chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Headache
Clinical narrative: headache; This case was reported by a consumer via media and described the occurrence of headache in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced headache. The patient was treated with ibuprofen (Advil). On an unknown date, the outcome of the headache was unknown.   It was unknown if the reporter considered the headache to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected as per the vaccine indication. After receiving the Shingrix the patient experienced headache. The patient asked Advil ok for treatment.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema multiforme, Rash
Clinical narrative: erythema multiforme; developed a rash; This case was reported by a nurse via call center representative and described the occurrence of erythema multiforme in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On 26th August 2020, unknown after receiving Shingrix, the patient experienced erythema multiforme (serious criteria GSK medically significant) and rash. On an unknown date, the outcome of the erythema multiforme was not recovered/not resolved and the outcome of the rash was unknown.   It was unknown if the reporter considered the erythema multiforme and rash to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient developed a rash, erythema multiforme after getting a Shingrix shot. The reporter was uncertain about vaccination date of Shingrix. The reporter consented to follow up.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: flu; Initial information was received on 14-Oct-2020 regarding an unsolicited valid non-serious case from the patient via social media.  This case involves an unknown demographic patient who had flu (influenza), while the patient received vaccine INFLUENZA VACCINE.  The patient's medical history, past medical treatment(s), vaccination(s), family history and concomitant medication were not reported.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number and other dosing details were not reported) for prophylactic vaccination.  On an unknown date, the patient developed non-serious flu (influenza), (unknown latency) following the administration of INFLUENZA VACCINE.  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, the event outcome was not reported.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: I got the flu; Initial information was received on 12-Oct-2020 regarding an unsolicited valid non-serious social media case from a consumer via social media.  This case involves 50-years-old patient (unknown gender) who got flu (influenza), while the patient received vaccine INFLUENZA VACCINE.  Medical history, medical treatment(s), concomitant medications, vaccination(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 an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed non-serious got flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE. It was reported that the patient was going to die after this.  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At the time of report, the outcome was unknown for the event.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: flu; Initial information was received on 10-Oct-2020 regarding an unsolicited valid non-serious social media case from a consumer via social media.  This case involves patient (unknown demography) who got flu (influenza), while the patient received vaccine INFLUENZA VACCINE.  Medical history, medical treatment(s), concomitant medications, vaccination(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 an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed non-serious got flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At the time of report, the outcome was unknown for the event.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: patient had flu after taking the flu shot; Initial information was received on 14-Oct-2020 regarding an unsolicited valid non-serious case from a consumer.  This case involves a patient (unknown demographics) who had flu (influenza) while he/she received INFLUENZA VACCINE.  Medical history, medical treatment, 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 had flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  Details of laboratory data not reported.  It was not reported if the patient received any corrective treatment.  At the time of report, the outcome of event was unknown.  There will be no information available on batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Gout
Clinical narrative: It can bring on the gout; Initial information was received on 14-Oct-2020 regarding an unsolicited valid non-serious case from a consumer or non-health care professional via social media.  This case involves a patient (unknown demographics) who had brought on the gout (gout) while he/ she received INFLUENZA VACCINE.  Medical history, medical treatment, 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 had brought on the gout (gout) (unknown latency) following the administration of INFLUENZA VACCINE.  Details of laboratory data not reported.  It was not reported if the patient received any corrective treatment.  At the time of report, the outcome of event was unknown.  There will be no information available on batch number for this case.
