chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: FLUX
Symptoms: Influenza, Vaccine positive rechallenge
Clinical narrative: patient had gotten a flu shot three times and caught the flu all three of those years; Initial information was received on 25-Oct-2021 regarding an unsolicited valid non-serious case from  a non-health care professional (patient) via Social Media.  This case involves an adult patient of unknown age who caught the flu (influenza), after receiving INFLUENZA VACCINE.  The patient's vaccination(s) included INFLUENZA VACCINE  for prophylactic vaccination and experienced Influenza after vaccination. The patient's medical history, concomitant therapy, medical treatment(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expirydate not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient caught the flu (Influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  It was unknown if the patient experienced any additional symptoms/events.  It was reported "Well, it may just be coincidence, but I've gotten a flu shot three times and caught the flu all three of those years. I can only think of one other time that I caught the flu. Of all the times, the time without vaccine was the mildest, which is why I don't take the shot anymore".  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment for the event.  At time of reporting, outcome of the event was unknown.  There will be no information available on batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Paralysis
Clinical narrative: paralyzed; Initial information received on 25-Oct-2021 regarding an unsolicited valid serious case received from a consumer/non-health care.  This case involves an unknown age and gender patient who was paralyzed (paralysis) after receiving INFLUENZA VACCINE.  The patient had no medical history, concomitant disease, or risk factor.  The patient medical treatment(s), vaccination(s), concomitant medication, and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer [lot number and expiry date not reported] via an unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a serious event paralyzed (paralysis) (unknown latency) following the administration of INFLUENZA VACCINE. This event was assessed as medically significant.  It was reported "patient never had a flu shot except the one time my doctor gave me the injection without me knowing it was coming. Patient knew of one reaction and that person was paralyzed. Patient would fall within that 1 percent, whatever measurement they had for negative reactions".   There were no laboratory data/results available.  It was unknown if the patient experienced any additional symptoms/events.  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.  Information on the batch number was requested.; Sender's Comments: This case involves an unknown age and unknown gender patient who had paralysis after vaccination with INFLUENZA VACCINE (unknown manufacturer). The time to onset is unknown. There is no further information regarding patient's medical condition at time of vaccination, history and laboratory tests ruling out alternate etiologies. Based upon the reported information, the role of a vaccine cannot be assessed.
Sex: U
Vaccine: COVID19, FLUX
Symptoms: Vaccination site pain
Clinical narrative: Arms sore; Initial information received on 26-Oct-2021 regarding an unsolicited valid non-serious case from a Social Media via a consumer/non-health care professional.  This case involves a patient (unknown demographics) who had arms sore (vaccination site pain) after receiving INFLUENZA VACCINE and corona virus diseases of 2019 (COVID-19) VACCINE MRNA (MRNA 1273) (MODERNA COVID-19 VACCINE).  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, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number and expiry not reported) via unknown route in the arm Not Otherwise Specified (NOS) for prophylactic vaccination.  On an unknown date, the patient received a dose of suspect MODERNA COVID-19 VACCINE (booster) not produced by Sanofi Pasteur (batch number and expiry not reported) via unknown route in the arm NOS for prophylactic vaccination.  On an unknown date the patient developed a non-serious arms sore (vaccination site pain) (unknown latency) following the administration of INFLUENZA VACCINE and MODERNA COVID-19 VACCINE.  It was reported "Got my flu shot in one arm and my Moderna booster in the other on Sunday! Makes both arms sore as hell worth it"  It was unknown if the patient experienced any additional symptoms/events.  There were no lab data/results available.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, outcome of the event was unknown.  The reporter did not report the causality of event with suspects.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Vaccination complication
Clinical narrative: a bit of a reaction; Initial information received on 25-Oct-2021 regarding an unsolicited valid non-serious case received from a consumer (patient) via social media.  This case involves an unknown demographic patient who experienced a bit of a reaction (unevaluable event) after receiving INFLUENZA VACCINE.  Medical history, past medical treatment, past vaccination, concomitant medication and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) [lot number and expiry date not reported] via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed non-serious a bit of a reaction (unevaluable event) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported "Got a flu shot 2 weeks ago. Had a bit of a reaction but it was gone in 12 hours and now I'm good to go."  Details of laboratory data not reported.  It was not reported if the patient received any corrective treatment.  On an unknown date, the patient recovered (it was gone in 12 hours) from the event.  There will be no information available on batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Unevaluable event
Clinical narrative: Patient do not intend to spend another 2 weeks in the hospital; Initial information received on 27-Oct-2021 regarding an unsolicited valid serious case received from a consumer or non-healthcare professional via social media.  This case involves adult patient who had not intend to spend another 2 weeks in the hospital (hospitalisation) after receiving INFLUENZA VACCINE.  It was unknown if the patient had concomitant disease or risk factor.   The patient medical history, medical treatment(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) [lot number and expiry date not reported] via unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a serious who had not intended to spend another 2 weeks in the hospital (hospitalisation) (unknown latency) following the administration of INFLUENZA VACCINE. The patient was hospitalized for this event.  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 reported event.  There will be no information available on the batch number for this case.; Sender's Comments: This case involves an adult patient (unknown gender) who presented with hospitalisation after the vaccination with INFLUENZA VACCINE (unknown manufacturer).Time of onset is unknown. Further information regarding medical condition during vaccination, previous vaccination and tolerance, other laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of the suspect vaccine cannot be assessed.
