chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Atrial fibrillation, Platelet count decreased, Pulmonary thrombosis
Clinical narrative: couple of blood clots in her lungs; she developed an A fib in the hospital; she had a problem with platelet production and was hospitalized. They gave her steroids and stuff to increase her platelet production; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 78-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Nov2022 as dose number unknown (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 series complete but unknown manufacturer), for COVID-19 immunization. The following information was reported: PULMONARY THROMBOSIS (hospitalization, medically significant) with onset 2023, outcome "unknown", described as "couple of blood clots in her lungs"; ATRIAL FIBRILLATION (hospitalization, medically significant) with onset 2023, outcome "unknown", described as "she developed an A fib in the hospital"; PLATELET COUNT DECREASED (hospitalization) with onset 2023, outcome "unknown", described as "she had a problem with platelet production and was hospitalized. They gave her steroids and stuff to increase her platelet production". Caller mentioned that he is calling on behalf of his wife and wants to know if his wife can get another booster shot because she is on blood thinners. Caller stated: his wife is 78 years and he need to know if she should not get the shot. For the first 3 months of this year (2023), she had a problem with platelet production and was hospitalized. They gave her steroids and stuff to increase her platelet production, she's at home now, but still gets a weekly checkup to see where her platelet count is and an infusion to make sure it doesn't go too low. He addition that that she developed an A fib in the hospital so they decided to give her blood thinners, so can be imagined the mixture because she had a couple of blood clots in her lungs. She's home now but she is taking eliquis because of the A Fib and because of the clots. The caller's questions is, because of that history, should she not take the Pfizer Booster. Therapeutic measures were taken as a result of pulmonary thrombosis, atrial fibrillation, platelet count decreased.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from contactable reporter(s) (Pharmacist). The reporter is the patient.  A 59-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Oct2022 at 15:00 as dose 4 (booster), single (Lot number: GJ2524), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, sngle (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Sulfa allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Apr2023, outcome "recovering" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test positive. Therapeutic measures were taken as a result of drug ineffective, covid-19, including Paxlovid from 26Apr2023 to 01May2023. Sender's Comments: Based on the current available limited information in the case provided, the causal association between the events Drug ineffective, Covid-19 and the use of suspect product Comirnaty cannot be fully excluded.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 26-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 24Feb2022 as dose 3 (booster), single (Lot number: FM0698) at the age of 25 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 19Mar2021 as dose 1, single (Lot number: 046A21A), in left arm and on 16Apr2021 as dose 2, single (Lot number: 046B21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Major depression" (unspecified if ongoing); "known allergies Echineacea" (unspecified if ongoing), notes: known allergies Echineacea. Concomitant medication(s) included: LO LOESTRIN FE, start date: Aug2022, stop date: 08May2023. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 08May2023 at 10:00, outcome "recovering" and all described as "COVID 19 Treatment". Therapeutic measures were not taken as a result of drug ineffective, covid-19 included Paxlovid.
Sex: U
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: She is not feeling well; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Lot number: FM9992) for covid-19 immunisation. 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. The following information was reported: MALAISE (non-serious), outcome "unknown", described as "She is not feeling well".
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 58-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 06Sep2022 as dose 5 (booster), single (Lot number: GH9694) at the age of 57 years, in right arm for covid-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Treatment for breast cancer (including chemo) " (unspecified if ongoing), notes: 2013-14. Concomitant medication(s) included: LETROZOLE, start date: Jan2015, stop date: May2023; MIRTAZAPINE, start date: Sep2013, stop date: May2023. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Apr2023, outcome "unknown" and all described as "Treatment of COVID-19". The patient was treated with Paxlovid from 29Apr2023 to 04May2023.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 53-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Jan2021 at 11:00 as dose 1, single (Lot number: EL1284), in left arm, on 22Jan2021 at 11:00 as dose 2, single (Lot number: EL3247), in left arm and on 22Oct2021 at 11:00 as dose 3 (booster), single (Lot number: EW0186) at the age of 51 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Apr2023, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (08May2023) Positive, notes: Positive antigen home test. Therapeutic measures were taken as a result of drug ineffective, covid-19 (Paxlovid).