Sex: U
Vaccine: FLU3
Symptoms: Influenza, Vaccine positive rechallenge
Clinical narrative: Ya I'm sure everytime I've gotta a flu shot I've had the flu care to explain that??; Initial information received on 10-Oct-2020 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case is linked to case 2020SA294157.  This case involves an unknown age patient who reported that patient everytime gotta a flu shot  patient have had the flu care to explain that (Influenza), while he/she received vaccine INFLUENZA USP TRIVAL A-B SUBVIRION NO PRESERVATIVE VACCINE [FLUZONE].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date the patient started taking INFLUENZA USP TRIVAL A-B SUBVIRION NO PRESERVATIVE VACCINE (dosage unknown) (with an unknown batch number)   On an unknown date, the patient reported that everytime gotta a flu shot  patient have had the flu care to explain that (influenza) Unknown latency following the administration of INFLUENZA USP TRIVAL A-B SUBVIRION NO PRESERVATIVE VACCINE.  Final diagnosis was Influenza.   Action taken was not applicable.  It was not reported if the patient received a corrective treatment.  The event outcome was unknown.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLU3
Symptoms: Illness, Malaise, Vaccine positive rechallenge
Clinical narrative: I had one in my 20s it made me so sick; Initial information received on 11-Oct-2020 regarding an unsolicited valid non-serious case received from a consumer (patient) via social media.  This case is linked to case 2020SA294157.  This case involves an unknown age patient who reported had one in her/his 20s it made he/she so sick (illness), while he/she received vaccine INFLUENZA USP TRIVAL A-B SUBVIRION NO PRESERVATIVE VACCINE [FLUZONE].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose  dose of suspect INFLUENZA USP TRIVAL A-B SUBVIRION NO PRESERVATIVE VACCINE lot number not reported in unknown administration site.  On an unknown date, the patient developed a non-serious it was reported that patient had one in her/his 20s it made he/she so sick(illness) (Unknown latency) following the administration of INFLUENZA USP TRIVAL A-B SUBVIRION NO PRESERVATIVE VACCINE.  Final diagnosis was patient had one in her/his 20s it made he/she so sick.   No relevant laboratory details were provided.  It was not reported if the patient received a corrective treatment.  Outcome of the event was unknown at the time of reporting.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLU3
Symptoms: Malaise, Vaccine positive rechallenge
Clinical narrative: I was sick for 2-3 mo this; Initial information received on 18-Oct-2020 regarding an unsolicited valid non-serious case received from a consumer (patient) via Social Media.  This case is linked to case 2020SA296074.  This case involves an unknown age patient who was sick for 2-3 month this (illness), while he/she received vaccine INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [FLUZONE].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose  dose of suspect INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED lot number not reported via unknown route in unknown administration site, for prophylactic vaccination.  On an unknown date (latency unknown), it was reported that Every time patient got a flu shot, patient was sick for 2-3 month this (illness), patient have not had a shot in seven or more years and have not been sick was reported following the administration of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED.  No relevant laboratory details were provided.  It was not reported if the patient received a corrective treatment.  Outcome of the event was unknown at the time of reporting.  There will be no information available on the batch number for this case.
Sex: F
Vaccine: FLUX
Symptoms: Influenza, Vaccine positive rechallenge
Clinical narrative: patient gets the flu shot every year, gets the flu every year too; Initial information received on 18-Nov-2020 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves female patient who experienced patient gets the flu shot every year, gets the flu every year too (influenza), while she received vaccine INFLUENZA VACCINE.  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.   Concomitant medications were unknown.  On an unknown date, 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 patient gets the flu shot every year, gets the flu every year too (influenza) (Unknown latency) following the administration of INFLUENZA VACCINE.  Relevant laboratory data was not reported.   It was not reported if the patient received a corrective treatment.  The event outcome was reported as Unknown.  There will be no information available on the batch number for this case.
Age: 74.0
Sex: F
Vaccine: FLU4
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: She said that she normally gets half of a 0.5 mL prefilled syringe in one dose and then she comes back three days later and gets the remaining of the dose (of the syringe) with no AE.; Initial information received on 12-Oct-2020 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 74 years old female patient who normally gets half of a 0.5 ml prefilled syringe of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] in one dose and then she comes back three days later and gets the remaining of the dose (of the syringe) (lot: unknown, expiry date: unknown), via unknown route, On an unknown date (inappropriate schedule of product administration).  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.   Concomitant medications were unknown.  It was an actual medication error due to the Inappropriate schedule of vaccine administered (latency unknown).   At the time of reporting, the patient had 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 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 information available on the batch number for this case.