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Product preparation issue, Underdose
Clinical narrative: diluent component of PENTACEL was administered to a patient; it was not reconstituted with the ACT-HIB component/no AE; diluent component of PENTACEL was administered to a patient; it was not reconstituted with the ACT-HIB component/no AE; Initial information received on 19-Oct-2021 regarding an unsolicited valid non-serious case received from a Physician and non-health care professional via Medical Information - 00818790.   This case involves a patient of unknown demographics who received only diluent component of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] it was not reconstituted with the ACT-HIB component (Product preparation issue)(vaccine underdose).  The patient's medical history, past medical treatment(s), concomitant therapy, vaccination(s) 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 unknown route in unknown administration site for prophylactic vaccination.  It was reported "Physician reports that the diluent component of PENTACEL was administered to a patient; it was not reconstituted with the ACTHIB component. Caller would like to know if the diluent counts as a valid dose of DTAP and can the ACTHIB component be diluted with sterile water. Caller would appreciate an email or call back from Customer Service regarding the purchase of 0.4 % saline solution to reconstitute the ACTHIB component of PENTACEL. Caller did not wish to be transferred to Customer Service as she was starting a webinar".  It was a case of an actual medication error due to Inappropriate reconstitution technique and vaccine underdose(latency was on same day).   At the time of report, 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.  There will be no information available on batch number for this case.
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased
Clinical narrative: This case involves a female patient (unknown age) whose arm was not normal after shot and arm could not move (injected limb mobility decreased) after receiving INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT]. The patient's medical history, 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 VACCINE (batch number and expiry not reported) via unknown route in the arm Not Otherwise Specified (NOS) for prophylactic vaccination. On an unknown date the patient developed a non-serious "arm was not normal after shot and arm could not move" (injected limb mobility decreased) (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE. It was reported "I don't know if this is the right place that I should be, but my arm is like not normal after my shot, and I had to Flu zone and my arm I can't move my arm it's been a month so let me know what's going on I don't know if this is the right place, I'm supposed to be so okay." No laboratory data was reported. It was not reported if the patient received a corrective treatment for the event. At time of reporting, the event was not resolved. There will be no information available on the batch number for this case.