Age: 42.0
Sex: M
Vaccine: PNC20
Symptoms: Vaccination site erythema, Vaccination site swelling
Clinical narrative: Site of injection swollen and red; Site of injection swollen and red; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). A 42-year-old male patient received pneumococcal 20-valent conjugate vaccine (diphtheria CRM197 protein) (PREVNAR 20), on 02May2023 at 17:00 as dose 1, single (Batch/Lot number: unknown) at the age of 42 years, in right arm. The patient's relevant medical history included: "Hypercholesterolaemia" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN. Past drug history included: Biaxin, reaction(s): "Allergy". The following information was reported: VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE SWELLING (non-serious) all with onset 04May2023, outcome "recovered" (07May2023) and all described as "Site of injection swollen and red". Therapeutic measures were taken as a result of vaccination site erythema, vaccination site swelling.  The information on the batch/lot number for pneumococcal 20-valent conjugate vaccine (diphtheria CRM197 protein) has been requested and will be submitted if and when received
Sex: F
Vaccine: PNC20
Symptoms: Dementia
Clinical narrative: dementia; This is a spontaneous report received from contactable reporter(s) (Nurse).  A female patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEMENTIA (medically significant), outcome "unknown". Phone call seeking assistance with Prevnar 20 for the patient. The reporter stated the patient had a little bit of dementia. The information on the batch/lot number for pneumococcal 20-val conj vac (dipht CRM197 protein) has been requested and will be submitted if and when received.; Sender's Comments: Dementia is considered not related to PREVNAR 20 use but more likely due to underlying medical conditions.  More information such as relevant medical history, concomitant medications, patient demographics, event details including onset date are needed for meaningful assessment.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate
Sex: F
Vaccine: UNK
Symptoms: Drug interaction
Clinical narrative: took the medication Miralax and had reaction to it; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), .  A female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation; macrogol 3350 (MIRALAX), (Batch/Lot number: unknown). The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INTERACTION (non-serious), outcome "unknown", described as "took the medication Miralax and had reaction to it". The action taken for macrogol 3350 was unknown.  Additional information: The caller is calling on behalf of his wife. Both of them took the covid 19 vaccine and his wife took the medication Miralax and had reaction to it. He is asking if there the Covid 19 vaccine has any reaction with the medication.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Magnetic resonance imaging, Tinnitus, Venogram
Clinical narrative: I hear the sound of my heart in my right ear; 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, 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: TINNITUS (non-serious) with onset 2020, outcome "unknown", described as "I hear the sound of my heart in my right ear". The event "i hear the sound of my heart in my right ear" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: In 2020, the patient encountered a medical complication that they hear the sound of their heart in their right ear, this sound never stops. The patient went to the otolaryngologist, after checking the MRI and MRV scan, he diagnosed that there was no problem, he referred them to the neurologist. At this stage, after taking the MRI and MRV from the neck and head again, the doctor said there was no problem. A doctor of the patient's country said that it might be due to the effect of the COVID-19 vaccine.  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: Polymyalgia rheumatica
Clinical narrative: Diagnosis is PMR related to the booster; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), on 08Oct2021 as dose number unknown (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 Series Completed, Unknown Manufacturer), for Covid-19 immunisation. The following information was reported: POLYMYALGIA RHEUMATICA (medically significant) with onset Oct2021, outcome "unknown", described as "Diagnosis is PMR related to the booster". The event "diagnosis is pmr related to the booster" required physician office visit. Clinical course: the patient received the booster shot on 08Oct2021. Within 10 days patient started developing multiple health issues which had been working with doctors to figure out the problem. It got to the point where the patient had been sent to a rheumatologist which took 6 months to get in with. Diagnosis is PMR related to the booster.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information currently available, a causal association between the reported polymyalgia rheumatica and BNT162b2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and investigators, as appropriate.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: got Covid -19; got Covid -19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): US-MODERNATX-MOC20230504000126 (Moderna).  A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "got Covid -19". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 antibody test, SARS-CoV-2 test
