chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: HEP
Symptoms: Alopecia
Clinical narrative: Hair loss; This case was reported by a pharmacist via call center representative and described the occurrence of hair loss in a adult male patient who received HBV (Engerix B) for prophylaxis.   On an unknown date, the patient received Engerix B at an unknown dose. On an unknown date, unknown after receiving Engerix B, the patient experienced hair loss. On an unknown date, the outcome of the hair loss was unknown.   It was unknown if the reporter considered the hair loss to be related to Engerix B.  Additional details were provided as follows: The age at vaccination was not reported. The patient experienced hair loss after receiving Engerix-B.  No additional details were provided. The pharmacist stated that the vaccination was not given at his pharmacy. This case has been linked to the case US2019094083, reported by same reporter for the same patient.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling cold, Injection site pain, Injection site warmth, Lethargy, Malaise
Clinical narrative: core of body felt cold; soreness at injection site; hot at injection site; did not feel well; lethargic; nausea; This case was reported by a consumer via call center representative and described the occurrence of feeling cold in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12th March 2019, the patient received the 1st dose of Shingrix (intramuscular). On 13th March 2019, 1 days after receiving Shingrix, the patient experienced feeling cold, injection site pain, injection site warmth, feeling unwell, lethargy and nausea. On 13th March 2019, the outcome of the feeling cold was recovered/resolved. On an unknown date, the outcome of the injection site pain, injection site warmth, feeling unwell, lethargy and nausea were recovered/resolved.   It was unknown if the reporter considered the feeling cold, injection site pain, injection site warmth, feeling unwell, lethargy and nausea to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix on left arm. The patient planned to follow up with her physician on an unknown date. The reporter gave consent to follow up.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea
Clinical narrative: core of body felt cold; soreness at injection site; hot at injection site; did not feel well; lethargic; nausea; This case was reported by a consumer via call center representative and described the occurrence of feeling cold in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12th March 2019, the patient received the 1st dose of Shingrix (intramuscular). On 13th March 2019, 1 days after receiving Shingrix, the patient experienced feeling cold, injection site pain, injection site warmth, feeling unwell, lethargy and nausea. On 13th March 2019, the outcome of the feeling cold was recovered/resolved. On an unknown date, the outcome of the injection site pain, injection site warmth, feeling unwell, lethargy and nausea were recovered/resolved.   It was unknown if the reporter considered the feeling cold, injection site pain, injection site warmth, feeling unwell, lethargy and nausea to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix on left arm. The patient planned to follow up with her physician on an unknown date. The reporter gave consent to follow up.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Injection site erythema
Clinical narrative: injection site redness; This case was reported by a physician via call center representative and described the occurrence of injection site erythema in a 68-year-old female patient who received Herpes zoster (Shingrix) (batch number ZP3P9, expiry date 10th September 2021) for prophylaxis.   Concurrent medical conditions included drug allergy (reactions to hydrocortisone butyrate).   On 21st May 2019, the patient received Shingrix (intramuscular). On 21st May 2019, immediately after receiving Shingrix, the patient experienced injection site erythema. On an unknown date, the outcome of the injection site erythema was not recovered/not resolved.   It was unknown if the reporter considered the injection site erythema to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in the right deltoid. The patient experienced localized redness at the injection site almost immediately after receiving Shingrix. There is a discrepancy with respect to the time to onset and outcome of reported adverse event redness at the injection site. In the source document, the event onset date is reported as 24th May 2019, however as per narrative, event started almost immediately after receiving Shingrix. Similarly outcome is mentioned in source document as recovering/ resolving however in narrative it was not recovered/ not resolved. Therefore, the event onset date is retained as 21st May 2019 and time to onset as immediately and outcome as not recovered/ not resolved as per narrative description.
Sex: M
Vaccine: DTAPIPVHIB, HIBV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: patient inadvertently received both ActHib and Pentacel same day during visit/ no AE; Initial information received on 29-May-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 3 months old male patient who received vaccines DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] and HIB (PRP/T) VACCINE [ACT-HIB].  The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) and ROTAVIRUS VACCINE (ROTAVIRUS VACCINE).  On 29-May-2019, the patient received a 0.5ml dose of suspect HIB (PRP/T) VACCINE lot UI900AA, expiry date 08-Oct-2019 via intramuscular route in the right thigh. On 29-May-2019, the patient received a 0.5ml dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot UJ100AA, expiry date 13-Jun-2020 via intramuscular route in the left thigh.  It was an actual medication error due to extra dose administered.  It was reported that p patient inadvertently received both ActHib and Pentacel same day during visit.  The patient did not experience any adverse reaction after the injection.   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.  List of documents held by sender: none.
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Pentacel was given to a patient who is 5 years and 10 months old; Initial information received on 29-May-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves a 5 years 10 months old patient who was vaccinated with DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (formulation: unknown, lot number, expiry date, route and site of administration were not reported), on an unknown date.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was an actual medication error 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.  Information on the batch number was requested.  List of document held by sender: none.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation error, Product preparation issue
Clinical narrative: given the ActHIB portion of the Pentacel, however sterile water was given instead of the provided diluent/No AE; Initial information received on 29-May-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves a four months old male patient who was vaccinated with a second dose of 0.5 mL of suspect vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] lot C5592A, expiry date: 15-nov-2019 via intramuscular route in unknown administration site on 28-May-2019, where only the ACTHIB part was administered.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant vaccinations included Rotavirus vaccine and Prevnar 13.  It was an actual medication error due to product preparation issue. It was reported that the patient was vaccinated with ActHIB portion of the Pentacel, where sterile water used instead of the provided diluent. The nurse did not give the DTAP or Ipol portion of the Pentacel injection.  It was reported that the patient had no adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Sex: F
Vaccine: TDAP
Symptoms: Pain, Swelling, Vaccination site mass
Clinical narrative: lump at the injection site; soreness and swelling; soreness and swelling; Initial information received on 29-May-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves a 69 years old female patient who experienced pain, swelling and vaccination site mass, while she received vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  The patient's past medical history included Drug hypersensitivity. The patient's past medical treatment(s), vaccination(s) and family history were not provided.   On 05-Apr-2019, the patient received a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (formulation: unknown) lot number not reported in the right deltoid.  On an unknown date, the patient developed a non-serious lump at the injection site (vaccination site mass), soreness and swelling (swelling) and soreness and swelling (pain) (Unknown latency) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE.  (Other relevant tests included No lab data.) Final diagnosis was pain, swelling and vaccination site mass.   It was not reported if the patient received a corrective treatment.  The patient was not recovered from vaccination site mass and recovered pain and the outcome for swelling was unknown.  Information on the batch number was requested.  List of document held by sender: none.
Sex: M
Vaccine: DTAP
Symptoms: Expired product administered
Clinical narrative: administered an 8 day expired Daptacel; Initial information received on 29-May-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 15 months old male patient who received fourth dose of vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] lot C50202AA, expiry date: 16-MAY-2019 via unknown route in the left vastus lateralis On 28-May-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. Caller stated that the office administered an 8 day expired Daptacel.   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.  Documents held by sender: none.
Sex: F
Vaccine: DTAP
Symptoms: Expired product administered
Clinical narrative: administered expired daptacel to patients; Initial information received on 29-May-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case is linked to cases 2019SA150849, 2019SA150852, 2019SA150840, 2019SA150851 and 2019SA150853 (same reporter).  This case involves a 5 years old female patient who received fifth dose of vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (formulation: unknown, lot: C52028A, expiry date: 17-May-2019) via unknown route in unknown administration site on 24-May-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); POLIO VACCINE INACT 3V (VERO) (IPOL POLIO VACCINE); and VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) for Immunisation.  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 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: 2.0
Sex: F
Vaccine: DTAP
Symptoms: Expired product administered
Clinical narrative: administered expired Daptacel to patient; Initial information received on 29-May-2019 regarding an unsolicited valid non-serious case received from a consumer.  This case is linked to cases 2019SA150840, 2019SA150850, 2019SA150851, 2019SA150852 and 2019SA150853 (same reporter).   This case involves a 24 months old female patient who was vaccinated with a 0.5 ml dose 4 of expired vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (lot C52028A and Exp. Date 17-May-2019) via unknown route in the right arm on 18-May-2019.  The patient's medical history not reported and concomitant medications included HIB VACCINE CONJ (TET TOX) (ACTHIB),  HEPATITIS A VACCINE (HEPATITIS A) and VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) for Immunisation  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.  Outcome of the event was reported as unknown.  List of documents held by sender: none.
Sex: M
Vaccine: DTAP
Symptoms: Expired product administered
Clinical narrative: administered expired product to patients; Initial information received on 29-May-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case is linked to cases 2019SA150849, 2019SA150852, 2019SA150840, 2019SA150851 and 2019SA150853 (same reporter).  This case involves a 4 years old male patient who received fifth dose of vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (formulation: unknown, lot: C52028A, expiry date: 17-May-2019) via unknown route in unknown administration site on 21-May-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); POLIO VACCINE INACT 3V (VERO) (IPOL POLIO VACCINE); and VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) for Immunisation.  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 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: administered expired Daptacel to patients; Initial information received on 29-May-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case is linked to cases 2019SA150849, 2019SA150850, 2019SA150840, 2019SA150852 and 2019SA150853 same reporter.  This case involves a 14 months old male patient who received fourth dose of vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] lot C52028A, expiry date: 17-May-2019 via unknown route in unknown administration site on 21-May-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HIB VACCINE CONJ (TET TOX) (ACTHIB) for Immunisation.  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 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: F
Vaccine: DTAP
Symptoms: Expired product administered
Clinical narrative: administered expired product to patients; Initial information received on 29-May-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case is linked to cases 2019SA150849, 2019SA150850, 2019SA150840, 2019SA150851 and 2019SA150853 (same reporter).  This case involves a 4 years old female patient who received fifth dose of vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (formulation: unknown, lot: C52028A, expiry date: 17-May-2019) via unknown route in unknown administration site on 21-May-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); POLIO VACCINE INACT 3V (VERO) (IPOL POLIO VACCINE); and VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) for Immunisation.  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 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: 11.0
Sex: F
Vaccine: DTAP, TDAP
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Daptacel was inadvertently administered to an adolescent patient instead of Adacel, no adverse event; Daptacel was inadvertently administered to an 11 years old patient, no adverse event; Initial information received on 30-May-2019 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 11 years old female patient who was vaccinated with a 0.5 ml dose of vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] instead of booster dose of vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (lot C5254AA and Exp. Date not reported) via intramuscular route in the left deltoid on 23-May-2019.  The patient's medical history not reported and concomitant medications included MENINGOCOCCAL VACCINE A/C/Y/W CONJ (DIP TOX) (MENACTRA) for Immunisation.  It was an actual medication error case due to wrong vaccine administered and inappropriate age at vaccine administration.  No adverse event experienced by patient 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.
Sex: F
Vaccine: TDAP
Symptoms: Extra dose administered
Clinical narrative: gave a booster of Adacel; Initial information received on 30-May-2019 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 27 years old female patient who received vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] and reported that gave a booster of Adacel to the patient.  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-2/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 extra dose 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.  Information on the batch number was requested  List of documents held by sender: none.
Sex: M
Vaccine: MMR, MNQ
Symptoms: Extra dose administered, Wrong product administered
Clinical narrative: inadvertently received two doses of Menactra; patient inadvertently received two doses of Menactra who was supposed to receive MMR vaccine not Menactra on 29-May-2019; Initial information received on 30-May-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 55 years old male patient who experienced inadvertently received two doses of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] lot number not reported via unknown route in unknown administration site on 22-May-2019 and 29-May-2019.  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 extra dose administered and wrong vaccine administered. It was reported that the patient inadvertently received two doses of Menactra who was supposed to receive MMR vaccine not Menactra on 29-May-2019.  It was not reported whether the patient had any adverse event or not.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in 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 batch number was requested.  List of documents held by sender: none.
Sex: M
Vaccine: DTAPIPV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Quadracel was given to a male patient at the age of 9 years old/no AE; Initial information received on 30-May-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves a 9 years old male patient who received vaccine DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  No concomitant therapy reported.   On 07-Aug-2018, the patient received a single 0.5 ml dose of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE lot C5248AA via intramuscular route in the left arm.  It was of actual medication error due to inappropriate age at vaccine administration.  No 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: U
Vaccine: IPV
Symptoms: Extra dose administered, Wrong product administered
Clinical narrative: IPOL vaccine was given to a 12 month old instead of the hib vaccine; the patient received 4 doses of the polio vaccine instead of 3 doses; Initial information received on 30-May-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 12 months old patient who received vaccine IPV (VERO) [IPOL] instead of HIB (PRP/T) VACCINE [ACT-HIB] and reported that she received 4 doses of the polio vaccine instead of 3 doses.  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 IPV (VERO) lot number not reported via unknown route in unknown administration site.  It was a case of actual medication error due to wrong vaccine administered and extra dose administered.  It was not reported if any adverse event occurred or not.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in 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: F
Vaccine: DTAP
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: patient, that is greater than 7 years old, received Daptacel; Initial information received on 29-May-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case is linked to case 2019SA150249.  This case involves a 12 years old female patient who experienced received vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL].  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) for Immunisation; and HPV VACCINE (HPV VACCINE) for Immunisation.  On 24-May-2019, the patient received a single 0.5 ml dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE lot C5307AA via unknown route in the right deltoid.  It was of actual medication error due to Inappropriate age at vaccine administration.  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 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.  List of documents held by sender: none.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Axillary pain, Body temperature, Breast pain, Breast swelling, Chills
Clinical narrative: Right arm injection site was sore, but no swelling.  However, right armpit & right side of breast became very swollen, red and painful!  By  5/29/19 the swollen area began to show bruising. Significant Bruising has continued in armpit & right side of breast.  That area is still sore today.   I?m concerned  because the reaction is unusual.  I intermittently placed ice packs in armpit & on side of swollen breast . I also took Tylenol for pain.   My more typical reaction was that by evening of vaccine I began to feel achy all over.  By middle of night I had a temperature and was shivering. Following day I needed to stay in bed bc of flu like symptoms, and exhaustion.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Contusion, Erythema, Fatigue, Influenza like illness, Injection site pain
Clinical narrative: Right arm injection site was sore, but no swelling.  However, right armpit & right side of breast became very swollen, red and painful!  By  5/29/19 the swollen area began to show bruising. Significant Bruising has continued in armpit & right side of breast.  That area is still sore today.   I?m concerned  because the reaction is unusual.  I intermittently placed ice packs in armpit & on side of swollen breast . I also took Tylenol for pain.   My more typical reaction was that by evening of vaccine I began to feel achy all over.  By middle of night I had a temperature and was shivering. Following day I needed to stay in bed bc of flu like symptoms, and exhaustion.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Oedema peripheral, Pain
Clinical narrative: Right arm injection site was sore, but no swelling.  However, right armpit & right side of breast became very swollen, red and painful!  By  5/29/19 the swollen area began to show bruising. Significant Bruising has continued in armpit & right side of breast.  That area is still sore today.   I?m concerned  because the reaction is unusual.  I intermittently placed ice packs in armpit & on side of swollen breast . I also took Tylenol for pain.   My more typical reaction was that by evening of vaccine I began to feel achy all over.  By middle of night I had a temperature and was shivering. Following day I needed to stay in bed bc of flu like symptoms, and exhaustion.
Age: 23.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site nodule, Tenderness
Clinical narrative: Patient presents with small nodule on the lateral aspect of the outer right arm. Mild painful to the touch with no erythema. No treatment and nodule has faded since onset.
Age: 67.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Incorrect route of product administration, Injected limb mobility decreased, Pain in extremity
Clinical narrative: Pneumovax 23 vaccine was injected into patient's left shoulder joint instead of her deltoid muscle.  A few hours after the injection the patient's left arm began hurting and she no longer could lift her left arm.  The next day she went to an Urgent Care because of loss of mobility in her arm.  A few days later she went to see her primary doctor.  She still cannot move her arm and has another doctor appointment coming.
Age: 67.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Mobility decreased, Product administered at inappropriate site
Clinical narrative: Pneumovax 23 vaccine was injected into patient's left shoulder joint instead of her deltoid muscle.  A few hours after the injection the patient's left arm began hurting and she no longer could lift her left arm.  The next day she went to an Urgent Care because of loss of mobility in her arm.  A few days later she went to see her primary doctor.  She still cannot move her arm and has another doctor appointment coming.
Age: 42.0
Sex: F
Vaccine: MMR, TDAP
Symptoms: Blood thyroid stimulating hormone, Differential white blood cell count, Full blood count, Glucose tolerance impaired, Lip swelling
Clinical narrative: 6/1/19 in the p.m., lymph nodes behind her ears and up the base of her skull began to swell. On 6/2/19 in the a.m. lips swelled slightly. Also had slight fever of 97 degrees (high per client). Client went to ED on 6/2 in early a.m. Discharged with Benadryl and diagnosis of lymphadenopathy. She was told to return if condition worsened or go to PCP. On 6/3 in the evening, she noticed a mild rash on her forehead. On 6/4 in the a.m. rash had spread to her face. Client plans on PCP visit next week, earlier if symptoms worsen.
Age: 42.0
Sex: F
Vaccine: MMR, TDAP
Symptoms: Lymphadenopathy, Pyrexia, Rash, Thyroxine
Clinical narrative: 6/1/19 in the p.m., lymph nodes behind her ears and up the base of her skull began to swell. On 6/2/19 in the a.m. lips swelled slightly. Also had slight fever of 97 degrees (high per client). Client went to ED on 6/2 in early a.m. Discharged with Benadryl and diagnosis of lymphadenopathy. She was told to return if condition worsened or go to PCP. On 6/3 in the evening, she noticed a mild rash on her forehead. On 6/4 in the a.m. rash had spread to her face. Client plans on PCP visit next week, earlier if symptoms worsen.
Age: 74.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Incorrect route of product administration, Injected limb mobility decreased, Pain in extremity
Clinical narrative: Patient received the Pnuemovax 23 injection in the left shoulder joint instead of the Deltoid muscle.  A few hours later patient had severe pain and could not move his left arm.   Pain was so severe that patient went to Urgent Care the next day.  Pain and loss of mobility continued so patient saw their primary doctor's physician's assistant and received pain meds.  Patient still has pain and still cannot move his left arm.
Age: 74.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Mobility decreased, Product administered at inappropriate site
Clinical narrative: Patient received the Pnuemovax 23 injection in the left shoulder joint instead of the Deltoid muscle.  A few hours later patient had severe pain and could not move his left arm.   Pain was so severe that patient went to Urgent Care the next day.  Pain and loss of mobility continued so patient saw their primary doctor's physician's assistant and received pain meds.  Patient still has pain and still cannot move his left arm.
Sex: M
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: received 2 doses of Gardasil 9 and never returned for third dose of Gardasil 9/unable to determine dosing schedule of Gardasil 9 doses which were received; No adverse effects; This spontaneous report was received from a healthcare worker via field employee and refers to a male patient of unknown age (reported as in teenage years). There was no information about the patient's concurrent conditions, concomitant therapies, drug reactions, allergies or past medical history provided.  On unspecified dates, the patient received two doses of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (strength, dose, frequency, routes of administration, anatomical location, lot# and expiration dates were not provided) for prophylaxis and never returned for third dose. It was unable to determine dosing schedule of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) doses which were received. No adverse effects were reported.
Age: 1.17
Sex: F
Vaccine: UNK
Symptoms: Injection site rash, Multiple allergies, Varicella post vaccine
Clinical narrative: Within a few days of the varicella vaccine, she developed what appeared to be chicken pox on her body and especially around the area where the vaccine dose was given. We went back to the dr on 5-6-09 and he said she had chicken pox, to not be near anyone else's babies that hadn't had the vaccines, or pregnant women, etc, and to cover the area and essentially quarantine ourselves until it had run it's course. He said she was not to have any more of this particular vaccine.
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site reaction, Rash, Rash erythematous, Rash pruritic
Clinical narrative: Red itchy patchy rash under both arms from elbow to axilla as well as between legs and near groin.  started after 2nd dose and has not gone away. worsens with warm weather and sweating
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash, Rash erythematous, Rash pruritic, Skin discolouration
Clinical narrative: Red itchy patchy rash under both arms from elbow to axilla as well as between legs and near groin.  started after 2nd dose and has not gone away. worsens with warm weather and sweating
Age: 12.0
Sex: F
Vaccine: VARCEL
Symptoms: Loss of consciousness, Seizure
Clinical narrative: Appx 8-10 minutes after vaccine administration, a medical provider witnessed patient become unconscious and then experience 15-20 seconds of seizure activity. Patient did become coherent, EMSA was called, and patient was transferred to the ER for further work up.
Age: 2.0
Sex: M
Vaccine: HEPA
Symptoms: Febrile convulsion
Clinical narrative: Febrile seizure
Age: 4.0
Sex: F
Vaccine: MMR
Symptoms: Crying, Electrocardiogram, Fall, Musculoskeletal stiffness, Staring
Clinical narrative: Patient came into office 5/31/19 @ 3:23pm For an MMR vaccination per Dr. After giving the vaccine patient cried then was standing with her mom at the front desk & fell to the floor. Eyes were fixed arms stiff above head lasting 1 minute. 911 was called she was brought to hospital.
Sex: U
Vaccine: DTAPHEPBIP
Symptoms: Irritability
Clinical narrative: Fussiness / irritability; This case was reported by a physician via sales rep and described the occurrence of irritability in an unspecified number of infant patients who received DTPa-HBV-IPV (Pediarix) for prophylaxis.  On an unknown date, the patient received Pediarix at an unknown dose. On an unknown date, unknown after receiving Pediarix, the patient experienced irritability. On an unknown date, the outcome of the irritability was unknown.   It was unknown if the reporter considered the irritability to be related to Pediarix.  Additional details were provided as follows: The age at vaccination was not applicable. The physician stated that when he first used Pediarix, infants experienced fussiness and irritability so he got tired for the calls so they switched to Pentacel and he has not seen this. The reporter did not agree to follow up.
Sex: U
Vaccine: RVX
Symptoms: Death, Pneumonia
Clinical narrative: This case was reported in a literature article and described the occurrence of pneumonia in a infant subject who received Rotavirus vaccine for prophylaxis. Concurrent medical conditions included combined immunodeficiency syndrome (severe combined immunodeficiency disease). On an unknown date, unknown after receiving Rotavirus vaccine, the subject developed pneumonia. Serious criteria included death and GSK medically significant. The outcome of pneumonia was fatal. The reported cause of death was pneumonia. The investigator considered that there was a reasonable possibility that the pneumonia may have been caused by Rotavirus vaccine. Additional information was provided. This case was reported in a literature article and described the occurrence of pneumonia in an infant of unspecified age and gender who was vaccinated with unspecified rotavirus vaccine (manufacturer unknown) for prophylaxis. This case corresponds to table 1 reported in this literature article. The patient was part of the study that characterize adverse events (AE) after rotavirus (RV) in infants with immunocompromising conditions (IC) reported to the Vaccine Adverse Event Reporting System (VAERS) from February 2006 to December 2015. The patient had severe combined immunodeficiency disease (SCID). No information on patient's medical or family history or concomitant medication were provided. On an unspecified date, the patient received unspecified rotavirus virus vaccine (administration route and site unspecified, dosage unknown; batch number not provided). The age of vaccination was not provided. On an unspecified date, an unknown period after vaccination, the patient developed pneumonia. On an unspecified date, the patient died. The cause of death was pneumonia. It was unknown if an autopsy was performed. This case has been considered as serious due to death. The treatment was unknown. The author stated and concluded, "Adverse event (AE) after RV in immunocompromised infants are rarely reported to VAERS, but most are clinically serious events. Additional data would be helpful in assessing the safety of RV in non-SCID IC including in-utero exposure to monoclonal antibodies MAB". This is 1 of the 11 valid cases reported in this literature article. The article corresponding to this case is not available for submission due to copyright restriction. Reported Cause(s) of Death: Pneumonia.
Sex: U
Vaccine: RVX
Symptoms: Death
Clinical narrative: This case was reported in a literature article and described the occurrence of unknown cause of death in a infant subject who received Rotavirus vaccine for prophylaxis. Concurrent medical conditions included combined immunodeficiency syndrome (severe combined immunodeficiency disease). On an unknown date, unknown after receiving Rotavirus vaccine, the subject developed unknown cause of death. Serious criteria included death and GSK medically significant. The outcome of unknown cause of death was fatal. The reported cause of death was unknown cause of death. The investigator considered that there was a reasonable possibility that the unknown cause of death may have been caused by Rotavirus vaccine. Additional information was provided. This case was reported in a literature article and described the occurrence of  death not otherwise specified (NOS) in an infant of unspecified age and gender who was vaccinated with unspecified rotavirus vaccine (manufacturer unknown) for prophylaxis. This case corresponds to table 1 reported in this literature article. The patient was part of the study that characterize adverse events (AE) after rotavirus (RV) in infants with immunocompromising conditions (IC) reported to the Vaccine Adverse Event Reporting System (VAERS) from February 2006 to December 2015. The patient had severe combined immunodeficiency disease (SCID). No information on patient's medical or family history or concomitant medication were provided. On an unspecified date, the patient received unspecified rotavirus virus vaccine (administration route and site unspecified, dosage unknown; batch number not provided). The age of vaccination was not provided. On an unspecified date, an unknown period after vaccination, the patient died. The cause of death was unknown. It was unknown if an autopsy was performed. This case has been considered as serious due to death. The author stated and concluded, "Adverse event (AE) after RV in immunocompromised infants are rarely reported to VAERS, but most are clinically serious events. Additional data would be helpful in assessing the safety of RV in non-SCID IC including in-utero exposure to monoclonal antibodies MAB" This is 1 of the 11 valid cases reported in this literature article. Reported Cause(s) of Death: unknown cause of death.