Age: 0.92
Sex: F
Vaccine: FLU4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 11 month patient received high dose flu vaccination with no adverse event; 11 month patient received high dose flu vaccination with no adverse event; Initial information regarding an unsolicited valid non-serious case was received from physician and other health care professional via Global Medical Information (GMI) (Reference number- 00820934) and transmitted to Sanofi on 20-Oct-2021.  This case involves a 11-month-old female patient who received INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (product administered to patient of inappropriate age and overdose).  Relevant medical history, medical treatment(s), vaccination(s) concomitant medication and family history were not provided.   On 20-Oct-2021, 11-month-old female patient received 0.7ml dose of supect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (batch number and expiry date were not reported) via an intramuscular route in the left thigh for prophylactic vaccination. (product administered to patient of inappropriate age and overdose).  It was reported "She wants to know what the side effets will be? the caller did not know for sure that the flu vaccination that was given to her daugher was fluzone HD for sure. she assumed there was only one high dose (HD) brand available. she will find out that info and the lot and expiry date and agreed to a call back".   This case was an actual medication error due to inappropriate age at vaccine administration and overdose (latency: same day).  At the time of reporting, no 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 by the regulatory authority. 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: 1.0
Sex: F
Vaccine: FLUR4
Symptoms: Medication error, Product administered to patient of inappropriate age
Clinical narrative: administered FLUBLOK QUADRIVALENT to a patient who is 1 years old (under the age of 18), with no reported adverse event; Initial information regarding an unsolicited valid non serious case was received from physician and other health professional via (Reference number: 00821061) and transmitted on 20-Oct-2021. This case involved a 12-month-old female patient (under the age of 18) receiving INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (product administered to patient of inappropriate age).  The patient past vaccination(s) included INFLUENZA VACCINE for prophylactic vaccination.  The patient medical history, medical treatment(s) and family history were not provided.  At the time of the event, the patient had ongoing egg allergy.  On 16-Oct-2021, the patient received a 0.5 mL dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [Strength: standard, frequency: once, lot QFAA2111, Expiration Date :02-Jun-2022] via an intramuscular route at a thigh site for prophylactic vaccination.  This was actual medication error case due to Inappropriate age at vaccine administration (latency same day)   It was reporter "Caller states that a patient that who is under the age of 18 received a FLUBLOK QUADRIVALENT vaccination in her clinic on 16-Oct-2021. Caller stated that the patient received the FLUBLOK QUADRIVALENT because they had an egg allergy. Caller states that the patient received a flu vaccine in 2020 that contained eggs and did not experience any adverse events."  No other vaccines.  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report was 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. The classification as a medical error was 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 had 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: Only the liquid componenet of the PENTACEL vaccine was given to a patient with no reported adverse event;Initial information received on 20-Oct-2021 regarding an unsolicited valid non-serious case from another health care professional via non-healthcare professional/consumer via Medical Information (Reference number- 00821192).   This case involves a patient (unknown demographics) who received only the liquid component of the DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] (Product preparation issue).  The patient's medical history, medical treatment, vaccination, concomitant medication and family history were not provided.  On 20-Oct-2021, the patient received a only liquid component 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 actual medication error due to inappropriate reconstitution technique (latency on same day).  It was reported "the caller states that only the liquid component of the PENTACEL vaccine was given to a patient today. What do they do?"   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.  There will be no information available on the batch number for this case.
Sex: F
Vaccine: FLU4
Symptoms: Blister, Skin exfoliation, Vaccination site reaction
Clinical narrative: skin had blisters; skin had peeling; pancake at injection site that is 4 1/2" down arm 4" across; Initial information was regarding an unsolicited valid non serious case was received from a consumer/non-health care professional via (Reference number- 00822708) and transmitted on 21-Oct-2021.This case involves a 83-year-old female patient who experienced skin blisters and peeling (skin exfoliation) and pancake at injection site that is 4 1/2 down arm 4 across (vaccination site reaction), after receiving INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  The patient's past vaccination(s) included RABIES VACCINE.  The patient's medical history, past medical treatment(s), concomitant medications and family history were not provided.  On an unknown date, the patient received a 0.7 mL dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On 05-Oct-2021, the patient developed non-serious skin had blisters and peeling (skin exfoliation) and pancake at injection site that is 4 1/2 down arm 4 across (vaccination site reaction) (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  Details of laboratory data not reported.  On an unknown date, the patient received DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL) as corrective treatment for events blisters and skin exfoliation.  It was reported "pancake at injection site that is 4 1/2 down arm 4 across. Her skin had blisters and peeling. She took Benadryl and it has now resolved. She states to when she got her fourth rabies vaccine she had same reaction."  At the time reporting, the unknown for the event vaccination site reaction.  On an unknown date, the patient was recovered from the event blisters and skin exfoliation.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLU4
Symptoms: No adverse event, Product storage error
Clinical narrative: The products reached negative 31.5 Fahrenheit for thirty-eight minutes with no AE; Initial information received on 21-Oct-2021 regarding an unsolicited valid non-serious case received from another health professional.  This case involves an unknown age and unknown gender patient for whom it was reported "the INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV] reached negative 31.5 Fahrenheit for thirty eight minutes" (product storage error).   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 dose of suspect INFLUENZA QUADRIVAL A-B VACCINE [prefilled, lot UT7383NA and expiry:30-Jun-2022] via an unknown route in unknown administration site for prophylactic vaccination.  It was  reported "the reason for excursion is unknown".  It was a case actual medication error due to product storage error [Latency: on the same day].  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. 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: 60.0
