chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: FLUX
Symptoms: Delirium, Hypersomnia, Pyrexia
Clinical narrative: was delirious/talked out of head; fever; slept often; Initial information regarding an unsolicited valid serious case was received from a consumer (patient) via social media  on 08-Dec-2020.  This case involves a patient of unknown demographics who was delirious/talked out of head (delirium), had fever (pyrexia) and slept often (hypersomnia), after receiving INFLUENZA VACCINE.  The patient's medical history, past medical treatments, past vaccinations, family history and concomitant medications were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number and expiration date not reported) via an unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient was delirious, had talked out of head (delirium) (unknown latency) following the administration of INFLUENZA VACCINE. The event delirious was assessed as medically significant as per important medical event (IME) list.  On an unknown date, the patient had fever (pyrexia) and slept often (hypersomnia),(non-serious event) (unknown latency) following the administration of INFLUENZA VACCINE.   It was reported as the patient had taken vaccine during college days in 1976 and was totally out of it for 7 days. Patient list wright from not eating but never had the flu since getting that vaccine. The patient was too afraid and not taking flu shot at all.  No laboratory data was reported.  It was not reported if the patient received a corrective treatment.  At the time of report, the outcome was unknown for the events.  There will be no information available on the batch number for this case.
Sex: F
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: got the flu; Initial information was received on 14-Dec-2020 regarding an unsolicited valid non-serious media case from the non-healthcare professional.  This case was linked to case 2020C015444 (same reporter).  This case involved a female patient of unknown age who got the flu (Influenza), after she received 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), some weeks 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 unknown.  There would be no information available on batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: had a relapse was sick for weeks; took the flu shot got the flu; Initial information regarding this unsolicited valid non-serious media case was received from a consumer (patient) and transmitted to Sanofi on 17-Dec-2020.  This case involved a patient with unknown demographics who got the flu (influenza), had a relapse was sick (illness), while the patient received the flu shot (INFLUENZA VACCINE).  Relevant medical history, past medical treatment, vaccination details, concomitant medications 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 in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious flu (influenza), had a relapse was sick (illness), unknown latency following the administration of INFLUENZA VACCINE.   Relevant laboratory test was not reported.   It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome was unknown for the reported event.  There would be no information available on batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: have not gotten the flu since not getting the shot; Initial information regarding this unsolicited valid non-serious media case was received from a consumer (patient) and transmitted to Sanofi on 17-Dec-2020.  This case involves a patient with unknown demographics who had flu (Influenza), while the patient received INFLUENZA VACCINE.  Relevant medical history, past medical treatment, vaccination details, concomitant medications 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 in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious flu (influenza), unknown latency following the administration of INFLUENZA VACCINE. It was reported that the patient had stopped taking flu shot since 15 years and since then the patient did not get the flu.  Relevant laboratory test was not reported.   It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome was unknown for the reported event.  There would be no information available on batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Vaccination site pain
Clinical narrative: Mild soreness in the vaccination site; Initial information regarding an unsolicited valid non-serious case received from a Consumer via other (email) from on 22-Dec-2020.  This case involves patient of unknown demographic detail who had mild soreness in the vaccination site (Vaccination site pain), while the patient received Influenza Vaccine.  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication was 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 as prophylactic vaccination.  On an unknown date, the patient stated that she had one INFLUENZA VACCINE, and experienced mild soreness in the vaccination site (Vaccination site pain).  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: FLUX
Symptoms: Influenza
Clinical narrative: Friends got the flu weeks after they had the flu shot; Initial information regarding an unsolicited valid non-serious case received from a consumer/Non-HCP via media on 14-Dec-2020.  This case involves a patients of unknown demographic who got flu (Influenza), while the patient received Influenza Vaccine.  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication was 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 as prophylactic vaccination.  On an unknown date, the patient stated that she had one INFLUENZA VACCINE, and had flu (Influenza).  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.