Sex: M
Vaccine: TDAP
Symptoms: Injection site pain, Muscular weakness
Clinical narrative: There is  weakness like when he  goes to grab something or a feeling of pressure, like it will snap off.; he got  Adacel and his right shoulder still hurts/he got a ADACEL shot in his right arm, it has been sore ever since; Initial information received on 14-Oct-2020 regarding an unsolicited valid non-serious case received from a consumer.  This case involves a 30 years old male patient who got adacel and his right shoulder still hurts/he got a adacel shot in his right arm, it has been sore ever since (injection site pain) and there is  weakness like when he goes to grab something or a feeling of pressure, like it will snap off (hypokinesia), while he received vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.   Concomitant medications were unknown.  On 13-Jul-2020, the patient received a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [lot number not reported and expiration date unknown] via unknown route in the right arm for prophylactic vaccination.  On an unknown date, (Unknown latency) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE patient right shoulder still hurts/he got a adacel shot in his right arm, it has been sore ever since (injection site pain) and there is  weakness like when he goes to grab something or a feeling of pressure, like it will snap off (hypokinesia).  Final diagnosis was injection site pain, hypokinesia.  Relevant laboratory data was not reported.  It was not reported if the patient received a corrective treatment.  The events outcome were reported as Unknown.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product dose omission issue
Clinical narrative: missed her four dose of the booster dose of HIB; Initial information regarding an unsolicited valid non-serious case was received from a health care professional via The Agency (Reference number- 00319395) and transmitted to Sanofi on 16-Oct-2020.  This case involves a 5-years-old patient who was vaccinated with HAEMOPHILUS TYPE B (HIB) VACCINE [ACT-HIB] (suspension for injection), (suspension for injection, batch number, expiry date not reported, it was not known on which arm the vaccine was administered) (product dose omission issue) on an unspecified date for prophylactic vaccination.  The patient's medical history, past medical treatment, vaccination and family history were not provided.  Concomitant medication of the patient was not reported.  It was an actual medication error case due to missed dose (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 Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: M
Vaccine: FLU4
Symptoms: Exposure via skin contact, No adverse event, Underdose
Clinical narrative: patient received part of flu shot out of state/it ran down arm/not sure how much was administered/no AE; Initial information regarding an unsolicited valid non-serious case was received from a nurse via Medical Information (Reference number- 00319556) and transmitted to Sanofi on 16-Oct-2020.  This case involved a 4-years-old male patient who was administered a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (lot number and expiry date were unknown) via unknown route in unknown administration site for prophylactic vaccination on an unspecified date.  On 15-Oct-2020, the patient received part of flu shot out of state, which ran down arm and patient was not sure how much was administered. It was unknown how much of the vaccine was administered and how much was lost. Limited information available. The nurse stated that the first dose was given by a pharmacist, the mother called them yesterday about the partial dose and did not have any specifics.  It was also a case of vaccine underdose.  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 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: DTAPIPVHIB
Symptoms: No adverse event
Clinical narrative: PENTACEL was administered to a 6 month old male patient without being reconstituted with no AE; Initial information received on 20-Oct-2020 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 6 month old male patient who was administered 0.5 ml dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] without being reconstituted, [lot UJ343ABA and expiration date unknown] via intramuscular route in unknown administration site for prophylactic vaccination on 1st dose on 06-Feb-2020, 2nd dose on 08-Mar-2020 and 3rd dose on 19-Oct-2020 (product preparation error).  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS B VACCINE (HEPATITIS B VACCINE); PNEUMOCOCCAL VACCINE (PNEUMOCOCCAL VACCINE); HIB VACCINE (HIB VACCINE) and ROTAVIRUS VACCINE (ROTAVIRUS VACCINE).  It was an actual medication error due to the Active ingredient not added to diluent (latency same day).It was reported as a patient got only the liquid part of the Pentacel.  At the time of report, no adverse event was reported.  Disclaimer: 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.  No further relevant information was reported.
