chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: DTAPIPVHIB, IPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: administered with an expired PENTACEL and IPOL (with no reported adverse event); Initial information was received on 22-Jun-2021 regarding an unsolicited valid non-serious case from a consumer or non-healthcare professional in the (Agency Inquiry number: 00651940).  It was reported that an expired dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] and IPV (VERO) [IPOL] was administered to a male patient (age not reported) on an unknown date for prophylactic vaccination (expired product administered).  It was a case of actual medication error due to expired vaccine used.  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.; Sender's Comments:  00651323: 00651982:
Sex: M
Vaccine: DTAPIPVHIB, IPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: A patient received expired pentacel and ipol, no AE; Initial information regarding an unsolicited valid non-serious case was received from consumer/non-healthcare propfessional via Agency (Reference number- 00651982) and transmitted to Sanofi on 22-Jun-2021.  This case involves a age male patient (age not reported) who experienced received an expired dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] (lot number and expiry date not reported) and IPV (VERO) [IPOL] (lot number and expiry date not reported) 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.   The mother wanted to know what side effects should they look out for her son.  This was a case of actual medication error due to expired vaccine used (latency same day).  At time of reporting, the outcome was unknown for the event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on the batch number for this case.
Age: 44.0
Sex: M
Vaccine: RAB
Symptoms: Incomplete course of vaccination, No adverse event
Clinical narrative: A patient received the first dose on 12Jun2021 and has not receive the second dose yet with no reported adverse event; Initial information was received on 22-Jun-2021 regarding an unsolicited valid non-serious case from a pharmacist and physician.  This case involves a 44-year-old male patient who received first dose of 1 ml RABIES (HDC) VACCINE [IMOVAX RABIES] on 12-Jun-2021 for and has not receive the second dose yet (lot T1C66, expiry date, route, site unknown) for unknown indication (wrong schedule).  Medical history, medical treatment, vaccination, concomitant medications and family history were not provided.  It was a case of an actual medication error due to wrong schedule.  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: 11.0
Sex: F
Vaccine: MNQ
Symptoms: No adverse event, Underdose
Clinical narrative: patient did not receive the full dose of Menquadfi/ only got 1/4 of a dose with no reported adverse event; Initial information was received on 22-Jun-2021 regarding an unsolicited valid non-serious case from a other health professional.  This case involves a 11-year-old female patient who did not received the full dose of 0.5 ml MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE [MENQUADFI]/ only got 1/4 of a dose (oral solution, lot U6935AA, expiry date 26-May-2023) via oral route for prophylactic vaccination (underdose).  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was a case of an actual medication error due to vaccine underdose (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.
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Expired product administered, No adverse event
Clinical narrative: The patient received a expired dose of PENTACEL vaccine (with no reported adverse event); Initial information regarding an unsolicited valid non-serious case was received from the other health professional via Agency (Reference number- 00653447) and transmitted to Sanofi on 23-Jun-2021.  This case involves patient with unknown demographics who received an expired dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] [expiry date: 13-June, lot number and other dosing details were not reported] on 22-Jun-2021 for prophylactic vaccination (expired product administered).  Medical history, medical treatment, vaccination, family history and concomitant medications were not reported.  It was a case of actual medication error due to expired vaccine used. (Latency: on the same day)  It was reported that, line was disconnected before reporter could gather demographic information.  At the time of report, no adverse event was reported.  At time of reporting, the outcome was of event reported as unknown.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 4.0
Sex: F
Vaccine: DTAPIPVHIB, MMR, VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: patient was given expired vaccine/ no AE; Initial information was received on 23-Jun-2021 regarding an unsolicited valid non-serious case received from a Other health care professional via Agency (Reference number- 00653450) and transmitted to Sanofi on 23-Jun-2021.  This case involves a four-year-old female patient who was vaccinated with 0.5 mL (once) (total) dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL].(injection) (lot number UJ325AAA, expiry date 13-Jun-2021) via intramuscular route in right arm on 22-Jun-2021 for prophylactic vaccination (expired product administered).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) and MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) for prophylactic vaccination.  It was a case of actual medication error due to expired vaccine used (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 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: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Expired product administered, No adverse event