Age: 66.0
Sex: M
Vaccine: FLU4
Symptoms: Extra dose administered
Clinical narrative: inadvertently administered the Fluzone High-Dose vaccine twice/no AE; Initial information was received on 10-Nov-2020 regarding an unsolicited valid non-serious case from a pharmacist.  This case involves a 66-year-old male patient who was inadvertently administered the INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] prefilled syringe twice (lot UJ535AA, expiry date not reported) (extra dose administered).  Medical history, medical treatment(s), vaccination(s) and family history were not provided. Patient received no concomitant vaccines.  It was reported that the patient was inadvertently administered the Fluzone High-Dose vaccine twice, once on 25-Sep-2020 and again on 09-Nov-2020. Patient received no concomitant vaccines. Vaccines were administered at a retail pharmacy.  Pharmacist reported that, so far, the patient has not reported any adverse effects related to the Fluzone High-Dose. Pharmacist had the lot number and expiration date for the second Fluzone High-Dose injection administered on 09-Nov-2020 but not for the first one administered on 25-Sep-2020.  It was case of actual medication error due to extra dose administered.  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.  There will be no information available on the lot number (of first dose) for this case.
Age: 46.0
Sex: F
Vaccine: FLU4
Symptoms: Syringe issue, Underdose
Clinical narrative: Patient of age 46 received a partial dose of Fluzon HD due to the dose leaking out around the hub at the luer lok with no AE.; Patient of age 46 received a partial dose of Fluzon HD due to the dose leaking out around the hub at the luer lok with no AE.; Patient of age 46 received a partial dose of Fluzon HD due to the dose leaking out around the hub at the luer lok with no AE.; Initial information regarding an unsolicited valid serious case was received from a Pharmacist via Agency (Reference number- 00353849) and transmitted to Sanofi on 10-Nov-2020.   This case involves a 46 years old female patient who received a partial dose of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (lot UJ517AA and expiration date: 30-Jun-2021) via unknown route at an unknown administration site for prophylactic vaccination due to the dose leaking out around the hub at the luer (product administered to patient of inappropriate age, Inappropriate dose of vaccine administered and syringe issue) on an 10-Nov-2020.  Medical history, past medical treatments, past vaccinations, concomitant medication and family history were not provided.  It was a case of actual medication error due to inappropriate age at vaccine administration, Inappropriate dose of vaccine administered and syringe issue.  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 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: 4.0
Sex: M
Vaccine: TDAP
Symptoms: Wrong product administered
Clinical narrative: Given ADACEL instead of DTaP; Initial information regarding an unsolicited valid non-serious case was received from a other health professional via Medical Information (Reference number-00381714) and transmitted to Sanofi on 04-Dec -2020 via call-center.  This case involves a 4-years-old male patient who received a vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (lot number: U6737AA and expiry date: 07-Sep -2022) on 09-Sep-2020 via an unknown route in Left Deltoid instead of DTaP (Wrong product administered) for prophylactic vaccination.  The patient's medical history, past medical treatment, vaccination and family history were not provided. The patient's concomitant medication included POLIO VACCINE INACT 3V (VERO) (IPOL [POLIO VACCINE INACT 3V (VERO)]); MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) and VARICELLA ZOSTER VACCINE (VARICELLA VACCINE).   It was an actual medication error case due to wrong vaccine administered (latency: unknown).  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.
Sex: F
Vaccine: FLU4
Symptoms: Injection site bruising, Injection site discolouration
Clinical narrative: two bruises showed up a couple of days after her vaccination/bruise on her left deltoid was purplish and about the size of a quarter, was near the injections site/other bruise was on the back of her left arm; Initial information received on 09-Dec-2020 regarding an unsolicited valid non-serious case from a pharmacist in the.  This case involves a 74 years old female patient for whom two bruises showed up a couple of days after her vaccination/bruise on her left deltoid was purplish and about the size of a quarter, was near the injections site/other bruise was on the back of her left arm (vaccination site bruising), while she received vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  No concomitant medication was reported.   On 16-Sep-2020, the patient received 0.7 mL once a day dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE via unknown route (lot number: 279801 and expiry date: 16-Jun-2021) for prophylactic vaccination.  On an unknown date in 2020 (latency unknown), the patient stated that two bruises showed up a couple of days after her vaccination. They were still present today but fading. The bruise on her left deltoid was purplish and about the size of a quarter, was near the injections site. The other bruise was on the back of her left arm (vaccination site bruising) and about 1/5 long and 1/2 wide.   No laboratory data was reported.  It was not reported if the patient received a corrective treatment.  At the time of report, outcome of the event was unknown.
