chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.75
Sex: M
Vaccine: DTAPIPVHIB, IPV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: patient received both Pentacel and Ipol in error with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from other health professional via Agency (Reference number- 00752128) and transmitted to Sanofi on 02-Sep-2021.  This case involves a nine-month-old male patient who received third 0.5 mL (total, once) dose of IPV (VERO) [IPOL] (suspension for injection) [lot RIS97, expiry date 03-Oct-2021] at right thigh and third dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (suspension for injection) [lot UJ543AA, expiry date not reported] at right thigh (route not reported for both suspects) on 02-Sep-2021 for prophylactic vaccination (extra dose administered).  Medical history, medical treatment, vaccination, concomitant medication and family history were not provided.  Concomitant medications included HEPATITIS B VACCINE RHBSAG (YEAST) (RECOMBIVAX) for and PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) for prophylactic vaccination.  It was a case of actual medication error due to extra dose (polio vaccine) administered (latency was on same day).  At the time of report, no adverse event reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: FLU4
Symptoms: Dermatitis contact, Rash, Urticaria
Clinical narrative: head-to-toe rash with hives; Initial information regarding an unsolicited valid non-serious case was received from pharmacist via Medical Information (Reference number- 00752389) and transmitted to Sanofi on 02-Sep-2021.  This case involves an unknown age and gender patient who experienced head-to-toe rash with hives (urticaria) after receiving INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  Medical history, past medical treatment, past vaccination, concomitant medication and family history were not provided.  On an unknown date, the patient received a 0.7 mL dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [lot number and expiry date not reported] via unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed non-serious head-to-toe rash with hives (urticaria) (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  It was reported "The caller does not have patient specifics regarding the event. She says she assumes that her business partner would have reported the event at the time. The patient was tested for allergies after the event and the only allergy that came back positive was to thimerosal."  It was not reported if the patient received any corrective treatment for the event.  On an unknown date, the patient recovered from the event.  There will be no information available on batch number for this case.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Expired product administered
Clinical narrative: patient received MENACTRA 2 days after expiration date/no AE; Initial information was received on 03-Sep-2021 regarding an unsolicited valid non-serious case from other healthcare professional.  This case involves a 11-year-old male patient who received MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] 2 days after expiration date (expired product administered).  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HPV VACCINE and DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (TDAP) for prophylactic vaccination.  On 25-Aug-2021, the patient received first dose of 0.5 ml suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (solution for injection, lot U669OAB and expiry date 23-Aug-2021) via an intramuscular route in the left deltoid for prophylactic vaccination (expired product administered).  It was reported, "caller reports that a patient was given expired MENACTRA; MENACTRA was administered 2 days after expiration date. Caller asks for recommendations following administration of expired product. "  It was a case of an actual medication error due to expired vaccine administered (latency-same day).  At time of reporting no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 11.0
Sex: M
Vaccine: FLU4
Symptoms: Malaise, Nausea, Pain in extremity
Clinical narrative: general Malaise all day on Sunday; sore arm; nausea; Initial information was received on 07-Sep-2021 regarding an unsolicited valid non-serious case from a consumer/non-Healthcare professional via Medical Information (Reference number-00757082).  This case involves a 11-year-old male patient who experienced sore arm (pain in extremity), nausea, general malaise (malaise), after receiving INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient's medical history, past medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  On 04-Sep-2021, the patient received a dose of 0.5 mL suspect INFLUENZA QUADRIVAL A-B VACCINE (suspension for injection, lot UJ685AA and expiry date was not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On 04-SEP-2021 the patient developed non-serious nausea and sore arm (pain in extremity) (same day) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  On 05-SEP-2021, the patient developed non-serious general malaise all day on Sunday (malaise) 1 day following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  It was reported " Caller reporting an adverse event that her son experienced after receiving a Fluzone Quadrivalent injection on Saturday. "Why did he experience a reaction this time and he has never had a reaction in the previous years? What is different? What can I do about his sore arm? Do it have anything to do with him receiving the vaccine at the clinic and not the pediatrician office? Are the flu shots the same? This is the first time ever he had such a reaction. He experienced nausea and next morning the nausea was gone. Plus his arm has been sore since Saturday and it is getting better now. He also experienced general Malaise all day on Sunday. Caller states that she used children's Tylenol Saturday and part of Sunday."  Details of laboratory data were not reported.  The patient received children's Tylenol for the events.  On 05-Sep-2021, the patient was recovered for the event nausea.  At time of reporting, the patient was recovering for the event sore arm, the outcome was unknown for the event general malaise.