Clinical narrative: The Patient received a 0.5 mL expired dose of ActHib with no AE; Initial information regarding an unsolicited valid non-serious case was received from the other health professional via Agency (Reference number- 00653461) and transmitted to Sanofi on 23-Jun-2021.  This case involves a 2 month old male patient who received a 0.5 mL expired dose of suspect HIB (PRP/T) VACCINE [ACT-HIB] [lot number: UJ324AA, expiry date: 14-Jun-2021], via an unknown route at the left thigh on 22-Jun-2021, for prophylactic vaccination (expired product administered).  On the same day, patient received PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13), DIPHTHERIA VACCINE TOXOID, HEPATITIS B VACCINE RHBSAG (YEAST), PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, POLIO VACCINE INACT 3V (VERO), TETANUS VACCINE TOXOID (PEDIARIX) and ROTOVIRIS as a concomitant medications.   Medical history, medical treatment, vaccination and family history were not reported.  It was a case of actual medication error due to expired vaccine used. (Latency: on same day)  At the time of report, no adverse event was reported.  At time of reporting, the outcome was of event reported as unknown.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired MENACTRA was administered to a patient, no AE; Initial information received on 23-Jun-2021 regarding an unsolicited valid non-serious case from a pharmacist and physician via Regulatory Authority (under reference number: 00653585).  This case involves a 16 years old female patient who was administered with 0.5 ml expired MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (Total, lot U6575AA and expiration date: 08-May-2021) via unknown route in unknown administration site for prophylactic vaccination on 23-Jun-202 (expired 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 an actual medication error due to expired vaccine used (same day latency).  Reported that the caller would like to know what to do next regarding matter.  At time of reporting, 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.
Age: 1.0
Sex: F
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient was given expired vaccine today/ no AE; Initial information was received on 23-Jun-2021 regarding an unsolicited valid non-serious case received from a Other health care professional via Medical Information (Reference number- 00653605) and transmitted to Sanofi on 23-Jun-2021.  This case involves a one-year-old female patient who was vaccinated 4th and final dose with 0.5 mL dose of HIB (PRP/T) VACCINE [ACT-HIB].(once) (lot number UJ320AA, expiry date 13-Jun-2021) via intramuscular route in right thigh on 23-Jun-2021 for prophylactic vaccination and reported that was given expired vaccine today with no adverse event (expired product administered).  Medical history, medical treatment(s), vaccination(s), concomitant medications 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 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: 0.33
Sex: F
Vaccine: DTAP, DTAPIPVHIB, PNC13, RVX
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: baby was received a PENTACEL vaccine, medical assistant administered the DTaP-IPV portion only due to misunderstanding/ no AE; DTaP-IPV portion twice within 2 days/ no AE; Initial information was received on 23-Jun-2021 regarding an unsolicited valid non-serious case received from a Other health care professional via Agency (Reference number- 00653789) and transmitted to Sanofi on 23-Jun-2021.  This case involves a four-month-old female patient who was vaccinated with 0.5 mL dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (lot number UJ425AAA, expiry date not reported) via intramuscular route in left thigh on 09-Jun-2021 for prophylactic vaccination and DIPHTHERIA, TETANUS, AC PERTUSSIS AND IPV VACCINE [lot number not reported and expiry date not reported] via unknown route on an administration site on an unknown date for prophylactic vaccination and reported that baby was received a PENTACEL vaccine, medical assistant administered the DTaP-IPV portion only due to misunderstanding with no adverse event (product preparation issue) and DTaP-IPV portion twice within 2 days with no adverse event (Inappropriate schedule of product administration).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) for prophylactic vaccination and PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) for prophylactic vaccination.  Caller stated PENTACEL was ordered DTAP and IPV was given not the ACTHIB. Caller stated there was a misunderstanding at the office as for the mixing, nursing staff believed that the MA had administered 0.4% saline (diluent for ActHIB) only, so a dose of PENTACEL was reconstituted appropriately and administered. Caller stated the patient came back and received the correct PENTACEL. Caller wanted to verify safety for the patient.  It was a case of actual medication error due to product preparation issue and inappropriate schedule of product administration (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 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: 28.0
Sex: F
Vaccine: TD
Symptoms: Expired product administered