Clinical narrative: He caught COVID around New Years Day of 2022 and then May2022.; He caught COVID around New Years Day of 2022 and then May2022.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): MOD-2023-722629 (Moderna).  A 65-year-old male patient received BNT162b2 (BNT162B2), on 02Apr2021 as dose 1, single (Batch/Lot number: unknown), on 29Apr2021 as dose 2, single (Batch/Lot number: unknown) and on 17Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Allergy: sulfa" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jan2022, outcome "not recovered" and all described as "He caught COVID around New Years Day of 2022 and then May2022.". The events "he caught covid around new years day of 2022 and then may2022." required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 antibody test: Positive, notes: COVID two months ago; SARS-CoV-2 test: Negative. Clinical course: He had COVID twice. Both times it started with a sore throat. The last time he caught COVID, he tested negative at the hospital at the emergency room. He called his doctor two months later. They did an antibody test, and the doctor told him he had COVID two months ago. He had to see neuro because of the side effects from the second time he caught COVID. He had all kinds of side effects. He caught COVID around New Years Day of 2022 and then May2022. The patient states he didn't have any side effects from his Pfizer doses (as reported).   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021400626 same patient /drug different dose number /AE;
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Called the reporter to verify she had been vaccinated for COVID.  She had been and provided Pfizer lot number GJ2524.; Called the reporter to verify she had been vaccinated for COVID.  She had been and provided Pfizer lot number GJ2524.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 78-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Lot number: GJ2524) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "heart attack", start date: 2021 (unspecified if ongoing), notes: heart attack two years ago. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Called the reporter to verify she had been vaccinated for COVID.  She had been and provided Pfizer lot number GJ2524.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive, notes: still tested positive for COVID. Therapeutic measures were taken as a result of drug ineffective, covid-19. Product Quality Group provided investigational results on 08May2023 for BNT162b2: The complaint for "Pfizer-BioNTech COVID-19 Vaccine" was investigated. The investigation included reviewing the involved batch records, deviation investigation, an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lot(s) of the reported lot GJ2524. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation and stability. # concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The process determined that no regulatory notification was required. The reported defect could not be confirmed. No root cause were identified as the complaint was not confirmed.  No follow-up attempts are possible. No further information is expected.
Age: 78.0
Sex: F
Vaccine: TTOX
Symptoms: Arthralgia, Haemorrhage, Hypersensitivity, Myalgia
Clinical narrative: bleeding all over; allergic reaction to the shot; lot of pain in her joints (hip pain); lot of pain in her joints (hip pain) and muscles; Initial information was received on 01-May-2023 regarding an unsolicited valid serious case received from a consumer/non-health-care professional.  This case is linked to case 2023SA138901.  This case involves 78 years old female patient who experienced bleeding all over, allergic reaction to the shot, lot of pain in her joints (hip pain) and lot of pain in her joints (hip pain) and muscles, after receiving vaccine tetanus toxoid and while treated with amoxicillin.  The patient's past medical history included Animal bite. The patient's past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included  for Allergic reaction.  On an unknown date, the patient started taking amoxicillin (form, strength, dose, frequency, batch number, expiry date: unknown) for unknown indication.  On an unknown date, the patient received a dose of suspect tetanus toxoid produced by unknown manufacturer (lot number, expiry date: not reported) via unknown route in unknown administration site (form, strength: unknown) for prophylactic vaccination.  On an unknown date the patient developed a serious event of bleeding all over (haemorrhage) (unknown latency) following the administration of tetanus toxoid and (unknown latency) following the first dose intake of amoxicillin.  On an unknown date the patient developed non-serious events of allergic reaction to the shot (hypersensitivity), lot of pain in her joints (hip pain) (arthralgia) and event of lot of pain in her joints (hip pain) and muscles (myalgia) following the administration of tetanus toxoid and (unknown latency) following the first dose intake of amoxicillin.  Patient got a tetanus shot and was on Amoxicillin. Patient developed an allergic reaction after 5 days of taking Amoxicillin and stopped taking the antibotics.  No lab data reported.  Action taken with tetanus toxoid was not applicable. amoxicillin was discontinued on an unknown date.  The patient received loratadine (Claritin) and cetirizine hydrochloride (Zyrtec) for Allergic reaction. It was not reported if the patient received any corrective treatment for other events.  At time of reporting, the outcome was Unknown for all the events.  Seriousness criteria: medically significant for the event haemorrhage.; Sender's Comments: Sanofi company comment dated 10-May-2023: This case involves 78 years old female patient who experienced bleeding all over, after receiving vaccine tetanus toxoid and while treated with amoxicillin. Furthermore, information regarding condition at the time of vaccination, medical history, lab data excluding other predisposing etiologies, intervention (if any), corrective treatment/medical management, family history would be needed for complete assessment of the case. Based upon the reported information, the role of an individual vaccine cannot be assessed.
