vaccine 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 an unknown date, the patient received a  dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE lot number not reported at an unknown dose via unknown route at unknown administration site for immunization.  On an unknown date, the patient developed a non-serious event 0f  menactra has been used every 5 years for patient's that are asplenic or are immunodeficient with no reported adverse event (inappropriate schedule of product administration) (unknown latency) 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 menactra has been used every 5 years for patient's that are asplenic or are immunodeficient with no reported adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: No adverse event, Product use issue
Clinical narrative: states patient had a dose of MENACTRA at age 11 and received the second dose 4 weeks ago. Caller states that patient did not need this third dose and was given mistakenly with no reported adverse event; Initial information received on 14-Jul-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 17 years old female patient who experienced states patient had a dose of menactra at age 11 and received the second dose 4 weeks ago. caller states that patient did not need this third dose and was given mistakenly with no reported adverse event while receiving vaccine 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.  Concomitant medications included MENINGOCOCCAL VACCINE B RFHBP/NADA/NHBA OMV (BEXSERO) for Immunisation.  On 14-Jul-2022, the patient received a  0.5 ml dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE lot U7492AA via intramuscular route in the right deltoid.  On 14-JUL-2022 the patient developed a non-serious states patient had a dose of menactra at age 11 and received the second dose 4 weeks ago. caller states that patient did not need this third dose and was given mistakenly with no reported adverse event (product use issue) following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE.  Action taken: not applicable.   At time of reporting, the outcome was Unknown for the event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 0.17
Sex: M
Vaccine: UNK
Symptoms: Expired product administered, No adverse event
Clinical narrative: gave an expired dose of PENTACEL, with no reproted adverse event; Initial information received on 14-Jul-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 9 weeks old male patient who was administered an expired dose of Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(Vero)/HIB(PRP/T) Vaccine [Pentacel (Vero), with no reproted adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Rotavirus Vaccine Live Reassort Oral 5V (Rotateq); and Hepatitis B Vaccine (Hep [Hepatitis B Vaccine]) for Prophylactic vaccination (Immunisation).  On 14-Jul-2022, the patient received a 0.5 ml dose once of suspect Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(Vero)/HIB(PRP/T) Vaccine (Suspension for injection) (lot: UJ528AAA; expiry date -10-Jul-22) via intramuscular route in the right thigh for prophylactic vaccination.   On 14-Jul-2022 the patient was administered an expired dose of Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(Vero)/HIB(PRP/T) Vaccine, with no reproted adverse event (expired product administered) (latency: same day).  Action taken with Diphtheria,Tetanus, AC Pertussis, IPV AND HIB Vaccine (Pentacel (Vero)) 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.
Sex: U
Vaccine: YF
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: YF-VAX was administered to a patient through the intramuscular route instead of the subcutaneous route with no reported adverse event; Initial information received on 14-Jul-2022 regarding an unsolicited valid  non-serious case received from a other health professional. GMI number: 01190930  This case involves an unknown age/gender patient who was administered Yellow Fever Vaccine [YF-VAX] through the intramuscular route instead of the subcutaneous route with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received suspect Yellow Fever Vaccine (strength, formulation, dose, route, administration site, batch number and expiry date: unknown) via intramuscular route instead of the subcutaneous route with no reported adverse event (incorrect route of product administration) for prophylactic vaccination.   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.