Sex: M
Vaccine: FLU4
Symptoms: Hypersensitivity, Pharyngeal swelling, Rash, Urticaria
Clinical narrative: his throat started swelling; he had hives/a rash about 1-2 hours; he had hives/a rash about 1-2 hours; had an allergic reaction; Initial information was received on 07-Sep-2021 regarding an unsolicited valid non-serious case from a consumer/non-healthcare professional.  This case involves a 52-year-old male patient who experienced his throat started swelling (pharyngeal swelling), he had hives/a rash about 1-2 hours (urticaria and rash) and an allergic reaction (hypersensitivity), after receiving INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient's medical history, past medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  On an unknown date in 2020, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot number and expiry date not reported) via an unknown route in unknown administration site for prophylactic vaccination.  On an unknown date in 2020, the patient developed non-serious his throat started swelling (pharyngeal swelling), he had hives/a rash about 1-2 hours (urticaria and rash) and an allergic reaction (hypersensitivity) (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  It was reported, "consumer wants to know the ingredients in FLUZONE QUADRIVALENT. He states that last year he took the vaccine and had an allergic reaction and is trying to find out if he can get the Covid-19 vaccination. He is not even sure what brand of "flu shot he had". He wants to receive a Covid-19 vaccine but since he had a reaction to another vaccine his Doctor wanted him to do "research" on the flu vaccines he might have received. He stated that he had hives/a rash about 1-2 hours after receiving the flu vaccination and he was given BENEDRYL by urgent care. Shortly after he started seeing the hives/rash his throat started swelling. Urgent care gave him another "BENEDRYL like medicine". He thinks this occurred in October or November of 2020. Both conditions resolved shortly after each medicine was administered".  Details of laboratory data were not reported.  The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL).  At time of reporting, the patient was recovered from the events.  There will be no information available on the lot number for this case.
Age: 35.0
Sex: F
Vaccine: FLU4
Symptoms: Expired product administered
Clinical narrative: patient received expired fluzone; Initial information was received on 08-Sep-2021 regarding an unsolicited valid non-serious case from a physician and non-healthcare professional via call center via Medical Information (Reference number- 00759516).  This case involves a 35 years old female patient who administered expired vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (expired product administered).  The patient's medical history, past medical treatment, vaccination and family history were not provided.  On 07-Sep-2021, the patient received a 0.5 mL dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot number: UT7073LA and expiry date: 30-Jun-2021) via an intramuscular route at an unknown administration site for prophylactic vaccination.  It was an actual medication error due to expired vaccine used (latency: same day).  At the time of reporting, no adverse event reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 23.0
Sex: F
Vaccine: FLU4
Symptoms: Expired product administered
Clinical narrative: patient given expired fluzone with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from physician and other health care professional via Medical Information (Reference number- 00759590) and transmitted to Sanofi on 08-Sep-2021.  This case involves 23-year-old female patient given expired INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV] (expired product administered).  Relevant medical history, medical treatment(s), vaccination(s) concomitant medication and family history were not provided.   On 07-Sep-2021, the patient received 0.5ml (total, 1X(once)] dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot: UT7073LA and expiry date: 30-Jun-2021) (Frequency = once) (Strength = standard) via intramuscular route in unknown administration site for prophylactic vaccination (expired product administered).  It was reported,"Caller stated that she needs guidance on if they need to revaccinate a patient, If so, what is the time frame she needs to wait?"   This case was an actual medication error due to expired vaccine used (latency: same day).  At the time of reporting, no adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 39.0
Sex: F
Vaccine: FLU4
Symptoms: Expired product administered
Clinical narrative: given expired FLUZONE, with no AE; Initial information was received on 08-Sep-2021 regarding an unsolicited valid non-serious case from a physician.  This case involves a 39-year-old female patient given expired INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV] (expired product administered).  The patient's medical history, past medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  On 07-Sep-2021, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot UT7073LA, expiry date unknown) via an intramuscular route in unknown administration site for prophylactic vaccination.  It was a case of actual medication error expired vaccine used (same day).  It was reported, "caller stated that she needs guidance on if they need to revaccinate a patient that was given EXPIRED FLUZONE on 07Sep2021".  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: F