Sex: M
Vaccine: FLU4
Symptoms: No adverse event, Product distribution issue, Product storage error
Clinical narrative: the shipment had been in transit to long with no AE; FLUZONE HIGH DOSE QUADRIVLAENT administered after the vaccine was in transit to long with no AE; Initial information received on 21-Oct-2020 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 80 years old male patient who received a 0.7 mL dose of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (lot number: UJ546AA, expiry date: 30-Jun-2021) via intramuscular route and left arm site on an unknown date for prophylactic vaccination which was administered after the vaccine in the shipment had been in transit to long (product storage error and product distribution issue).  The patient's medical history, past medical treatments, vaccinations and family history were not provided.  No concomitant medication was given to the patient.  It was an actual medication error due incorrect product storage.  It was a case of product shipment delay.  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 Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 15.0
Sex: M
Vaccine: FLUR4
Symptoms: No adverse event, Wrong product administered
Clinical narrative: was given Flublok Quadrivalent in error due to pharmacy holding flu vaccine with no adverse event; Initial information received on 27-Oct-2020 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 15 years old male patient who was given flublok quadrivalent in error due to pharmacy holding flu vaccine with no adverse event (Wrong product administered), while he received vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 27-Oct-2020, the patient received a dose suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE of 0.5 ml once  lot UJ455AA, expiration date: 17-Mar-2021 for immunization.   It was an actual medication error due to the wrong vaccine administered. It was reported patient was given flublok quadrivalent in error due to pharmacy holding flu vaccine.  Final diagnosis was Not Applicable was given flublok quadrivalent in error due to pharmacy holding flu vaccine with no adverse event.  At the time of reporting, the patient had 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 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.
Age: 0.42
Sex: F
Vaccine: FLU4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 5 month old female patient was administered FLUZONE QUADRIVALENT with no adverse event; Initial information received on 28-Oct-2020 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 5 months old female patient who experienced 5 month old female patient was administered fluzone quadrivalent with no adverse event (Product administered to patient of inappropriate age), while she received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 28-Oct-2020, the patient received a  dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot UT7000AB via intramuscular route in the left thigh for prophylactic vaccination.   It was an actual medication error due to Inappropriate age at vaccine administration. It was reported that 5 month old female patient was administered fluzone quadrivalent (product administered to patient of inappropriate age).  Final diagnosis was Not Applicable 5 month old female patient was administered fluzone quadrivalent.  At the time of reporting, the patient had 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 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.
Age: 1.75
Sex: M
Vaccine: FLU3, HEPA
Symptoms: Extra dose administered, No adverse event
Clinical narrative: two Fluzone Quadrivalent doses were given to a 21 month old child 5 days apart/ no AE; Initial information regarding an unsolicited valid non-serious case was received from a nurse via Medical Information (MI) (Reference number- 00337530 ) and transmitted to Sanofi on 29-Oct-2020.  This case involves a 21 months old male patient who received two doses of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [FLUZONE] (strength- standard, presentation- multidose vial) 5 days apart on 24-Oct-2020 ( lot number UJ477AC expiration date: 30-Jun-2021) via intramuscular route in the right thigh and again on 29-Oct-2020 (lot number UJ452AB expiration date: 30-Jun-2021) via intramuscular route in the left thigh for prophylactic vaccination (Extra dose administered).  It was reported as the patient had received 2 doses of vaccine last year.  Medical history, medical treatments, and family history were not provided.  Concomitant therapy was reported as none on 24-Oct-2020 and Hepatitis A vaccine on 29-Oct-2020 (batch number and dosing details not reported) for prophylactic vaccination .  It was a actual medication error due to Extra dose administered.  It was reported as the patient was supposed to get only one dose this year. Reported wanted to know about to side effects if any to look for.  At the time of this reporting, patient had 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 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.