Age: 64.0
Sex: F
Vaccine: FLUX
Symptoms: Malaise, Rash
Clinical narrative: Sick; rash; Initial information received on 05-May-2023 regarding an unsolicited valid non-serious case received from non-healthcare professional.  This case involves a 64 years old female patient who experienced sick and rash after receiving vaccine Influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received an unknown dose of suspect Influenza vaccine produced by unknown manufacturer (strength, formulation, frequency, lot number and expiry date: not reported) via unknown route in unknown administration site as prophylactic vaccination (Immunization). Information on the batch number was requested.  On an unknown date, the patient developed non-serious event sick (illness) and rash (unknown latency) following the administration of influenza vaccine.  No lab data was reported.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the events (Sick and rash).  At time of reporting, the outcome was Unknown for the event sick and the event rash.
Age: 73.0
Sex: M
Vaccine: MNQ
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: patient was given an expired menactra with no reported adverse event; Initial information received on 04-May-2023 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 73 years old male patient who was given an expired Meningococcal A-C-Y-W135 (D CONJ) vaccine [Menactra] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Pneumococcal vaccine Polysacch 23V (Pneumovax) for Immunization.  On 04-May-2023, the patient received 0.5 ml dose (dose 1) (total) of suspect Meningococcal A-C-Y-W135 (D CONJ) vaccine (strength: standard) Solution for injection of lot U7268AA and expiry: 22-Apr-2023 via intramuscular route in the right deltoid for immunization.  On 04-May-2023, the patient developed a non-serious event patient was given an expired Meningococcal A-C-Y-W135 (D CONJ) vaccine with no reported adverse event (expired product administered) (latency: Same day).  No lab data was reported.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 1.25
Sex: F
Vaccine: UNK
Symptoms: Expired product administered
Clinical narrative: nurses administered expired PENTACEL to a patient with no reported adverse event; Initial information received on 05-May-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 15 months old female patient and it was reported nurse administered expired diphtheria/tetanus/5 hybrid AC pertussis/IPV(vero)/HIB(PRP/T) vaccine [Pentacel (vero)] to a patient with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included hepatitis A vaccine (hepatitis A) for Prophylactic vaccination.  On 05-MAY-2023, nurse administered an expired 0.25 mL (Dose 4) of diphtheria/tetanus/5 hybrid AC pertussis/IPV(vero)/HIB(PRP/T) vaccine [Pentacel (vero)] suspension for injection (batch/lot number: UJ672AAA; strength: standard; expiry date: 27-Apr-2023) to a patient via intramuscular route in the thigh NOS for prophylactic vaccination (immunization) with no reported adverse event (expired product administered) (latency: same day).  Action taken: Not applicable.  At time of reporting, the outcome was Unknown for the event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 0.67
Sex: F
Vaccine: DTAPIPV
Symptoms: No adverse event
Clinical narrative: third dose of quadracel administered to patient under 4 years of age with no reported adverse event; Initial information received on 05-May-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 8 months old female patient who was administered third dose of diphtheria-15/tetanus/5 hybrid AC pertussis/IPV (MRC5) vaccine [Quadracel] under 4 years of age with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HIB vaccine CONJ (OMPC) (Liquid Pedvaxhib) and Pneumococcal vaccine CONJ 13V (CRM197) (Prevnar 13) both for Prophylactic vaccination.  On 05-May-2023, the patient received a dose of 0.5 ml (dose 3) once of suspect diphtheria-15/tetanus/5 hybrid AC pertussis/IPV (MRC5) vaccine (Suspension for injection) (lot C5970AA; strength: standard; expiry date: 02-Feb-2024) via intramuscular route in the left deltoid muscle for immunization.  On 05-May-2023 the patient was administered third dose of diphtheria-15/tetanus/5 hybrid AC pertussis/IPV (MRC5) vaccine [Quadracel] under 4 years of age with no reported adverse event (product administered to patient of inappropriate age) (latency: same day).  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 0.58
Sex: M
Vaccine: UNK
Symptoms: Expired product administered, No adverse event