Sex: F
Vaccine: FLU4, FLUA3, PPV
Symptoms: Extra dose administered, Wrong product administered
Clinical narrative: receiving FLUZONE HIGH DOSE QUADRIVALENT when patient already received Fluad vaccine with no AE; had intended on getting the pneumonia vaccine, she already had a flu vaccine with no AE; Initial information received on 10-Dec-2020 regarding an unsolicited valid non-serious case from a pharmacist.  This case involves a 68 years old female patient who received fluzone high dose quadrivalent when patient already received fluad vaccine (extra dose administered) and had intended on getting the pneumonia vaccine, she already had a flu vaccine (wrong product administered), while she received vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT], INFLUENZA VACCINE INACT SAG 3V [FLUAD] and PNEUMOCOCCAL VACCINE.  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.   No concomitant medication was reported.  On 08-Oct-2020, the patient received suspect FLUAD (INFLUENZA VACCINE INACT SAG 3V) with an unknown dose, route, frequency, strength and formulation for prophylactic vaccination.  On 12-Oct-2020, the patient received 0.7 ml to 2 ml once a day dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE via intramuscular route in right arm (lot number: UJ540AA and expiry date: 30-Jun-2021) for prophylactic vaccination.  On an unknown date, the patient received PNEUMOCOCCAL VACCINE with an unknown dose, route, frequency, strength and formulation for prophylactic vaccination.  On an unknown date (latency unknown), the patient received FLUZONE HIGH DOSE QUADRIVALENT when the patient already received FLUAD vaccine (extra dose administered) and pharmacist stated that the patient came in to the pharmacy and requested a Flu vaccine. She filled out the consent form and checked the influenza vaccine box. Then, after she received it, she asked the pharmacist if that was the 23 that she had received. The patient had intended on getting the pneumonia vaccine, she already had a flu vaccine in October (year unknown) (wrong product administered).  This was an actual medication error due to extra dose administered and wrong vaccine administered.  No laboratory data reported.  At the time of reporting, no adverse event was reported to the patient.  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: 0.58
Sex: U
Vaccine: FLUR4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: children received FLUBLOK QUADRIVALENT, with no adverse event; Initial information received on 17-Dec-2020 regarding an unsolicited valid non-serious case from a  nurse.  This case involves 7 months old patient of unknown age, who was vaccinated with INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (Lot: QFAA2056 and expiry date: 30-Jun-2021) children received flublok quadrivalent (product administered to patient of inappropriate age).   The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.  On 16-Dec-2020, the patient received INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (Lot: QFAA2056 and expiry date: 30-Jun-2021) at a dose  of 0.5 ml, via unknown route at right thigh for prophylactic vaccination.  On 16-Dec-2020, (latency: unknown) children received FLQUADRIVALENT RECOMBINANT VACCINE  as their second doses in their influenza vaccine series (product administered to patient of inappropriate age). Their first doses were of Flulaval on 16-Nov-2020. She asked if their entire series needs to be repeated or just the second doses.  It was an actual medication error case due to Product administered to patient of inappropriate age.  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: U
Vaccine: FLU4
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: accidentally injected a FLUZONE HIGH DOSE into an 8 year old patient with no AE; accidentally injected a FLUZONE HIGH DOSE into an 8 year old patient with no AE; accidentally injected a FLUZONE HIGH DOSE into an 8 year old patient with no AE; Initial information regarding an unsolicited valid non-serious case was received from a pharmacist via call-center via Medical Information (Reference number- 00397824) and transmitted to Sanofi on 17-Dec-2020).  This case involves a 8-year-old patient of unknown gender who had got accidentally injected a FLUZONE HIGH DOSE (wrong product administered) (product administered to patient of inappropriate age) (accidental overdose) while the patient got Influenza Quadrival A-B High Dose Hv Vaccine (FLUZONE HIGH-DOSE QUADRIVALENT) (frequency, strength, lot number and expiry date unknown) via an unknown route for prophylactic vaccination.  The patient's medical history, past medical treatment, vaccination and family history were not provided.  Concomitant medications were not reported.  It was an actual medication error case as the patient had got ccidentally injected a influenza Quadrival A-B High Dose Hv Vaccine (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: U
Vaccine: HIBV
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: 4-month-old was administered both Pentacel and ActHib at the 2-month appointment with no AE; Initial information received on 17-Dec-2020 regarding an unsolicited valid non-serious case received from a pharmacist in the United States.  This case involves a 4-month-old patient patient who was vaccinated with both Pentacel and ActHib at the 2-month appointment (Product administered to patient of inappropriate age).  Medical history, medical treatment, vaccination and family history were not provided.  Concomitant medications were included diphtheria vaccine toxoid, hib vaccine conj (tet tox), pertussis vaccine acellular 5-component, polio vaccine inact 3v (mrc 5), tetanus vaccine toxoid (Pentacel).  On an unknown date, the patient received 0.5 ml dose of suspect HAEMOPHILUS TYPE B (HIB) VACCINE (lot and expiry date unknown via an unknown route for immunization.   It was a case of actual medication error as both Pentacel and ActHib at the 2-month appointment (latency on same day).  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.