Clinical narrative: A patient received an expired vaccine, no AE; Initial information regarding an unsolicited valid non-serious case was received from physician via Agency (Reference number- 00653846) and transmitted to Sanofi on 23-Jun-2021.  This case involves a 28-year-old female patient who received a 0.5 mL dose of expired DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC] (lot C5638AA and expiry date: 19-Jun-2021) via an intramuscular route in the right deltoid for prophylactic vaccination on 23-Jun-2021 (expired product administered).  The patient's medical history, past medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   The patient did not receive any other medications or vaccinations.  This was a case of actual medication error due to expired vaccine used (latency same day).  At time of reporting, the outcome was unknown for the event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 0.5
Sex: F
Vaccine: HIBV
Symptoms: No adverse event, Product preparation error
Clinical narrative: the sterile diluent for frozen vaccines was mixed in rather than the packaging that comes with the vaccine/ no AE; Initial information was received on 23-Jun-2021 regarding an unsolicited valid non-serious case received from a Other health care professional via Medical Information (Reference number- 00653853) and transmitted to Sanofi on 23-Jun-2021.  This case involves a six-month-old female patient who was vaccinated with 0.5 mL (total) dose of HIB (PRP/T) VACCINE [ACT-HIB] [lot number UJ425AAA, expiry date25-Jun-2022] via intramuscular route in right vastus lateralis on 23-Jun-2021 for prophylactic vaccination and reported that the sterile diluent for frozen vaccines was mixed in rather than the packaging that comes with the vaccine with no adverse event (product preparation error).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) for prophylactic vaccination.  The caller had a minor patient receive the ACHIB vaccine, however, the sterile diluent for frozen vaccines was mixed in rather than the packaging that comes with the vaccine. The caller did not have patient information available during time of call.  It was a case of actual medication error due to wrong solution used in drug reconstitution (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 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: F
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: Expired ACTHIB was administered to a patient, with no adverse event; Initial information regarding an unsolicited valid non-serious case was received from the other health professional via Regulatory Authority (Reference number- 00653907) and transmitted to Sanofi on 23-Jun-2021.  This case involves a 1-year-old female patient who received a 0.5 mL expired dose of suspect HIB (PRP/T) VACCINE [ACT-HIB] [lot number: UJ264AAA, expiry date: 04-Jun-2021], via intramuscular route at the left thigh on 23-Jun-2021, for prophylactic vaccination (expired product administered).  The patient received no other vaccination.  Medical history, medical treatment, concomitant medication and family history were not reported.  It was a case of actual medication error due to expired vaccine used. (Latency: on same day)  At the time of report, no adverse event was reported.  At time of reporting, the outcome was of event reported as unknown.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation issue
Clinical narrative: the patient only getting the DTap-IPV portion and not getting the Hib portion with no adverse event; Initial information regarding an unsolicited valid non-serious case was received from a pharmacist via Medical Information (Reference number- 00654048) and transmitted to Sanofi on 23-Jun-2021.  This case involves an unknown age and unknown gender patient who received 0.5 ml dose of DTAP -IPV portion and not the HIB portion of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] due to being distracted during a vaccination (other dosing details unknown) (lot: powder and expiry date: unknown) for prophylactic vaccination on 23-Jun-2021 (Product preparation issue).  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medication was not reported.  It was a case of an actual medication error due to inappropriate reconstitution technique (latency same day).  At the time of report, no adverse event was reported. At the time of reporting, the event outcome was unknown  The caller stated that the patient not getting the Hib portion but only getting the DTap-IPV portion due to being distracted during the Pentacel vaccination. The caller reported that he does not have any more information on the event other than the dose took place today, that the patient has already left the clinic and the caller wanted to know how to proceed with being able to use the Hib portion.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: TYP
Symptoms: Expired product administered, No adverse event
Clinical narrative: The Patient received an expired dose of Typhim Vi vaccine with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from the pharmacist via Agency (Reference number- 00654049) and transmitted to Sanofi on 23-Jun-2021.  This case involves a patient with unknown demographics who received a 0.5 mL dose of suspect TYPHOID VI POLYSACCHARIDE VACCINE [TYPHIM VI] [once, lot number: R2A251M, expiry date: 11-May-2021] via an intramuscular route at the right deltoid on 23-Jun-2021 for prophylactic vaccination (expired product administered).   Medical history, medical treatment, vaccination and family history were not reported.  At the time of report, list of concomitant medications reported as no other vaccines.  It was case of actual medication error due to expired vaccine used (Latency: on the same day).  At the time of report, reporter wanted to know if there is an extension to the expiration date and what course of action to take if they gave a patient an expired dose of TYPHIM.  At the time of report, no adverse event was reported.  At time of reporting, the outcome was of event reported as unknown.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: F