Vaccine: FLU3
Symptoms: Mouth swelling, Oral pruritus, Pharyngeal swelling, Throat irritation
Clinical narrative: mouth and throat were itchy and swollen; mouth and throat were itchy and swollen; mouth and throat were itchy and swollen; Initial information regarding an unsolicited valid non-serious case was received from consumer (patient) via Medical Information (Reference number- 00759668) and transmitted to Sanofi on 08-Sep-2021.  This case involves an unknown age female patient who experienced mouth and throat were itchy and swollen (mouth swelling, pharyngeal swelling and pruritus) after receiving INFLUENZA USP TRIVAL A-B SUBVIRION NO PRESERVATIVE VACCINE [FLUZONE].  The patient's medical history included COVID-19.  The patient's past medical treatment(s), vaccination(s) and family history were not provided.  In 2005, the patient received a dose (once) of suspect INFLUENZA USP TRIVAL A-B SUBVIRION NO PRESERVATIVE VACCINE (Injection) [lot number and expiry date not reported] via unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed non-serious mouth and throat were itchy and swollen (mouth swelling, pharyngeal swelling and pruritus) (unknown latency) following the administration of INFLUENZA USP TRIVAL A-B SUBVIRION NO PRESERVATIVE VACCINE.  It was reported "she went to the emergency room. The doctors told her that she had reacted to something in the vaccine, so she should not get any more flu vaccines, which she has not. But now, she wants a COVID19 vaccine. She states that she had COVID last spring, and she cannot handle having it again. Her physician is telling her that she shouldn't get the vaccine, as she may react to it, as well. She is trying to get a copy of the PI for the flu vaccine that she received, so she and her doctor can compare ingredients with current COVID vaccines."  Details of laboratory data not reported.  It was not reported if the patient received any corrective treatment for the events.  On an unknown date, the patient recovered from all the events.  There will be no information available on batch number for this case.
Age: 80.0
Sex: M
Vaccine: FLU4
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: 80 year old male patient administered expired dose of Fluzone High Dose, with no reported adverse event; Initial information received on 08-Sep-2021 regarding an unsolicited valid non-serious case from a physician via other health professional via Medical Information (Reference number- 00759809).  This case involves 80-year-old male patient who was vaccinated with the expired dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (expired product administered).  Medical history, medical treatment, concomitant medication, vaccination and family history were not provided.   On 07-Sep-2021, the patient received a 0.7ml dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot UJ567AA and expiry date: 30-Jun-2021) (Frequency: Once) via intramuscular route in the right deltoid for prophylactic vaccination.  It was an actual medication error case due to expired vaccine used (latency on same day).  It was reported "they administered expired FLUZONE HIGH DOSE to a patient. what are the proper steps for the patient after this situation?"  At time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 43.0
Sex: M
Vaccine: FLU4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: FLUZONE HIGH-DOSE QUADRIVALENT was given to a 43 years old adult male patient/ no AE; Initial information was received on 08-Sep-2021 regarding an unsolicited valid non-serious case from other healthcare professional and non-healthcare professional via call center via Information (Reference number- 00759924).  This case involves a 43 years old male patient who received INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] with no reported adverse event (product administered to patient of inappropriate age).  The patient's medical history, medical treatments, vaccinations, concomitant medications and family history were not provided.  On 08-Sep-2021, the patient received a 0.7 ml dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (frequency: once, strength: standard, lot number: UJ715AA and expiry date: 30-JUN-2023) via an intramuscular route in the left deltoid for prophylactic vaccination.  It was of actual medication error due to inappropriate age at vaccine administration (latency: same day).  At the time of reporting, no adverse event reported.  It was reported "caller would like further information regarding adverse effects on individuals under 65 years of age".  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. 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: 50.0
Sex: F
Vaccine: TDAP
Symptoms: Medication error
