chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 22.0
Sex: F
Vaccine: DTAPIPV, TTOX
Symptoms: Medication error, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: 22 year old patient received Quadracel with no adverse event; physician ordered a tetanus shot, but the MA grabbed the vaccine from the wrong shelf and administered Quadracel instead with no adverse event; Initial information was received on 22-Mar-2021 regarding an unsolicited valid non-serious case from a nurse.  This case involves a 22-year-old female patient received dose of 0.5 ml DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] instead of TETANUS TOXOID,  as the physician ordered a Tetanus shot, but the medical assistant [MA] grabbed the vaccine from the wrong shelf and administered QUADRACEL (lot C5635AA, expiry date-18-Jun-2021) via intramuscular route in the left arm for prophylactic vaccination on 19-Mar-2021, (product administered to patient of inappropriate age and wrong product administered).  Medical treatment(s), vaccination(s), concomitant medications and family history were not provided. It was reported that the patient came with the splinter which was removed before vaccination.  It was a case of actual medication error due to inappropriate age at vaccine administration and wrong vaccine administered (latency 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 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: 5.0
Sex: M
Vaccine: IPV
Symptoms: Expired product administered, Medication error
Clinical narrative: A patient received an expired vaccine, no AE; Initial information regarding an unsolicited valid non-serious case was received from other healthcare professional via Global Medical Information (GMI) (Reference number- 00531838) and transmitted to Sanofi on 23-Mar-2021.  This case involves a five-year-old male patient who received an expired 0.5 mL 4th dose of IPV (VERO) [IPOL] (lot R1B25 and expiry date: 13-Mar-2021) via an intramuscular route in the thigh for prophylactic vaccination on 18-Mar-2021 (expired product administered).  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, TETANUS VACCINE TOXOID (INFANRIX) and 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.  This was a case of actual medication error due to expired vaccine used (latency same day).  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization 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: 1.25
Sex: M
Vaccine: HIBV
Symptoms: Expired product administered, Medication error
Clinical narrative: 15 month old patientan expired dose of Acthib with no ae; Initial information regarding an unsolicited valid non-serious was received from a Physician (Reference number- 00533747) and transmitted to Sanofi on 23-Mar-2021s.  This case involves a 15 months old male patient who received 0.5 mL expired dose of suspect HIB (PRP/T) VACCINE [ACT-HIB] (lot UJ143AA and expiration date: 22-Mar-2021) via intramuscular route in the right deltoid (expired product administered) on 23-Mar-2021.  Medical history, past medical treatments, past vaccinations and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) and DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP) for Immunisation.  It was actual medication error due to expired vaccine used (on same day).  It was reported that after administration they noticed that it expired yesterday.  At the time of report, the patients experienced no adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: TDAP
Symptoms: Extra dose administered, Medication error
Clinical narrative: Patient inadvertently received an additional dose within 12 hours with no adverse event.; Initial information regarding an unsolicited valid non-serious was received from other health professional (Reference number- 00532090) and transmitted to Sanofi on 23-Mar-2021.  This case involves a patient with unknown demography who inadvertently received an (one dosage form) additional dose DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (lot number and expiration date were not reported) via unknown route at an unknown administration site (extra dose administered) for prophylactic vaccination within 12 hours.  Medical history, past medical treatments, past vaccinations, concomitant medication and family history were not provided.   It was actual medication error due to extra dose administered (on same day).  It was reported that patient received a dose in the emergency department and then inadvertently received an additional dose when the patient arrived to the unit at the hospital. Reporter had questions on potential adverse reactions.  At the time of report, the patients experienced no adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information on the batch number for this case.
Age: 3.0
Sex: F
Vaccine: DTAP, TDAP
Symptoms: Medication error, Wrong product administered
Clinical narrative: The practice was out of Daptacel and the MA got confused and instead administered Adacel /No AE; Initial information was received on 24-Mar-2021 regarding an unsolicited valid non-serious case from a consumer or non-healthcare professional. (Inquiry number: 00533623).  It was reported that DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (lot number: U6737AA).(Suspension For Injection) was administered to a 3 years old female patient, instead of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] on 11-Mar-2021 via intramuscular route for prophylactic vaccination (wrong product administered).  It was a case of actual medication error due to wrong vaccine administered.  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: U
Vaccine: IPV
Symptoms: Expired product administered
Clinical narrative: expired Ipol vaccination had been given today, with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from other health care professional via Agency (Reference number- 00533950) and transmitted to Sanofi on 24-Mar-2021.  This case involves a patient (unknown age and gender) who was administered an expired dose of POLIOMYELITIS VACCINE (INACTIVATED) [IPOL] (lot R1V25, expiry date: 13-Mar-2021) via unknown route in unknown administration site for prophylactic vaccination on an unknown date (expired product administered).  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  Expired Ipol vaccination had been given to consumer. Patient wants to know if it needs to be given again. Expiration 13 Mar 2021 Additional Description of event Adverse events :Caller states that she has no additional information.  It was a case of an actual medication error due to expired vaccine used (latency 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 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: M
Vaccine: DTAPIPVHIB, HEP, HIBV, PNC13, RVX
Symptoms: Extra dose administered, Medication error
Clinical narrative: 7-month-old was administered an extra dose of HIB; Initial information received on 25-Mar-2021 regarding an unsolicited valid non-serious case from a other health professional (Inquiry number: 00535159).  It was reported that an extra dose of HIB (PRP/T) VACCINE [ACT-HIB] (lot number: UJ359AAA).(Suspension For Injection) was administered to a 7-month-old patient, on 25-Mar-2021 via an unknown route for prophylactic vaccination (extra dose administered).  It was a case of actual medication error due to extra dose administered.  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 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: FLUR4
Symptoms: Expired product administered, No adverse event
Clinical narrative: A patient receievd an expired vaccine, no AE; Initial information regarding an unsolicited valid non-serious case was received from a pharmacist via Medical Information (Reference number- 00327404) and transmitted to Sanofi on 25-Mar-2021.  This case involves a patient (unknown demographics) who received an expired 0.5 mL dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (lot UJ455AA and expiry date: ) via an unknown route in an unknown administration site for prophylactic vaccination on an unknown date (expired product administered).  The patient's medical history, past medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   This was a case of actual medication error due to expired vaccine used (latency same day).  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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.
Sex: U
Vaccine: TDAP
Symptoms: Expired product administered, Medication error
Clinical narrative: ADACEL administered was already approximately two weeks expired; Initial information received on 25-Mar-2021 regarding an unsolicited valid non-serious case from a pharmacist.  It was reported that DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] Suspension For Injection) was administered to a patient which was already approximately two weeks expired, on an unknown date via an unknown route for prophylactic vaccination (expired vaccine used).  It was a case of actual medication error due to expired product administered.  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 Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on batch number for this case.
Sex: M
Vaccine: HIBV
Symptoms: No adverse event, Product preparation issue
Clinical narrative: ACTHIB was given with sterile water instead of saline to the 2 month patient, with no AE; Initial information regarding an unsolicited valid non-serious case was received from a physician (Reference number- 00535851) and transmitted to Sanofi on 25-Mar-2021.  This case involves a 2-months-old male patient who received vaccine 0.5 mL dose of suspect HIB (PRP/T) VACCINE [ACT-HIB] (batch number: UJ405AAB and expiry date: 10-Aug-2021) which was given with sterile water instead of saline (product preparation error) on an unknown date for prophylactic vaccination.  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.  It was an actual medication error case due to (wrong solution used in drug reconstitution) (latency: same day).  Caller would like to know if they need to re-dose  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization 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: 33.0
Sex: F
Vaccine: FLUR4
Symptoms: Expired product administered
Clinical narrative: a patient received an expired dose of FLUBLOK QUADRIVALENT vaccine/No AE; Initial information received on 26-Mar-2021 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 33 years old female patient who received an expired 0.5 ml dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] prefilled syringe batch number not reported and expiry date: 22-Mar-2021 via an intramuscular route in the left deltoid on 24-Mar-2021, frequency: once, strength: standard for prophylactic vaccination (expired product administered).  The patient's medical history, medical treatments, vaccinations, concomitant medications and family history were not provided.   It was an actual medication error due to expired vaccine used (latency: same day).  Potential Product Technique Complain: No, Description: Healthcare Professional (HCP) stated the administered FLUBLOK on Wednesday and it expired on Monday. HCP wanted to know how soon after can the patient come back in to get another shot. Or should the patient wait a certain amount of time. The nurse states that usually the Flublok vaccines expire in Jun-2021 so she was surprised to see that this one expired in on 22-Mar-2021 after the vaccine was given. There was no adverse events reported or treatment needed. The nurse plans to revaccinate the patient with the Flublok as soon as possible. Product used, First time product used: Yes, Still using product: Yes, Was Device Used: Yes.  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. 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 on the batch number for this case.
Sex: M
Vaccine: TD
Symptoms: Chills, Laboratory test, Loss of personal independence in daily activities, Pain, Posture abnormal
Clinical narrative: bedridden; aches; sinus problems; curled up like a baby; chills; Initial information received on 26-Mar-2021 regarding an unsolicited valid non-serious case received from a consumer. This case involves a 62 year old male patient who experienced bedridden, aches (pain), sinus problems (sinusitis), curled up like a baby (posture abnormal) and chills, while he received vaccine DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC].  Past vaccination included he realized that Tetanus vaccine was what had made him sick in 1988 as well.  Medical treatment, concomitant medication and family history were not provided.  At the time of the event, the patient had ongoing allergic to Penicillin and sulfa drugs.  In 2006, the patient received a 0.5 ml dose of suspect DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT (lot number and expiry date: not reported) via an intramuscular route at an unknown administration site for prophylactic vaccination. On an unknown date, the patient developed a non-serious bedridden, aches (pain), sinus problems (sinusitis), curled up like a baby (posture abnormal) and chills, (unknown latency) following the administration of DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT.  It was also reported that   Details of laboratory data not reported.  His doctor has given him an epipen to bring with him when he receives the COVID (coronavirus disease) vaccine.  At the time of reporting, the outcome of events was reported as unknown.
Sex: M
Vaccine: TD
Symptoms: Sinus disorder
Clinical narrative: bedridden; aches; sinus problems; curled up like a baby; chills; Initial information received on 26-Mar-2021 regarding an unsolicited valid non-serious case received from a consumer. This case involves a 62 year old male patient who experienced bedridden, aches (pain), sinus problems (sinusitis), curled up like a baby (posture abnormal) and chills, while he received vaccine DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC].  Past vaccination included he realized that Tetanus vaccine was what had made him sick in 1988 as well.  Medical treatment, concomitant medication and family history were not provided.  At the time of the event, the patient had ongoing allergic to Penicillin and sulfa drugs.  In 2006, the patient received a 0.5 ml dose of suspect DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT (lot number and expiry date: not reported) via an intramuscular route at an unknown administration site for prophylactic vaccination. On an unknown date, the patient developed a non-serious bedridden, aches (pain), sinus problems (sinusitis), curled up like a baby (posture abnormal) and chills, (unknown latency) following the administration of DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT.  It was also reported that   Details of laboratory data not reported.  His doctor has given him an epipen to bring with him when he receives the COVID (coronavirus disease) vaccine.  At the time of reporting, the outcome of events was reported as unknown.
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Expired product administered, Product storage error
Clinical narrative: 2 expired PENTACEL vaccines were administered with no AE; Initial information received on 26-Mar-2021 regarding an unsolicited valid non-serious case received from other health professional via Medical Information (Reference number- 00537025).  This case involves a male patient (child) who received expired dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL].  Medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.  On 24th (month unspecified), the patient received a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot UJ146AAA, expiry date- 14-Feb-2021) via unknown route in unknown administration site for prophylactic vaccination.  It was a case of an actual medication error due to expired vaccine used (latency 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: 1.08
Sex: F
Vaccine: HIBV
Symptoms: Expired product administered, Medication error
Clinical narrative: administered an expired dose of ActHIB with no reported adverse event; Initial information received on 26-Mar-2021 regarding an unsolicited valid non-serious case from a physician.  This case involves a 13 months old female patient who was given an expired 0.5 ml fourth dose of HIB (PRP/T) VACCINE [ACT-HIB] (Lot numbers: carton and powder: UJ144AAA liquid: U6573AA and expiration date : 22-Mar-2021 and also 28-May-2021) via intramuscular route in the left thigh for prophylactic vaccination on 23-Mar-2021 (formulation was however reported as oral solution)(expired product administered).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medication included HEPATITIS A VACCINE for prophylactic vaccination.  It was an actual medication error due to expired vaccine used (same day latency).  Reporter was with the question that what do they need to do?  It was not reported that the patient experienced any 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: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Expired product administered, Medication error
Clinical narrative: 17 year old male patient received expired dose of Menactra with no reported adverse event; Initial information received on 26-Mar-2021 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 17 year old male patient who was vaccinated with an expired dose of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (expired product administered).  Medical history, medical treatment, concomitant medication, vaccination and family history were not provided.   On 23-Mar-2021, the patient received a 0.5 ml dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (lot U654343AA and expiry date: 23-Feb-2021) (Frequency once) via an intramuscular route in the left deltoid for prophylactic vaccination.  It was a case of actual medication error due to expired vaccine used (latency on same day).  It was also reported that the description: Office manager states that staff gave expired dose within a month of expiration date and asks if there is potential harm, how potent the vaccine is, and should another injection be given.  Reporter relationship: health care professional (HCP) Product used: used Still using product: no   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: 13.0
Sex: M
Vaccine: IPV
Symptoms: Expired product administered, Medication error
Clinical narrative: patient was given an expired vaccine/no AE; Initial information received on 26-Mar-2021 and additional information received on 12-Apr-2021 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 13 years old male patient who received expired dose of IPV (VERO) [IPOL].  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS B VACCINE for Immunisation.  On 12-Apr-2021, the patient received a 0.5 mL dose of suspect IPV (VERO) (lot R1B251M, expiry date- 13-Mar-2021, Injection) via intramuscular route in unknown administration site for prophylactic vaccination.  It was a case of an actual medication error due to expired vaccine used.  The caller would like to know if the patient must be revaccinated and if so, when is it safe to revaccinate the patient. The caller also wants to know of any possible side effects for the patient at this time. Treatment- will be repeated.  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, Medication error
Clinical narrative: expired ActHib was given with no adverse event; Initial information received on 30-Mar-2021 regarding an unsolicited valid non-serious case from a physician.  This case involves patient of unknown age and demography to whom an expired HIB (PRP/T) VACCINE [ACT-HIB] (lot number and expiration date not reported) was given via unknown route in unknown administration site for prophylactic vaccination on an unknown date.   The patient's medical history, past medical treatment(s), vaccination(s), family history and concomitant medication were not provided.  It was a case of actual medication error due to expired vaccine used (same day latency).  Pediatrician asks for appropriate follow-up after expired vaccine was given and also asked what would be adverse reactions to monitor for.    It was not reported whether the patient had any adverse event.  No further information available at the time of report and health care professional stated they will be reporting it later.  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 batch number for this case.
Age: 1.58
Sex: M
Vaccine: IPV
Symptoms: Extra dose administered, Incorrect dose administered
Clinical narrative: received an extra dose of IPOL, no AE; Initial information received on 30-Mar-2021 regarding an unsolicited valid non-serious case from a physician.  This case involves a 19 months old male patient who received an extra dose of IPV (VERO) [IPOL] (Dose 3: lot number and expiration date not reported,via unknown route in unknown administration site and Dose 4: lot T1D481M and expiration date: 25-Jul-2022, via intramuscular route in the left thigh) for prophylactic vaccination on 17-Mar-2020 and 30-Mar-2021 respectively (extra dose administered).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP) ; HIB VACCINE (HIB) and HEPATITIS A VACCINE (HEPATITIS A).  It was a case of actual medication error due to extra dose administered (same day latency).  It was reported that the caller was with questions on expected adverse effects.  At the time of reporting, It was not reported whether the patient had any adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 4.0
Sex: F
Vaccine: TYP
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired TYPHIM VI was inadvertently administered to patients, no AE; Initial information received on 30-Mar-2021 regarding an unsolicited valid non-serious case from other health professional and physician.  This case involves a 4 years old female patient who was inadvertently given 0.5 ml expired dose of suspect TYPHOID VI POLYSACCHARIDE VACCINE [TYPHIM VI] (lot R1B741M and expiration date :23-Mar-2021) via intramuscular route in the left deltoid for prophylactic vaccination on 30-Mar-2021 (expired product administered).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included MENINGOCOCCAL VACCINE A/C/Y/W CONJ (DIP TOX) (MENACTRA) .  It was a case of actual medication error due to expired vaccine used (same day latency).  It was reported that the caller with questions on whether dose needs repeating and in what time frame.  It was not reported whether the patient had any adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 8.0
Sex: M
Vaccine: MNQ, TYP
Symptoms: Expired product administered, Medication error
Clinical narrative: The patient was administered expired TYPHIM VI, no AE; Initial information regarding an unsolicited valid non-serious case was received from the other healthcare professional via Agency (reference number- 00541756) and transmitted to Sanofi on 30-Mar-2021.  This case was linked to case 2021SA108603 (same reporter).  This case involves an eight year old male patient who was administered 0.5 ml dose of an expired suspect TYPHOID VI POLYSACCHARIDE VACCINE [TYPHIM VI] (lot number: R1B741M; expiry date: 23-Mar-2021) via intramuscular route in the left deltoid for prophylactic vaccination on 30-Mar-2021 (expired product administered).  Medical history, medical treatment(s), past vaccination(s), and family history were not provided.  Concomitant medications included MENINGOCOCCAL VACCINE A/C/Y/W CONJ (DIP TOX) (MENACTRA) for prophylactic vaccination.   It was a case of an actual medication error due to expired vaccine used (latency same day).  The reporter stated that an expired TYPHIM VI was inadvertently administered to the patient. Also, the reporter questioned whether the dose needs to be repeated and in what time frame  At the time of  this 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.; Sender's Comments:  US-SANOFI-00541741:Linked report
Age: 36.0
Sex: F
Vaccine: FLUX
Symptoms: Inappropriate schedule of product administration, Migraine
Clinical narrative: migraine; patient received postponed Dupixent dose after the INFLUENZA VACCINE; Initial information regarding an unsolicited valid non-serious case was received from a consumer/non-health care professional via Medical Information (Reference number- 00545146) and transmitted to Sanofi on 01-Apr-2021.  This case involves a 36-years-old female patient who experienced migraine, while she received vaccine INFLUENZA VACCINE and while treated with DUPILUMAB [DUPIXENT].  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.   On an unknown date, the patient started taking DUPIXENT (DUPILUMAB) 300 mg QOW route an unknown (with an unknown batch number) for atopic dermatitis.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious migraine (unknown latency) following the administration of INFLUENZA VACCINE and intake of DUPILUMAB.  This is also medication error case due to patient postponed her Dupixent dose and after the INFLUENZA VACCINE (intentional dose omission) (latency: same day).  Laboratory details were not reported.   It was not reported if the patient received a corrective treatment.  The event outcome was unknown for migraine.  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.  There will be no information available on the batch number for this case.
Sex: M
Vaccine: HIBV, MNQ
Symptoms: Medication error, Wrong product administered
Clinical narrative: patient was suppose to receive Menactra but mistakenly received ActHIB with no reported adverse event; Initial information received on 06-Apr-2021 regarding an unsolicited valid non-serious case from a non-health care professional (lead medical assistant).  This case involves male patient of unknown age who was suppose to receive MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] but mistakenly received HIB (PRP/T) VACCINE [ACT-HIB] (lot number and expiration date for both the vaccines were not reported) via unknown route in unknown administration site for prophylactic vaccination on an unknown date (wrong product administered).  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.   It was a case of actual medication error due to wrong vaccine administered (same day latency).  Reported that lead Medical Assistant was requesting for guidance and receptionist states she was out for the rest of the day. Left call back.  It was not reported whether the patient had any adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on batch number for this case.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Diffuse urticaria
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Nasal congestion, Nasopharyngitis
Clinical narrative: cold.  stuffy nose
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: Sore arm starting 30 minutes after vaccination, lasting 1.5 days.  Severe headache starting 45 minutes after vaccination lasting 1 hour.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pain, Pyrexia
Clinical narrative: I had COVID in March and the symptoms I experienced were the same symptoms I experienced when having Covid but even more severe. I have chills, aches, fever and fatigue lasting from 8 pm the day of the injection and have not let up the next morning
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Polymenorrhoea
Clinical narrative: Period started heavier than normal and 7 days early
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Dysphonia, Dyspnoea, Injection site pain, Nausea
Clinical narrative: Soreness in injection site after 12 hours. After 18 hours, weezing , coughing, difficulty breathing. Deep breathing painful. Nauseous.   It is 5 am on the 18th, almost 3 days after injection.  Symptoms are getting better.  Still raspy when breathing. Will call My Doctor if continues
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Painful respiration, Wheezing
Clinical narrative: Soreness in injection site after 12 hours. After 18 hours, weezing , coughing, difficulty breathing. Deep breathing painful. Nauseous.   It is 5 am on the 18th, almost 3 days after injection.  Symptoms are getting better.  Still raspy when breathing. Will call My Doctor if continues
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Paraesthesia, Paraesthesia oral
Clinical narrative: tingling in lips, hands, feet chest tightness
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Seizure
Clinical narrative: Fever of 103.1, seizures needing 911 to be called by my child and a trip to the ED, and entire body aches.   The fever started within the hours after the injection and lasted through the night and and my child found me seizing the next morning.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain
Clinical narrative: Armpit pain during movement
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature increased, Bone pain, Dry skin, Fatigue, Feeling cold
Clinical narrative: I feel arm snoring, high temperature, dryness and fever. I feel tired and very cold and my bones hurts. This began after 3 hours of my shot and continue until the moment of reporting.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Snoring
Clinical narrative: I feel arm snoring, high temperature, dryness and fever. I feel tired and very cold and my bones hurts. This began after 3 hours of my shot and continue until the moment of reporting.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Hyperhidrosis, Injection site erythema, Injection site induration
Clinical narrative: Chills, sweating, fatigue, muscle soreness across body, ?COVID arm? redness and firmness underneath injection site (not at injection site, about 2 inches down the arm)
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site reaction, Myalgia, Rash erythematous
Clinical narrative: Chills, sweating, fatigue, muscle soreness across body, ?COVID arm? redness and firmness underneath injection site (not at injection site, about 2 inches down the arm)
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Ear infection, Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: I experienced a sore arm at first, with redness, which then grew in size, to about 3 inches in diameter. The pain and swelling, along with itchiness were unbearable. I also developed respiratory symptoms: cough, congestion and an ear infection. I was concerned enough to get a COVID 19 test, which was negative. The symptoms did not not subside until almost 3 weeks after the 1st dose.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Respiratory tract congestion, SARS-CoV-2 test negative
Clinical narrative: I experienced a sore arm at first, with redness, which then grew in size, to about 3 inches in diameter. The pain and swelling, along with itchiness were unbearable. I also developed respiratory symptoms: cough, congestion and an ear infection. I was concerned enough to get a COVID 19 test, which was negative. The symptoms did not not subside until almost 3 weeks after the 1st dose.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Injection site erythema, Injection site pain
Clinical narrative: Injection site soreness, redness and pain. Fatigue and chills. Slight headache.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Axillary pain, Back pain, Body temperature increased, Breast pain
Clinical narrative: At approximately 6pm on 4/16/21, I began feeling as if I were in a fog (second dose of COVID-19 vaccine received at 10:30am previous day).  I began to feel weak and tired; all I wanted to do was lay down.  I laid in bed and took my temperature via ear.  100.8 in the right ear and a reading of 101.2 in the left ear (I've not had a fever since maybe 12 years of age).  I was also experiencing a headache (back of head) and neck discomfort.  I felt hot, specifically ears and face.  I took 400mg of ibuprofen at approximately 7pm and 1000mg of acetaminophen at approximately 10pm.  by 10:30 my temp was 98.9.  I woke up at 1:30am on 4/17/21 and was completely drenched I sweat.  I assumed this was from the fever break but I woke up again at approximately 4am drenched again.  After waking and getting up around 8am on 4/17/21, I felt great; back to normal.  I went about my day.  I woke again around 1:30am on 4/18/21 with a sore neck and the back, lower area of the head hurting (this wasn't the same feeling as having a stiff neck or laying in an awkward position).  When I sat up, I felt some sore, throbbing on the top of my head which then subsided.  I woke again at 4:30am with the same issue.  I was also, again, completely drenched in sweat but no fever this time that I am aware of.  My pajamas were soaked.  I felt some relief with the head and neck discomfort when I got up at 6;30am.  As I type this now, my head and neck feel basically normal.  I also wish to report that in addition to injection site soreness which I think is always to be expected, I have been experiencing quite a bit of soreness and discomfort under my left arm.  It runs down my left side from my arm pit to the side of my left breast.  This area has been sore and tender since the evening of the day I received the shot (4/15/21).  I'm assuming this could be due to stolen lymph nodes which I was told by a health care professional, could be a side effect of the vaccine.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Breast tenderness, Fatigue, Feeling abnormal, Feeling hot, Head discomfort
Clinical narrative: At approximately 6pm on 4/16/21, I began feeling as if I were in a fog (second dose of COVID-19 vaccine received at 10:30am previous day).  I began to feel weak and tired; all I wanted to do was lay down.  I laid in bed and took my temperature via ear.  100.8 in the right ear and a reading of 101.2 in the left ear (I've not had a fever since maybe 12 years of age).  I was also experiencing a headache (back of head) and neck discomfort.  I felt hot, specifically ears and face.  I took 400mg of ibuprofen at approximately 7pm and 1000mg of acetaminophen at approximately 10pm.  by 10:30 my temp was 98.9.  I woke up at 1:30am on 4/17/21 and was completely drenched I sweat.  I assumed this was from the fever break but I woke up again at approximately 4am drenched again.  After waking and getting up around 8am on 4/17/21, I felt great; back to normal.  I went about my day.  I woke again around 1:30am on 4/18/21 with a sore neck and the back, lower area of the head hurting (this wasn't the same feeling as having a stiff neck or laying in an awkward position).  When I sat up, I felt some sore, throbbing on the top of my head which then subsided.  I woke again at 4:30am with the same issue.  I was also, again, completely drenched in sweat but no fever this time that I am aware of.  My pajamas were soaked.  I felt some relief with the head and neck discomfort when I got up at 6;30am.  As I type this now, my head and neck feel basically normal.  I also wish to report that in addition to injection site soreness which I think is always to be expected, I have been experiencing quite a bit of soreness and discomfort under my left arm.  It runs down my left side from my arm pit to the side of my left breast.  This area has been sore and tender since the evening of the day I received the shot (4/15/21).  I'm assuming this could be due to stolen lymph nodes which I was told by a health care professional, could be a side effect of the vaccine.