Vaccine: RAB
Symptoms: Headache, Injection site erythema, Neck pain, Paraesthesia, Sleep disorder
Clinical narrative: red, warm arm with a induration of 2x3.5 inches; neck pain; red, warm arm with a induration of 2x3.5 inches; Patient woke in the night two nights ago with feeling as if she is being bitten; pin prickling sensations that feels like she is being bitten  also a rippling feeling down her left calf that happened a couple of times; headache; red, warm arm with a induration of 2x3.5 inches; Initial information was received on 23-Jun-2021 regarding an unsolicited valid non-serious case from a consumer/non-hcp (healthcare professional).  This case involves a female patient who experienced red, warm arm with induration of 2x3.5 inches (erythema, skin warm and vaccination site induration), neck pain, woke in the night two nights ago with feeling as if she is being bitten (sleep disorder), pin prickling sensations that feels like she is being bitten  also a rippling feeling down her left calf that happened a couple of times (paraesthesia) and headache, while receiving vaccine RABIES (HDC) VACCINE [IMOVAX RABIES].  The patient's medical history, past medical treatments, past vaccinations, concomitant medication and family history were not provided.   On an unknown date, the patient received a 1 mL dose of suspect RABIES (HDC) VACCINE (lot number and expiry date were not reported) via unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious red, warm arm with induration of 2x3.5 inches (erythema, skin warm and vaccination site induration), neck pain, woke in the night two nights ago with feeling as if she is being bitten (sleep disorder), severe pin prickling sensations that feels like she is being bitten  also a rippling feeling down her left calf that happened a couple of times (paraesthesia) and headache, (unknown latency) following the vaccination.  The reporter asked if it is something that she needs to go to urgent care about. Also asked are the pin prickling sensations she experiencing severe such that she need to see care and is it serious.  It was also reported that she is glad for the need for only 4 shots due to her symptoms of side effects.  Laboratory data was not reported.  It was not reported if the patient received a corrective treatment for the events.  At time of reporting, the patient was not recovered from the reported events.  There will be no information on the batch number for this case.
Sex: F
Vaccine: RAB
Symptoms: Vaccination site induration, Vaccination site warmth
Clinical narrative: red, warm arm with a induration of 2x3.5 inches; neck pain; red, warm arm with a induration of 2x3.5 inches; Patient woke in the night two nights ago with feeling as if she is being bitten; pin prickling sensations that feels like she is being bitten  also a rippling feeling down her left calf that happened a couple of times; headache; red, warm arm with a induration of 2x3.5 inches; Initial information was received on 23-Jun-2021 regarding an unsolicited valid non-serious case from a consumer/non-hcp (healthcare professional).  This case involves a female patient who experienced red, warm arm with induration of 2x3.5 inches (erythema, skin warm and vaccination site induration), neck pain, woke in the night two nights ago with feeling as if she is being bitten (sleep disorder), pin prickling sensations that feels like she is being bitten  also a rippling feeling down her left calf that happened a couple of times (paraesthesia) and headache, while receiving vaccine RABIES (HDC) VACCINE [IMOVAX RABIES].  The patient's medical history, past medical treatments, past vaccinations, concomitant medication and family history were not provided.   On an unknown date, the patient received a 1 mL dose of suspect RABIES (HDC) VACCINE (lot number and expiry date were not reported) via unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious red, warm arm with induration of 2x3.5 inches (erythema, skin warm and vaccination site induration), neck pain, woke in the night two nights ago with feeling as if she is being bitten (sleep disorder), severe pin prickling sensations that feels like she is being bitten  also a rippling feeling down her left calf that happened a couple of times (paraesthesia) and headache, (unknown latency) following the vaccination.  The reporter asked if it is something that she needs to go to urgent care about. Also asked are the pin prickling sensations she experiencing severe such that she need to see care and is it serious.  It was also reported that she is glad for the need for only 4 shots due to her symptoms of side effects.  Laboratory data was not reported.  It was not reported if the patient received a corrective treatment for the events.  At time of reporting, the patient was not recovered from the reported events.  There will be no information on the batch number for this case.