Clinical narrative: received two-doses of ADACEL in 28-days without realizing already received injection with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from pharmacist via Global Medical Information (Reference number- 00759955) and transmitted to Sanofi on 08-Sep-2021.  This case involves a 50-year-old female patient who received two-doses of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (suspension for injection) 0.5 mL (total, once) [lot U67028A, expiry date 20-Jun-2022] via intramuscular route at an unknown administration site on 08-Sep-2021 for prophylactic vaccination in 28-days without realizing already received injection (extra dose administered).  Medical history, past medical treatment, past vaccination, concomitant medication and family history were not provided.  It was a case of actual medication error due to extra dose administered (latency was on same day).  At the time of report, no adverse event reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 74.0
Sex: F
Vaccine: FLU4
Symptoms: Medication error
Clinical narrative: administered the vaccine before realizing that the vaccine had expired/ no AE; Initial information regarding an unsolicited valid non-serious case was received from other health care professional via Medical Information (Reference number- 00760288).  This case involves a 74-year-old female patient who vaccinated with a 0.7 mL (once) dose of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (lot UJ549AB and expiry date 30-Jun-2021) via intramuscular route in the left deltoid on 08-Sep-2021 for prophylactic vaccination while nurse administered the vaccine before realizing that the vaccine had expired (expired product administered).  Medical history, medical treatment, vaccination, concomitant medication and family history were not provided.  It was a case of actual medication error due to expired vaccine used (latency was on same day).  At the time of report, no adverse event reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements. 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: FLU3
Symptoms: Hypersensitivity
Clinical narrative: allergic reaction; Initial information regarding an unsolicited valid non-serious case was received from a nurse via consumer/non-health care professional via Medical Information (Reference number- 00760331).  This case involves a female patient (age unspecified) who had an allergic reaction (hypersensitivity) after receiving INFLUENZA USP TRIVAL A-B SUBVIRION VACCINE [FLUZONE].  Medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On an unknown date in 2009, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B SUBVIRION VACCINE (lot U3366AA, expiry not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious allergic reaction (hypersensitivity) (unknown latency) following the administration of INFLUENZA USP TRIVAL A-B SUBVIRION VACCINE.  It was reported, "The caller (nurse) states that a patient received FLUZONE QUADRIVALENT (from MULTI-DOSE VIAL) in 2009 Lot # U3366AA. The patient had an allergic reaction after receiving the vaccine and she would like to know if the vaccine was a swine flu (H1N1) vaccine or regular flu vaccine. The caller also would like ingredients of the 2009 Fluzone Quadrivalent Multi-dose Vials. The nurse states that the client is working with an allergist so that she can get the Coronavirus Disease (COVID vaccine) and she is the middleman."  No laboratory data was reported.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome of the event was unknown.
Age: 7.0
Sex: U
Vaccine: DT
Symptoms: Medication error, No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: physician gave a 7 year old a DT vaccine rather than the TENIVAC with no A/E;Initial information was received on 09-Sep-2021 regarding an unsolicited valid non-serious case received from another health care professional via consumer under Medical Information Inquiry Number: 00761764).  This case involves a seven- years old with an unknown gender patient who was administered with dt vaccine rather than the tenivac by a physician with no adverse event (wrong product administered) DIPHTHERIA VACCINE TOXOID, TETANUS VACCINE TOXOID [DT VACCINE]  On an unknown date, the patient received a dose of suspect DT VACCINE (injection) not produced by Sanofi Pasteur lot number and expiry date not reported via unknown route in unknown administration site for prophylactic vaccination.  It was a case of actual medication error due to wrong vaccine administered (latency: same day).  It was reported "Caller wanted to know if they needed to re-inject with TENIVAC. MIA (Medical Information Anywhere) tried to transfer caller to an MIS (Management Information Systems), however, no MIS was available at the time of call. Outbound call was made on 09-Sep-2021 at 13:16 employee stated that the nurse was not available and she did not have a way to leave her a message. Outbound call made on 09-Sep-2021 at 14:57. Employee stated the nurse was not available. Left message to contact us back with the inquiry."  At the time of reporting, no adverse event reported.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: F
Vaccine: FLU4
Symptoms: Adverse reaction, Pain, Pain in extremity, Product storage error
