chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: swelling; chills; nausea; aches; tiredness; stomach upset; This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a 64-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 11th June 2019, the patient received the 1st dose of Shingrix (intramuscular). On 11th June 2019, less than a day after receiving Shingrix, the patient experienced injection site swelling, chills, nausea, pain, tiredness and upset stomach. The patient was treated with ibuprofen (Advil). The action taken with Shingrix was unknown. On an unknown date, the outcome of the injection site swelling, chills, nausea, pain, tiredness and upset stomach were not recovered/not resolved.   It was unknown if the reporter considered the injection site swelling, chills, nausea, pain, tiredness and upset stomach to be related to Shingrix.  Additional details were provided as follows: The patient received 1st dose in left arm at doctor's office. On the same day night, the patient started to experience swelling on his left arm, chills, nausea, aches, tiredness, and stomach upset.  On 11th June 2019, the patient did take an Advil. The patient could not provide address and first name of the physician. There is a discrepancy in the reporting the outcome was reported in the structured field as not recovered/not resolved, but the outcome reported in the source document recovering/ resolving, however outcome is retain as per database fields. The reporter consented to follow up.
Age: 1.25
Sex: M
Vaccine: DTAP
Symptoms: Circumstance or information capable of leading to medication error, Immediate post-injection reaction, Scratch, Underdose
Clinical narrative: Scratch; Underdose; accidental exposure to product; This case was reported by a nurse via call center representative and described the occurrence of scratch in a 15-month-old male patient who received DTPa (Infanrix) (batch number 5553K, expiry date unknown) for prophylaxis.   On 5th June 2019, the patient received Infanrix. On 5th June 2019, immediately after receiving Infanrix, the patient experienced scratch, accidental underdose and accidental exposure to product. On an unknown date, the outcome of the scratch, accidental underdose and accidental exposure to product were unknown.   It was unknown if the reporter considered the scratch to be related to Infanrix.  Additional details were provided as follows: The patient received dose of Infanrix in the unknown thigh. The reporter inadvertently given a partial dose of Infanrix to the patient, which led to accidenatl underdose. The nurse who was administering the vaccine was not holding the patient well, and when the patient moved, the needle came out of his leg, causing a scratch. it was unknown how much of the vaccine was successfully given, there was some vaccine remaining in the syringe. The reporter reported that, it was unknown, in which led the vaccine was given. The nurse who administered the vaccine to the patient, canceled the order in the documentation system.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Loss of consciousness, Musculoskeletal pain, Pain, Syncope
Clinical narrative: syncope instance; getting close to passing out; Dizzy; Pain; pain in the shoulder; This case was reported by a pharmacist via call center representative and described the occurrence of syncope in a 71-year-old female patient who received Herpes zoster (Shingrix) (batch number 9277N, expiry date 27th June 2021) for prophylaxis.   The patient's past medical history included shoulder operation (previously had a shoulder surgery).   On 14th March 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 14th March 2019, 1 hr after receiving Shingrix, the patient experienced syncope (serious criteria GSK medically significant), passed out (serious criteria GSK medically significant), dizziness, pain localized and shoulder pain. On an unknown date, the outcome of the syncope, passed out, dizziness, pain localized and shoulder pain were unknown.   It was unknown if the reporter considered the syncope, passed out, dizziness, pain localized and shoulder pain to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in the same arm where she had previously had shoulder surgery and had ended up with pretty bad side effect and was taken to emergency room. About an hour or two after receiving Shingrix, the patient experienced very dizzy and had a syncope instance and got close to passing out.  She also had a lot of pain in the area and an extreme pain in the shoulder.  In the emergency room she got X-rays and everything was normal. It was reported that nothing was noted while administering the vaccine.  The emergency room visit did not feel it was related to the vaccine itself, but the pharmacy decided not to administer the second dose of Shingrix and referred her to the physician.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: X-ray normal