Sex: U
Vaccine: TYP
Symptoms: Expired product administered, No adverse event
Clinical narrative: patient received an expired dose of vaccine/no AE; Initial information was received on 24-Jun-2021 regarding an unsolicited valid non-serious case received from a nurse via Medical Information (Reference number- 00655131).  This case is linked with case 2021SA213671 (same reporter).  This case involves a patient of unknown age and gender who was vaccinated with 0.5 mL [once; standard] expired dose of TYPHOID VI POLYSACCHARIDE VACCINE [TYPHIM VI] (batch number R2A301M and expiry date 31-May-2021) via an intramuscular route at the left deltoid on 23-Jun-2021 for prophylactic vaccination (expired product administered).  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided. No concomitant therapy was given.  It was a case of an actual medication error due to expired vaccine used (latency was on same day).  It was reported that "Wanted to know what to do and what recommendations were".  At the time of report, no adverse event reported.  Result of assessment was not reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in 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: 1.0
Sex: F
Vaccine: HIBV, PNC13
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient was administered expired vaccine/ no AE; Initial information was received on 24-Jun-2021 regarding an unsolicited valid non-serious case received from a Other health care professional via Agency (Reference number- 00655521) and transmitted to Sanofi on 24-Jun-2021.  This case involves a one-year-old female patient who was vaccinated with 0.5 mL (once) dose of vaccine HIB (PRP/T) VACCINE [ACT-HIB] (lot number UJ316AAB, expiry date 08-Jun-2021) via intramuscular route in left vastus lateralis on 24-Jun-2021 for prophylactic vaccination and reported that patient was administered expired vaccine with no adverse event (expired product administered).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) for prophylactic vaccination.  Caller wanted to know if the product was still active or do the patient need to be re-vaccinate.  It was a case of actual medication error due to expired vaccine used (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 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: 2.0
Sex: M
Vaccine: TDAP
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Adacel was accidentally administered to a 2 year old patient/ no AE; Initial information was received on 24-Jun-2021 regarding an unsolicited valid non-serious case received from a Other health care professional via Agency (Reference number- 00655775) and transmitted to Sanofi on 24-Jun-2021.  This case involves a two-year-old male patient who was vaccinated with 0.5 mL (once) dose of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (total) (lot number C5687AA, expiry date 09-Dec-2021) via intramuscular route in left thigh on 24-Jun-2021 for prophylactic vaccination (inappropriate age at vaccine administration).  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  It was a case of actual medication error due to product administered to patient of inappropriate age (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 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: 1.33
Sex: F
Vaccine: HIBV, PNC13
Symptoms: Expired product administered, No adverse event
Clinical narrative: a 16 month old received an expired dose of Acthib with no adverse event; Initial information was received on 25-Jun-2021 regarding an unsolicited valid non-serious case from a other health professional.  This case involves 16-month-old female patient who received expired dose of HIB (PRP/T) VACCINE [ACT-HIB] (lot number: UJ316AAA and expiry date unknown] via an intramuscular route in the left vastus lateralis on 24-Jun-2021 for prophylactic vaccination (expired product administered).  Medical history, medical treatment, vaccination, and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) for prophylactic vaccination.  It was 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: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Urinary tract infection, Vomiting
Clinical narrative: aches; vomiting the day following vaccination for about 12 hours; Severe UTI on the second day; Fever; This is a spontaneous report from a contactable consumer (patient). A 56-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL9266), via an unspecified route of administration, administered in left arm on 02Mar2021 15:30 (at the age of 56-year-old) as single dose for COVID-19 immunization. Medical history included Diabetes II. Concomitant medications included Metformin, Rybelsus, Glipizide, Atorvastatin, B12 (Cyanocobalamin). The patient previously took Motrin (ibuprofen) and experienced drug hypersensitivity, Erythromycin and experienced drug hypersensitivity, bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number- EL8982) administered in right arm on 09Feb2021 for COVID-19 immunization. On 04Mar2021 15:00, the patient experienced fever, aches, vomiting the day following vaccination for about 12 hours, severe UTI on the second day. If COVID prior vaccination and COVID tested post vaccination was reported as no. The patient did not receive treatment. The outcome of all events was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 13.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abnormal uterine bleeding, Anaemia, Dizziness, Dyspnoea exertional, Haemoglobin decreased
Clinical narrative: Dysfunctional uterine bleeding causing symptomatic anemia requiring hospitalization and transfusions.  Onset of menarche 4/2021. Received first shot 5/18/2021 and 2nd shot 6/8/2021.  Third menses onset 6/7/2021. Started becoming symptomatic with DOE, lightheadedness, and pallor 6/17/2021 (day 10 of menses). Hospitalized on 6/19/2021. Still bleeding as of date of this form (7/1/2021)
Age: 13.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pallor, Platelet count decreased, Transfusion
Clinical narrative: Dysfunctional uterine bleeding causing symptomatic anemia requiring hospitalization and transfusions.  Onset of menarche 4/2021. Received first shot 5/18/2021 and 2nd shot 6/8/2021.  Third menses onset 6/7/2021. Started becoming symptomatic with DOE, lightheadedness, and pallor 6/17/2021 (day 10 of menses). Hospitalized on 6/19/2021. Still bleeding as of date of this form (7/1/2021)
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pruritus, Sunburn
Clinical narrative: It was afternoon. I was in the field, manning the disc toss station and waiting for participants to come up for the ring toss. I first set up shop within the fenced area, facing northeast. I made several calls looking for people to play, but only one contender arrived. I decided to move northeast, toward the treeline but remained within where the sun could shine upon me. Now I was facing southwest. I often turned and looked for participants, but no one came. I helped out on a nearby station, which faced west. At the end of the day, my school watched a magic show at the front doors, facing northeast. I don?t remember exactly how I was turning, but there was one critical mistake I made... I forgot my sunscreen. A bit later my arms started to rich from the sunburns. It wasn?t really painful to have them, but one thing struck as off: my left arm was slightly itchier and hurt slightly more when hit (not simply touched) than my right arm. It struck me as a little odd since both of my Pfizer shots were to the left arm (the first shot was on April 16 this year), but this could simply be a coincidence. Just thought this could be noteworthy.  Both sunburns were left untreated, but subsided by the next day.
Age: 16.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal X-ray, Abdominal pain upper, Blood test normal, Computerised tomogram abdomen, Fatigue
Clinical narrative: The 1st vaccine my daughter had a  sore arm (a few days)  very tired (a few days) and very nauseous. she was nauseous until her 2nd vaccine.  about 12 hours after her 2nd vaccine she had a fever off & on for 3 days threw up off & on for 3 days had a headache off and on 4 days. extremely tired for 3 days, stomach ache and nauseous for almost 2 wks.
Age: 16.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Gastritis, Headache, Nausea, Pain in extremity, Pyrexia
Clinical narrative: The 1st vaccine my daughter had a  sore arm (a few days)  very tired (a few days) and very nauseous. she was nauseous until her 2nd vaccine.  about 12 hours after her 2nd vaccine she had a fever off & on for 3 days threw up off & on for 3 days had a headache off and on 4 days. extremely tired for 3 days, stomach ache and nauseous for almost 2 wks.
Age: 16.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Ultrasound abdomen normal, Vomiting
Clinical narrative: The 1st vaccine my daughter had a  sore arm (a few days)  very tired (a few days) and very nauseous. she was nauseous until her 2nd vaccine.  about 12 hours after her 2nd vaccine she had a fever off & on for 3 days threw up off & on for 3 days had a headache off and on 4 days. extremely tired for 3 days, stomach ache and nauseous for almost 2 wks.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Breast discomfort, Breast tenderness, Eczema, Nausea, Pain
Clinical narrative: I have had aching and increasing discomfort to my left breast, very tender to touch and swollen since day 1 of receiving the 2nd Moderna vaccine. I have also been feeling intermittently nauseous. My eczema has been flaring up daily since getting the vaccine.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: I have had aching and increasing discomfort to my left breast, very tender to touch and swollen since day 1 of receiving the 2nd Moderna vaccine. I have also been feeling intermittently nauseous. My eczema has been flaring up daily since getting the vaccine.