Clinical narrative: body aches; pain in left arm; Initial information regarding an unsolicited valid non-serious case was received from other health professional via consumer/non-health care professional via Medical Information (Reference number- 00762056) and transmitted to Sanofi on 09-Sep-2021.  This case is linked to case 2021SA300941 (same reporter).  This case involves a 48-year-old female patient who had body aches (pain) and pain in left arm (pain in extremity) after receiving INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV].  Medical history, past vaccination, medical treatment(s), and family history were not provided.  The patient had no other concomitant vaccines.  On 08-Sep-2021, the patient received a 0.5 ml first dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot UT7319LA, expiry: 30-Jun-2022 and form: prefilled syringe) via intramuscular route in the left deltoid for prophylactic vaccination.  On an unknown date the patient developed a non-serious body aches (pain) and pain in left arm (pain in extremity) (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE. The intensity of events was moderate to severe   It was reported "Caller asked for information regarding the product composition of FLUZONE QIV NP Prefilled syringes. Caller states that representatives from pharmacy administered FLUZONE QIV NP vaccines at her facility on 08SEP2021 and that 3 coworkers had adverse reactions to the vaccine. Caller asked if patients were having more site reactions this year and asked if anything was added to the vaccine. Caller states that switching from the prefilled syringe to the multi dose vial (MDV) containing preservative (FLUZONE QIV T) had relieved site reactions in the past. Caller provided information on 2 of 3 coworkers that experienced adverse reactions and stated that she would contact Medical Information when she obtained information on the third coworker. Caller states that she can be contacted by Sanofi Safety if further information is needed and asked for the direct phone number for Medical Information. This information is regarding the second of two reported patients that experienced an adverse reaction to FLUZONE QIV NP on 08SEP2021. Caller states that there was a third patient who experienced adverse reactions but that she does not have the information at this time and would call back. Caller states that a representative from pharmacy came to her facility on 08SEP2021 to administer FLUZONE QIV NP vaccines and that this patient experienced moderate to severe pain in left arm as well as moderate to severe body aches compared to past reactions. This patient was sent home to rest"  Caller also states that the representatives did not have a cooler for the vaccines and that they appeared out at room temperature when she saw them  No laboratory data was reported.  It was not reported if the patient received a corrective treatment for the events.  At time of reporting, the outcome of the events was unknown.
Sex: F
Vaccine: TD
Symptoms: Arthralgia, Injection site rash, Insomnia, Joint range of motion decreased, Loss of personal independence in daily activities
Clinical narrative: Pain in shoulder/ joint pain in that shoulder; pain in left upper arm; a rash under the arm she had the injection in (left); Decrease in range of motion/ trouble getting dressed; Trouble sleeping because of the pain; Initial information received on 09-Sep-2021 regarding an unsolicited valid non-serious case from a consumer/non-healthcare professional and physician via Information Media..  This case involves a 61 years old female patient who had pain in left upper arm (pain in extremity), pain in shoulder/ joint pain in that shoulder (arthralgia) , rash under the arm she had the injection (vaccination site rash), trouble sleeping because of the pain (insomnia) and decrease in range of motion/ trouble getting dressed (joint range of motion decreased), after receiving DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  patient did not received concomitant medication(s).   On 30-Aug-2021, the patient received a dose of suspect DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT (lot U6852AA and expiration date: not reported) via unknown route in the left arm for prophylactic vaccination.  On 30-in Aug-2021, the patient developed a non-serious pain in left upper arm (pain in extremity), pain in shoulder/ joint pain in that shoulder (arthralgia) , rash under the arm she had the injection (vaccination site rash), on the same day following vaccination.  In Aug-2021, The patient developed a non-serious trouble sleeping because of the pain (insomnia) and decrease in range of motion/ trouble getting dressed (joint range of motion decreased), [unknown latency] following the administration of vaccine.  It was reported "The caller stated that she is having side effects from a tetnus vaccine she received on 8-30-2021. She does not have the brand name of the vaccine. She did say that Pasteur is the manufacturer. She stated that the decrease in range of motion and pain are still present today, 10 days later. She has been in contact with her Dr about the issues. The patient is also not sure of the dose she received."   No laboratory data reported.  The patient was given Cold Packs and PARACETAMOL (TYLENOL) as a corrective treatment.  At time of reporting, the patient did not recovered from the reported events.