Sex: F
Vaccine: FLU4
Symptoms: Extra dose administered, Medication error, Product administered to patient of inappropriate age
Clinical narrative: A 60-year-old patient received flu zone high-dose no AE; A 60-year-old patient received flu zone high-dose no AE; Initial information regarding an unsolicited valid non-serious case was received from a pharmacist via a consumer/non-health care professional via (Reference number- 00824766) and transmitted on 22-OCT-2021. This case is linked to cases 2021SA356392 and 2021SA355376 (same reporter). This case involves a 60-year-old female patient who received INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (product administered to patient of inappropriate age and overdose). At the time of the event, the patient had ongoing medical history of Chronic obstructive pulmonary disease (COPD) and Neoplasm malignant (unspecified cancer). The patient's past medical treatment(s), vaccination(s) and family history were not provided. The patient had no other concomitant vaccine. On 22-Oct-2021, the patient received a 0.7 mL dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot UJ769AA, expiry: 30-Jun-2022) via intramuscular route in the left arm for prophylactic vaccination. It was a case of an actual medication error due to inappropriate age at vaccine administration and overdose (latency same day).  It was reported "Pharmacist states that during a flu-shot clinic, three of the patients who received FLUZONE QUADRIVALENT HIGH-DOSE, after attesting to be less than 65 years of age, were found to be younger. Two of the women were 60 and one was 45 years old. Caller asking what should be done." No other 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. 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: 46.0
Sex: F
Vaccine: YF
Symptoms: Expired product administered
Clinical narrative: YF-VAX was administered to 5 patients using an expired diluent with no reported adverse event; Initial information was received on 25-Oct-2021 regarding an unsolicited valid non-serious case from a other healthcare professional via Medical Information (under reference:00826473).  This case involves a 46-year-old female patient who was administered YELLOW FEVER VACCINE - US [YF-VAX] using an expired diluent (expired product administered).  The patient's medical history, past 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 YELLOW FEVER VACCINE - US (0.5ml, once, total,  lot U6428AA, expiry date: 30-Sep-2021) via intramuscular route in the right deltoid for prophylactic vaccination.  It was a case of actual medication error due to expired vaccine used (latency same day)  It was reported "Operations manager is following-up, providing additional information on expired YF-VAX administered to 5 patients."  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.; Sender's Comments:  00824899: US-SA-2021SA354618: US-SA-2021SA356701: US-SA-2021SA354616:
Sex: F
Vaccine: YF
Symptoms: Expired product administered, No adverse event
Clinical narrative: YF-VAX was administered using an expired diluent with no reported adverse event; Initial information received on 25-Oct-2021 regarding an unsolicited valid non-serious case received from a other health professional and non health care professional via Medical Information number: 00826516.  This case involves 58 years old female patient was administered expired YELLOW FEVER VACCINE - US [YF-VAX] (expired product administered).  This case is linked to cases US-SA-2021SA356051, 2021SA357534 and 2021SA356051(CLUSTER).  The patient's medical history, past medical treatments, vaccinations, and family history were not provided.  Concomitant medications included TYPHOID VACCINE (TYPHIM).  On an unknown date, the patient received a 0.5 ml dose of suspect YELLOW FEVER VACCINE - US (lot number: U6428AA and expiry date: 30-SEP-2021) via intramuscular route in the left deltoid site for prophylactic vaccination.  It was case of an actual medication error due to expired vaccine used (latency: same day).  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 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.as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.; Sender's Comments:  US-SA-2021SA354616: US-SA-2021SA356701: US-SA-2021SA354618:
Sex: M
Vaccine: FLUR4
Symptoms: Erythema, Extravasation blood, Injection site swelling, Skin discolouration
Clinical narrative: Parts of it turning even yellow so hemoglobin breakout; area became very red, erythema extending, over the next day, all the way down to the antecubital fossa and that's over 10 cm; swelling at the site; Initial information received on 22-Oct-2021 regarding an unsolicited valid non-serious received from physician and non-healthcare professional via phone via Global Medical Information (GMI) (Reference number- 00826520).  This case involves a male patient who experienced area became very red, erythema extending, over the next day, all the way down to the antecubital fossa and that over 10 cm (erythema), parts of it turning even yellow so hemoglobin breakout (Extravasation blood) and swelling at the site (swelling) when received vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV].  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious area became very red, erythema extending, over the next day, all the way down to the antecubital fossa and that over 10 cm (erythema), parts of it turning even yellow so hemoglobin breakout (Extravasation blood), swelling at the site (swelling) (one day) following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE.  It was reported "I have been a big component of it and have had it myself ever since it was introduced and just a few days ago, I got an unexpected reaction myself to the vaccination. I have never had anything like this to any vaccination. The area became very red, erythema extending, over the next day, all the way down to the antecubital fossa and that over 10 cm. Parts of it turning even yellow so hemoglobin breakout. No other symptoms and swelling at the site. So this is my question, I wonder if there has been any change to the formulation for the 2021-2022 product. Your quadrivalent. Something is different because I have never had anything like this. This was remarkable, grade 3, I have a 10 centimeter."   Laboratory details were not reported.  It was not reported if the patient received a corrective treatment for the events.  At the time of reporting, the outcome was unknown for the events (erythema, extravasation blood, swelling).  As per reporter the causal relationship for events (erythema, Extravasation blood) with the FLUBLOK QIV was not reported.  There will be no information available on the batch number for this case.
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Incomplete course of vaccination
Clinical narrative: 4 year-old child who received 1 PENTACEL vaccine at 4 months of age and has had no others since then/no AE; Initial information was received on 25-Oct-2021 regarding an unsolicited valid non-serious case received from another healthcare professional via Medical Information (under reference:00826706).  This case involves a four-year-old female patient who received one DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] at 4 months of age and has had no others since then (product dose omission issue).  The patient's medical history, past 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 DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE (lot number and expiry date were not reported) via unknown route at an unknown administration site for prophylactic vaccination.  It was an actual case of medication error due to missed dose (latency unknown).  It was reported "4 year-old child who received 1 PENTACEL vaccine at 4 months of age and has had no others since then."  At time of reporting, the outcome was unknown for the event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on the lot number for this case.
Age: 0.5
Sex: M
Vaccine: IPV, UNK
Symptoms: Extra dose administered, No adverse event
Clinical narrative: both IPOL and PENTACEL were administered on same day to a patient with no A/E; Initial information was received on 25-Oct-2021 regarding an unsolicited valid non-serious case received via a nurse via consumer via phone call (under Medical Information (MI) Inquiry Number:00827476).  This case is linked to case 2021SA357977(cluster).  This case involves a 6-month-old male patient who received both IPV (VERO) [IPOL] and DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] on the same day with no adverse event (extra dose administered).  The patient's medical history, past medical treatments, concomitant medications, vaccinations and family history were not provided.  Concomitant medications included HEPATITIS B VACCINE ROTAVIRUS VACCINE and PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) for prophylactic vaccination.  On 25-Oct-2021, the patient received a third 0.5 ml dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE (lyophilized powder for preparation for injection) (lot number: UJ494AAA and expiry date: 09-Jul-2022) via intramuscular route in the left thigh, a third dose of suspect IPV (VERO) (lot number: T1E871M and expiry date: 10-Oct-2022) via intramuscular route in the right thigh for prophylactic vaccination respectively.  It was case of an actual medication error due to extra dose administered (latency: same day).  It was reported "Caller would like information possible adverse effects of extra dose of IPOL so that she can inform patient's mother. Caller has (package inserts) PIs for IPOL and PENTACEL, caller was referred to product PIs for more information on potential adverse effects of IPOL administration and PENTACEL administration."  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 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: 4.0
Sex: F
Vaccine: DTAP, TDAP
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: 4 years 2 month old female patient vaccinated with Adacel instead of Dtap vaccine with no reported adverse event; 4 years 2 month old female patient vaccinated with Adacel vaccine with no reported adverse event; Initial information received on 26-Oct-2021 regarding an unsolicited valid non-serious case from a Physician and other healthcare professional via Medical Information (MI) (Reference number- 00828641).  This case involves a four year two month old female patient who inadvertently vaccinated with DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] instead of DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID [DTAP] (wrong product administered and product administered to patient of inappropriate age).  The patient's medical history, medical treatment, vaccination, concomitant medication and family history were not provided.  On 14-Oct-2021, the patient received a 0.5 ml third dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (lot number and expiry date: not reported) (Frequency: once) via an intramuscular route at an unknown administration site for prophylactic vaccination.  It was an actual medication error case due to Wrong vaccine administered (with respect to use of ADACEL and DTAP) and inappropriate age at vaccine administration (with respect to use of ADACEL) (latency on same day).  It was reported "Caller reported that a patient inadvertently received a dose of Adacel (TDap) instead of DTap, as her last dose of the three-dose series. She requested guidance on how to proceed".   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 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: 1.25
Sex: F
Vaccine: DTAP, DTAPIPV
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: 15 month old female patient who was inadvertently administered QUADRACEL instead of DTAP with no reported adverse event; 15 month old female patient who was inadvertently administered QUADRACEL with no reported adverse event; Initial information received on 26-Oct-2021 regarding an unsolicited valid non-serious case from a Physician via other healthcare professional and non-healthcare professional/consumer via Medical Information (MI) (Reference number- 00829028).  This case involves a 15 month old female patient who inadvertently vaccinated with DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] instead of DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID [DTAP], (wrong product administered and product administered to patient of inappropriate age).  The patient's medical history, medical treatment, vaccination and family history were not provided.  Concomitant medications included Influenza Vaccine (Flu) and Hib Vaccine (Hib) for Prophylactic vaccination.  On 18-Oct-2021, the patient received a 0.5 ml first dose of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE (lot C5851AA and expiry date: 25-Mar-2023) (Suspension for injection) via an intramuscular route in the left thigh for prophylactic vaccination.  It was an actual medication error case due to Wrong vaccine administered (with respect to use of QUADRACEL and DTAP) and inappropriate age at vaccine administration (with respect to use of QUADRACEL) (latency on same day).  It was reported "Call received from reporting a dose of QUADRACEL was inadvertently administered instead of DTAP to a 15 month old patient".  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 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: F
Vaccine: RAB
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: got the vaccine on 05Oct2021 (day 0) and did not come for the second dose on day 7, came back on (26Oct2021) for 2nd dose, with no reported adverse event; Initial information was received on 26-Oct-2021 regarding an unsolicited valid non-serious case from pharmacist and non-healthcare professional via call center via Medical Information (MI) (Reference number- 00829196).  This case involves a female patient who received RABIES (HDC) VACCINE [IMOVAX RABIES] on 05-Oct-2021 (day 0) and did not come for the second dose on day 7, came back on 26-Oct-2021 for 2nd dose (inappropriate schedule of product administration).  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.  On 05-Oct-2021 and 26-Oct-2021, the patient received a first dose and second dose of suspect RABIES (HDC) VACCINE respectively, (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  It was an actual medication error due to inappropriate schedule of vaccine administered (latency: seven days).  It was reported "When should her third dose be administered?".  At the time of reporting, no adverse event reported.  The reporter assessed the causal relationship for event with the IMOVAX RABIES as not 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.
Sex: U
Vaccine: FLU4
Symptoms: Contraindicated product administered, No adverse event
Clinical narrative: The patient had administered Fluzone High Dose Quadrivalent has an egg allergy with no ae; Initial information received on 26-Oct-2021 regarding an unsolicited valid  non-serious case received from a pharmacist and non health care professional via number: 00829213..  This case involves an unknown age and unknown gender patient who was administered  INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (contraindicated product administered).  The patient's past medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  At the time of the event, the patient had Food allergy, Swelling lips and Tingling lips (ongoing status was reported as: yes).   On an unknown date, the patient received a 0.7 ml dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE lot number and expiry date not reported via unknown route in unknown administration site.  It was case of an actual medication error due to contraindicated product administered (latency: same day).  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 the Directive 2001/83/EC and Module VI. 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: 75.0
Sex: M
Vaccine: FLU4
Symptoms: Expired product administered, No adverse event
Clinical narrative: administering expired FLUZONE HIGH DOSE QUADRIVALENT to two patients with no reported adverse event; Initial information was received on 26-Oct-2021 regarding an unsolicited valid non-serious case received from other healthcare professional and non-healthcare professional via  (Global Medical Information-00829494) in a specific country. This case involves a 75-years old male patient who was vaccinated with expired dose of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (Expired product administered).  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.  No other concomitant vaccines were not provided.   On 26-Oct-2021, the patient received a 0.7ml {total} dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (Oral solution, lot number UJ443AB and expiry date 30-Jun-2021) via intramuscular route at an unknown administration site for prophylactic vaccination.  It was a case of an actual medication error due to expired vaccine used (latency was on same day).  At the time of report, no adverse event reported.  Event 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 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.