Sex: U
Vaccine: HIBV
Symptoms: Expired product administered
Clinical narrative: 25 yrs ago an expired Hep A was given to a child and this was reported back then with no AE; Initial information received on 17-Dec-2020 regarding an unsolicited valid non-serious case received from a patient.  This case involves a child patient who was vaccinated with an expired dose of HIB (PRP/T) VACCINE [ACT-HIB] (expired product administered).  Medical history, medical treatment, vaccination and family history were not provided.  Concomitant medications were not reported.  On an unknown date in 1995 (reported as 25 years ago), the patient received a unspecified dose of suspect HIB (PRP/T) VACCINE (lot and expiry date unknown via an unknown route in the left deltoid for prophylactic vaccination. A product complaint with HIB (PRP/T) VACCINE. When the nurse attempted to extract the medicine from the vial, the medicine was not extracted. It had only occurred with one vial of HIB (PRP/T) VACCINE (lot no UJ359AA and expiry 21-Jul-2021). It was reported that 2 different nurses tried 2 different syringes and were still was not able to extract all the liquid from the HIB (PRP/T) VACCINE vial. There was still quite a bit liquid in this vial and it would not come out. It was reported that all the medication would not draw up and the nurses tried different needles and syringes. Some liquid came out but not enough to give dose. The nurses noted that the diluent vial was checked twice to make sure it was empty and all diluent was drawn out.  This happened last Friday (11-Dec-2020).   It was a case of actual medication error due to expired vaccine used (latency on same day).  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: MNQ
Symptoms: Inappropriate schedule of product administration
Clinical narrative: received his second dose, 7 months before he would have turned 16, with no adverse event; Initial information received on 18-Dec-2020 regarding an unsolicited valid non-serious case from a physician.  This case involves a 15-years-old male patient who received his second dose, 7 months before he would have turned 16 (inappropriate schedule of product administration).  The patient's medical history, past medical treatment(s), vaccination(s), concurrent conditions and family history were not provided.  On an unknown date, the patient received MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE  (batch number and expiry date unknown) via an unknown dose via unknown route at unknown administration site for prophylactic vaccination  The pediatrician was asking whether a male patient should be re-dosed. He was given a booster vaccine in less than 4 years from the prior dose. He received his first Menactra on 19-Oct-2016, which he was 12-year-old at that time. When he came in on 22-Aug-2019  (latency unknown), he received his second dose, 7 months before he would have turned 16 (inappropriate schedule of product administration). The pediatrician asked if they should re-dose now that he was over 16. The patient Information not obtained. An attempts were made to obtain the patient information but the pediatrician was unavailable.   It was an actual medication error case due to product storage error.  At the time of reporting, 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. There will be no information available on the batch number for this case.
Sex: F
Vaccine: MNQ
Symptoms: Wrong product administered
Clinical narrative: a dose of MENACTRA was inadvertently administered instead of Meningitis B with no adverse event; Initial information received on 21-Dec-2020 regarding an unsolicited valid non-serious case from a other health professional.  This case involves a 17 years old female patient who received a dose of Menactra was inadvertently administered instead of Meningitis B (wrong product administered), while she received vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA]. On 21-Dec-2020, the patient received a dose of 0.5 mL suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (lot number: U6641AB and expiry date: 30-Jul-2021) via intramuscular route in the left deltoid. Reporter stated patient had already received both (two) doses of MENACTRA, the second dose was administered 18-Jun-2020.      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 wrong vaccine administered (latency: same day).  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.
Sex: F
Vaccine: FLUX
Symptoms: Exposure during pregnancy
Clinical narrative: patient, who is pregnant, with no AE; Initial information regarding an unsolicited valid non-serious case received from a pharmacist on 21-Dec-2020.  This case involves a 27 years old female patient who was exposed to vaccine INFLUENZA QUADRIVAL A-B VACCINE in context of patient, who is pregnant, (exposure during pregnancy). Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known.   The date of last menstrual period was not reported. The estimated due date was not reported. The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  On 18-Dec-2020, the patient received an unknown dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot UT7081NA) via intramuscular route in the left deltoid for prophylactic vaccination.  On an unknown date, (unknown latency) after initiation of INFLUENZA QUADRIVAL A-B VACCINE, the patient was pregnant (exposure during pregnancy).  At the time of report, no adverse event was reported.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLU4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: a 6 month old accidently received the FLUZONE HDQ with no adverse event; Initial information received on 21-Dec-2020 regarding an unsolicited valid non-serious case from a pharmacist.  This case involves a 6 months old patient accidently received the INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (product administered to patient of inappropriate age). On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot number and expiry date: unknown) via unknown route in 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 product administered to patient of inappropriate age (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.  There will be no information about batch number was reported for the case.
