chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Eczema, Pain, Pruritus, Rash, SARS-CoV-2 test
Clinical narrative: I broke out in full-body hives; Extremely itchy and painful, even spread to my face; Extremely itchy and painful; mixture of hives and eczema; have otherwise caused this rash; This is a spontaneous report from a contactable consumer.  A 21-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EN6207), dose 1 via an unspecified route of administration, administered in Arm Left on 10Mar2021 (at the age of 21-years-old ) as dose 1, single for covid-19 immunisation. Medical history included Hashimoto's disease and Diflucan Allergy. Concomitant medication included levothyroxine sodium (SYNTHROID), Birth control and pre/probiotics.  On 04Apr2021, the patient experienced i broke out in full-body hives, extremely itchy and painful, even spread to my face, extremely itchy and painful, mixture of hives and eczema, have otherwise caused this rash. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 07May2021 covid test type post vaccination: Nasal Swab. Treatment with steroids and antihistamines was given for the events. The patient received the 2nd dose of the vaccine (Lot number: ER8731) on 21Apr2021 in left arm for covid-19 immunisation. The patient received no other vaccine in four weeks. 3 weeks following the first dose, the patient broke out in full-body hives. Extremely itchy and painful, even spread to her face. Now, four months later, she was still suffering flare-ups of a mixture of hives and eczema that cover her stomach, legs, neck, and arms. She had seen several doctors to rule out allergies, autoimmune etc that might have otherwise caused this rash. There are still no concrete results on why the rash was persisting. AE resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The patient was not COVID prior vaccination. The patient tested covid post vaccination. Outcome of the events were not recovered.   Follow-up (24Aug2021): Follow-up attempts are completed. No further information is expected.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: I broke out in full-body hives; Extremely itchy and painful, even spread to my face; Extremely itchy and painful; mixture of hives and eczema; have otherwise caused this rash; This is a spontaneous report from a contactable consumer.  A 21-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EN6207), dose 1 via an unspecified route of administration, administered in Arm Left on 10Mar2021 (at the age of 21-years-old ) as dose 1, single for covid-19 immunisation. Medical history included Hashimoto's disease and Diflucan Allergy. Concomitant medication included levothyroxine sodium (SYNTHROID), Birth control and pre/probiotics.  On 04Apr2021, the patient experienced i broke out in full-body hives, extremely itchy and painful, even spread to my face, extremely itchy and painful, mixture of hives and eczema, have otherwise caused this rash. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 07May2021 covid test type post vaccination: Nasal Swab. Treatment with steroids and antihistamines was given for the events. The patient received the 2nd dose of the vaccine (Lot number: ER8731) on 21Apr2021 in left arm for covid-19 immunisation. The patient received no other vaccine in four weeks. 3 weeks following the first dose, the patient broke out in full-body hives. Extremely itchy and painful, even spread to her face. Now, four months later, she was still suffering flare-ups of a mixture of hives and eczema that cover her stomach, legs, neck, and arms. She had seen several doctors to rule out allergies, autoimmune etc that might have otherwise caused this rash. There are still no concrete results on why the rash was persisting. AE resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The patient was not COVID prior vaccination. The patient tested covid post vaccination. Outcome of the events were not recovered.   Follow-up (24Aug2021): Follow-up attempts are completed. No further information is expected.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Diarrhoea
Clinical narrative: Diarrhea; stomach cramping severe; This is a spontaneous report from a contactable consumer (patient). A 45-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number and expiration date was not reported) via an unspecified route of administration in left arm on 10Jul2021 11:00 as dose 1, single for COVID-19 immunization (at the age of 45-year-old). Medical history included benign essential tremors from an unknown date and unknown if ongoing, Patient had COVID-19 prior vaccination from an unknown date and unknown if ongoing. Patient had no known allergies. There were no concomitant medications. Patient did not receive any other vaccine in four weeks or other medications in two weeks. The patient experienced diarrhea and stomach cramping severe on 11Jul2021 17:00. AE resulted in doctor or other healthcare professional office/clinic visit. Covid was not tested post vaccination. Patient did not receive any treatment for the events. The outcome of the events was not recovered.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.  Follow-up (23Sep2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Sex: M
Vaccine: FLU4
Symptoms: Adverse event, Vaccination complication
Clinical narrative: strong systemic reaction; Initial information regarding an unsolicited valid non-serious case was received on 16-Sep-2021 from physician (patient) via consumer/ non-health care professional via the Agency (reference number- 00772421).  This case involves a male patient (age unspecified) who experienced strong systemic reaction (adverse event following immunisation), after receiving INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  The patient's past medical treatment, vaccination, concomitant medications and family history were not provided.  The patient's medical history included viral titers increased.  On an unknown date in 2020, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [batch number and expiry date not reported] via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date in 2020, the patient experienced a non-serious strong systemic reaction (adverse event following immunisation) approximately few months following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  It was reported "Physician reports that he experienced a reaction to the FLUZONE HIGH-DOSE QUADRIVALENT vaccine last year, and he had a strong, systemic reaction to it. He states that his immune system is always primed because he was a pediatrician for so long. He reports that he used to have various viral titers drawn for his job, and they were always surprised at how high his titers were. He believes that he does not need the high dose vaccine due to a very reactive immune system"  Details of laboratory data not reported.  It was not reported if the patient received any corrective treatment for the event.  At the time of report, the patient was recovered from the reported event on an unknown date.  The reporter did not report causality of event with suspect vaccine.  There will be no information available on batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Illness, Influenza
Clinical narrative: flu; got sick; Initial information received on 21-Sep-2021 regarding an unsolicited valid non-serious case received from a consumer/Non-Healthcare Professional via Social Media.  This case involves an unknown age and unknown gender patient who experienced flu (influenza) and got sick (illness) while receiving INFLUENZA VACCINE.  Medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.  On an unknown date (15 years ago), the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious flu (influenza) and got sick (illness) (right after) following the administration of INFLUENZA VACCINE.  Other relevant lab data was not reported.  It was reported "Haven't had the flu shot since and never will. I'll take my immune IV over any shot, keeping my Vitamin D levels high, eating healthy and exercising. It is unknown if the patient experienced any additional symptoms/events."  It was not reported if the patient received a corrective treatment for the events (flu, got sick).  At time of reporting, the outcome was Unknown for the event flu and sick.  There will be no information available on the batch number for this case.
Sex: M
Vaccine: TDAP
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: expired vaccine administered, with no reported adverse event; Initial information received on 20-Sep-2021 regarding an unsolicited valid non-serious case received from a other health professional. This case involves male patient with an unknown age who received expired dose of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  Medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.  On 20-Sep-2021, the patient received a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot number not reported, expiry date- 17-Sep-2021 via unknown route in unknown administration site for prophylactic vaccination.  It was a case of actual medication error due to expired vaccine used (latency same day).  It was reported "It is unknown if the patient experienced any additional symptoms/events."  At time of reporting, no adverse event was reported.   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.  There will be no information available on the batch number for this case.
Age: 31.0
Sex: F
Vaccine: FLU4
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: The mother received vaccine during pregnancy, no AE; Initial information was received on 16-Sep-2021 regarding an unsolicited valid non-serious case from a physician.  This case involves a 31-year-old female patient who was exposed to vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV] during pregnancy (Exposure during pregnancy).  Data regarding this pregnancy were received prospectively, i.e., before pregnancy outcome was known.   The date of last menstrual period was reported as 15-May-2021.  The estimated due date is  27-Feb-2022.  It was unknown if the patient had any medical history, concomitant disease or risk factor  Medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  On 15-Sep-2021, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot UT7323JA, expiry date: 30-Jun-2022) via unknown route in unknown administration site for prophylactic vaccination.  It was a case of vaccine exposure during pregnancy (latency same day).  The mother did not experience any adverse events during vaccine.  At time of reporting, the outcome of the pregnancy is unknown.
Sex: M
Vaccine: TDAP
Symptoms: Expired product administered
Clinical narrative: Patient was administered Adacel vaccine on 9/20/21, Product had expired on 9/17/21 with no reported adverse event; Initial information was received on 20-Sep-2021 regarding an unsolicited valid non-serious case from a other healthcare professional.  This case involves an unknown age male patient who was administered with DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] on 20-Sep-2021, which had expired on 17-Sep-2021 (expired product administered).  It was unknown if the patient had any medical history, concomitant disease or risk factor  The patient's past medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.   On 20-Sep-2021, the patient received a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (lot number and expiry date were not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  It was a case of actual medication error due to expired vaccine used (same day).  It was unknown if the patient experienced any additional symptoms/events.   At time of reporting, no adverse event was reported and the outcome was unknown for the reported 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.  There will be no available information on lot number for this case.
Sex: U
Vaccine: FLU4
Symptoms: Adverse reaction
Clinical narrative: Bad reaction; Initial information was received on 21-Sep-2021 regarding an unsolicited valid non-serious case from a consumer/non-health care professional via social media.  This case involves a patient (unknown demographics) who had bad reaction (adverse reaction) after receiving INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  It was unknown if the patient had any medical history, concomitant disease or risk factor.  Medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (batch number and expiry not reported) (formulation: unknown) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious bad reaction (adverse reaction) (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  It was reported "I am on the fence about getting a flu shot this year. last year I got one in September, had a bad reaction to it and went to Emergency Room (ER) the next day. So scary!"  It was unknown if the patient experienced any additional symptoms/events.  It was unknown if there were lab data/results available.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome of the event was unknown.  The reporter did not report the causality of event with suspect.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLU4
Symptoms: Malaise
Clinical narrative: sick for 2 weeks; Initial information received on 21-Sep-2021 regarding an unsolicited valid non-serious case from a consumer/non-healthcare professional via social media.   This case involves a patient (unknown age and gender) who was sick (illness) for 2 weeks, after receiving QUADRIVALENT INFLUENZA VACCINE (FLUZONE HIGH-DOSE QUADRIVALENT).  It was unknown if the patient had any medical history, concomitant disease or risk factor.   The patient's past medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.   On an unknown date in 1995, the patient received a dose of suspect FLUZONE HIGH-DOSE QUADRIVALENT (lot number and expiration date were not reported) via unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date, the patient was sick (illness, non-serious) for 2 weeks (unknown latency) following the administration of vaccine.  It was unknown if the patient experienced any additional symptoms/events.  It was unknown if there were laboratory data/results available.  It was not reported if the patient received a corrective treatment.   At time of reporting, the outcome was unknown for the reported event.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Pain
Clinical narrative: Hurts like son of a gun; Initial information received on 18-Sep-2021 regarding an unsolicited valid non-serious case received from a consumer/non-hcp (non-health care professional).  This case involved an (unknown age and gender) patient who experienced hurts like son of a gun (pain) while receiving INFLUENZA VACCINE.  Past medical treatment(s), vaccination(s) concomitant medication and family history were not provided.  It was unknown if the patient had any medical history, concomitant disease or risk factor.   On an unknown date, the patient received in last weekend a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date were not reported) via unknown route in unknown administration site for prophylactic vaccination   On an unknown date the patient developed a non-serious hurt like son of a gun (pain) (unknown latency) following the administration of INFLUENZA VACCINE.  It was unknown if the patient experienced any additional symptoms/events.  It was unknown if there were lab data/results available.  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.  There will be no information available on the batch number for this case.
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity
Clinical narrative: Arm pain; Initial information was received on 22-Sep-2021 regarding an unsolicited valid non-serious case from other health-care professional.  This case involves a 57-year-old female patient who had arm pain (pain in extremity) after receiving INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  It was unknown if the patient had any medical history, concomitant disease or risk factor.  Medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.   On 22-Sep-2021, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (batch number and expiry not reported) via unknown route in unknown administration site for prophylactic vaccination.  On 22-Sep-2021 the patient developed a non-serious arm pain (pain in extremity) on the same day following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  It was unknown if the patient experienced any additional symptoms/events.  It was unknown if there were lab data/results available.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome of the event was unknown.  The reporter did not report the causality of event with suspect.  There will be no information available on the batch number for this case.
Age: 69.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Headache, Lip swelling, Pain, Pain in jaw
Clinical narrative: right side of the top lip was swollen; cheek sore when she pushed on it and radiates to jaw; cheek sore when she pushed on it and radiates to jaw; chills; headache; 102 fever; Initial information received on 17-Sep-2021 regarding an unsolicited valid non-serious case from a consumer/non-health care professional via Agency (under the reference 00775106).  This case involved a 69 years old female patient who had right side of the top lip was swollen (lip swelling), cheek sore when she pushed on it and radiates to jaw (oral pain), cheek sore when she pushed on it and radiates to jaw (pain), chills, headache and 102 fever (pyrexia) after receiving INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  The patient's past medical history included Nasopharyngitis.  The patient's past medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On 14-Sep-2021, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (0.7 ml, lot UJ730AA and expiration date not provided) via intramuscular route in the left arm for prophylactic vaccination.  On 14-SEP-2021, the patient developed a non-serious chills, headache, 102 fever (pyrexia) on the same day following the administration of vaccines.  On an unknown date, the patient developed a non-serious right side of the top lip was swollen (lip swelling), cheek sore when she pushed on it and radiates to jaw (oral pain), cheek sore when she pushed on it and radiates to jaw (pain) [unknown latency] following the administration of vaccine.  Relevant laboratory test results included:  Body temperature : 102 On an unknown date  The patient was treated with LORATADINE (CLARITINE) and PARACETAMOL (TYLENOL).  At time of reporting, the outcome was unknown for the reported events.
Age: 69.0
Sex: F
Vaccine: FLU4
Symptoms: Pyrexia
Clinical narrative: right side of the top lip was swollen; cheek sore when she pushed on it and radiates to jaw; cheek sore when she pushed on it and radiates to jaw; chills; headache; 102 fever; Initial information received on 17-Sep-2021 regarding an unsolicited valid non-serious case from a consumer/non-health care professional via Agency (under the reference 00775106).  This case involved a 69 years old female patient who had right side of the top lip was swollen (lip swelling), cheek sore when she pushed on it and radiates to jaw (oral pain), cheek sore when she pushed on it and radiates to jaw (pain), chills, headache and 102 fever (pyrexia) after receiving INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  The patient's past medical history included Nasopharyngitis.  The patient's past medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On 14-Sep-2021, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (0.7 ml, lot UJ730AA and expiration date not provided) via intramuscular route in the left arm for prophylactic vaccination.  On 14-SEP-2021, the patient developed a non-serious chills, headache, 102 fever (pyrexia) on the same day following the administration of vaccines.  On an unknown date, the patient developed a non-serious right side of the top lip was swollen (lip swelling), cheek sore when she pushed on it and radiates to jaw (oral pain), cheek sore when she pushed on it and radiates to jaw (pain) [unknown latency] following the administration of vaccine.  Relevant laboratory test results included:  Body temperature : 102 On an unknown date  The patient was treated with LORATADINE (CLARITINE) and PARACETAMOL (TYLENOL).  At time of reporting, the outcome was unknown for the reported events.
Age: 2.0
Sex: F
Vaccine: IPV
Symptoms: Drug abuse
Clinical narrative: a patient was administered a 1 ml dose of IPOL vaccine/ No AE; Initial information received on 17-Sep-2021 regarding an unsolicited valid non-serious case received from an other health care professional via physician via consumer via phone via Medical Information number: 00775126.    This case is linked to cases 2021SA311330, 2021SA314182, 2021SA312255 and 2021SA312326 (same reporter).  This case involved 2 year-4-month-old female patient who was administered a 1 ml dose of IPV (VERO) [IPOL] vaccine (overdose).  Relevant medical history, medical treatment(s), vaccination(s) concomitant medication and family history were not provided.   On an unknown date, the patient received 1ml total dose of suspect IPV (VERO) (lot: U1A452M and expiry date: 20-Feb-2023) frequency: once, strength: standard via unknown route in unknown administration site for prophylactic vaccination (overdose).  It was a case of actual medication error due to overdose (latency: same day).   It was reported " Caller/ Medical Assistant reports that IPOL was administered to 5 patients, caller states that she does not know if patients received a 1 mL dose or a 0.5 mL dose, caller requests information on possible adverse effects from a 1 mL dose of IPOL. Caller states she does not have time to look through all patient charts for adverse event information, she will call back at a less busy time."  At time of reporting, no adverse event was reported.
Sex: M
Vaccine: FLU4
Symptoms: Injection site extravasation, Syringe issue
Clinical narrative: technician went to retract the needle and pulled the needle out of the consumer's skin the technician noticed there was leakage; plunger was difficult to depress; Initial information was received on 20-Sep-2021 regarding an unsolicited valid non-serious case from a pharmacist.  This case involves an infant male patient (age unknown) who experienced "technician went to retract the needle and pulled the needle out of the consumer's skin the technician noticed there was leakage" (injection site extravasation) and "plunger was difficult to depress" (syringe issue) while receiving vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV].  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On 19-Sep-2021, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot number and expiry date were not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious technician went to retract the needle and pulled the needle out of the consumer's skin the technician noticed there was leakage (injection site extravasation) (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  It was also a case of syringe issue (latency-same day).  It was reported "Pharmacist is at home on her day off and states a technician yesterday attempted to give a male consumer the vaccine and stated to the pharmacist the plunger was difficult to depress and when the technician went to retract the needle and pulled the needle out of the consumer's skin the technician noticed there was leakage. Pharmacist stated there was no crack or anything with the syringe as far as the leaking. Pharmacist states she didn't give the injection and doesn't have any further details, but someone may call today from her pharmacy."  Details of laboratory data were not reported.  At the time of report outcome was unknown for the events.  There will be no available information on lot number for this case.
Sex: U
Vaccine: FLU4
Symptoms: Device leakage, No adverse event, Occupational exposure to product, Underdose
Clinical narrative: one fourth to half of the vaccine leaked out/no AE; there was liquid dripping down both sides of her arm/no AE; one fourth to half of the vaccine leaked out/no AE; Initial information was received on 20-Sep-2021 regarding an unsolicited valid non-serious case from a pharmacist.  This case involves an patient of unknown demographics who experienced liquid dripping down both sides of her arm (occupational exposure via skin contact with product) and 1/4-1/2 of the vaccine leaked out (underdose and device leakage) while receiving INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV].  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On 17-Sep-2021, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot number, expiry date were not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  It was case of occupational exposure via skin contact with product, underdose and device leakage (latency- same day).  It was reported call received from Pharmacist reporting a patient received partial dose of FLUZONE QUADRIVALENT PREFILLED SYRINGE on 17Sep2021. Caller reporting vaccine was administered and discarded in the sharps box when the patient noticed there was liquid dripping down both sides of her arm. Caller reporting she would estimate 1/4-1/2 of the vaccine leaked out. Caller with question on whether vaccine needs repeating and in what time frame to repeat dose. Caller also with question on whether we have any information on patient receiving over the recommended amount when repeating the full dose.  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in 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.  There will be no available information on lot number for this case.
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Medication error, Wrong technique in product usage process
Clinical narrative: patient has received the Diluted portion of the Pentacel and they have the patient coming in to received the powder form of the Pentacel with no adverse event reported.; Initial information regarding an unsolicited valid non serious case was received from another health professional via Medical Information (Reference number- 00778419) and transmitted to Sanofi on 21-Sep-2021.   This case involves an unknown demographic (unknown age and unknown gender) patient who received DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] which was "patient has received the diluted portion of the pentacel and they have the patient coming in to received the powder form of the pentacle" (wrong technique in product usage process).  The patient's medical history, past medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  On an unknown date, the patient received a 0.5 mL dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot UJ543AA, expiry date 10-Jul-2021) via an unknown route at an unknown administration site for prophylactic vaccination.  It was an actual medication error due to wrong technique in product usage process (latency unknown).  It was reported "patient has received the Diluted portion of the PENTACEL and they have the patient coming in to received the powder form of the Pentacel and now what can they use instead of the diluent that come with the Pentacel? Can she use sterile water? Healthcare professional (HCP) asks what can be used to mix the HIB part of Pentacel? Also, what amount of 0.4% NaCl is used?"  At time of reporting, no adverse event reported.  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: 0.5
Sex: M
Vaccine: HIBV
Symptoms: No adverse event, Product preparation error
Clinical narrative: Vaccine was reconstituted with sterile water with no reported adverse event; Initial information was regarding an unsolicited valid non serious case was received from a other health professional via Agency (Reference number- 00778472) and transmitted to Sanofi on 21-Sep-2021.  This case involves a six-month-old male patient who received HIB (PRP/T) VACCINE [ACT-HIB] vaccine was reconstituted with sterile water (product preparation error).  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA, TETANUS, AC PERTUSSIS, IPV AND HIB VACCINE (PENTACEL) for Immunisation, PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) for Immunisation and ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ) for Immunisation.  On 14-Sep-2021, the patient received a third dose of 0.5 mL of suspect HIB (PRP/T) VACCINE (Powder and solvent for solution for injection, Powder: lot: UJ585AA expiry date: 22-Oct-2022, Diluent: lot: U7146AB expiry date: 16-Oct-2022) via an unknown route in the right thigh (VASTUS) for prophylactic vaccination.  It was an actual medication error due to product preparation error (latency: same day).  It was reported "ACT-HIB being administered to a patient. Vaccine was reconstituted with sterile water and would like to know if this dose would count as valid? Would also like to know how to proceed if not counted as a valid dose?"  At time of reporting, no adverse event reported.  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: FLU4
Symptoms: Medication error, No adverse event, Product storage error
Clinical narrative: Product spent too long in transit and product was no longer suitable for use with no adverse event; Initial information received on 21-Sep-2021 regarding an unsolicited valid non-serious case received from a other health care profession and non-healthcare professional via [Medical Information under reference - 00778575].  This case involves a 100 patient's of (unknown demographics) were vaccinated INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] which went spent too long in transit and product was no longer suitable for use (product temperature excursion issue).  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.  No concomitant therapy was given.  On an unknown date, the patient's received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot - UT7317KA and expiry date 30-06-2022) via an unknown route at an unknown administration site for prophylactic vaccination.  It was reported "she had a shipment of FLUZONE QUADRIVALENT which was shipped on Friday and delivered on Monday; caller states she was told that it spent too long in transit and product was no longer suitable for use. Caller states she has already administered this FLUZONE QUADRIVALENT to 100 patients post-excursion."  It was a case of actual medication error due to product temperature excursion issue.  At the time of reporting, no adverse event reported.  Outcome of event was unknown.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 0.25
Sex: M
Vaccine: UNK
Symptoms: Product preparation issue
Clinical narrative: only received the DTap-IPV diluent portion of PENTACEL and that it was not reconstituted with lyophilized Hib component prior to injection/ no AE; Initial information was received on 21-Sep-2021 regarding an unsolicited valid non-serious case from other healthcare professional and consumer/non-healthcare professional via call center via Medical Information (Reference number- 00778581).  This case involves a 3-month-old male patient who received only received DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] which DTaP-IPV diluent was not reconstituted with lyophilized HIB component (product preparation issue).  The patient's medical history, past medical treatments, vaccinations and family history were not provided.  Concomitant medications included ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) and PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) for prophylactic vaccination.  On 20-Sep-2021, the patient received a first dose of 0.5 mL of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE (lot number: U69445AA and expiry date: 22-Jul-2022) via an intramuscular route in the right quadricep for prophylactic vaccination.  It was an actual medication error case due to inappropriate reconstitution technique (latency: same day).  It was reported "Nurse states that a patient on 20SEP2021 only received the DTaP-IPV diluent portion of PENTACEL and that it was not reconstituted with lyophilized HIB component prior to injection. Nurse asked for information on how to proceed and whether or not the patient would need to receive the entire PENTACEL injection over again."  At the time of reporting, no adverse event was reported.  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 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: 0.33
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Expired product administered, Medication error
Clinical narrative: patient received expired vaccine PENTACEL/no AE; Initial information regarding an unsolicited valid non-serious case was received from the other health professional, non-healthcare professional, physician via Medical Information (Reference number- 00778696) and transmitted to Sanofi on 21-SEP-2021.  This case involves a 4 months old male patient who received expired vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (expired product administered).  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.  Concomitant medications included ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) and PNEUMOCOCCAL VACCINE (PNEUMOCOCCAL VACCINE) for prophylactic vaccination.  On 19-Jul-2021, the patient received a 2 ml dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot number: UJ214AAA and expiry date: 02-MAY-2021) via an intramuscular route at an unknown administration site for prophylactic vaccination.  It was a case of an actual medication error due to expired vaccine used (on the same day).  It was reported "Caller reports the patient received expired PENTACEL, the new office does not offer PENTACEL they offer Pediarix, the patient is coming in for the 6 month shots, so they need to know how to make sure the child will receive a complete series; is there any leeway with the expiration date of PENTACEL, if the expired dose is not valid how do they catch the patient up with the Pediarix vaccine instead of PENTACEL."  At the time of report, 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.
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Product preparation issue
Clinical narrative: Pentacel that only the diluent was used for the DTAP portion of the vaccine wih no AE; Patient administered  0.25 ml dose of Pentacel with no AE; Initial information received on 21-Sep-2021 regarding an unsolicited valid non-serious case received from an other health professional.   This case involves a 6-month-old and unknown gender patient for whom it was reported "pentacel that only the diluent was used for the dtap portion of the vaccine" [product preparation issue] and patient administered 0.25 ml dose of pentacel while receiving DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] [incorrect dose administered].  The patient medical history, medical treatment(s), vaccination(s), concomitant medication, and family history were not provided.   On an unknown date, the patient received a 0.25 ml dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [lot UJ528AA and expiry date: not reported] via an intramuscular route in the right thigh for prophylactic vaccination.  It was reported patient visit on 03-Sep-2021.   No other vaccines were reported.   It was a case of actual medication error due to incorrect dose administered and product preparation issue [Latency: on the same day].   It was not reported if the patient received any corrective treatment for the events.  At time of reporting, the outcome was unknown for the events.  At the time of report no adverse event was reported.   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: DTAPIPVHIB
Symptoms: Medication error, Product preparation issue
Clinical narrative: patient received the DTaP-IPV portion of PENTACEL and not the ACTHIB portion/no AE; Initial information was received on 21-Sep-2021 regarding an unsolicited valid non-serious case from non-healthcare professional via call center via Medical Information (Reference number- 00778882).  This case involves a patient of (unknown demographics) who received the dtap-ipv portion and not the HAEMOPHILUS TYPE B (HIB) VACCINE [ACTHIB] portion of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)].  The patient's past medical treatment, vaccination, concomitant medication and family history were not provided.  On an unknown date, the patient received a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  It was a case of an actual medication error due to inappropriate reconstitution technique (on the same day).  It was reported "caller would like to know if sterile water or 0.9 percent sodium chloride can be used to reconstitute the ACTHIB vial that was left from the original administration and how to get the patient back on schedule; patient has not yet received the ACTHIB portion of PENTACEL, caller would also like to know what volume of 0.4 percent sodium chloride is required to reconstitute the ACTHIB vial of PENTACEL."  At the time of report, 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.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLU4
Symptoms: Expired product administered
Clinical narrative: already administered fluzone high dose not suitable for use with no reported adverse event; Initial information received on 21-Sep-2021 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves an unknown age and unknown gender patient who already administered INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] dose not suitable for use [expired product administered].   The patient medical history, medical treatment(s), vaccination(s), concomitant medication, and family history were not provided.   On 21-Sep-2021, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [lot UJ759AB and expiry date: not reported] via an unknown route in unknown administration site for prophylactic vaccination.  It was a case of actual medication error due to expired product administered [Latency: on the same].   It was reported "Pharmacist reports that they received a shipment of FLUZONE HIGH DOSE today; states he received a call from Sanofi and was told that his products were supposed to be delivered yesterday, and since they were delivered today his products are not suitable for use. Pharmacist states they had already administered this FLUZONE HIGH DOSE to 2 patients before they received the call from Sanofi. Pharmacist states he does not have complete information for an AE/safety report at this time, states he has to speak to the other pharmacists to determine exactly what happened".  No other vaccines were reported.  Details of laboratory data not reported.  It was not reported if the patient received any corrective treatment for the event.  At time of reporting, the outcome was unknown for the event.  At the time of report no adverse event was reported. 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.