Clinical narrative: nurse, stated she just gave a Pentacel vaccine that was 1 day expired (with no reported adverse event); Initial information received on 08-May-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 7 months old male patient and Nurse stated she just gave a Diphtheria/Tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [pentacel (VERO)] vaccine that was 1 day expired with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Pneumococcal Vaccine CONJ (pneumococcal conjugate vaccine), Rotavirus Vaccine and Hepatitis B vaccine, all for Immunisation.  On 28-APR-2023, the patient received a dose of 0.5 mL (dose 2; 1x) of diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (vero)] suspension for injection (batch/lot number: UJ673AAA and expiry date: 27-Apr-2023; frequency: once; strength: standard) that was 1 day expired via unknown route in the left thigh for  Prophylactic vaccination (immunization), with no reported adverse event (expired product administered) (latency: same day).  Action taken: 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: 0.58
Sex: F
Vaccine: UNK
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: nurse stated she just gave a pentacel vaccine that was 1 day expired, with no reported adverse event; Initial information received on 08-May-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 7 months old female patient and it was reported nurse stated she just gave a diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (vero)] that was 1 day expired, 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 rotavirus vaccine; hepatitis B vaccine; and pneumococcal vaccine CONJ all for Immunisation.  On 28-APR-2023, nurse gave 0.5 mL (dose 2; 1x) of diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (vero)] Suspension for injection (batch/lot number: UJ673AAA and expiry date: 27-Apr-2023; frequency: once; strength: standard) that was 1 day expired via unknown route in the left thigh for immunization, with no reported adverse event (expired product administered) (latency: same day).  Action taken: Not applicable.  At time of reporting, the outcome was Unknown for the event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 0.5
Sex: F
Vaccine: UNK
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired product was administered to a patient with no reported adverse event; Initial information received on 08-May-2023  regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 6 months old female patient who was administered expired vaccine diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (Vero)] 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 rotavirus vaccine; hepatitis B vaccine; pneumococcal vaccine conj 7V (CRM197) (Prevnar); and influenza vaccine for Immunisation.  On 08-May-2023, the patient received an expired 0.5 mL (dose number: 3) of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(vero)/HIB(PRP/T) vaccine, suspension for injection (batch number: UJ662AAA; Expiry date: 04-May-2023) via intramuscular route in the right thigh for immunization with no reported adverse event (expired product administered) (same day latency). The reporter was not aware of any adverse reactions post administration.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event expired product was administered to a patient with no reported adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 9.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 9 year old patient had received quadracel with no reported adverse event; Initial information received on 08-May-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 9 years old female patient who received diphtheria-15/tetanus/5 hybrid AC pertussis/IPV (MRC5) vaccine [Quadracel] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included diphtheria vaccine toxoid, pertussis vaccine acellular 3-component, polio vaccine inact 3V (vero), tetanus vaccine toxoid (Kinrix) for Prophylactic vaccination.  On 14-Apr-2023, the patient received a dose of 0.5 ml (dose 2) once of suspect diphtheria-15/tetanus/5 hybrid AC pertussis/IPV (MRC5) vaccine (Suspension for injection) (lot C6002BA; expiry date: 18-May-2024; strength: standard) via intramuscular route in the left deltoid for immunization.  On 14-Apr-2023, 9 years old female patient had received quadracel with no reported adverse event (product administered to patient of inappropriate age) (latency: same day).  It was reported, "Nurse would like to like guidance on how to proceed since this is not indicated for Patients 9 years of age. Transferred nurse who reported 9 year old patient had received QUADRACEL ON 14-apr-2023. She had been given Kenrix on 18-MAR-2022. She asked what is appropriate follow-up. What is follow-up after non-Sanofi vaccine has been given prior."   Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired diluent of ACTHIB was given at a clinic with no reported adverse event; Initial information received on 08-May-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves unknown age and unknown gender patient who was given expired diluent of haemophilus type B (HIB) (PRP/T) vaccine [ACT-HIB] at a clinic with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of 0.5 ml total of suspect haemophilus type B (HIB) (PRP/T) vaccine Powder and solvent for solution for injection (lot U7261AA) (with an unknown strength and expiry date) via unknown route in unknown administration site for Immunization.  On an unknown date the patient developed a non-serious event of expired diluent of haemophilus type B (HIB) (PRP/T) was given at a clinic with no reported adverse event (expired product administered) (latency- same day). Caller is inquiring if the dose is valid.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: UNK