Sex: F
Vaccine: IPV
Symptoms: Product storage error
Clinical narrative: had an excursion with refrigerator problem then had another excursion and since it wasn't taken out of circulation/no AE; Initial information received on 21-Dec-2020 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involved an unknown age female patient who was administered IPV (VERO) [IPOL] (lot R1B252M and expiry date: 31-Mar-2021) on 24-Nov-2020 via an unknown route at an unknown administration site for prophylactic vaccination, which had an excursion due to refrigerator at the end of August then kept the vial which had another excursion then someone gave a dose from the same vial (Product storage error).  Medical history, medical treatment, vaccination and family history were not provided.  Concomitant medications included NA (NA).  It was an actual medication error case due to incorrect product storage (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 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.
Sex: F
Vaccine: FLU4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: inadvertently received an additional dose of Fluzone quadrivalent today, with no ae; Initial information received on 22-Dec-2020 regarding an unsolicited valid non-serious case from a other health professional.  This case involves a 2 years old female patient who inadvertently received an additional dose of fluzone quadrivalent today (extra dose administered), while she received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV].  The patients past medical history, concomitant medication, medical treatment(s), vaccination(s) and family history were not provided.  On 16-Dec-2020, the patient was vaccinated with 0.5 ml INFLUENZA QUADRIVAL A-B VACCINE (lot: UT7102JA; expiration date: 30-Jun-2021) via intramuscular route in the left deltoid.   On 22-Dec-2020, 6 days after patient received the vaccine, patient inadvertently received an additional dose of Fluzone quadrivalent (extra dose administered).  No adverse event reported 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 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: 22.0
Sex: F
Vaccine: DTAP
Symptoms: Product use issue, Wrong product administered
Clinical narrative: Daptacel was inadvertently administered instead of Adacel to a 22-year-old patient; with no AE; vaccine was given to a 22 year old and it was supposed to be for the age group 6-8 weeks; with no AE; Initial information received on 23-Dec-2020 regarding an unsolicited valid non-serious case from a other health professional.  This case involves a 22 years old female patient who for whom it was reported that diphtheria-15/tetanus/5 ac pertussis vaccine [Daptacel] was inadvertently administered instead of Adacel (wrong product administered) and it was supposed to be for the age group 6-8 weeks (product use issue).   The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.   No concomitant medication was received.  On 22-Dec-2020, the patient received a dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE at a dose of 0.5 ml once (lot C5624AA and expiry date: 10-Jun-2021) via intramuscular route in the left deltoid for prophylaxis vaccination instead of Adacel (wrong product administered) and it was supposed to be for the age group 6-8 weeks (product use issue).  No laboratory data was provided.   It was not reported if the patient received a corrective treatment.  At the time of report, the outcome was not applicable 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 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: 41.0
Sex: M
Vaccine: FLU4
Symptoms: Expired product administered
Clinical narrative: Patient received a dose of expired Fluzone Quadrivalent, no AE; Initial information regarding an unsolicited valid non-serious case was received from a nurse practitioner via Medical Information (Reference number- 00405238) and transmitted to Sanofi on 23-Dec-2020.  This case involves a 41 years old male patient who was administered with a 0.5 ml standard dose of expired INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (lot number UT6656KA and expiry date 30-Jun-2020) once via unknown route in an unknown administration site for prophylactic vaccination on 23rd December 2020 (Expired product administered).  Medical history, past medical treatment(s), vaccination(s), and family history were not provided. No other vaccine was administered concomitantly.  This was an actual medication error due to expired vaccine used [latency was same day].  No laboratory data reported.  At the time of reporting, no adverse event was reported.  Reporter asked for appropriate follow-up after expired dose of Fluzone Quadrivalent was administered.  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.  Potential PTC (product technical complaint)- No
Sex: M
Vaccine: FLU4
Symptoms: Extra dose administered
Clinical narrative: states that a male patient age 86, was injected with with Fluzone High Dose on two different occasions this year because the patient forgot that he already had a flu shot, with no ae; Initial information received on 23-Dec-2020 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 86 years old male patient for whom it was reported that a male patient age 86, was injected with fluzone high dose on two different occasions this year because the patient forgot that he already had a flu shot (overdose), while he received vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  The patients medical history, concomitant medication, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date of 2020, the patient was vaccinated with INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (Lot UJ505AA; expiration date: unknown) via unknown route in the left deltoid as prophylactic vaccination.   On an unknown date of 2020, (unknown latency) after the patient was injected with fluzone high dose second time this year because the patient forgot that he already had a flu shot (overdose).  No adverse event reported 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 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: 54.0
