chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 84.0
Sex: M
Vaccine: VARZOS
Symptoms: Muscular weakness, Night sweats, Pain, Pyrexia
Clinical narrative: night sweats; low grade fever; not good appetite/ appetite does not seem to be very good; headaches; low energy/feels with low energy; lethargic; leg weakness; achy/ overall achy feeling; flu like symptoms; This case was reported by a consumer via call center representative and described the occurrence of lower extremities weakness of in a 84-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 22nd April 2019, the patient received the 1st dose of Shingrix. On 22nd April 2019, 3 hrs after receiving Shingrix, the patient experienced lower extremities weakness of, pain and influenza-like symptoms. On an unknown date, the patient experienced night sweat, low grade fever, appetite disorder, headache, energy decreased and lethargy. The patient was treated with steroids nos (Steroids). On an unknown date, the outcome of the lower extremities weakness of, pain, influenza-like symptoms, night sweat, low grade fever, appetite disorder, headache, energy decreased and lethargy were not recovered/not resolved.   It was unknown if the reporter considered the lower extremities weakness of, pain, influenza-like symptoms, night sweat, low grade fever, appetite disorder, headache, energy decreased and lethargy to be related to Shingrix.  Additional details were provided as follows: The patient reported received the first Shingrix vaccine. Three hours after the vaccine he started experiencing the following symptoms: leg weakness, overall achy feeling, flu-like symptoms. The patient also experienced night sweats and low grade fever (up to 102 degrees) for the past 2 weeks. The patient had low grade fever was not as high anymore, but he still had it. The patient appetite does not seem to be very good. The patient was also having mild headaches, feels with low energy and lethargic. The patient said that all the symptoms come and goes in waves during the day. The patient had visited his physician twice since he started having these symptoms. The physician had given him steroid shots. The reporter consented to follow up.      Lab Comments: In 2019, body temperature was up to 102.
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Injection site erythema, Injection site pain, Injection site swelling, Malaise
Clinical narrative: possible fever; tiredness; not feeling well; redness; swelling; painful; This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 97-year-old female patient who received Herpes zoster (Shingrix) (batch number F3D7H, expiry date 5th July 2021) for prophylaxis.   On 1st May 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 2nd May 2019, 1 days after receiving Shingrix, the patient experienced injection site erythema, injection site swelling and injection site pain. On 6th May 2019, the patient experienced fever, tiredness and feeling unwell. On an unknown date, the outcome of the injection site erythema and injection site swelling were not recovered/not resolved and the outcome of the injection site pain, fever, tiredness and feeling unwell were unknown.   It was unknown if the reporter considered the injection site erythema, injection site swelling, injection site pain, fever, tiredness and feeling unwell to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix on left deltoid. The patient experienced swelling, redness and pain at the sight of injection. At the time of reporting, the swelling seems to be going down but the patient was not feeling well. The site was very red and the patient was told she might have a fever which was determined by touch and she was very tired.
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: possible fever; tiredness; not feeling well; redness; swelling; painful; This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 97-year-old female patient who received Herpes zoster (Shingrix) (batch number F3D7H, expiry date 5th July 2021) for prophylaxis.   On 1st May 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 2nd May 2019, 1 days after receiving Shingrix, the patient experienced injection site erythema, injection site swelling and injection site pain. On 6th May 2019, the patient experienced fever, tiredness and feeling unwell. On an unknown date, the outcome of the injection site erythema and injection site swelling were not recovered/not resolved and the outcome of the injection site pain, fever, tiredness and feeling unwell were unknown.   It was unknown if the reporter considered the injection site erythema, injection site swelling, injection site pain, fever, tiredness and feeling unwell to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix on left deltoid. The patient experienced swelling, redness and pain at the sight of injection. At the time of reporting, the swelling seems to be going down but the patient was not feeling well. The site was very red and the patient was told she might have a fever which was determined by touch and she was very tired.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site erythema
Clinical narrative: injection site redness; This case was reported by a pharmacist via call center representative and described the occurrence of erythema of extremities in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 30th April 2019, the patient received Shingrix (intramuscular) .5 ml. On 4th May 2019, 4 days after receiving Shingrix, the patient experienced erythema of extremities. On an unknown date, the outcome of the erythema of extremities was resolved with sequelae.   It was unknown if the reporter considered the erythema of extremities to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The pharmacist inquired on behalf of the patient who reported spreading of injection site redness. The patient was complaining of redness spreading inside of arm.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Lymph node pain, Lymphadenopathy, Skin discolouration
Clinical narrative: Swollen lymph nodes; Painful lymph nodes; Pain at injection site; Black and blue torso; This case was reported by a consumer via call center representative and described the occurrence of enlargement of lymph nodes in a 83-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than a day after receiving Shingrix, the patient experienced enlargement of lymph nodes, lymph node pain, injection site pain and skin discoloration. On an unknown date, the outcome of the enlargement of lymph nodes, lymph node pain, injection site pain and skin discoloration were recovered/resolved.   It was unknown if the reporter considered the enlargement of lymph nodes, lymph node pain, injection site pain and skin discoloration to be related to Shingrix.  Additional details were provided as follows: The case was reported by the patient for herself. The patient received Shingrix vaccine into the left arm about 5 months ago.  Shortly after getting the vaccine, her left torso became black and blue which lasted for 2 weeks. On the day of vaccination, she experienced swollen and painful lymph nodes that lasted for one week.  The patient also experienced pain at the injection site that lasted for one day. The patient provided the consent to follow up.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Herpes zoster, Ophthalmic herpes zoster
Clinical narrative: shingles on forehead and around her eye; worsening shingles; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 56-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included shingles (experienced on 3rd May 2019).   On 6th May 2019, the patient received Shingrix (intramuscular). In May 2019, less than a week after receiving Shingrix, the patient experienced shingles and condition aggravated. On an unknown date, the outcome of the shingles and condition aggravated were not recovered/not resolved.   It was unknown if the reporter considered the shingles and condition aggravated to be related to Shingrix.  Additional details were reported as follows: The patient started symptoms of shingles on 3rd May 2019. The patient went to the physician and was diagnosed with shingles on 6th May 2019. On same day, the physician administered Shingrix to the patient in an attempt to prevent shingles from developing further. The shingles had continued to spread and it was worsened on 8th May 2019. The shingles were on the patient's forehead and around her eye.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Peripheral swelling, Pruritus
Clinical narrative: redness in the injected arm; swelling in the injected arm; redness, swelling and itching in the injected arm; This case was reported by a pharmacist via call center representative and described the occurrence of erythema of extremities in a 75-year-old female patient who received Herpes zoster (Shingrix) (batch number HB2B2, expiry date unknown) for prophylaxis.   On 22nd April 2019, the patient received the 1st dose of Shingrix. On 23rd April 2019, 1 days after receiving Shingrix, the patient experienced erythema of extremities, swelling arm and itchy upper limbs. On an unknown date, the outcome of the erythema of extremities, swelling arm and itchy upper limbs were unknown.   It was unknown if the reporter considered the erythema of extremities, swelling arm and itchy upper limbs to be related to Shingrix.  Additional details were provided as follows: The pharmacist reported that the patient developed redness, swelling, and itching in the injected arm (left arm) the day after vaccination. The pharmacist informed the patient that the patient might experience redness and swelling but she was concerned about the itching.  The pharmacist inquired if there were any incidences reported for itching and should the patient receive the 2nd dose.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Myalgia, Pain
Clinical narrative: chills; facial swelling; headache; pain, soreness; muscle aches; fever; fatigue; This case was reported by a nurse via call center representative and described the occurrence of chills in a 68-year-old female patient who received Herpes zoster (Shingrix) (batch number C7B9P, expiry date unknown) for prophylaxis.   On 4th March 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced chills, facial swelling, headache, pain, muscle pain, fever and fatigue. On an unknown date, the outcome of the chills, headache, pain, muscle pain, fever and fatigue were recovered/resolved and the outcome of the facial swelling was not recovered/not resolved.   It was unknown if the reporter considered the chills, facial swelling, headache, pain, muscle pain, fever and fatigue to be related to Shingrix.  Additional details were provided as follows: The nurse practitioner reported that the patient developed chills, facial swelling, headache, pain, soreness, muscle aches, fever, and fatigue after receiving Shingrix vaccine. These events had resolved except the facial swelling.  The patient had 4 episodes of facial swelling since getting the vaccine. Most of these episodes happened at night. The last episode was a couple of days ago before the day of reporting. The nurse practitioner did not have the expiration date.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Swelling face
Clinical narrative: chills; facial swelling; headache; pain, soreness; muscle aches; fever; fatigue; This case was reported by a nurse via call center representative and described the occurrence of chills in a 68-year-old female patient who received Herpes zoster (Shingrix) (batch number C7B9P, expiry date unknown) for prophylaxis.   On 4th March 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced chills, facial swelling, headache, pain, muscle pain, fever and fatigue. On an unknown date, the outcome of the chills, headache, pain, muscle pain, fever and fatigue were recovered/resolved and the outcome of the facial swelling was not recovered/not resolved.   It was unknown if the reporter considered the chills, facial swelling, headache, pain, muscle pain, fever and fatigue to be related to Shingrix.  Additional details were provided as follows: The nurse practitioner reported that the patient developed chills, facial swelling, headache, pain, soreness, muscle aches, fever, and fatigue after receiving Shingrix vaccine. These events had resolved except the facial swelling.  The patient had 4 episodes of facial swelling since getting the vaccine. Most of these episodes happened at night. The last episode was a couple of days ago before the day of reporting. The nurse practitioner did not have the expiration date.
Sex: U
Vaccine: VARZOS
Symptoms: Myelitis transverse
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of myelitis transverse in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced myelitis transverse (serious criteria GSK medically significant). On an unknown date, the outcome of the myelitis transverse was unknown. It was unknown if the reporter considered the myelitis transverse to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The reporter did not has any information about said patient or the event. This patient was not the patient of reporter. Her patient inquired about transverse myelitis because they heard of someone that developed it after receiving SHINGRIX.
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect route of product administration, Injection site erythema, Injection site swelling
Clinical narrative: Wrong injection technique; Redness at injection site; Swelling at injection site; This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 80-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 3rd May 2019, the patient received the 1st dose of Shingrix (subcutaneous). On 3rd May 2019, unknown after receiving Shingrix, the patient experienced intramuscular formulation administered by other route. In May 2019, the patient experienced injection site erythema and injection site swelling. On an unknown date, the outcome of the injection site erythema, injection site swelling and intramuscular formulation administered by other route were unknown.   It was unknown if the reporter considered the injection site erythema and injection site swelling to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not provided. The patient received Shingrix but the injection was given lower on the arm than the deltoid muscle and believed that it was given subcutaneously rather than intramuscularly, which led to intramuscular formulation administered by other route. The patient experienced injection site reactions of redness and swelling at the site. She was seen by her physician. This was considered as medication error with adverse event.
Age: 1.42
Sex: F
Vaccine: DTAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: an expired Daptacel vaccine is given to a patient/No side effects reported; Initial information received on 01-May-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to cases 2019SA124198, 2019SA124199, 2019SA123826 and 2019SA124200 (same reporter).  This case involves a 17 months old female patient who received an expired dose of vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (Suspension for injection) lot C5171AA, expiry date-23-Mar-2019 via unknown route in the left thigh on 02-Apr-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) ; PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) and VARICELLA ZOSTER VACCINE (VARICELLA VACCINE).   It was a case of actual medication error due to expired vaccine used.  No side effects 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.
Sex: M
Vaccine: DTAP
Symptoms: Expired product administered
Clinical narrative: an expired Daptacel vaccine is given to a patient; Initial information received on 01-May-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to cases 2019SA123826, 2019SA124197, 2019SA124199 and 2019SA124200 (same reporter).  This case involves a 5 years old male patient who received an expired dose of vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (Suspension for injection) lot C5171AA, expiry date-23-Mar-2019 via unknown route in the right thigh on 04-Apr-2019.  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 expired vaccine used.  It was unknown if any adverse event was occurred.   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 and Module VI of the 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: 1.42
Sex: M
Vaccine: DTAP
Symptoms: Expired product administered
Clinical narrative: an expired Daptacel vaccine is given to a patient; Initial information received on 01-May-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to cases 2019SA124198, 2019SA123826, 2019SA124197 and 2019SA124200 (same reporter).  This case involves a 17 months old male patient who was vaccinated with a 0.5 ml dose of expired vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (lot C5171AA and Exp. Date 23-Mar-2019) via unknown route in the left thigh on 24-Apr-2019.  The patient's medical history not reported and no concomitant medications reported as none.  It was an actual medication error case due to expired vaccine used.  It was unknown whether the patient experienced any adverse event post 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.  List of documents held by sender: none.
Age: 5.0
Sex: F
Vaccine: DTAP
Symptoms: Expired product administered
Clinical narrative: an expired Daptacel vaccine is given to a patient; Initial information received on 01-May-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to cases 2019SA124198, 2019SA123826, 2019SA124197 and 2019SA124199 (same reporter).  This case involves five years old female patient who was vaccinated with an expired dose of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (Lot C5171AA, Expiry date: 23-Mar-2019) vaccine on 24-Apr-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included POLIO VACCINE INACT (IPV) for Immunisation; MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) for Immunisation; and VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) for Immunisation.  It was a case of actual medication error due to expired vaccine used.  It was not reported if the patient experienced any adverse event 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.  List of documents held by sender: none.
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Product preparation issue
Clinical narrative: Hib component of the vaccine was inadvertently reconstituted; Initial information received on 02-May-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves a 1 years old male patient who received Hib component of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] without DTaP-IPV component.  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); and PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13).  On 23-Apr-2019, the patient received a 0.5 ml single dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot C5543AA.  It was of actual medication error due to  inappropriate reconstitution technique.  It was not reported 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.
Age: 20.0
Sex: F
Vaccine: RAB
Symptoms: Product preparation issue, Syringe issue
Clinical narrative: reconstituted the Imovax vaccine; drawing it with a syringe the vial leaked/ leaking was coming through the previously pierced hole in the septum and that the cause was most likely because the needle guage provided in the kit with the Imogam was too large; Initial information received on 02-May-2019 regarding an unsolicited valid non-serious case received from a pharmacist by phone. This case involves a 20 years old female patient who was vaccinated with third dose of RABIES (HDC) VACCINE [IMOVAX RABIES] (Batch number: P1C851M and expiry date: 25-Sep-2020, dose, route and site of administration were not reported) on an unknown date.   The patient's past medical history, medical treatment(s), vaccination(s), family history and concomitant medications were not provided.   It was a case of potential medication error due to inappropriate reconstitution technique.  It was also a case of syringe leak.  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 and Module VI of the 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 the sender: none.
Age: 1.5
Sex: F
Vaccine: DTAP
Symptoms: Expired product administered
Clinical narrative: administered an expired dose of Daptacel; Initial information received on 03-May-2019 regarding an unsolicited valid non-serious case received from a physician by phone.  This case involves a 18 months old female patient who was vaccinated with an expired 0.5 ml fourth dose of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (Batch number: C5190AA and expiry date: 24-Apr-2019 and route of administration were not reported) in the left thigh on 03-May-2019.  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 VACCINE) on an unknown date.  It was a case of actual medication error due to expired vaccine used.  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.   Documents held by the sender: none.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: No adverse event, Product storage error
Clinical narrative: the vaccines experienced multiple excursions/ no adverse event; Initial information received on 02-May-2019 regarding an unsolicited valid non-serious case received from a Nurse by phone.  This case was cross-referenced with cases 2019SA125033, 2019SA125041, 2019SA125047, 2019SA125054, 2019SA125066, 2019SA125072, 2019SA125087 and 2019SA125094 (same reporter).  This case involves a four-years-old female patient who was vaccinated with a 0.5 ml dose of IPV (VERO) [IPOL] (Batch number: N1K931M and expiry date: 19-Nov-2018) via intramuscular route and DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (details not reported) on 16-Feb-2019.  The patient's past medical history, medical treatment(s), vaccination(s), family history and concomitant medications were not provided.   It was a case of actual medication error due to incorrect product storage. The vaccines experienced multiple excursions.  Case details: there was temperature excursion of multiple vaccines.  1st excursion excursion: 13Feb2019-14Feb2019 was out of range for 8 hours and 45 mins was at 1.56 degrees C. for the Fluzone Quad, Daptacel and ActHIB. 2nd excursion: 13Feb2019 9 hours 15 mins 1.56 degrees C. 3rd Excursion: 15Feb2019-22Feb2019 was out of range for 9 hours 30 mins at 1.56 degrees C. 4th excursion: 13Feb2019-22Feb2019 was out of range for 13 hours at a temperature of 1.18 degrees C for the Daptacel, Menactra and Adacel 5th excursion 13Feb2019-25Feb2019 were out of range for 24 hours and 15 mins at a temperature of 1.18 degrees C. Fluzone Quad and Pentacel 6th excursion 22Feb2019-26Feb2019 out of range for 23 hours 45 mins at 1.18 degrees C. Fluzone Quad, Pentacel and Daptacel 7th excursion: 13Feb2019-26feb2019 out of range for 33 hours and 4 mins at 1.18 degrees C for Adacel, Menactra, Ipol, ActHIB, Dapatacel, Pentacel and Fluzone Quad.  Caller stated their Ipol MDV was opened and administered to patient. The patient also received Daptacel injection at the same visit.  No adverse event was reported following 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.   Documents held by the sender: none.
Sex: F
Vaccine: DTAP, IPV
Symptoms: Expired product administered, Product storage error
Clinical narrative: vaccine expired on 19-Nov-2018 was administered to patient on 23-Feb-2019; vaccines experienced multiple excursions was administered to patient; Initial information received on 02-May-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to cases 2019SA125041, 2019SA125047, 2019SA125008, 2019SA125094, 2019SA125087, 2019SA125072, 2019SA125066 and 2019SA125054 same reporter.  This case involves a 4 years old female patient who received vaccines DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] and IPV (VERO) [IPOL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) for Immunisation; VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) for Immunisation; and TUBERCULIN PPD (TUBERCULIN PPD) for Tuberculin test received on 23-Feb-2019.  On 23-Feb-2019, the patient received a 0.5 mL dose of suspect IPV (VERO) lot N1K931M, expiry date- 19-NOV-2018 via intramuscular route in the deltoid nos.  On 23-Feb-2019, 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 incorrect product storage and expired vaccine used.  This was reported to the Agency- Fluzone Quadrivalent, Daptacel, ActHIB, Pentecel, IPOL, Adacel, Menactra. The vaccines experienced multiple excursions. 1st excursion excursion: 13Feb2019-14Feb2019 was out of range for 8 hours and 45 mins was at 1.56 degrees C. for the Fluzone Quad, Daptacel and ActHIB. 2nd excursion: 13Feb2019 9 hours 15 mins 1.56 degrees C. 3rd Excursion: 15Feb2019-22Feb2019 was out of range for 9 hours 30 mins at 1.56 degrees C. 4th excursion: 13Feb2019-22Feb2019 was out of range for 13 hours at a temperature of 1.18 degrees C for the Daptacel, Menactra and Adacel 5th excursion 13Feb2019-25Feb2019 were out of range for 24 hours and 15 mins at a temperature of 1.18 degrees C. Fluzone Quad and Pentacel 6th excursion 22Feb2019-26Feb2019 out of range for 23 hours 45 mins at 1.18 degrees C. Fluzone Quad, Pentacel and Daptacel 7th excursion: 13Feb2019-26feb2019 out of range for 33 hours and 4 mins at 1.18 degrees C for Adacel, Menactra, Ipol, ActHIB, Dapatacel, Pentacel and Fluzone Quad  It was unknown if any adverse event was occurred.   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: F
Vaccine: DTAP, IPV
Symptoms: Expired product administered, Product storage error
Clinical narrative: vaccines experienced multiple excursions, Vaccine stored at temperature outside the recommended range; expired vaccine administer to patient; Initial information received on 02-May-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to cases 2019SA125033, 2019SA125047, 2019SA125008, 2019SA125094, 2019SA125087, 2019SA125072, 2019SA125066 and 2019SA125054 same reporter.  This case involves a 4 years old female patient who received vaccines DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] and IPV (VERO) [IPOL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) for Immunisation; VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) for Immunisation; and TUBERCULIN PPD (TUBERCULIN PPD) for Immunisation received on 23-Feb-2019.  On 23-Feb-2019, the patient received a 0.5 mL dose of suspect IPV (VERO) (Suspension for injection) lot N1K931M, expiry date- 19-NOV-2018 via intramuscular route in the deltoid nos.  On 23-Feb-2019, the patient received a dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE (Suspension for injection) lot number not reported via unknown route in unknown administration site.  It was a case of actual medication error due to incorrect product storage and expired vaccine used.  This was reported to the MIA- Fluzone Quadrivalent, Daptacel, ActHIB, Pentecel, IPOL, Adacel, Menactra. The vaccines experienced multiple excursions. 1st excursion excursion: 13Feb2019-14Feb2019 was out of range for 8 hours and 45 mins was at 1.56 degrees C. for the Fluzone Quad, Daptacel and ActHIB. 2nd excursion: 13Feb2019 9 hours 15 mins 1.56 degrees C. 3rd Excursion: 15Feb2019-22Feb2019 was out of range for 9 hours 30 mins at 1.56 degrees C. 4th excursion: 13Feb2019-22Feb2019 was out of range for 13 hours at a temperature of 1.18 degrees C for the Daptacel, Menactra and Adacel 5th excursion 13Feb2019-25Feb2019 were out of range for 24 hours and 15 mins at a temperature of 1.18 degrees C. Fluzone Quad and Pentacel 6th excursion 22Feb2019-26Feb2019 out of range for 23 hours 45 mins at 1.18 degrees C. Fluzone Quad, Pentacel and Daptacel 7th excursion: 13Feb2019-26feb2019 out of range for 33 hours and 4 mins at 1.18 degrees C for Adacel, Menactra, Ipol, ActHIB, Dapatacel, Pentacel and Fluzone Quad  It was unknown if any adverse event was occurred.   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 and Module VI of the 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.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Expired product administered, Product storage error
Clinical narrative: vaccines experienced multiple excursions, vaccine stored at temperature outside the recommended range, no adverse event; expired ipol vaccine administered to patient, no adverse event; Initial information received on 02-May-2019 regarding an unsolicited valid non-serious case received from a Nurse.   This case is linked to cases 2019SA125041, 2019SA125054, 2019SA125008, 2019SA125094, 2019SA125033, 2019SA125066, 2019SA125072 and 2019SA125087 (Same reporter).  This case involves a four years old female patient who was vaccinated with a 0.5 ml dose of expired vaccine IPV (VERO) [IPOL] (lot number N1K931M and Exp. Date 19-Nov-2018) via intramuscular route in the deltoid nos and received dose of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (lot number and Exp. Date not reported) via intramuscular route in the deltoid nos both on 04-Mar-2019.   The patient's medical history not reported and concomitant medications included MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR), VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) and TUBERCULIN PPD on 04-Mar-2019   .  It was an actual medication error case due to expired vaccine used and incorrect product storage.  It was reported that, vaccines stored at temperature outside the recommended range. The vaccines experienced multiple excursions. 1st excursion excursion: 13Feb2019-14Feb2019 was out of range for 8 hours and 45 mins was at 1.56 degrees C. for the Fluzone Quad, Daptacel and ActHIB. 2nd excursion: 13Feb2019 9 hours 15 mins 1.56 degrees C. 3rd Excursion: 15Feb2019-22Feb2019 was out of range for 9 hours 30 mins at 1.56 degrees C. 4th excursion: 13Feb2019-22Feb2019 was out of range for 13 hours at a temperature of 1.18 degrees C for the Daptacel, Menactra and Adacel 5th excursion 13Feb2019-25Feb2019 were out of range for 24 hours and 15 mins at a temperature of 1.18 degrees C. Fluzone Quad and Pentacel 6th excursion 22Feb2019-26Feb2019 out of range for 23 hours 45 mins at 1.18 degrees C. Fluzone Quad, Pentacel and Daptacel 7th excursion: 13Feb2019-26feb2019 out of range for 33 hours and 4 mins at 1.18 degrees C for Adacel, Menactra, Ipol, ActHIB, Dapatacel, Pentacel and Fluzone Quad.  It was unknown whether the patient experienced any adverse event post 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.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Expired product administered, Product storage error
Clinical narrative: vaccines experienced multiple excursions, vaccine stored at temperature outside the recommended range; expired ipol vaccine administered to patient; Initial information received on 02-May-2019 regarding an unsolicited valid non-serious case received from a nurse.   This case is linked to cases 2019SA125047, 2019SA125066, 2019SA125008, 2019SA125094, 2019SA125041, 2019SA125033, 2019SA125072 and 2019SA125087 (same reporter).  This case involves a four years old (also reported as 5 years) male patient who was vaccinated with a 0.5 ml dose of expired vaccine IPV (VERO) [IPOL] (lot number N1K931M and Exp. Date 19-Nov-2018) via intramuscular route in the deltoid NOS and a dose of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (lot number and Exp. Date not reported) via intramuscular route in the deltoid NOS both on 04-Mar-2019, which were exposed to multiple excursions.   The patient's medical history not reported and concomitant medications included MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR), VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) and TUBERCULIN PPD via intramuscular route in the deltoid nos on 04-Mar-2019.  It was an actual medication error case due to expired vaccine used and incorrect product storage.  It was reported that, vaccines (Fluzone Quadrivalent, Daptacel, ActHIB, Pentecel, IPOL, Adacel, Menactra) stored at temperature outside the recommended range. The vaccines experienced multiple excursions. 1st excursion excursion: 13Feb2019-14Feb2019 was out of range for 8 hours and 45 mins was at 1.56 degrees C. for the Fluzone Quad, Daptacel and ActHIB. 2nd excursion: 13Feb2019 9 hours 15 mins 1.56 degrees C. 3rd Excursion: 15Feb2019-22Feb2019 was out of range for 9 hours 30 mins at 1.56 degrees C. 4th excursion: 13Feb2019-22Feb2019 was out of range for 13 hours at a temperature of 1.18 degrees C for the Daptacel, Menactra and Adacel 5th excursion 13Feb2019-25Feb2019 were out of range for 24 hours and 15 mins at a temperature of 1.18 degrees C. Fluzone Quad and Pentacel 6th excursion 22Feb2019-26Feb2019 out of range for 23 hours 45 mins at 1.18 degrees C. Fluzone Quad, Pentacel and Daptacel 7th excursion: 13Feb2019-26feb2019 out of range for 33 hours and 4 mins at 1.18 degrees C for Adacel, Menactra, Ipol, ActHIB, Dapatacel, Pentacel and Fluzone Quad  It was unknown whether the patient experienced any adverse event post 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 and Module VI of the 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.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: No adverse event, Product storage error
Clinical narrative: The vaccines experienced multiple excursions, vaccine stored at temperature outside the recommended range, no adverse event; patient received IPOl vaccine that was expired, no aderse event; Initial information received on 02-May-2019 regarding an unsolicited valid non-serious case received from a Nurse by phone.  This case is linked to cases 2019SA125054, 2019SA125072, 2019SA125008, 2019SA125094, 2019SA125047, 2019SA125041, 2019SA125033, 2019SA125087 and 2019SA125087 (same reporter).  This case involves a four years old female patient who was vaccinated with a 0.5 ml once dose of IPV (VERO) [IPOL] (Batch number: N1K931M and expiry date: 19-Nov-2018, intramuscularly in deltoid NOS) and DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] on 05-Mar-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR VACCIN); VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) and TUBERCULIN PPD (TUBERCULIN PPD) for Tuberculin test on same visit (05-Mar-2019).  It was a case of actual medication error due to incorrect product storage and expired vaccine used.  Case details: The vaccines experienced multiple excursions.  1st excursion excursion: 13Feb2019-14Feb2019 was out of range for 8 hours and 45 mins was at 1.56 degrees C. for the Fluzone Quad, Daptacel and ActHIB. 2nd excursion: 13Feb2019 9 hours 15 mins 1.56 degrees C. 3rd Excursion: 15Feb2019-22Feb2019 was out of range for 9 hours 30 mins at 1.56 degrees C. 4th excursion: 13Feb2019-22Feb2019 was out of range for 13 hours at a temperature of 1.18 degrees C for the Daptacel, Menactra and Adacel 5th excursion 13Feb2019-25Feb2019 were out of range for 24 hours and 15 mins at a temperature of 1.18 degrees C. Fluzone Quad and Pentacel 6th excursion 22Feb2019-26Feb2019 out of range for 23 hours 45 mins at 1.18 degrees C. Fluzone Quad, Pentacel and Daptacel 7th excursion: 13Feb2019-26feb2019 out of range for 33 hours and 4 mins at 1.18 degrees C for Adacel, Menactra, Ipol, ActHIB, Dapatacel, Pentacel and Fluzone Quadrivalent.  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.   Information on the batch number was requested for Daptacel.  Documents held by the sender: none.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Expired product administered, Product storage error
Clinical narrative: vaccines experienced multiple excursions, vaccine stored at temperature outside the recommended range; expired ipol vaccine administered to patient; Initial information received on 02-May-2019 regarding an unsolicited valid non-serious case received from a nurse.   This case is linked to cases 2019SA125066, 2019SA125087, 2019SA125008, 2019SA125094, 2019SA125047, 2019SA125041, 2019SA125033 and 2019SA125054 (same reporter).  This case involves a four years old (reported as 5 years) female patient who was vaccinated with a 0.5 ml dose of expired vaccine IPV (VERO) [IPOL] (lot number N1K931M and Exp. Date 19-Nov-2018) via intramuscular route in the deltoid NOS and a dose of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (lot number and Exp. Date not reported) via intramuscular route in the deltoid NOS both on 08-Mar-2019, which were exposed to multiple excursions.   The patient's medical history not reported and concomitant medications included MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR), VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) and TUBERCULIN PPD.  It was an actual medication error case due to expired vaccine used and incorrect product storage.  It was reported that, vaccines (Fluzone Quadrivalent, Daptacel, ActHIB, Pentecel, IPOL, Adacel, Menactra) stored at temperature outside the recommended range. The vaccines experienced multiple excursions. 1st excursion excursion: 13Feb2019-14Feb2019 was out of range for 8 hours and 45 mins was at 1.56 degrees C. for the Fluzone Quad, Daptacel and ActHIB. 2nd excursion: 13Feb2019 9 hours 15 mins 1.56 degrees C. 3rd Excursion: 15Feb2019-22Feb2019 was out of range for 9 hours 30 mins at 1.56 degrees C. 4th excursion: 13Feb2019-22Feb2019 was out of range for 13 hours at a temperature of 1.18 degrees C for the Daptacel, Menactra and Adacel 5th excursion 13Feb2019-25Feb2019 were out of range for 24 hours and 15 mins at a temperature of 1.18 degrees C. Fluzone Quad and Pentacel 6th excursion 22Feb2019-26Feb2019 out of range for 23 hours 45 mins at 1.18 degrees C. Fluzone Quad, Pentacel and Daptacel 7th excursion: 13Feb2019-26feb2019 out of range for 33 hours and 4 mins at 1.18 degrees C for Adacel, Menactra, Ipol, ActHIB, Dapatacel, Pentacel and Fluzone Quad  It was unknown whether the patient experienced any adverse event post 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 and Module VI of the 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.