Symptoms: Medication error, No adverse event, Poor quality product administered, Product storage error
Clinical narrative: received a dose of PENTACEL post excursion with no reported adverse event; lowest temperature reached 31.5 F and lasted 24 hours, highest temperature reached 47.1 F and lasted 24 hours with no reported adverse event; Initial information received on 08-May-2023 regarding an unsolicited valid non-serious case received from other health professional.  This case involves an unknown age and gender patients who were administered a dose of diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (Vero)] post excursion with lowest temperature reached 31.5 f and lasted 24 hours, highest temperature reached 47.1 f and lasted 24 hours 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 patients received a dose of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(vero)/HIB(PRP/T) vaccine, suspension for injection (batch number: UJ666AAA; expiry date: 04-May-2023) via unknown route in unknown administration site for immunization post excursion with no reported adverse event (poor quality product administered) (same day latency).  On 07-Feb-2023 the lowest temperature reached 31.5 f and lasted 24 hours, highest temperature reached 47.1 f and lasted 24 hours with no reported adverse event (product storage error) (unknown latency).  Action taken: not applicable.  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: U
Vaccine: HIBV
Symptoms: No adverse event, Poor quality product administered, Product storage error
Clinical narrative: temperature excursion of acthib lowest temperature reached 31.5 f and lasted 24 hours with no reported adverse events; 2 patients received ACTHIB post excursion with no reported adverse events; Initial information received on 08-May-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a patients of an unknown age and gender and reporter reported that temperature excursion of HIB (PRP/T) VACCINE [ACT-HIB] lowest temperature reached 31.5 f and lasted 24 hours with no reported adverse event and 2 patients received acthib post excursion with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 07-Feb-2023, the patients received suspect HIB (PRP/T) VACCINE for Powder and solvent for solution for injection (dosage, strength, route: not reported, Batch number: UJ646AAA and expiry date: 05-Mar-2023) via unknown route in unknown administration site for immunization (immunization) and temperature excursion of acthib lowest temperature reached 31.5 f and lasted 24 hours with no reported adverse events (product storage error) and 2 patients received acthib post excursion with no reported adverse events (poor quality product administered) (latency: same day).  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the events.  At time of reporting, the outcome was 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: U
Vaccine: TD
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: an expired shot of Tenivac was administered to a patient with no reported adverse event; Initial information received on 09-May-2023 regarding an unsolicited valid non-serious case received from other health professional.  This case involves an unknown age and gender patient who had an expired shot of diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult [Tenivac] 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 was administered with an expired dose of suspect diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult (batch number: U6831AA; expiry date: 08-Oct-2022) via unknown route in unknown administration site for immunization with no reported adverse event (expired product administered) (same day latency).  Action taken with diphtheria and tetanus toxoids (Tenivac) was not applicable.  At time of reporting, the outcome was Unknown for the event an expired shot of tenivac was administered to a patient 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.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs/PQCs reported; VARIVAX was administered following temperature excursion; This spontaneous report was received from an other health professional referred to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 01-MAY-2023, the patient was vaccinated with a dose of improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) lot# W031815, expiration date: 05-OCT-2024 (strength, route of administration and anatomical location were not reported) for prophylaxis.   Administered dose of vaccine was exposed for the temperature excursion of 9 degrees Fahrenheit for 2 hours and 6 minutes.  No previous temperature excursion had occurred. There were no additional adverse events reported.  This is one of the five cases reported by same reporter.; Sender's Comments:  US-009507513-2305USA001392: US-009507513-2305USA001570: US-009507513-2305USA001594: US-009507513-2305USA001746: