chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Swelling
Clinical narrative: rash that consist of "little tiny bumps"; little tiny bumps; Rash is Warm to Touch; Became a litle redder; This case was reported by a pharmacist via call center representative and described the occurrence of rash in a 58-year-old male patient who received Herpes zoster (Shingrix) (batch number 3HX44, expiry date 15th November 2021) for prophylaxis.   On 2nd August 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 7th August 2019, 5 days after receiving Shingrix, the patient experienced rash, swelling, skin warm and erythema. On an unknown date, the outcome of the rash, skin warm and erythema were not recovered/not resolved and the outcome of the swelling was unknown.   It was unknown if the reporter considered the rash, swelling, skin warm and erythema to be related to Shingrix.  Additional information received were as follows: The patient received Shingrix on right deltoid. a day before the reporting date, the patient presented to the pharmacist with a rash that consisted of little tiny bumps surrounding the injection site.  The reporting pharmacist reported that the patient's rash was warm to touch and had mostly remained the same but became a little redder. The onset of rash was eporting pharmacist reports the patient's rash is warm to touch and has mostly remained the same but became a little redder.  The onset of rash was unknown.
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash generalised
Clinical narrative: Shingles; Rash onleft, lower arm and "other parts of his body"; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 53-year-old male patient who received Herpes zoster (Shingrix) (batch number Z4359, expiry date unknown) for prophylaxis.   On 2nd August 2019, the patient received the 2nd dose of Shingrix. In August 2019, less than a week after receiving Shingrix, the patient experienced shingles and generalized rash. On an unknown date, the outcome of the shingles and generalized rash were unknown.   It was unknown if the reporter considered the shingles and generalized rash to be related to Shingrix.  Additional details were provided as follows: The patient experienced a rash on his left lower arm and other parts of his body. The reporter could not confirm if it was only a rash or if it was shingles. The reporter also could not confirm when the rash started after receiving the vaccine. The reporter consented to follow up.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: feet pain; feet swelling; This case was reported by a consumer via call center representative and described the occurrence of foot pain in a 61-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th August 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 6th August 2019, less than a day after receiving Shingrix, the patient experienced foot pain and swelling of feet. On an unknown date, the outcome of the foot pain and swelling of feet were not recovered/not resolved.   It was unknown if the reporter considered the foot pain and swelling of feet to be related to Shingrix.  Additional details were provided as follows: The patient received dose of Shingrix in the left arm. The patient reported that, several hours after vaccination with Shingrix, experienced left foot pain and swelling. The patient stated that, next day after vaccination, experienced right foot pain and swelling. Till the date of reporting, both feets were painful and swollen. The patient did not consent to follow up.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Erythema, Headache, Nausea, Peripheral swelling
Clinical narrative: Chills; Fever; Nausea; Headache; Redness; Swollen Arm; This case was reported by a pharmacist via call center representative and described the occurrence of chills in a 70-year-old female patient who received Herpes zoster (Shingrix) (batch number 3LL4P, expiry date 19th October 2021) for prophylaxis.   On 5th August 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 6th August 2019, 1 days after receiving Shingrix, the patient experienced chills, fever, nausea, headache, erythema and swelling arm. Shingrix was discontinued. On an unknown date, the outcome of the chills, fever, nausea, headache, erythema and swelling arm were unknown.   It was unknown if the reporter considered the chills, fever, nausea, headache, erythema and swelling arm to be related to Shingrix.  Additional details were provided as follows: The patient received dose of Shingrix in the left deltoid. On the following day after vaccination with Shingrix, the patient experienced chills, fever, headache, redness, nausea, and swollen arm. The pharmacist asked if patient could be reimbursed because, the patient did not considered to receive 2nd dose of Shingrix.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Chills; Fever; Nausea; Headache; Redness; Swollen Arm; This case was reported by a pharmacist via call center representative and described the occurrence of chills in a 70-year-old female patient who received Herpes zoster (Shingrix) (batch number 3LL4P, expiry date 19th October 2021) for prophylaxis.   On 5th August 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 6th August 2019, 1 days after receiving Shingrix, the patient experienced chills, fever, nausea, headache, erythema and swelling arm. Shingrix was discontinued. On an unknown date, the outcome of the chills, fever, nausea, headache, erythema and swelling arm were unknown.   It was unknown if the reporter considered the chills, fever, nausea, headache, erythema and swelling arm to be related to Shingrix.  Additional details were provided as follows: The patient received dose of Shingrix in the left deltoid. On the following day after vaccination with Shingrix, the patient experienced chills, fever, headache, redness, nausea, and swollen arm. The pharmacist asked if patient could be reimbursed because, the patient did not considered to receive 2nd dose of Shingrix.
Age: 83.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: injection site soreness; This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 83-year-old female patient who received Herpes zoster (Shingrix) (batch number Z9E99, expiry date 2nd June 2021) for prophylaxis.   On 14th May 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 14th May 2019, less than a day after receiving Shingrix, the patient experienced injection site pain. On 15th May 2019, the outcome of the injection site pain was recovered/resolved.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix on left arm. The patient experienced injection site soreness that lasted for one day. The reporter consented to follow up. For tolerance of 2nd dose of Shingrix, refer case US2019144925.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Nausea, Pain in extremity, Product complaint, Pyrexia
Clinical narrative: Pharmaceutical product complaint; Tired; drowsy; Nauseous; Low grade fever; Arm Aching; This case was reported by a pharmacist via call center representative and described the occurrence of tiredness in a 60-year-old female patient who received Herpes zoster (Shingrix) (batch number K9L3M, expiry date 29th October 2021) for prophylaxis. This case was associated with product complaint.  On 31st July 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 31st July 2019, less than a day after receiving Shingrix, the patient experienced tiredness, drowsiness, nausea, low grade fever and pain in arm. On an unknown date, the patient experienced pharmaceutical product complaint. On 2nd August 2019, the outcome of the tiredness, drowsiness, nausea and low grade fever were recovered/resolved. On an unknown date, the outcome of the pain in arm and pharmaceutical product complaint were unknown.   It was unknown if the reporter considered the tiredness, drowsiness, nausea, low grade fever and pain in arm to be related to Shingrix.  Additional details were provided as follows: The reporter stated that, the patient felt very tired, nauseous, had a low grade fever, and her arm ached. The reporter stated that, her mother-in-law reports the events started the same night and lasted about two days, with the exception of her arm which continued to hurt through the  weekend. The reporter consented to follow up. The reporter questioned batch number, stating three patients experienced sides effects to the same batch number. pharmaceutical product complaint filed for this reason.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Somnolence
Clinical narrative: Pharmaceutical product complaint; Tired; drowsy; Nauseous; Low grade fever; Arm Aching; This case was reported by a pharmacist via call center representative and described the occurrence of tiredness in a 60-year-old female patient who received Herpes zoster (Shingrix) (batch number K9L3M, expiry date 29th October 2021) for prophylaxis. This case was associated with product complaint.  On 31st July 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 31st July 2019, less than a day after receiving Shingrix, the patient experienced tiredness, drowsiness, nausea, low grade fever and pain in arm. On an unknown date, the patient experienced pharmaceutical product complaint. On 2nd August 2019, the outcome of the tiredness, drowsiness, nausea and low grade fever were recovered/resolved. On an unknown date, the outcome of the pain in arm and pharmaceutical product complaint were unknown.   It was unknown if the reporter considered the tiredness, drowsiness, nausea, low grade fever and pain in arm to be related to Shingrix.  Additional details were provided as follows: The reporter stated that, the patient felt very tired, nauseous, had a low grade fever, and her arm ached. The reporter stated that, her mother-in-law reports the events started the same night and lasted about two days, with the exception of her arm which continued to hurt through the  weekend. The reporter consented to follow up. The reporter questioned batch number, stating three patients experienced sides effects to the same batch number. pharmaceutical product complaint filed for this reason.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles; This case was reported by a other health professional via call center representative and described the occurrence of shingles in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 42 days after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The patient demographic details were not provided. The age at vaccination was not reported. The health care professional stated that, the dose of Shingrix was administered in May or June 2019. 6 weeks after vaccination with Shingrix, the patient experienced shingles. The reporter consented to follow up.
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: gave the child Quadracel thinking that was the answer and realized afterwards that is is only; The child was supposed to get DTap and Polio vaccines; Initial information received on 07-Aug-2019 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 22 months 21 days old female patient and reported that gave the child Quadracel thinking that was the answer and realized afterwards that is is only and received vaccine DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] but the child was supposed to get Dtap and polio vaccines.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect 0.5 ml DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE lot C5500CA and 16-Aug-2020 via intramuscular route in the left thigh.  It was a case of actual medication error due to inappropriate age at vaccine administration and wrong vaccine administered.  It was unknown if the patient had any adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Sex: M
Vaccine: TDAP
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: medical assistant with a supervisor present pulled the wrong drug to give, TDaP (Adacel) was given instead of DTaP/ no AE; 15 month old child who was given the Tdap vaccination (Adacel)/ no AE; Initial information received on 07-Aug-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 15 months old male patient who received vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] lot U6273AA and expiry date: 24-Apr-2021 via intramuscular route in the left thigh on 05-Aug-2019.  The patient's past medical history, medical treatment(s), vaccination(s), and family history were not provided.  No other vaccines given during this visit.  This was a case of actual medication error due to wrong product administered  and inappropriate age at vaccine administration.   It was reported that the resident ordered Dtap but the medical assistant with a supervisor present pulled the wrong drug to give. Adacel was given.  The patient did not experience any adverse event  (patient was fine).  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.  List of documents held by sender: none.
Sex: U
Vaccine: DTAPIPV
Symptoms: Incorrect route of product administration
Clinical narrative: Quadracel was administered SQ instead of IM.; Initial information received on 07-Aug-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 4 years old patient received a dose of DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] (lot and expiry date was not reported) via subcutaneous route instead of intramuscular.  The patients past medical history, concomitant medication and family history were not provided.  It was an actual medication error due to inappropriate route of vaccination.  It was unknown whether the patient had any adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Information on the batch number was requested.  List of documents held by sender: none.
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: a  5 year old is behind in vaccination schedule described as up until now they have had three vaccinations including 2- Pediarix and 1 dose of Pentacel/No AE; Initial information received on 07-Aug-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a five years old patient (gender unknown) is behind in vaccination schedule described as up until now they have had three vaccinations including 2- pediarix and 1 dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] lot number not reported via unknown route in unknown administration site on an unknown date.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included two doses of DIPHTHERIA VACCINE TOXOID, HEPATITIS B VACCINE RHBSAG (YEAST), PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, POLIO VACCINE INACT 3V (VERO), TETANUS VACCINE TOXOID (PEDIARIX).  It was an actaul medication error due to inappropriate schedule of vaccine administered.  No adverse event reported.  The patient was in need for Quadracel vaccine.  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.  List of document held by sender: none.
Age: 3.0
Sex: M
Vaccine: IPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: a 3 years old male patient was administered an expired dose of Ipol; Initial information received on 07-Aug-2019 regarding an unsolicited valid non-serious case received from a non-health care professional (office staff).  This case involves a 36 months old male patient who was administered an expired 0.5ml dose of IPV (VERO) [IPOL] on 06-Aug-2019 (lot N1G511M, expiry date: 02-Aug-2019 via intramuscular route in the left thigh).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant vaccine included Hepatitis B vaccine.   It was an actual medication error due to expired vaccine used.  No adverse event was reported at the time of report.  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.  List of document held by sender: none.
Sex: F
Vaccine: TDAP
Symptoms: Extra dose administered, No adverse event
Clinical narrative: patient received second Adacel doses one week apart; Initial information received on 07-Aug-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 11 years old female patient who received 0.5 ml second dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot U5980EA (Expiry date 22-Jun-2020) via intramuscular route in the right deltoid on 07-Aug-2019 and she also received a first dose of the same vaccine with an unknown batch number via unknown route in unknown administration site on 31-Jul-2019.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included MENINGOCOCCAL VACCINE A/C/Y/W CONJ (DIP TOX) (MENACTRA) and HPV VACCINE VLP RL1 4V (YEAST) (GARDASIL).  It was an actual medication error case due extra dose administered.   It was reported that that patient received a dose of Adacel on 31Jul2019 at another clinic with one parent and received a 2nd dose on 07Aug2019 with the other parent.  At a time of vaccination no adverse events were 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.  Information on batch number of first vaccine is requested.  List of documents held by sender: none.
Sex: M
Vaccine: MNQ
Symptoms: Extra dose administered
Clinical narrative: patient received a Menactra vaccine on 07-JUN-2019 and also received a second vaccine of Menactra, today, 08-AUG-2019 in error; Initial information received on 08-Aug-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves a 18 years old male patient who received first dose of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] on 07-Jun-2019 and 0.5 ml second dose of the same vaccine (with lot: U6455CA, expiry date: 15-Nov-2020, via intramuscular route in the left deltoid) on 08-Aug-2019 in error.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  No other vaccine was given that time.   It was an actual medication error due to the extra dose administered.  It was unknown whether the patient had any adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Sex: F
Vaccine: HIBV
Symptoms: No adverse event, Product preparation error
Clinical narrative: gave an ActHIB injection to a 16 month old female that was reconstituted with sterile water instead of 0.4% Sodium Chloride/ No AE; Initial information received on 08-Aug-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 16 months old female patient who received 0.5 mL dose of vaccine HIB (PRP/T) VACCINE [ACT-HIB] lot UI918AA, Expiry date- 05-12-2019 via intramuscular route in right Antereolateral On 07-May-2019, that was reconstituted with sterile water instead of 0.4% sodium chloride.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS A VACCINE (HEPATITIS A) for Immunisation; PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) for Immunisation; and MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) for Immunisation.  It was a case of actual medication error due to Wrong solution used in drug reconstitution .  No AE 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.  Documents held by sender: none.
Age: 1.5
Sex: U
Vaccine: DTAP, DTAPIPV
Symptoms: Wrong product administered
Clinical narrative: Doctor states that his 18 month old patient received Quadracel this morning instead of prescribed Daptacel; Initial information received on 08-Aug-2019 regarding an unsolicited valid non-serious case received from a physician via phone and additional information was received on 09-Aug-2019.  This case involves a 18 months old patient (gender not reported) who was vaccinated with a 0.5 ml dose of DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] (Batch number: C5656AA and expiry date: 18-Aug-2021) instead of prescribed DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] via unknown route in the left thigh on 08-Aug-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included patient was vaccinated with a dose of HEPATITIS A VACCINE (HEPATITIS A VACCINE) on an unknown date.  It was a case of actual medication error due to wrong vaccine administered.  It was unknown if any adverse event occurred or not following the vaccination.  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.   Information on batch number was requested.  Documents held by the sender: none.
Sex: U
Vaccine: IPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: patient was given an injection of IPOL on 08/02/19 and the vaccine expiration date was 06/23/19; Initial information received on 07-Aug-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves unknown demographic  patient who received an expired dose of IPV (VERO) lot number not reported (Expiry date 23-Jun-2019) via unknown route in unknown administration site on 02-Aug-2019.  It was a case of actual medication error due to expired vaccine used.  At a time of reporting no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Information on the batch number was requested.  List of documents held by sender: none.
Sex: U
Vaccine: DTAP, TDAP
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: 11 year old patient who should have gotten Adacel so the patient was given the wrong injection which was not age appropriate/ no AE; 11 year old patient who should have gotten Adacel so the patient was given the wrong injection which was not age appropriate/ no AE; Initial information received on 08-Aug-2019 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional.  This case involves a 11 years old patient (gender not reported) who received DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] instead of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] and reported that 11 year old patient who should have gotten Adacel so the patient was given the wrong injection which was not age appropriate.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE lot number not reported via unknown route in unknown administration site.  It was a case of actual medication error due to inappropriate age at vaccine administration and wrong vaccine administered.  No issues with the patient following vaccination.  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.  Information on the batch number was requested.  List of documents held by sender: none.
Sex: M
Vaccine: RAB
Symptoms: Expired product administered
Clinical narrative: patient received the first dose of expired Imovax vaccine; Initial information received on 08-Aug-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 8 years old male patient who received the first dose of 0.5 mL expired vaccine RABIES (HDC) VACCINE [IMOVAX RABIES] lot N16402M, expiry date- 29-JUL-2019 via intramuscular route in the right arm on 07-Aug-2019 at 07:00 PM.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included IMMUNOGLOBULIN HUMAN ANTI-RABIES (IMOGAM) for Immunisation.  It was a case of actual medication error due to expired vaccine used.  It was unknown whether the patient had any adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Documents held by sender: none.
Sex: M
Vaccine: IPV
Symptoms: Expired product administered
Clinical narrative: administered an expired Ipol; This was dose number 2 in the series.; Initial information received on 08-Aug-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 6 years old male patient who received expired dose of vaccine IPV (VERO) [IPOL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  concomitant vaccines were Hepatitis A and Hepatitis B   On 08-Aug-2019, the patient received a 0.5 ml second dose of suspect IPV (VERO) lot N1G511M. (expiry date: 02-Aug-2019) subcutaneous in the left thigh.  It was of actual medication error due to expired vaccine used and Inappropriate age at vaccine administration.  It was unknown whether adverse event was experienced..  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.  List of documents held by sender: none.
Sex: M
Vaccine: MNQ
Symptoms: Expired product administered
Clinical narrative: 18-year-old male received an expired dose of Menactra; Initial information received on 07-Aug-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 18 years old male patient who received 0.5 ml dose of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA]  (lot: U5766AE and expiry date: 02-Dec-2018) via unknown route in the right arm, on 07-Aug-2019.  Concomitant medications included MENINGOCOCCAL VACCINE B RFHBPA/FHBPB (TRUMENBA) in left arm for Immunisation on 07-Aug-2019.  The patients past medical history, concomitant medication and family history were not provided.  It was an actual medication error due to expired vaccine used.  It was unknown whether the patient had any adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Sex: M
Vaccine: DTAP
Symptoms: Diarrhoea, Ear infection, Ear pain, Faeces discoloured, Influenza like illness
Clinical narrative: flu-like symptoms; ear infection; complained of his ear hurting; there was red in his stool; diarrhea,; his 11 year old son received his 5th dose of Daptacel; Initial information received on 09-Aug-2019 regarding an unsolicited valid serious case received from a consumer/non-hcp.  This case involves a 11 years old male patient who experienced flu-like symptoms, ear infection, red in his stool and diarrhea, while he received vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL].  The patient's past medical history, medical treatment(s), and family history were not provided.  The patient developed similar symptoms with every Daptacel immunization, but the symptoms resolved after a few days.   On 15-May-2019, the patient received a 0.5 ml fifth dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE lot number not reported via intramuscular route in the left arm.  On an unknown date, the patient had flu-like symptoms (influenza like illness), ear infection, red in his stool (faeces discoloured), diarrhea (diarrhoea) and complained of his ear hurting (ear pain) (Unknown latency) following the administration of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE.   These events were assessed as medically significant.  It was also a case of medication error due to inappropriate age at vaccine administration.  Lab data was not reported.  Final diagnosis was diarrhea, there was red in his stool, ear infection and flu-like symptoms.   Corrective treatment: antibiotics for ear infection, BRAT ( bland) diet for diarrhea.  At the time of report, the patient had not been recovered from the events.  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.  Information on the batch number was requested.  List of document held by sender: none.; Sender's Comments: This case involved a 11 year old male patient who had flu-like symptoms, ear infection, red in his stool and diarrhea after vaccination with DAPTACEL. Time to onset is unknown. The Patient's past medical history, concomitant medications  and lab data excluding other etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of the vaccine cannot be assessed.
Sex: M
Vaccine: DTAP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: flu-like symptoms; ear infection; complained of his ear hurting; there was red in his stool; diarrhea,; his 11 year old son received his 5th dose of Daptacel; Initial information received on 09-Aug-2019 regarding an unsolicited valid serious case received from a consumer/non-hcp.  This case involves a 11 years old male patient who experienced flu-like symptoms, ear infection, red in his stool and diarrhea, while he received vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL].  The patient's past medical history, medical treatment(s), and family history were not provided.  The patient developed similar symptoms with every Daptacel immunization, but the symptoms resolved after a few days.   On 15-May-2019, the patient received a 0.5 ml fifth dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE lot number not reported via intramuscular route in the left arm.  On an unknown date, the patient had flu-like symptoms (influenza like illness), ear infection, red in his stool (faeces discoloured), diarrhea (diarrhoea) and complained of his ear hurting (ear pain) (Unknown latency) following the administration of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE.   These events were assessed as medically significant.  It was also a case of medication error due to inappropriate age at vaccine administration.  Lab data was not reported.  Final diagnosis was diarrhea, there was red in his stool, ear infection and flu-like symptoms.   Corrective treatment: antibiotics for ear infection, BRAT ( bland) diet for diarrhea.  At the time of report, the patient had not been recovered from the events.  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.  Information on the batch number was requested.  List of document held by sender: none.; Sender's Comments: This case involved a 11 year old male patient who had flu-like symptoms, ear infection, red in his stool and diarrhea after vaccination with DAPTACEL. Time to onset is unknown. The Patient's past medical history, concomitant medications  and lab data excluding other etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of the vaccine cannot be assessed.
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Product preparation issue
Clinical narrative: nurse gave the Dtap-IPV portion of the Pentacel vaccine only; Initial information received on 09-Aug-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves patient of an unknown demographics who received the dtap-ipv portion only, while received vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (batch number, expiry date, route and site of administration were unknown).  The patient's past medical history, medical treatment(s), vaccination(s) and family history and concomitant therapis were not provided.   It was a case of actual medication error due to inappropriate reconstitution technique.  It was unknown whether the patient had any adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Information on the batch number was requested  Documents held by sender: none.
Sex: M
Vaccine: HIBV, MNQ
Symptoms: Wrong product administered
Clinical narrative: a 19 month old patient was administered Menactra by mistake instead of ActHIB; a 19 month old patient was administered Menactra by mistake instead of ActHIB; Initial information received on 09-Aug-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves a 19 month old patient who received a dose of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] by mistake instead of HIB (PRP/T) VACCINE [ACT-HIB] batch, expiry date via unknown route and unknown site of administration.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was an actual medication error due to wrong vaccine administered and Inappropriate age at vaccine administration.  It was unknown whether the patient had any adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Sex: M
Vaccine: DTAPIPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired Quadracel dose given to 4-year-old patient; Initial information received on 09-Aug-2019 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 4 years old male patient who received an expired 0.5 ml dose of DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE lot C5222AA (Expiry date 23-Jun-2019) via intramuscular route in the right thigh on 08-Aug-2019.  It was a case of actual medication error due to expired vaccine used.  At a time of reporting no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Sex: U
Vaccine: DTAP
Symptoms: Expired product administered
Clinical narrative: Daptacel expired 5/17/19 and was administered today; Initial information received on 31-May-2019 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a patient of unknown demography who received vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] and reported that Daptacel expired 5/17/19 and was administered today.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE lot number not reported and expiry date: 17-Sep-2019 via unknown route in unknown administration site. It was a case of actual medication error due to expired vaccine used.  It was unknown if the patient had any adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Information on the batch number was requested.  List of documents held by sender: none.
Sex: M
Vaccine: DTAPIPV, HPV4
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: gave a 17 year old Quadracel instead of Gardasil; gave a 17 year old Quadracel instead of Gardasil; Initial information received on 09-Aug-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves a 17 years old male patient who received vaccines DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] lot C5497AA via intramuscular route in the left deltoid on 08-Aug-2019 instead of GARDASIL.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was a case of actual medication error due to inappropriate age at vaccine administration and wrong vaccine administered.  It was unknown whether the patient had any adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Documents held by sender: none.