Sex: M
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: two patients (twins) were administered expired doses of ACTHIB.; Initial information regarding an unsolicited valid non-serious case received from  via other health care professional on 02-Nov-2020.  This case involves a 01 year old patient who received administered expired doses of HAEMOPHILUS TYPE B (HIB) VACCINE (ACTHIB) (lot: UJ112AAB, expiry date: 21-Jun-2020), via unknown route, on an unknown date (PT Expired product administered)  The patient's past medical history, medical treatments, vaccinations and family history were not provided.  It was an actual medication error due to the Expired vaccine used (LLT). It was reported that the vaccine was two patients (twins) were administered expired doses of ACTHIB.  At the time of reporting, the patient had 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 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 information available on the batch number for this case.
Age: 49.0
Sex: F
Vaccine: FLUR4
Symptoms: Injection site erythema, Injection site swelling, Oropharyngeal discomfort, Throat tightness
Clinical narrative: Her throat was scratchy and tight; swelling and redness at the injection site which was the left deltoid; swelling and redness at the injection site which was the left deltoid; Initial information received on 02-Nov-2020 regarding an unsolicited valid non-serious case from a other health professional.  This case involves a 49 years old female patient whose throat was scratchy and tight (Throat tightness), swelling and redness at the injection site which was the left deltoid (Injection site swelling) and (Injection site erythema), while she received vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included sodium (NA).  On 22-Oct-2020, the patient received a 0.5 ml once dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE lot QFAA2049, expiration date: 30-Jun-2021, via intramuscular route in the left deltoid for immunization.  On same day, 15 mins, after the administration, the patient's throat was scratchy and tight (throat tightness), swelling and redness at the injection site which was the left deltoid (injection site swelling) and (injection site erythema).  Final diagnosis was swelling and redness at the injection site which was the left deltoid, swelling and redness at the injection site which was the left deltoid and her throat was scratchy and tight.   No laboratory data was reported.  Her friend gave her an antihistamine and a steroid, and she did not need any intervention after that.  The event outcome were reported as resolved on an unknown date for all.  No further relevant information was reported.
Sex: F
Vaccine: FLU4, FLU4
Symptoms: No adverse event, Wrong product administered
Clinical narrative: receiving a dose of Fluzone High Dose Quadrivalent, it turned out to be Fluzone Quadrivalent, with no advere event; Initial information received on 05-Nov-2020 regarding an unsolicited valid non-serious case from a pharmacist.  This case involves a female patient of unknown age, who was told to be receiving QUADRIVALENT INFLUENZA VACCINE (FLUZONE HIGH-DOSE QUADRIVALENT), but it turned out to be QUADRIVALENT INFLUENZA VACCINE (FLUZONE QUADRIVALENT) (wrong product administered), (batch number and expiration date: unknown for both) both via unknown route at unknown administration site for prophylactic vaccination.  The patient's medical history, past medical treatment(s), vaccination(s), concurrent condition and family history were not provided.  Concomitant medication was not reported.  It was an actual medication error case since the patient was at another facility and who was told to be receiving QUADRIVALENT INFLUENZA VACCINE (FLUZONE HIGH-DOSE QUADRIVALENT), but it turned out to be QUADRIVALENT INFLUENZA VACCINE (FLUZONE QUADRIVALENT) (wrong product administered).  The pharmacist wanted to know if patient met the age requirement for QUADRIVALENT INFLUENZA VACCINE (FLUZONE HIGH-DOSE QUADRIVALENT), and received QUADRIVALENT INFLUENZA VACCINE (FLUZONE QUADRIVALENT) and that if the patient can receive high dose as well and  information in regards to safety and reactions.  At the time of reporting, no adverse event was reported.  No lab data was reported.  Disclaimer: 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 information about batch number was reported for this case.
Age: 4.0
Sex: F
Vaccine: FLU4
Symptoms: Exposure via skin contact, No adverse event, Underdose
Clinical narrative: the vaccine went down the arm  not in the arm  with no adverse event; the vaccine went down the arm  not in the arm  with no adverse event; Initial information received on 06-Nov-2020 regarding an unsolicited valid non-serious case from  a Medical Assistant.  This case involves a 4 year-old-female patient for whom it was reported when she moved influenza quadrival a-b vaccine [Fluzone QIV] went down the arm  not in the arm (Exposure via skin contact and Underdose) on 05-Nov-2020 (lot: UT7049LA, expiry date 30-Jun-2021) at a dose of 0.5 ml of unknown frequency via unknownroute in right arm  for prophylactic vaccination.  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medication was none.  The patient was not using the vaccine first time.  This was an actual medication error case due to the event Exposure via skin contact and Underdose (latency: same day).  No laboratory data was reported.  Disclaimer: 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.
Age: 0.5
Sex: M
Vaccine: FLU4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Office vaccinated a 6 month old with Fluzone Quad and gave the baby 2 doses of 0.5 mL with no adverse event; Initial information received on 06-Nov-2020 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves a 6 month old who was vaccinated by an office with influenza quadrival a-b vaccine [Fluzone Qiv] and gave the baby 2 doses of 0.5 ml (extra dose administered) (batch number: UT7041JA and expiration date: 30-Jun-2021) via intramuscular route in 1 in right and 1 left unknown administration site for prophylactic vaccination.  Medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.  This was an actual medication error case due to the event extra dose administered (latency: unknown).  At the time of reporting, no adverse event was reported.  No laboratory data was reported.  Disclaimer: 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.
Age: 16.0
Sex: F
Vaccine: FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Medical assistant reported that an employee accidentally gave FLUBLOK to a 16-year-old with no AE; Initial information received on 09-Nov-2020 regarding an unsolicited valid non-serious case received from an other health professional.  This case involves a 16 years old female patient who received INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (product administered to patient of inappropriate age).  Relevant medical history, medical treatment, vaccination, concomitant medications and family history were not provided.  Concomitant medications included MENINGOCOCCAL VACCINE A/C/Y/W CONJ (DIP TOX) (MENACTRA).  On 06-Nov-2020, the patient received a 0.5 ml (Lot number- UT7035LA, Expiration date- 30-Jun-2021) dose of suspect via intramuscular route in the left deltoid for prophylactic vaccination (Product administered to patient of inappropriate age).  It was a case of an actual medication error due to inappropriate age at vaccine administration.  No relevant laboratory data 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 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: 35.0
Sex: F
Vaccine: FLUR4
Symptoms: Injection site swelling, Pain, Peripheral swelling
Clinical narrative: left arm became very swollen (1/2 inch thicker); pain; Initial information regarding an unsolicited valid non-serious case was received from a consumer (patient) via Medical Information (Reference number- 00353583) and transmitted to Sanofi on 10-Nov-2020.  This case involves a 35 years old female patient who experienced left arm became very swollen (1/2 inch thicker) and pain, while she received vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV].  Medical history, medical treatment, vaccination, concomitant medication and family history were not provided.   On 04-Sep-2020, the patient received a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [formulation: prefilled syringe, lot number and expiry date not reported] via an intramuscular route at the left arm for prophylactic vaccination.  On 10-Nov-2020, the patient developed a non-serious left arm became very swollen (1/2 inch thicker) (vaccination site swelling) and pain 2 months 6 days following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE.  It was reported that, the swelling initially increased outside of the sharpie marking and then decreased.  Product used: Used  First time product used: Yes  Still using product: No  Details of laboratory data not reported.   The patient was treated with PREDNISONE and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]). However, patient tried heat, ice and massage and did not help the pain to go away.  At the time of reporting, the event outcome reported as unknown for events.  There will be no information available on the batch number for this case.
Age: 1.25
Sex: M
Vaccine: DTAPIPVHIB, FLU4, HEPA, HIBV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: the patient received two doses of HIB accidentallywith no adverse event; Initial information received on 10-Nov-2020 regarding an unsolicited valid non-serious case from a other health professional.  This case is linked to case 2020SA317968.  This case involves a 1 years old male patient who experienced the patient received two doses of hib accidentallywith no adverse event (Product administration error, while he received vaccine HIB (PRP/T) VACCINE [ACT-HIB].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS A VACCINE (HEPATITIS A VACCINE) for Immunisation; QUADRIVALENT INFLUENZA VACCINE (FLUZONE QUADRIVALENT) for Immunisation; and DIPHTHERIA, TETANUS, AC PERTUSSIS, IPV AND HIB VACCINE (PENTACEL (VERO)) for Immunisation.  On 10-Nov-2020, the patient received a 5 dose of suspect HIB (PRP/T) VACCINE lot UJ353AAA via intramuscular route in the left thigh for immunization.  On 10-Nov-2020, (same day) the patient developed a non-serious the patient received two doses of hib accidentally with no adverse event (product administration error) following the administration of HIB (PRP/T) VACCINE..  It was not reported if the patient received a corrective treatment.  The event outcome was reported as not applicable at the time of reporting.  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.
Age: 63.0
Sex: F
Vaccine: FLUR4
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Patient supposed to get fluzone high dose but received the FLUBLOK QUADRIVALENT/no AE; Initial information regarding an unsolicited valid non-serious case was received from a consumer (patient) via Medical Information (GMI) (Reference number- 00356636) and transmitted to Sanofi on 12-Nov-2020.   This case is linked to case 2020SA322386 (same reporter).  This case involves a 63 years old female patient who supposed to get fluzone high dose but received INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] [lot number: QFAA2054 and expiry date not reported] via an unknowns route at an unknown administration site for prophylactic vaccination [wrong product administered].  The patient medical history included brain tumor.  The patient past medical treatment(s), concomitant medication and vaccination(s) and family history were not provided.  At the time of the event, the patient had ongoing multiple sclerosis.  It was an actual medication error due to wrong vaccine administered (latency: at the time of vaccination).  At the time of reporting, patient did not experience any adverse event.  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 and Regulatory Authority Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on the batch number for this case.
Sex: F
Vaccine: DTAP, HEPA, TDAP
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: accidentally gave an 18 month old ADACEL instead of DAPTACEL today with no adverse event; accidentally gave an 18 month old ADACEL instead of DAPTACEL today with no adverse event; Initial information received on 12-Nov-2020 regarding an unsolicited valid non-serious case received (reference number: US-SANOFI-00356979) via a physician.  This case involves a 19-month-old female patient for whom it was reported that a nurse accidentally gave an 18 month old DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] instead of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] today with no adverse event (Wrong product administered and Product administered to patient of inappropriate age).  The medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medication included hepatitis A vaccine.  On an unknown date, a nurse accidentally gave an 18 month old DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE instead of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE that day with no adverse event (Wrong product administered and Product administered to patient of inappropriate age). lot number not reported via an unknown route for prophylactic vaccination.  Final diagnosis was Not Applicable accidentally gave an 18 month old adacel instead of daptacel today with no adverse event and Not Applicable accidentally gave an 18 month old adacel instead of daptacel today with no adverse event.   Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  Outcome was not applicable for the events at the time of reporting.  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 information available on the batch number for this case.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Nausea, Pain, Pyrexia
Clinical narrative: Caller experienced a fever, headache, body aches, fatigue, nausea & vomiting over a 3 day period.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Vomiting
Clinical narrative: Caller experienced a fever, headache, body aches, fatigue, nausea & vomiting over a 3 day period.
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: improperly stored product administered; no adverse event; This spontaneous report was received from a medical assistant and refers to an unknown number of patients of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On an unknown date, the patient was vaccinated with a dose of improperly stored vaccines: measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD), 0.5 ml, lot T010651 exp. date: 22-SEP-2021 (formulation, frequency and route of administration were not reported) as a prophylaxis. Administered dose of vaccine experienced the temperature excursion of 22.8 degrees Fahrenheit for 13 hour and 25 minutes. Data logger was involved. There was a previous excursion reported: 17.4 degrees Fahrenheit  for 31 minutes and 30 seconds..