Clinical narrative: syncope instance; getting close to passing out; Dizzy; Pain; pain in the shoulder; This case was reported by a pharmacist via call center representative and described the occurrence of syncope in a 71-year-old female patient who received Herpes zoster (Shingrix) (batch number 9277N, expiry date 27th June 2021) for prophylaxis.   The patient's past medical history included shoulder operation (previously had a shoulder surgery).   On 14th March 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 14th March 2019, 1 hr after receiving Shingrix, the patient experienced syncope (serious criteria GSK medically significant), passed out (serious criteria GSK medically significant), dizziness, pain localized and shoulder pain. On an unknown date, the outcome of the syncope, passed out, dizziness, pain localized and shoulder pain were unknown.   It was unknown if the reporter considered the syncope, passed out, dizziness, pain localized and shoulder pain to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in the same arm where she had previously had shoulder surgery and had ended up with pretty bad side effect and was taken to emergency room. About an hour or two after receiving Shingrix, the patient experienced very dizzy and had a syncope instance and got close to passing out.  She also had a lot of pain in the area and an extreme pain in the shoulder.  In the emergency room she got X-rays and everything was normal. It was reported that nothing was noted while administering the vaccine.  The emergency room visit did not feel it was related to the vaccine itself, but the pharmacy decided not to administer the second dose of Shingrix and referred her to the physician.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Discomfort, Fatigue, Influenza like illness, Pain in extremity
Clinical narrative: Pain/ Soreness; Fatigue; Flu like symptoms; This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 65-year-old male patient who received Herpes zoster (Shingrix) (batch number 9277N, expiry date 27th June 2021) for prophylaxis.   The patient's past medical history included shoulder operation.   On 13th March 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 13th March 2019, less than a day after receiving Shingrix, the patient experienced pain in arm, fatigue and influenza-like symptoms. On 14th March 2019, the outcome of the pain in arm was recovered/resolved. On an unknown date, the outcome of the fatigue and influenza-like symptoms were recovered/resolved.   It was unknown if the reporter considered the pain in arm, fatigue and influenza-like symptoms to be related to Shingrix.  Additional details were provided as follows: The pharmacist on the line reporting the patient had Shingrix in the same arm that he previously he had shoulder surgery and had quite a bit of pain in the area, more so than most people reported. The patient also had flu like symptoms, stating he was down and out, with fatigue and soreness. The symptoms started later that evening of the vaccine and lasted for about 24 hours. The patient received the second dose in the opposite arm, caller has not heard anything from the patient regarding any side effects at the time of reporting. No further information was provided. Separate adverse event reported for the most patients.
Sex: F
Vaccine: UNK
Symptoms: Anaphylactic reaction
Clinical narrative: Anaphylaxis; This case was reported by a pharmacist via call center representative and described the occurrence of anaphylaxis in a female patient who received Rabies NVS (Rabies Vaccine (Chicken Embryo Cell) for Human Use) for prophylaxis.   On an unknown date, the patient received Rabies Vaccine (Chicken Embryo Cell) for Human. On an unknown date, unknown after receiving Rabies Vaccine (Chicken Embryo Cell) for Human Use, the patient experienced anaphylaxis (serious criteria GSK medically significant). On an unknown date, the outcome of the anaphylaxis was unknown.   It was unknown if the reporter considered the anaphylaxis to be related to Rabies Vaccine (Chicken Embryo Cell) for Human Use.  Additional details were provided as follows: The age at vaccination was not reported. The reporter did not specify brand name of rabies vaccine. No lot number, expiration date, or full patient demographics was provided. The reporter noted that, the reaction took place when the patient was in junior high.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site haemorrhage, Underdose
Clinical narrative: injection site bleeding; underdose; This case was reported by a pharmacist via call center representative and described the occurrence of injection site hemorrhage in a 75-year-old male patient who received Herpes zoster (Shingrix) (batch number 2Y9R4, expiry date 28th June 2021) for prophylaxis.   On 26th March 2019, the patient received the 1st dose of Shingrix. On 26th March 2019, less than a day after receiving Shingrix, the patient experienced injection site hemorrhage (serious criteria GSK medically significant) and underdose. On an unknown date, the outcome of the injection site hemorrhage and underdose were unknown.   It was unknown if the reporter considered the injection site hemorrhage to be related to Shingrix.  Additional details were provided as follows: The patient experienced bleeding at the injection site. The health care professional felt like he had not received the full dose of Shingrix, which led to underdose and asked if an additional dose was needed. On 12th June 2019, the patient received the 2nd dose of Shingrix.
Sex: U
Vaccine: MENB
Symptoms: Body temperature increased, Pyrexia
Clinical narrative: 102 degree fever; This is a spontaneous report from a contactable physician via a sales representative. A patient of unspecified age and gender started received meningococcal group b rlp2086 (TRUMENBA), via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's concomitant medications were not reported.  The patient experienced 102 degree fever on a unspecified date. The outcome of the event was unknown.
Sex: U
Vaccine: PNC13
Symptoms: Injection site pain
Clinical narrative: Burning sensation at injection site; This is a spontaneous report from a contactable nurse received via a Pfizer sales representative. A patient of unspecified age and gender received pneumococcal 13-valent conjugate vaccine (diphtheria CRM197 protein) (PREVNAR 13), via an unspecified route of administration on an unspecified date at a single dose for immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced burning sensation at injection site on an unspecified date. The outcome of the event was unknown.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: DTAPIPVHIB, HIBV, MNQ
Symptoms: No adverse event, Product storage error
Clinical narrative: the temperatures the vaccines were exposed to were unknown due to the data logger was down and not recording any temperature information for 11-hours; Initial information received on 06-Jun-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves Adult patient who experienced the temperatures the vaccines were exposed to were unknown due to the data logger was down and not recording any temperature information for 11-hours, while he/she received vaccines DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL], MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] and HIB (PRP/T) VACCINE [ACT-HIB].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.    It was of actual medication error due to  incorrect product storage. There is a possibility of administration of vaccines that may have not been suitable for use after experiencing a temperature excursion. It is unknown if the event occurred due to it is unknown if the vaccines involved have been used  No adverse event was reported.  Information on the batch number was requested:  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.
Sex: M
Vaccine: UNK
Symptoms: Inflammation, Injection site erythema, Injection site reaction, Injection site warmth, Wound
Clinical narrative: cut on his leg; had the site got really red and thick, the thickness was 8th of inch and hot and red; Initial information received on 07-Jun-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 12 years old male patient who experienced cut on his leg and had the site got really red and thick, the thickness was 8th of inch and hot and red, while he received vaccine DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE.  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, TETANUS AND ACELLULAR PERTUSSIS VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site.  On an unknown date, following the vaccination the patient experienced wound and inflammation localized (inflammation).  (Other relevant tests included no lab data.)  Final diagnosis was wound and inflammation localized (inflammation).  It was not reported if the patient received a corrective treatment.  The outcome of the events was reported as unknown at the time of reporting.  Information on the batch number was requested.  List of documents held by sender: none.
Age: 10.0
Sex: F
Vaccine: DTAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired Daptacel administered to 10 years old patient; expired Daptacel administered to 10 years old patient; Initial information received on 10-Jun-2019 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 10 years old female patient who administered expired 0.5ml dose of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] lot C5180BA, expiry date: 06-Apr-2019 via intramuscular route in the right deltoid on 07-Jun-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included was POLIO VACCINE INACT 3V (VERO) (IPOL POLIO VACCINE) and HEPATITIS B VACCINE (HEPATITIS B VACCINE).  It was an actual medication error due to expired vaccine used and inappropriate age at vaccine administration.  At the time of reporting, adverse event was not 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 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: F
Vaccine: FLUX
Symptoms: Exposure during pregnancy
Clinical narrative: does the flu shot dose his mother received while pregnant count for the baby's vaccine record; Initial information received on 07-Jun-2019 regarding an unsolicited valid non-serious case received from  a consumer/non-hcp.  This case involves a female patient (age not reported) who was exposed to vaccine INFLUENZA VACCINE while she was pregnant .  Data regarding this pregnancy were received retrospectively, i.e. after pregnancy outcome was known.   Gestation period was unknown at the time of vaccination. The date of last menstrual period was not reported. The estimated due date was not reported. The actual date of delivery was not reported. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient previous pregnancy/ies not reported.    On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site.  It was a case of vaccine exposure during pregnancy.  Medical inquiry: Caller asked about his six month son whose day care center requires him to get the flu shot, but the MD said he cannot get the flu shot because the doses expire by 6/30/2019 so it is too late for the child to receive his 2 dose series. Caller asked does the flu shot dose his mother received while pregnant count for the baby's vaccine record and is it ok for the baby to just receive one dose of Fluzone Quadrivalent before it expires.  It was not reported if any adverse event occurred following vaccination.  Outcome: at the time of report, the patient had 6 month old son.  Batch number had been requested.  List of document held: none
Age: 1.17
Sex: F
Vaccine: DTAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired dose of Daptacel was inadvertently administered to a patient /no AE; Initial information received on 11-Jun-2019 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 14 months old female patient who inadvertently received an expired dose of 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 HIB VACCINE CONJ (TET TOX) (ACT-HIB).  On 11-Jun-2019, the patient received 4th dose (expired) of suspect 0.5 ml DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE lot C5202AA and expiry date: 16-May-2019 via intramuscular route in the thigh NOS.  It was a case of actual medication error due to expired vaccine used. It was reported that expired dose of Daptacel was inadvertently administered to a patient on 11Jun2019.  No adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation issue
Clinical narrative: only DTaP-IPV portion of Pentacel was inadvertently administered to twin male patients on 04Jun2019/no AE; Initial information received on 11-Jun-2019 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 6 months old male patient who received vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] and reported that only Dtap-IPV portion of Pentacel was inadvertently administered to twin male patients on 04jun2019/no AE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ (PNEUMOCOCCAL CONJUGATE VACCINE).  On 04-Jun-2019, the patient received 1st dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot UJ104AA and expiry date: 13-Oct-2020 via intramuscular route in the left thigh.  It was a case of actual medication error due to inappropriate reconstitution technique.  No adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Sex: F
Vaccine: FLU3
Symptoms: Aspiration joint abnormal, Injected limb mobility decreased, Injection site infection, Injection site inflammation, Nuclear magnetic resonance imaging
Clinical narrative: site suspicious for inflammation; site suspicious for infection; limited range of motion; pain; Initial information received on 11-Jun-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves 86 years old female patient who experienced site suspicious for inflammation, site suspicious for infection, limited range of motion and pain, while she received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 15-Nov-2018, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot UJ044AB via intramuscular route in the left deltoid.  On an unknown date, the patient developed a non-serious site suspicious for inflammation (inflammation), site suspicious for infection (localised infection), limited range of motion (mobility decreased) and pain following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE.  Relevant laboratory test results included: Aspiration - On an unknown date: positive T and B cells, MRI test and X-ray.  (Other relevant tests included no lab data.)  Final diagnosis was pain, limited range of motion, site suspicious for infection and site suspicious for inflammation.   The patient was treated with CORTISONE (CORTISONE) injection.  Patient has had multiple orthopedic Appointments: 01/07/19, 02/18/19, 04/22/19, 04/23/19, 04/29/19, 05/06/19, and 05/20/19. Patient referred to Infectious Disease Specialist appointment today 06/11/19.  The outcome of the events was Unknown.  Documents held by sender: none.
Sex: F
Vaccine: FLU3
Symptoms: Pain, X-ray
Clinical narrative: site suspicious for inflammation; site suspicious for infection; limited range of motion; pain; Initial information received on 11-Jun-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves 86 years old female patient who experienced site suspicious for inflammation, site suspicious for infection, limited range of motion and pain, while she received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 15-Nov-2018, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot UJ044AB via intramuscular route in the left deltoid.  On an unknown date, the patient developed a non-serious site suspicious for inflammation (inflammation), site suspicious for infection (localised infection), limited range of motion (mobility decreased) and pain following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE.  Relevant laboratory test results included: Aspiration - On an unknown date: positive T and B cells, MRI test and X-ray.  (Other relevant tests included no lab data.)  Final diagnosis was pain, limited range of motion, site suspicious for infection and site suspicious for inflammation.   The patient was treated with CORTISONE (CORTISONE) injection.  Patient has had multiple orthopedic Appointments: 01/07/19, 02/18/19, 04/22/19, 04/23/19, 04/29/19, 05/06/19, and 05/20/19. Patient referred to Infectious Disease Specialist appointment today 06/11/19.  The outcome of the events was Unknown.  Documents held by sender: none.
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Product preparation issue
Clinical narrative: a patient inadvertently received only the DTaP-IPV portion of Pentacel; Initial information received on 11-Jun-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves Child patient who received only the DTaP-IPV portion of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] without Act-HIB component.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot number not reported.  It was of actual medication error case due to  inappropriate reconstitution technique.  It was unknown if adverse event was experienced..  Information on the batch number was requested:  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: No adverse event, Product preparation issue
Clinical narrative: only DTaP-IPV portion of Pentacel was inadvertently administered to twin male patients on 04Jun2019/no AE; Initial information received on 11-Jun-2019 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 6 months old male patient who received vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] and reported that only Dtap-IPV portion of Pentacel was inadvertently administered to twin male patients on 04jun2019/no AE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ (PNEUMOCOCCAL CONJUGATE VACCINE).  On 04-Jun-2019, the patient received 1st dose of suspect 0.5 ml DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot UJ104AA and expiry date: 13-Oct-2020 via intramuscular route in the left thigh.  It was a case of actual medication error due to inappropriate reconstitution technique.  No adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Sex: M
Vaccine: HIBV
Symptoms: No adverse event, Product preparation error
Clinical narrative: ActHIB that has been diluted with sterile water instead of the 0.4% Sodium Chloride diluent that comes with the ActHIB/no AE; Initial information received on 12-Jun-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves Infant male patient who received vaccine HIB (PRP/T) VACCINE [ACT-HIB] hat has been diluted with sterile water instead of the 0.4% Sodium Chloride diluent that comes with the ActHIB  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, HEPATITIS B VACCINE RHBSAG (YEAST), PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, POLIO VACCINE INACT 3V (VERO), TETANUS VACCINE TOXOID (PEDIARIX); PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13); and ROTAVIRUS VACCINE (ROTAVIRUS VACCINE).  On 12-Jun-2019, the patient received a 0.5 ml dose of suspect HIB (PRP/T) VACCINE lot U19648A via intramuscular route.  It was of actual medication error case due to Inappropriate dilution of medication.  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: M
Vaccine: DTAPIPV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Quadracel was accidentally administered to a 24 month old, male child/ No AE; Initial information received on 12-Jun-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 24 months old male patient who received vaccine DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL].  The patients past medical history and family history were not provided.  Concomitant medication included HEPATITIS B VACCINE.   On 12-Jun-2019, the patient received first dose of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE lot C5500CA, expiry date 16-Aug-2020 via intramuscular route in the left thigh.  It was an actual medication error due to inappropriate age at vaccine administration.  It was reported that Quadracel was accidentally administered to a 24 month old, male child.  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.
Age: 1.0
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Product preparation issue
Clinical narrative: only received the Dtap- IPV portion of the Pentacel; second dose at age of 6 months and third dose at age of 12 months; Initial information received on 12-Jun-2019 regarding an unsolicited valid non-serious case received from a non-health care professional.  This case involves a 12 months old female patient who was vaccinated with a second dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] on an unknown date of Dec 2018 at age of 7 months (doses with unknown batch number, route and site of administration) and received a 0.5 ml third dose (at 12 months and also reported as 13 months) of same vaccine with lot number UI953AAA, Exp. Date 30-JUN-2020, via intramuscular route in the left leg on 11-Jun-2019 (Exterior Box: Lot- UI953AAA, expiry date: 30Jun2020 , and NDC: 4928151005; ActHIB: LOT: UI953AA expiry date: 30Jun2020, and NDC: 4928151005; and Dtap- IPV: LOT: U6138AB, expiry date: 30Jun2020)  Patient recieved first dose DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] on an unknown date of JUL-2018 at age of 2 months.  The patient's medical history.   Concomitant medications included Hepatitis A vaccine.  It was an actual medication error case due to inappropriate schedule of vaccine administered and inappropriate reconstitution technique. It was reported that, for the third dose of pentacel, patient only received the Dtap- IPV portion of the Pentacel. Patient visited doctor on 11-Jun-2019.  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 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.  List of documents held by sender: none.
Sex: M
Vaccine: IPV, RVX
Symptoms: No adverse event, Wrong product administered
Clinical narrative: gave a patient an IPOL on accident instead of Rotovirus(oral)/ no symptoms; Initial information received on 13-Jun-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 2 months old male patient who received vaccine IPV (VERO) [IPOL] instead of ROTAVIRUS VACCINE.  The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, HEPATITIS B VACCINE RHBSAG (YEAST), PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, POLIO VACCINE INACT 3V (VERO), TETANUS VACCINE TOXOID (PEDIARIX) for Immunisation; PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) for Immunisation; and HIB VACCINE CONJ (TET TOX) (ACT HIB) for Immunisation.  On 13-Jun-2019, the patient received a dose of suspect IPV (VERO) lot NIG511M , expiry date 02Aug-2019, via left vastus lateralis instead of suspect ROTAVIRUS VACCINE not produced by Sanofi Pasteur lot number not reported via oral route.  It was an actual medication error due to wrong vaccine administered.  It was reported that patient was given IPOL on accident instead of Rotovirus (oral).  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: M
Vaccine: TDAP
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Adacel was given to an 18 month old by mistake/ no symptoms; Initial information received on 13-Jun-2019 regarding an unsolicited valid non-serious case received from Other health care professional (office staff).  This case involves an 18 months old male patient who received vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HIB VACCINE (HIB) for Immunisation.  On 11-Jun-2019, the patient received a 0.5ml dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot C5560AA, expiry date 21-Jan-2021 via intramuscular route in left leg.  It was an actual medication error due to Inappropriate age at vaccine administration.  It was reported that Adacel was given to an 18 month old by mistake.  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 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: DTAPIPVHIB
Symptoms: No adverse event, Product preparation issue
Clinical narrative: didn't reconstitute the Hib with the (DTaP/IPV). The cohort also didn't reconstitute the Hib with the 0.4 percent NaCl and gave it / no adverse event; Initial information received on 13-Jun-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves patient (with unknown demographic) who received dose of vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (PENTACEL) (lot number and Expiry date unknown) via unknown route in unknown administration site.  The patients' medical history and concomitant medications were not reported.   It was a case of actual medication error due to inappropriate reconstitution technique. (it was reported that The cohort didnt reconstitute the Hib with the (DTaP/IPV). The cohort also didnt reconstitute the Hib with the 0.4 percent NaCl and gave it)  At the time of reporting, no adverse reaction 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.  Information on the batch number was requested.  Documents held by sender: none.
Sex: M
Vaccine: DTAP
Symptoms: Expired product administered
Clinical narrative: expired Daptacel was administered to a patient; Initial information received on 13-Jun-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves an unknown age male patient who was vaccinated with expired vaccine 0.5ml dose of  DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (lot number: C5190AA, expiry date: 24-Apr-2019) via intramuscular route in the left thigh, on 06-Jun-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included MMR vaccine.   It was an actual medication error due to expired vaccine used.  It was unknown if any adverse event 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: 4.0
Sex: F
Vaccine: DTAP, IPV, MMRV, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Local reaction
Clinical narrative: Large red, firm, tender area on right thigh at site of DTaP, started about 20 hours after vaccination, got progressively larger and more tender over following 6-8 hours.  The following morning the redness was larger, but much less tender, so they brought her to the office for evaluation.  I felt it was most likely an aggressive local response rather than cellulitis or allergic reaction.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Rash
Clinical narrative: Developed fever of 101 the morning after which was 6/6/2019 lasting a few days.  Had a few rash spots on chest which all have cleared up in about a week.
Age: 49.0
Sex: F
Vaccine: PPV
Symptoms: Breast swelling, Chest discomfort, Erythema, Pain, Pain in extremity
Clinical narrative: Patient presented with complaints of swelling and redness to left arm, neck, and breast, chest pressure, left arm pain. Was seen in ER and given Toradol and Benadryl IM but swelling and pain became worse after leaving so she returned 12 hours later.  She was placed on med/surg unit in observation at that time and given Benadryl po, Vancomycin IV, and Solu Medrol IV.
Age: 49.0
Sex: F
Vaccine: PPV
Symptoms: Peripheral swelling, Swelling
Clinical narrative: Patient presented with complaints of swelling and redness to left arm, neck, and breast, chest pressure, left arm pain. Was seen in ER and given Toradol and Benadryl IM but swelling and pain became worse after leaving so she returned 12 hours later.  She was placed on med/surg unit in observation at that time and given Benadryl po, Vancomycin IV, and Solu Medrol IV.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Diarrhoea, Erythema, Impaired work ability, Influenza like illness, Nausea
Clinical narrative: The client stated he felt like he had "the flu." He said he had diarrhea, nausea, and a low-grade fever for "a couple of days." He denies having chills. He said the entire upper half of his left arm (the arm the vaccine was administered in) was "red and splotchy" for a week after administration. The client stated he was so ill he missed two days of work. He stated he took Ibuprofen 2 tablets every six hours regularly the entire time he had symptoms. He stated he did not change medications or was around anyone who had similar symptoms. He did not seek medical treatment or see a doctor because  he "figured a doctor would not be able to do anything different" for him. He said he is feeling better and has fully recovered.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia, Rash macular
Clinical narrative: The client stated he felt like he had "the flu." He said he had diarrhea, nausea, and a low-grade fever for "a couple of days." He denies having chills. He said the entire upper half of his left arm (the arm the vaccine was administered in) was "red and splotchy" for a week after administration. The client stated he was so ill he missed two days of work. He stated he took Ibuprofen 2 tablets every six hours regularly the entire time he had symptoms. He stated he did not change medications or was around anyone who had similar symptoms. He did not seek medical treatment or see a doctor because  he "figured a doctor would not be able to do anything different" for him. He said he is feeling better and has fully recovered.
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Urticaria
Clinical narrative: Approximately 5.5 hrs post vaccine - patient developed hives on his back, buttocks and backs of arm. No hives near injection site. No generalized swelling, no respiratory concerns, no shortness of breath, signs of anaphylaxis, etc. Patient got better that night after Benadryl. Next morning did go to school and approximately 11:30AM (20 hours post vaccine) hives returned - same description and places per mother's accounting. Was instructed to add Zyrtec to Benadryl and monitor for other concerning sx's (SOB, weakness, dizziness, rapid HR, etc). No further questions or calls from parents.
Age: 1.0
Sex: M
Vaccine: MMR, UNK, VARCEL
Symptoms: Allergy test, Drug hypersensitivity, Skin test
Clinical narrative: The Nurse reports that on an unspecified date, "during allergy testing, the patient had a localized allergic skin test reaction to NEOMYCIN"; Information has been received from a nurse referring to a 4 years old male child. The patient has none concomitant therapy or pertinent medical history.  In approximately 2016 (reported as about three years ago), the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II)(strength, dose, frequency, route, lot#, therapy type and expiration date were unknown) and varicella virus vaccine live (oka/merck)(VARIVAX) (strength, dose, frequency, route, lot# and expiration date were unknown) for prophylaxis. Serile diluent (strength, dose, frequency, route, lot# and expiration date were unknown) was used. The Nurse reports that "the patient did not have any adverse reactions to the measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) and varicella virus vaccine live (oka/merck)(VARIVAX)".  On an unknown date, during allergy testing, the patient had a localized allergic skin test reaction to neomycin. It was unknown if a treatment was given for the event. No lab diagnostics or studies were performed for the event. The patient went to doctors' office to seek medical attention. The outcome of the event was recovered on an unknown date. The causality assessment was not provided by the reporter.
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Myalgia
Clinical narrative: significant fatigue; significant myalagias; This case was reported by a physician via call center representative and described the occurrence of myalgia in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced myalgia and fatigue. On an unknown date, the outcome of the myalgia was recovered/resolved and the outcome of the fatigue was unknown.   It was unknown if the reporter considered the myalgia and fatigue to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The patient received 1st dose of Shingrix and experienced significant myalgia for 4 days and significant fatigue. The reporter was asking that how important was it to patient to receive 2nd dose of Shingrix.