Sex: F
Vaccine: TD
Symptoms: Pain in extremity, Sleep disorder
Clinical narrative: Pain in shoulder/ joint pain in that shoulder; pain in left upper arm; a rash under the arm she had the injection in (left); Decrease in range of motion/ trouble getting dressed; Trouble sleeping because of the pain; Initial information received on 09-Sep-2021 regarding an unsolicited valid non-serious case from a consumer/non-healthcare professional and physician via Information Media..  This case involves a 61 years old female patient who had pain in left upper arm (pain in extremity), pain in shoulder/ joint pain in that shoulder (arthralgia) , rash under the arm she had the injection (vaccination site rash), trouble sleeping because of the pain (insomnia) and decrease in range of motion/ trouble getting dressed (joint range of motion decreased), after receiving DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  patient did not received concomitant medication(s).   On 30-Aug-2021, the patient received a dose of suspect DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT (lot U6852AA and expiration date: not reported) via unknown route in the left arm for prophylactic vaccination.  On 30-in Aug-2021, the patient developed a non-serious pain in left upper arm (pain in extremity), pain in shoulder/ joint pain in that shoulder (arthralgia) , rash under the arm she had the injection (vaccination site rash), on the same day following vaccination.  In Aug-2021, The patient developed a non-serious trouble sleeping because of the pain (insomnia) and decrease in range of motion/ trouble getting dressed (joint range of motion decreased), [unknown latency] following the administration of vaccine.  It was reported "The caller stated that she is having side effects from a tetnus vaccine she received on 8-30-2021. She does not have the brand name of the vaccine. She did say that Pasteur is the manufacturer. She stated that the decrease in range of motion and pain are still present today, 10 days later. She has been in contact with her Dr about the issues. The patient is also not sure of the dose she received."   No laboratory data reported.  The patient was given Cold Packs and PARACETAMOL (TYLENOL) as a corrective treatment.  At time of reporting, the patient did not recovered from the reported events.
Sex: U
Vaccine: DTAPIPVHIB, HIBV, IPV
Symptoms: Product storage error
Clinical narrative: A temperature excursion because the dial in the refrigerator was turned too low, reached up to Negative 3.4 Celsius for a total of 17 hours, 7 minutes, and 30 seconds/no AE;Initial information was received on 09-Sep-2021 regarding an unsolicited valid non-serious case from a non-healthcare professional via Medical Information (Reference number- 00762504).   This case involves vaccines that undergoes a temperature excursion of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)], (lot UJ414AAA, expiry date 12-MAR-2022), HIB (PRP/T) VACCINE [ACT-HIB] (lot UJ405AAA, expiry date 08-OCT-2021  ) and IPV (VERO) [IPOL] (lot R1G101M, expiry date 08-OCT-2021) because the dial in the refrigerator was turned too low reached up to negative 3.4 Celsius for a total of 17 hours, 7 minutes, and 30 seconds (product storage error).  It was reported, "caller states that a temperature excursion occurred because the dial in the refrigerator was turned too low. The lowest temperature reached was Negative 3.4C for a total of 17 hours, 7 minutes, and 30 seconds. The products involved were a punctured MDV of IPOL as well as unopened: ACTHIB, IPOL, and PENTACEL. Caller requested stability information for these products".  It was a case potential medication error due to product storage error temperature too low (same day).  At time of reporting no adverse was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Product preparation error
Clinical narrative: only pulled the green powder vial and mixed it with sterile water that comes with Varivax, did not mix it with the blue diluent that comes packaged in Pentacel with no reported adverse event; Initial information received on 10-Sep-2021 regarding an unsolicited valid non-serious case from a other healthcare professional and non-healthcare professional via Media information (under the reference 00763662).  This case involves a patient of (unknown demographics) who received DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] which pulled only the green powder vial and mixed it with sterile water that comes with varivax, did not mix it with the blue diluent (product preparation error).  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.  On 09-Sep-2021, the patient received a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  It was an actual medication error due to wrong solution used in drug reconstitution (same day).  It was reported "Nurse practitioner asks what are the safety guidelines and how do I give the patient the blue liquid component?".  At time of reporting, it was unknown whether the patient had any adverse event or not and the outcome was unknown for the reported event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on the batch number for this case.
Age: 63.0
Sex: F
Vaccine: MNQ
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: A 68 year old patient was vaccinated with MENACTRA, no AE; Initial information regarding an unsolicited valid non-serious case was received from other health professional via consumer/non-health care professional via Medical Information (Reference number- 00763830) and transmitted to Sanofi on 10-Sep-2021.  This case involves a 68-year-old female patient who was vaccinated with MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] [Product administered to patient of inappropriate age].  The patient had ongoing medical history of Basal cell carcinoma.   Past vaccination(s) and family history were not provided.  Concomitant medications included ECULIZUMAB (SOLIRIS); and RUXOLITINIB PHOSPHATE (JAKAFI).  On 06-May-2016, the patient received a dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (batch number and expiry not reported) via unknown route in unknown administration site for prophylactic vaccination.  It was a case of an actual medication error due to inappropriate age at vaccine administration (latency same day).  No adverse event was reported.  It was reported "Registered pharmacist (RPh) Intern has questions regarding MENACTRA and a patient who had received an injection on 5/6/2016 and is also being treated for Basal Cell Carcinoma. The pharmacy intern states that she is aware of what it says in the Principal Investigator (PI) but she is making sure on what the procedure is for this patient because it has been more than 5 years and she is on chemotherapy. The pharmacy intern states that the patient is being treated for basal cell carcinoma and they are on Soliris and Jakafi. She states that the last time they received Menactra was on 05/06/16"  She was asked for the lot number for the Menactra the patient received on 05/06/16 but she did not have this information so the rest of the questions on the Management of Adverse Events and Product Technical Complaints and for the Pasteur adverse event (AE) Reporting were not asked   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on the batch number for this case.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: No adverse event, Product storage error
Clinical narrative: Vaccine was exposed to 34.7 degree Fahrenheit for 5 hours and 36 minutes/ no AE; Initial information was received on 10-Sep-2021 regarding an unsolicited valid non-serious case received from a Physician via Medical Information (Reference number- 00763943) and transmitted to Sanofi on 10-Sep-2021.  This case involves a four-year-old male patient reported that DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] was exposed to 34.7-degree Fahrenheit for 5 hours and 36 minutes with no adverse event (Product storage error)  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included MEASLES VACCINE LIVE (ENDERS-EDMONSTON), MUMPS VACCINE LIVE (JERYL LYNN), RUBELLA VACCINE LIVE (WISTAR RA 27/3), VARICELLA ZOSTER VACCINE LIVE (OKA/MERCK) (PROQUAD) for Prophylactic vaccination.  On an unknown date, the patient received a 0.5 ml (total) dose of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [lot C5772BA and expiry date 17-Sep-2022] via intramuscular route in the right deltoid for prophylactic vaccination.  It was reported, "Caller stated they had a temperature excursion of unknown cause. Caller stated it was a total of 5 hours and 36 minutes. Caller stated the refrigerator temperature reached 34.7 degrees Fahrenheit. Caller also stated 5 children received vaccines after the excursion occurred. Caller is checking on stability."   It was a case of actual medication error due to incorrect product storage (latency was on same day).  At the time of 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 guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.; Sender's Comments:  US-SA-2021SA304325:
Sex: U
Vaccine: FLU4
Symptoms: No adverse event, Syringe issue, Underdose
Clinical narrative: leaked from the syringe where it connects to the needle and they did not receive the full amount of vaccine with no reported adverse event; leaked from the syringe where it connects to the needle and they did not receive the full amount of vaccine with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from other health care professional and consumer/non-health care professional via Medical Information (Reference number- 00764055) and transmitted to Sanofi on 10-Sep-2021.  This case involved an unknown (age and gender) patient received INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] leaked from the syringe where it connects to the needle and they did not receive the full amount of vaccine (underdose) and their symptom (syringe issue)  Relevant medical history, medical treatment(s), vaccination(s) concomitant medication and family history were not provided.   On 08-Sep-2021, the patient received first dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot: UJ704AA and expiry date: 30-Jun-2022) (Frequency = once) via intramuscular route in the left deltoid for prophylactic vaccination leaked from the syringe where it connects to the needle and they did not receive the full amount of vaccine (underdose) and their symptom (syringe issue)  It was reported"Caller asked how to proceed in this situation. Caller states that a nursing student prepared and administered the vaccine from a prefilled syringe and that the needle was not twisted on tight enough. The nurse that was present stated that "the vaccine leaked out where the needle connects to the syringe". Caller states that the cause of the leak was due to human error and that there have been no other issues with FLUZONE HIGH-DOSE QUADRIVALENT prefilled syringes. Caller states that she can be contacted if additional patient information is needed. Caller did not wish to provide specific patient information at this time. Caller states that she may be contacted in the future if it is necessary".  This case was vaccine underdose and syringe leak (latency: same day)  At the time of reporting, no adverse event