Sex: M
Vaccine: RAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: a delay of over 5 weeks from the first dose, with no ae; Initial information received on 23-Dec-2020 regarding an unsolicited valid non-serious case received from a pharmacist .  This case involves a 54 years old male patient who experienced a delay of over 5 weeks from the first dose (inappropriate schedule of product administration), while he received vaccine RABIES (HDC) VACCINE [IMOVAX RABIES].  The patients medical history, concomitant medication, medical treatment(s), vaccination(s) and family history were not provided.   On 14-Nov-2020, the patient was vaccinated of suspect RABIES (HDC) VACCINE (lot unknown and expiration date: unknown) via unknown route in unknown administration site for immunization.  On 23-Dec-2020, 1 month 9 days after initiation of suspect, a delay of over 5 weeks from the first dose (inappropriate schedule of product administration).   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: TDAP
Symptoms: Expired product administered
Clinical narrative: had given an expired Tdap to a patient, with no ae; Initial information received on 28-Dec-2020 regarding an unsolicited valid non-serious case from a nurse.  This case involves unknown age male patient who had given an expired tdap to a patient (expired product administered), while he received vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  The patients medical history, concomitant medication, medical treatment(s), vaccination(s) and family history were not provided.   On 21-Dec-2020, the patient was vaccinated with 0.5 ml  DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (lot U6141AB and expiration date: 15-Dec-2020) via unknown route in the right deltoid for prophylactic vaccination.  On an unknown date December-2020, (unknown latency) after initiation suspect medication, patient had given an expired tdap to a patient (expired product administered).  No adverse event reported 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 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: 1.5
Sex: U
Vaccine: TDAP
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: gave Adacel to an 18 month old with no adverse event; Initial information received on 29-Dec-2020 regarding an unsolicited valid non-serious case from a nurse.  This case involves a 18 month old patient who was administered diphtheria-2/tetanus/5 ac pertussis vaccine (Adacel) by mistake (product use issue) (batch number: U6830AA and expiration date: unknown) 4th dose via unknown route in unknown administration site for prophylactic vaccination.  The patient's medical history, medical treatment(s), vaccination(s), family history and concomitant medications were not provided.   This was an actual medication error case due to the event product use issue (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.
Sex: F
Vaccine: FLU4
Symptoms: Chest X-ray normal, Cough, Head discomfort, Injection site pain, Oropharyngeal pain
Clinical narrative: congestion in her head; tender and painful at the injection site; sore throat; bad cough; achy; Initial information received on 29-Dec-2020 regarding an unsolicited valid non-serious case from a consumer (patient).  This case involves a 52 years old female patient who experienced sore throat (oropharyngeal pain), bad cough (cough), was achy (pain), had congestion in her head (head discomfort) and was tender and painful at the injection site (vaccination site pain), while she received vaccine influenza quadrival a-b vaccine [Fluzone Quadrivalent].  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included sodium (NA).  On 20-Oct-2020, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (with unknown strength, formulation, dose, frequency, lot number and expiration date) via unknown route in the right arm for prophylaxis vaccination.   On 22-Oct-2020, 2 days after administration of suspect vaccine, sore throat (oropharyngeal pain), bad cough (cough), achy (pain) and stated intense for 3-4 days.  On an unknown date, (latency unknown) after administration of suspect vaccine, had congestion in her head (head discomfort) but it was less troublesome than the cough and was tender and painful at the injection site (vaccination site pain).   She has had flu vaccines before but did not knew the brand and had not done well with them and stated for many years she did not get a flu vaccine due to this but had to take care of her dad so did this year.   No laboratory data was provided.   Patient received inhalers and had 2 courses of 10 days steroids, codeine type syrup for cough and it was not reported if the patient received a corrective treatment for other events.   At the time of report, the outcome was not resolved for cough and head discomfort while unknown for other events.     There would be no information available on the batch number for this case.