chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: This is a literature report. This literature report from a physician reporting same event under the same suspect product for 9 patients. This is one of 9 reports.  Many pregnant persons are receiving messenger RNA (mRNA) coronavirus disease 2019 (Covid-19) vaccines, but data are limited on their safety in pregnancy. Method: From 14Dec2020, to 28Feb2021, authors used data from the "safe after vaccination health checker" surveillance system, the v-safe pregnancy registry, and the Vaccine Adverse Event Reporting System (VAERS) to characterize the initial safety of mRNA Covid-19 vaccines in pregnant persons. Result: A total of 35,691 v-safe participants 16 to 54 years of age identified as pregnant. Injection-site pain was reported more frequently among pregnant persons than among nonpregnant women, whereas headache, myalgia, chills, and fever were reported less frequently. Among 3958 participants enrolled in the v-safe pregnancy registry, 827 had a completed pregnancy, of which 115 (13.9%) resulted in a pregnancy loss and 712 (86.1%) resulted in a live birth (mostly among participants with vaccination in the third trimester). Adverse neonatal outcomes included preterm birth (in 9.4%) and small size for gestational age (in 3.2%); no neonatal deaths were reported. Although not directly comparable, calculated proportions of adverse pregnancy and neonatal outcomes in persons vaccinated against Covid-19 who had a completed pregnancy were similar to incidences reported in studies involving pregnant women that were conducted before the Covid-19 pandemic. Among 221 pregnancy-related adverse events reported to the VAERS, the most frequently reported event was spontaneous abortion (46 cases). Conclusions: Preliminary findings did not show obvious safety signals among pregnant persons who received mRNA Covid-19 vaccines. However, more longitudinal follow-up, including follow-up of large numbers of women vaccinated earlier in pregnancy, is necessary to inform maternal, pregnancy, and infant outcomes.  An adult female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported.  The patient experienced COVID infection more than 14 days after first eligible dose of vaccination on an unspecified date. The mother reported she became pregnant while taking bnt162b2.  The outcome of the event was unknown.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. However, full immunity is only expected 7 days after the second dose.,Linked Report(s) : US-PFIZER INC-2021480902 Pfizer;US-PFIZER INC-2021480902 Pfizer
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: This literature report from a physician reporting same event under the same suspect product for 9 patients. This is one of 9 reports.  Many pregnant persons are receiving messenger RNA (mRNA) coronavirus disease 2019 (Covid-19) vaccines, but data are limited on their safety in pregnancy. Method: From 14Dec2020, to 28Feb2021, authors used data from the "safe after vaccination health checker" surveillance system, the v-safe pregnancy registry, and the Vaccine Adverse Event Reporting System (VAERS) to characterize the initial safety of mRNA Covid-19 vaccines in pregnant persons. Result: A total of 35,691 v-safe participants 16 to 54 years of age identified as pregnant. Injection-site pain was reported more frequently among pregnant persons than among nonpregnant women, whereas headache, myalgia, chills, and fever were reported less frequently. Among 3958 participants enrolled in the v-safe pregnancy registry, 827 had a completed pregnancy, of which 115 (13.9%) resulted in a pregnancy loss and 712 (86.1%) resulted in a live birth (mostly among participants with vaccination in the third trimester). Adverse neonatal outcomes included preterm birth (in 9.4%) and small size for gestational age (in 3.2%); no neonatal deaths were reported. Although not directly comparable, calculated proportions of adverse pregnancy and neonatal outcomes in persons vaccinated against Covid-19 who had a completed pregnancy were similar to incidences reported in studies involving pregnant women that were conducted before the Covid-19 pandemic. Among 221 pregnancy-related adverse events reported to the VAERS, the most frequently reported event was spontaneous abortion (46 cases). Conclusions: Preliminary findings did not show obvious safety signals among pregnant persons who received mRNA Covid-19 vaccines. However, more longitudinal follow-up, including follow-up of large numbers of women vaccinated earlier in pregnancy, is necessary to inform maternal, pregnancy, and infant outcomes.  An adult female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported.  The patient experienced COVID infection more than 14 days after first eligible dose of vaccination on an unspecified date. The mother reported she became pregnant while taking bnt162b2.  The outcome of the event was unknown.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. However, full immunity is only expected 7 days after the second dose.,Linked Report(s) : US-PFIZER INC-2021480902 Pfizer;US-PFIZER INC-2021480902 Pfizer
Age: 4.0
Sex: F
Vaccine: IPV
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 other healthcare professional via Medical Information (MI) (Reference number- 00567200) and transmitted to Sanofi on 19-Apr-2021.  This case involves a four-year-old female patient received an expired 0.5 mL 4th dose IPV (VERO) [IPOL] (lot R1B25 and expiry date: 13-Mar-2021) via an intramuscular route in the right thigh for prophylactic vaccination on 16-Apr-2021 (expired product administered).  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) and DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP) for prophylactic vaccination.  This was a case of actual medication error case 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.
Sex: U
Vaccine: HIBV
Symptoms: Expired product administered
Clinical narrative: A patient received an expired diluent part, no AE; Initial information regarding an unsolicited valid non-serious case was received from a nurse via Global Medical Information (GMI) (Reference number- 00574822) and transmitted to Sanofi on 23-Apr-2021  This case involves a patient (unknown demographics) who received an expired 0.5 mL dose of diluent part of HIB (PRP/T) VACCINE [ACT-HIB] (lot UJ144AAA and expiry date: 22-Mar-2021) via an unknown route in an unknown administration site for prophylactic vaccination on an unknown date (in between 22-Mar-2021 to 22-Apr-2021) (expired product administered).  The patient's medical history, past medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   A Nurse seeking to know if ActHib would be valid if the diluent used was expired. The nurse was reporting a possible medication error occurred described as the ActHib was given after the expiration date of the diluent. The caller reported that at the time of this call the exact patients that received the vaccine are unknown due to being too early in the investigation.  This was a case of actual medication error case due to expired product administered (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 by the regulatory authority . The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 22.0
Sex: F
Vaccine: TD, TDAP
Symptoms: Medication error, No adverse event, Wrong product administered
Clinical narrative: patient received Tenivac instead of Adacel, no AE; Initial information regarding an unsolicited valid non-serious case was received from a other healthcare professional via Medical Information (MI) (Reference number- 00574999) and transmitted to Sanofi on 23-Apr-2021.  This case involves a 22-year-old female patient who received a 0.5 mL dose of  DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC] (lot U6669AA and expiry date: 15-May-2022) via an intramuscular route in the left deltoid for prophylactic vaccination on 23-Apr-2021 instead of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (wrong 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 case due to wrong vaccine administered (latency same day).  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: M
Vaccine: TD
Symptoms: Expired product administered, Product storage 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 (Reference number- 00575182) and transmitted to Sanofi on 23-Apr-2021.  This case involves a male patient (age not reported) who received a 0.5 mL dose of expired DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC] (lot U6265AA and expiry date: 19-Apr-2021) via an unknown route in the deltoid for prophylactic vaccination on 23-Apr-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 at the time of reporting.   This was a case of actual medication error case 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: 0.17
Sex: F
Vaccine: HIBV
Symptoms: Incorrect route of product administration, Medication error, No adverse event
Clinical narrative: Patient received ACTHIB subcutaneously with no adverse event; Initial information regarding an unsolicited valid non-serious case was received from other health professional via Medical Information (Reference number- 00576929) and transmitted to Sanofi on 26-Apr-2021.  This case involves a 2 months old female patient who received a 0.5 mL dose of HIB (PRP/T) VACCINE [ACT-HIB] (lot UJ423AA and expiry date: 20-May-2022) via subcutaneous route in the right thigh instead of intramuscular route (incorrect route of product administration) for prophylactic vaccination on 26-Apr-2021.  Medical history, past medical treatments, past vaccinations and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, HEPATITIS B VACCINE RHBSAG (YEAST), PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, POLIO VACCINE INACT 3V (VERO), TETANUS VACCINE TOXOID (PEDIARIX); PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) for Immunisation; and ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ) for Immunisation.  It was an actual medication error case due to inappropriate route of vaccination (latency: same day).   The reporter wanted to know whether dose needs repeating.  At the time of reporting, the patient experienced no specific 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 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: TD
Symptoms: Expired product administered
Clinical narrative: Patient was administered an expired tenivac, no AE; Initial information received on 28-Apr-2021 regarding an unsolicited valid  non-serious case from nurse manager (inquiry number :00580496).  This case involves a patient (student of unknown age and gender) who was given an expired dose of DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC] (lot number not reported and expiration date:19-Apr-2021) via unknown route in an unknown administration site for prophylactic vaccination by one of the nurses on 27-Apr-2021 (expired product administered).  The patient's past medical history, medical treatment(s), concomitant medication(s), vaccination(s) and family history were not provided.   It was an actual medication error due to expired vaccine used (same day latency).  It was reported that they asked about what to do, and if they should revaccinate. Nurse manager was not able to provide the patient's information due to HIPAA (Health Insurance Portability and Accountability Act). She will inform the patient first, and the patient may call Medical Information back for the information needed.  It was unknown if the patient experienced any adverse event or not.    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 on the batch number for this case.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: patient received expired dose of MENACTRA/ NO AE; Initial information regarding an unsolicited valid serious case was received from a Nurse via Medical Information (Reference number- 00580513) and transmitted to Sanofi on 28-Apr-2021.  This case involves a 11-years-old female patient to whom medical assistant from the office gave 0.5 mL first dose MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (batch number: U6585AB and expiry date: 11-Apr-2021 via intramuscular route in gluteus maximus) (expired product administered) on 27-Apr-2021 for prophylactic vaccination.  The patient's past medical history, medical treatment, vaccination, concomitant medication and family history were not provided.  Concomitant medications included HPV VACCINE VLP RL1 4V (YEAST) (GARDASIL) and DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (TDAP) for prophylactic vaccination.  It was an actual medication error case due to expired vaccine used (latency: same day).  No adverse events or symptoms reported, she was fine, after 15 minutes.  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: IPV
Symptoms: Expired product administered
Clinical narrative: expired dose of the Ipol was given with no reported adverse event; Initial information received on 28-Apr-2021 regarding an unsolicited valid  non-serious case from a other health professional via (inquiry reference number 00580556).  This case involves a patient (unknown age and gender) who received an expired dose of IPV (VERO) [IPOL] (lot R1B251M and expiration date:13-Mar-2021) via unknown route in unknown administration site for prophylactic vaccination on the other day (date unspecified) (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 an actual medication error due to expired vaccines used (same day latency).  I was reported that the practice manager called for recommendation because an expired dose of the Ipol was given to consumer the other day. She called to find out if it required or recommended to repeat the dose. At time of the call, practice manager said she does not have NDC (national drug code). Practice manager confirmed it was not her but she also refused to provide the information. Hours of operation: 9 AM to 5 PM. Practice manager refused to provide consumer information saying she was not allowed to disclose it. Thus, limited information was obtained.  It was unknown of 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: 1.42
Sex: M
Vaccine: DTAPIPV
Symptoms: Medication error, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: A 17 month old patient recievd Quadracel, no AE; Initial information regarding an unsolicited valid non-serious case was received from other healthcare professional via Agency (Reference number- 00580846) and transmitted to Sanofi on 28-Apr-2021.  This case involves a 17-month-old male patient who received a 0.5 mL dose of DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] (lot C5763AA and expiry date: 26-Aug-2022) via an intramuscular route in an unknown administration site for prophylactic vaccination on 28-Apr-2021 (product administered to patient of inappropriate age) .  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 case due to extra dose administered (latency same day).  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Expired product administered
Clinical narrative: PENTACEL was given 3 days post expiration, with no reported adverse event; Initial information was received on 28-Apr-2021 regarding an unsolicited valid non-serious case from a nurse.  This case involves an unknown age and gender patient who was given DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (lot number- UJ160AAA, expiry date-24-Apr-2021) via an unknown route in unknown administration site for prophylactic vaccination, 3 days post expiration on 27-Apr-2021, with no reported adverse event while receiving vaccine.  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  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 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: 11.0
Sex: F
Vaccine: MNQ
Symptoms: No adverse event, Syringe issue, Underdose
Clinical narrative: During administration MENACTRA to patient, maybe it was not on tight and most of the vaccine came out with no reported adverse event; Patient probably didn't get majority of the vaccine with no AE; Initial information regarding an unsolicited valid non-serious case was received from the other health professional (Reference number- 00580918) and transmitted to Sanofi on 28-Apr-2021.  This case involves a 11 year old female patient who probably did not got majority of the vaccine as during administration of 0.5 mL first dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] [lot number and expiry date not reported, via an intramuscular route at the left arm] for prophylactic vaccination, on 28-Apr-2021 to patient, maybe it was not on tight and most of the vaccine came out (underdose and product leakage).   Medical history, medical treatment, vaccination, family history and concomitant medication were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR 5-COMPONENT, TETANUS VACCINE TOXOID (ADACEL) and HPV VACCINE VLP RL1 9V (YEAST) (GARDASIL 9).  It was a case of vaccine underdose and product leakage. (Latency: same day)  Product used: Used   First time product used: Yes  At the time of report, no adverse event was reported.  Event outcome for reported event was not applicable.
Sex: M
Vaccine: FLU4
Symptoms: Injection site mass
Clinical narrative: a small lump on at injection site; Initial information regarding an unsolicited valid non-serious case was received from a pharmacist via Medical Information (Reference number- 00580956).  This case involves a 45-year-old male patient who had a small lump on at injection site (vaccination site mass) while receiving INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient's medical history, past medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   In August 2020 (date not reported), the patient received a 0.5 mL dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot UJ432AA and expiry date: 30-Jun-2021) via an intramuscular route in the arm for prophylactic vaccination.  On an unknown date, the patient developed a non-serious a small lump on at injection site (vaccination site mass) (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  The patient recently presented to pharmacy with a small lump on his right upper arm. He stated that this bump developed at the FLUZONE injection site and has not gone away for 8 months. When providing template information, pharmacist stated that their documentation indicates that patient received vaccine in his left arm. Pharmacist states that he may have switched arms after the information was keyed into the computer. Pharmacist reported that bump was about as small as "the circle part" of a ball-point pen- definitely smaller than a dime. It was hard and painless and feels like scar tissue.  The details of laboratory data were not reported.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the patient had not recovered from the event.
Age: 1.0
Sex: M
Vaccine: HIBV
Symptoms: Expired product administered
Clinical narrative: 12 month old male patient administered expired dose of ActHib, with no adverse event; Initial information received on 28-Apr-2021 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 12 months old male patient who was administered expired dose of HIB (PRP/T) VACCINE [ACT-HIB] (expired product administered).  Medical history, medical treatment, vaccination and family history were not provided.  Concomitant medications included HEPATITIS A VACCINE INACT (HAVRIX) for Immunisation; PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) for Immunisation; and MEASLES VACCINE LIVE (ENDERS-EDMONSTON), MUMPS VACCINE LIVE (JERYL LYNN), RUBELLA VACCINE LIVE (WISTAR RA 27/3) (MMR II) for Immunisation.  On 28-Apr-2021, the patient received a 0.5 ml dose of suspect HIB (PRP/T) VACCINE (Hib portion lot UJ136AA and expiry date: 05-Mar-2021, diluent vial lot U6574AA and expiry date: 25-Mar-2021) (Frequency: once) via an intramuscular route in the right thigh 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 caller reported that ActHIB was administered to a patient today. The caller stated that the product expired on 05 MAR 2021. The caller would like know if the patient must be re-vaccinated and if there will be any potential adverse effects for the patient. 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 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: 0.17
Sex: F
Vaccine: DTAPIPVHIB, HIBV
Symptoms: Extra dose administered
Clinical narrative: 2 month old was administered Act-HIB and Pentacel/no AE; Initial information was received on 28-Apr-2021 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional (office manager).  This case involves a 2 month-old female patient who was vaccinated with DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] and HIB (PRP/T) VACCINE [ACT-HIB] (extra dose administered).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included ROTAVIRUS VACCINE and PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVENAR 13) for prophylactic vaccination.  On 28-Apr-2021, the patient received first dose 0.5 mL(once) of suspect HIB (PRP/T) VACCINE (lot UJ399AA and expiry date 02-OCT-2021) via an intramuscular route at the right thigh for prophylactic vaccination and a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot number and expiry date not reported) via an unknown route at unknown administration site for prophylactic vaccination.  It was a case of actual medication error due to extra dose administered (latency was on same day).  At the time of report, no adverse event reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in 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 Pentacel
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: Expired Pentacel given to 3 consumers with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from the consumer or other non-professional via Agency (Reference number- 00581215) and transmitted to Sanofi on 28-Apr-2021.  This case involves 3 child (age and gender unspecified) patients who had received expired dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] [lot number: UJ206ABA, expiry date: 24-Apr-2021 and other dosing details were not reported] on 27-Apr-2021 for prophylactic vaccination (expired product administered).  Medical history, medical treatment, vaccination, family history and concomitant medication were not reported.  It was a case of actual medication error due to expired vaccine used.  It was reported that, community health service manager refused to provide information of the 3 consumers who received the expired Pentacel. She stated that they called the parents and the parents stated they are not bringing their children back to receive another vaccine.  Product used: Used  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 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: Expired product administered
Clinical narrative: An expired dose of Pentacel was given to a consumer, no AE; Initial information was received on 28-Apr-2021 regarding an unsolicited valid non-serious case from a Nurse.  This case involves a patient (demographics unknown) who was administered dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (lot UJ225AAA, expiry date: 23-Apr-2021) via unknown route in unknown administration site on an unknown date for prophylactic vaccination (Expired product administered).  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  It was a case of an actual medication error due to Expired vaccine used (latency same day).  The nurse called for recommendation after an expired dose of Pentacel was given to a consumer.  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: 60.0
Sex: M
Vaccine: IPV
Symptoms: Medication error, No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: supposed to get the TUBERSOL test but instead got IPOL with no AE; 60 year old patient received IPOL/no AE; Initial information received on 28-Apr-2021 regarding an unsolicited valid non-serious case from a other health professional.  This case is linked to cases 2021SA148354 and 2021SA149533 (same reporter).  This case involves a 60-year-old male patient who received intradermal 0.1 ml dose of IPV (VERO) [IPOL] (in the left forearm, lot R1F801M, expiry date-28-Sep-2021) by mistake instead of TUBERCULIN TEST [TUBERSOL] for tuberculin test on 19-Apr-2021 (product administered to patient of inappropriate age) and (wrong 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 wrong vaccine administered and inappropriate age at vaccine administration (latency same day).  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in 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: DTAP, HIBV
Symptoms: Medication error, Wrong product administered
Clinical narrative: patient got a second dose of Daptacel instead of HIB with no AE; Initial information regarding an unsolicited valid non-serious case was received from Consumer/non-hcp (healthcare professional) via Medical Information (Reference number- 00582667).  This case involves a patient with unknown demography who experienced received a second dose of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (lot number and expiry date was not reported) instead of HIB (PRP/T) VACCINE [ACT-HIB] (lot number and expiry date was not reported) via unknown route at an unknown administration site (wrong product administered) for prophylactic vaccination on 29-Apr-2021.  Medical history, past medical treatments, past vaccinations, concomitant medication and family history were not provided.   It was an actual medication error case due to wrong vaccine administered (latency: same day).   It was reported that patient received a 0.5 mL dose DAPTACEL (lot C5643CA and expiry date: 17-Jul-2021) via unknown route at an unknown administration site on 14-Apr-2021 for prophylactic vaccination and was supposed to get HIB on 29-Apr-2021 but got a second dose of DAPTACEL. The reporter wanted to know for appropriate follow-up side effects.  At the time of reporting, the patient experienced no specific 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. 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: 32.0
Sex: F
Vaccine: IPV
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: 32 year old patient got IPOL (with no reported adverse event); supposed to get the TUBERSOL test but instead got IPOL (with no reported adverse event); Initial information received on 28-Apr-2021 regarding an unsolicited valid non-serious case from a other health professional.  This case is linked to cases 2021SA149533 and 2021SA148624 (same reporter).  This case involves a 32-year-old female patient who received intradermal 0.1 ml dose of IPV (VERO) [IPOL] (lot R1F801M, expiry date-28-Sep-2021) by mistake instead of TUBERCULIN TEST [TUBERSOL] for tuberculin test on 09-Apr-2021 (product administered to patient of inappropriate age) and (wrong 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 wrong vaccine administered and inappropriate age at vaccine administration (latency same day).  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 60.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity
Clinical narrative: The patient received Afluria Quadrivalent in left arm and experienced pain on her whole arm down to wrist; This spontaneous case was received on 26-Apr-2021 from other non-health professional (consumer) via Communications (reference number: SEQW21-01228) and concerned a 60-year-old, female patient.  The patient's medical history was not reported. The patient's concomitant medication included unspecified multivitamins, used for an unreported indication.   On 21-Sep-2020, the patient was vaccinated with Afluria Quadrivalent (influenza vaccine; dose: 0.5 ml, anatomical location: left deltoid/arm and route of administration: not reported) for influenza prophylaxis. The batch number reported was P100230210 and expiration date was 21-Jun-2021.  On an unspecified date in 2020, reported as one to two weeks after receiving Afluria Quadrivalent, the patient experienced pain on her whole arm down to wrist.  At the time of initial reporting on 26-Apr-2021, the patient had not recovered from the event of 'painful L arm'.   The patient did not provide a causality assessment.   This case is linked to cases 202102298 and 202102299 (the same reporter).  Company comment: The event of 'painful L arm' is assessed as related to Afluria Quadrivalent.; Sender's Comments: The event of 'painful L arm' is assessed as related to Afluria Quadrivalent.
Age: 66.0
Sex: F
Vaccine: FLUX
Symptoms: Drug hypersensitivity
Clinical narrative: Drug allergy; This spontaneous case was received on 26-Apr-2021 from other non-health professional (reference number: NUS2021US024669/NC_PK) and concerned a 66-year-old, female patient.  The patient's medical history and concomitant medications were not reported.    On an unknown date, the patient was vaccinated with influenza virus vaccine polyvalent (brand not specified; route of administration, indication, dose and anatomical location: not reported). The batch number was not reported.   On an unknown date, unknown amount of time after receiving influenza virus vaccine polyvalent, the patient developed drug allergy.  The outcome of event was not reported.   The reporter did not provide causality assessment.  Company comment: A 66-year-old, female patient was vaccinated with influenza virus vaccine polyvalent. On an unknown date, unknown amount of time after receiving influenza virus vaccine polyvalent, the patient developed drug allergy. The patient's medical history was not reported. Causal role of the suspect vaccine is unassessable, due to unclear information regarding temporal relationship and diagnostic findings.; Sender's Comments: A 66-year-old, female patient was vaccinated with influenza virus vaccine polyvalent. On an unknown date, unknown amount of time after receiving influenza virus vaccine polyvalent, the patient developed drug allergy. The patient's medical history was not reported. Causal role of the suspect vaccine is unassessable, due to unclear information regarding temporal relationship and diagnostic findings.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Ringing in ear. Both ears
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Injection site pain, Mobility decreased, Muscle spasms, Myalgia
Clinical narrative: Hello,  Had the 2nd Moderna COVID-19 vaccine at the pharmacy on April 2nd at 6:45 PM.  The nurse asked me to stay around the store for 15 minutes for any immediate side effects, and to drink plenty of water when I got home.  Did some shopping, and probably left about 30-45 minutes after the shot with no side-effects, and when I arrived home about another 45 minutes later still had no side effects.  Upon waking the next morning my right arm where I received the shot was extremely painful, and I could not raise any higher than parallel to the floor without extreme pain for 2-3 days.  Then I also started with a slight fever, which of the times checked, reached about 101.  Also was getting muscle and joint soreness, and later that started getting extreme cramping in my leg calf muscles while sitting on the couch.  I then had to stand up for 5-10 minutes, or walk around a little and then after sitting the extreme cramping would begin again so I would have to stand up again.  That went on all day.  When laying down that night the cramping would subside enough to sleep a little on and off during the night.  The calf muscle cramping started to gradually subside, but took about 17 days to go completely away.  The day after the vaccine when my legs were cramping I was extremely worried about possible leg clots since I had never had extreme leg cramping like that my entire life, and I was drinking plenty of water like the nurse recommended.  Best regards,
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Sleep disorder
Clinical narrative: Hello,  Had the 2nd Moderna COVID-19 vaccine at the pharmacy on April 2nd at 6:45 PM.  The nurse asked me to stay around the store for 15 minutes for any immediate side effects, and to drink plenty of water when I got home.  Did some shopping, and probably left about 30-45 minutes after the shot with no side-effects, and when I arrived home about another 45 minutes later still had no side effects.  Upon waking the next morning my right arm where I received the shot was extremely painful, and I could not raise any higher than parallel to the floor without extreme pain for 2-3 days.  Then I also started with a slight fever, which of the times checked, reached about 101.  Also was getting muscle and joint soreness, and later that started getting extreme cramping in my leg calf muscles while sitting on the couch.  I then had to stand up for 5-10 minutes, or walk around a little and then after sitting the extreme cramping would begin again so I would have to stand up again.  That went on all day.  When laying down that night the cramping would subside enough to sleep a little on and off during the night.  The calf muscle cramping started to gradually subside, but took about 17 days to go completely away.  The day after the vaccine when my legs were cramping I was extremely worried about possible leg clots since I had never had extreme leg cramping like that my entire life, and I was drinking plenty of water like the nurse recommended.  Best regards,
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: Big red rash below the injection site. Circular - I guess it's called Covid arm
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure increased, Dizziness, Loss of consciousness, Visual impairment
Clinical narrative: 1 or 2 minutes after shot started feeling dizzy.  Heart rate felt like it dropped and blood pressure felt very low.  Vision was dark and I spent most of the time concentrating on breathing.  I did not lose consciousness or pass out at any time.   I was with my wife and children so they were able to give me the timeline.  My wife noted I started sweating after about 5 minutes.  The symptoms peaked at about 10 minutes and faded slowly after that.  Because I felt like the worst of the event had passed we did not report the event at the time.  When we got home I laid down for about an hour.  My shoulder started hurting about this time as well.  I feel I was recovered from the initial symptoms within 2 days.  My shoulder was in pain for about 3 days, with the first two days being much worse than the third.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Chest X-ray, Cough, Dyspnoea, Electrocardiogram, Pneumonia
Clinical narrative: presyncope  penumonia  Cough:  SOB chest congestion and wheezing  antibiotics prednisone
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Presyncope, Respiratory tract congestion, Troponin, Wheezing
Clinical narrative: presyncope  penumonia  Cough:  SOB chest congestion and wheezing  antibiotics prednisone
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Oropharyngeal pain, Pyrexia, SARS-CoV-2 test
Clinical narrative: Sore Throat Cough Fever
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation delayed, Menstruation irregular, No reaction on previous exposure to drug
Clinical narrative: My period is a week late, yet two home pregnancy tests I took were negative. First dose did not affect my period at all. I have always been regular, give or take a few days. I am in the process of switching doctors, so I could not go to a doctor yet, and I did not have medical info to list.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Pain, Peripheral swelling, Skin warm
Clinical narrative: Pain in arm where shot was given, worsening a week later, upper arm is swollen and hot, shooting pains over 24 hours
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Pyrexia
Clinical narrative: Loss of taste and smell Fever
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chills, Gait disturbance, Irritability, Muscle spasms
Clinical narrative: Around 4 AM I started to experience a fever of 101.2, full body weakness, trouble walking, muscle spasms, irritability, and chills. It was a very strange experience. I took 3 Tylenol at about 7 AM and symptoms started to alleviate around 8:30 AM. The rest of the day I had random body aches, chills, and fatigue. I felt 100 percent by 10 PM on 5/7/2021