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: PROQUAD underwent a temperature excursion and was administered; This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender. On 11-JUN-2021, the patient was vaccinated with a dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (lot # T036562 exp date 26-APR-2022) rHA (dose and route not reported) that underwent a temperature excursion. Previous temperature of excursion was 6°F to 14°F (14F) for 2 hours, 14°F to 46°F (45.5F) 1 hour and 30 minutes and 6°F t o14°F (14.4F) for 2 hours.  This is one of several reports received from the same source.; Sender's Comments:  US-009507513-2106USA006064: US-009507513-2106USA006458: US-009507513-2106USA006459: US-009507513-2106USA006460: US-009507513-2106USA006461: US-009507513-2106USA006462: US-009507513-2106USA006463: US-009507513-2106USA006464: US-009507513-2106USA006465: US-009507513-2106USA006466: US-009507513-2106USA006467: US-009507513-2106USA006468: US-009507513-2106USA006469: US-009507513-2106USA006470: US-009507513-2106USA006471: US-009507513-2106USA006472: US-009507513-2106USA006473: US-009507513-2106USA006474: US-009507513-2106USA006475: US-009507513-2106USA006476: US-009507513-2106USA006477: US-009507513-2106USA006478: US-009507513-2106USA006479: US-009507513-2106USA006480: US-009507513-2106USA006481: US-009507513-2106USA006482: US-009507513-2106USA006483: US-009507513-2106USA006484: US-009507513-2106USA006485: US-009507513-2106USA006486: US-009507513-2106USA006488: US-009507513-2106USA006489: US-009507513-2106USA006490: US-009507513-2106USA006491: US-009507513-2106USA006492: US-009507513-2106USA006493: US-009507513-2106USA006494: US-009507513-2106USA006495: US-009507513-2106USA006496: US-009507513-2106USA006497: US-009507513-2106USA006498:
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: PROQUAD underwent a temperature excursion and was administered; This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender. On 11-JUN-2021, the patient was vaccinated with a dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (lot # T036562 exp date 26-APR-2022) rHA (dose and route not reported) that underwent a temperature excursion. Previous temperature of excursion was 6°F to 14°F (14F) for 2 hours, 14°F to 46°F (45.5F) 1 hour and 30 minutes and 6°F t o14°F (14.4F) for 2 hours.  This is one of several reports received from the same source.; Sender's Comments:  US-009507513-2106USA006064: US-009507513-2106USA006458: US-009507513-2106USA006459: US-009507513-2106USA006460: US-009507513-2106USA006461: US-009507513-2106USA006462: US-009507513-2106USA006463: US-009507513-2106USA006464: US-009507513-2106USA006465: US-009507513-2106USA006466: US-009507513-2106USA006467: US-009507513-2106USA006468: US-009507513-2106USA006469: US-009507513-2106USA006470: US-009507513-2106USA006471: US-009507513-2106USA006472: US-009507513-2106USA006473: US-009507513-2106USA006474: US-009507513-2106USA006475: US-009507513-2106USA006476: US-009507513-2106USA006477: US-009507513-2106USA006478: US-009507513-2106USA006479: US-009507513-2106USA006480: US-009507513-2106USA006481: US-009507513-2106USA006482: US-009507513-2106USA006483: US-009507513-2106USA006484: US-009507513-2106USA006485: US-009507513-2106USA006486: US-009507513-2106USA006487: US-009507513-2106USA006489: US-009507513-2106USA006490: US-009507513-2106USA006491: US-009507513-2106USA006492: US-009507513-2106USA006493: US-009507513-2106USA006494: US-009507513-2106USA006495: US-009507513-2106USA006496: US-009507513-2106USA006497: US-009507513-2106USA006498: