chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Headache, Pain
Clinical narrative: right knee and ankle were sore; headache; This case was reported by a consumer via call center representative and described the occurrence of headache in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included sjogren's syndrome.   In June 2019, the patient received the 1st dose of Shingrix (intramuscular). In June 2019, less than a day after receiving Shingrix, the patient experienced headache. On an unknown date, the patient experienced pain. On an unknown date, the outcome of the headache was recovered/resolved and the outcome of the pain was unknown.   It was unknown if the reporter considered the headache and pain to be related to Shingrix.  Additional details were provided as follows: The patient had the first dose of Shingrix in June 2019 on left arm and had a headache that night but it was gone the next morning. Her right knee and ankle were also sore. The patient consented to follow up. This case has been linked with case US2019AMR173285, reported by the same reporter.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: sore arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included breast cancer (breast cancer in one breast treated with radiation). Concurrent medical conditions included immune system disorder (hyperimmune system).   In June 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in early June in the left arm and the only effect she experienced was a sore arm that resolved within several days. The reporter consented to follow up. Emergency room visit required. For tolerances of 2nd dose, refer case US2019AMR173490, reported by same reporter for the same patient.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site swelling, Paraesthesia oral, Rash
Clinical narrative: redness; rash; Injection site swelling; lip tingling; This case was reported by a other health professional via call center representative and described the occurrence of injection site swelling in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   In September 2019, the patient received the 1st dose of Shingrix. In September 2019, 2 days after receiving Shingrix, the patient experienced injection site swelling, tingling lips and rash. On an unknown date, the patient experienced erythema. On an unknown date, the outcome of the injection site swelling, tingling lips, erythema and rash were unknown.   It was unknown if the reporter considered the injection site swelling, tingling lips, erythema and rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The batch number was not reported. The patient received Shingrix last week, and two days later she developed the following symptoms lip tingling; injection site swelling, redness, and rash.  The reporter consented to follow up. The reporter declined to provide date of birth.  The vaccine was administered elsewhere.; Sender's Comments: Medical assistant reported that a patient received her first dose of Shingrix last week, and two days later she developed the following symptoms: lip tingling; injection site swelling, redness, and rash. Consented to follow up.Call Notes:Reporter declined to provide DOB. Vaccine was administered elsewhere, so the lot # was not available.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site erythema, Injection site pruritus, Injection site warmth, Pain in extremity
Clinical narrative: Sore Arm; Itching; Redness; Hot area; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 30th July 2019, the patient received the 1st dose of Shingrix (intramuscular) 50 µg. On 31st July 2019, 1 days after receiving Shingrix, the patient experienced pain in arm, pruritus, erythema and skin warm. The patient was treated with non-drug therapy (Warm Compress) and benadryl (nos) (Benadryl). On an unknown date, the outcome of the pain in arm, pruritus, erythema and skin warm were recovered/resolved.   It was unknown if the reporter considered the pain in arm, pruritus, erythema and skin warm to be related to Shingrix.  Additional details were provide as follows: The patient received dose of Shingrix in the left arm. After vaccination with dose of Shingrix, experienced sore arm, which lasted for 5 to 7 days. The patient also experienced redness, itching and hot area starting from the site of injection site to above the elbow for about 5 to 7 days. No further details were provided. The patient did not consent to follow up.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Skin warm
Clinical narrative: Sore Arm; Itching; Redness; Hot area; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 30th July 2019, the patient received the 1st dose of Shingrix (intramuscular) 50 µg. On 31st July 2019, 1 days after receiving Shingrix, the patient experienced pain in arm, pruritus, erythema and skin warm. The patient was treated with non-drug therapy (Warm Compress) and benadryl (nos) (Benadryl). On an unknown date, the outcome of the pain in arm, pruritus, erythema and skin warm were recovered/resolved.   It was unknown if the reporter considered the pain in arm, pruritus, erythema and skin warm to be related to Shingrix.  Additional details were provide as follows: The patient received dose of Shingrix in the left arm. After vaccination with dose of Shingrix, experienced sore arm, which lasted for 5 to 7 days. The patient also experienced redness, itching and hot area starting from the site of injection site to above the elbow for about 5 to 7 days. No further details were provided. The patient did not consent to follow up.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Dyspepsia
Clinical narrative: heartburn; This case was reported by a consumer via call center representative and described the occurrence of heartburn in a 55-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 2 days after receiving Shingrix, the patient experienced heartburn. On an unknown date, the outcome of the heartburn was recovering/resolving.   It was unknown if the reporter considered the heartburn to be related to Shingrix.  Additional details were provided as follows: The patient stated that approximately 2 days after receiving the vaccine, she developed heartburn. The patient did not consent to follow up. The patient did not provide any additional information.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Itching; Redness; This case was reported by a pharmacist via call center representative and described the occurrence of injection site itching in a 56-year-old female patient who received Herpes zoster (Shingrix) (batch number 9H524, expiry date 22nd October 2021) for prophylaxis.   On 10th September 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 10th September 2019, less than a day after receiving Shingrix, the patient experienced injection site itching and injection site erythema. On an unknown date, the outcome of the injection site itching and injection site erythema were recovering/resolving.   It was unknown if the reporter considered the injection site itching and injection site erythema to be related to Shingrix.  Additional details were provided as follows: The reporter stated that, the patient developed an itchy red area around the infection site the evening the product was administrated. The reporter stated that after about 11 days, the patient came in and the itching and redness were improving and have been improving everyday. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Pain, Pyrexia
Clinical narrative: fever; muscle aches; body aches; This case was reported by a physician via call center representative and described the occurrence of fever in a 56-year-old female patient who received Herpes zoster (Shingrix) (batch number 52R7X, expiry date 10th October 2021) for prophylaxis.   On 22nd July 2019, the patient received the 1st dose of Shingrix (intramuscular). On 22nd July 2019, less than a day after receiving Shingrix, the patient experienced fever. On an unknown date, the patient experienced muscle pain and general body pain. The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the fever, muscle pain and general body pain were recovered/resolved.   It was unknown if the reporter considered the fever, muscle pain and general body pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported but it could be between 55 or 56 years. The reporter stated that the patient developed fever, muscle aches and body aches following her first dose of Shingrix. The reporter stated that, the patient within 24 hours of vaccination called the MD stating she had a fever. The fever went up to 101 F. The patient took with good effects. The reporter stated that the fever was followed by muscle aches throughout the week. The Tylenol helped with that too. The patient also experienced body aches. Onset  and resolution time of muscle aches and body aches was unknown. The physician believed that the symptoms resolved within 24-48 hours because the patient would have called otherwise. The reporter consented to follow up. The reporter did not wish to provide patient's dob or initials.
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Heart rate increased
Clinical narrative: Headache; Heart rate rose to 88 Beats per minute; This case was reported by a consumer via call center representative and described the occurrence of headache in a 77-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 24th September 2019, the patient received the 1st dose of Shingrix. On 24th September 2019, less than a day after receiving Shingrix, the patient experienced headache and heart rate increased. On an unknown date, the outcome of the headache and heart rate increased were not recovered/not resolved.   It was unknown if the reporter considered the headache and heart rate increased to be related to Shingrix.  Additional details were provided as follows: A patient reported that he received the 1st dose of Shingrix yesterday and developed a headache not resolved by the next day.  He also stated that his heart rate rose to 88 Beats per minute. The reporter consented to follow up.
Age: 24.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site induration, Injection site warmth, Product administered at inappropriate site
Clinical narrative: Vaccine Administered at Inappropriate Site; erythema at injection site; warmth at injection site; induration at injection site; This case was reported by a other health professional via call center representative and described the occurrence of injection site erythema in a 24-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2019-2020 season) (batch number 2LL97, expiry date 30th June 2020) for prophylaxis.   On 24th September 2019, the patient received Fluarix Quadrivalent 2019-2020 season (intramuscular). In September 2019, less than a week after receiving Fluarix Quadrivalent 2019-2020 season, the patient experienced injection site erythema, injection site warmth and injection site induration. On 24th September 2019, the patient experienced vaccine administered at inappropriate site. On an unknown date, the outcome of the injection site erythema, injection site warmth and injection site induration were not recovered/not resolved and the outcome of the vaccine administered at inappropriate site was unknown.   It was unknown if the reporter considered the injection site erythema, injection site warmth and injection site induration to be related to Fluarix Quadrivalent 2019-2020 season.  Additional details were reported as follows: Caller was a nurse practitioner in a hospital.  One of the hospital employees received a dose of Fluarix and caller states that the vaccine was not injected into the deltoid muscle.  The vaccine was injected in the left arm below the deltoid, and more in the tricep area, which led to vaccine administered at inappropriate site. The patient had developed erythema and induration at the injection site and the injection site was warm to the touch.  The erythematous area was approximately 9 cm by 7 cm in size. Emergency room visit required. Caller did not provide any additional details.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Fatigue, Feeling abnormal, Headache, Influenza, Pain
Clinical narrative: Inappropriate schedule of vaccine; Circumstance or information capable of leading to medication error; mildly fluish; very sore arm; achy; tired; headache; "out of it"; This case was reported by a other health professional via call center representative and described the occurrence of influenza in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 12th August 2019, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On 13th August 2019, 1 days after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced influenza, pain in arm, pain, tiredness, headache and spaced out. On an unknown date, the patient experienced drug dose administration interval too short and circumstance or information capable of leading to medication error. On an unknown date, the outcome of the influenza, pain in arm, pain, tiredness, headache and spaced out were recovered/resolved and the outcome of the drug dose administration interval too short and circumstance or information capable of leading to medication error were unknown.   It was unknown if the reporter considered the influenza, pain in arm, pain, tiredness, headache and spaced out to be related to Shingrix.  Additional details were reported as follows: Health care provider was also the patient.  Asking about receiving the second dose of Shingrix before 2 months.  Also reported feeling mildly fluish, very sore arm, headache, tired, "out of it" the next day. AE reported for the possibility of early dose administered, which led to shortening of the vaccination schedule and or information capable of leading to medication error.  The patient or HCP did not state that they would be receiving the second dose early, this was a near miss.   No lot number or expiry date of vaccine available since nothing had been administered. The reporter did not give consent to follow up.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pain in extremity
Clinical narrative: Inappropriate schedule of vaccine; Circumstance or information capable of leading to medication error; mildly fluish; very sore arm; achy; tired; headache; "out of it"; This case was reported by a other health professional via call center representative and described the occurrence of influenza in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 12th August 2019, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On 13th August 2019, 1 days after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced influenza, pain in arm, pain, tiredness, headache and spaced out. On an unknown date, the patient experienced drug dose administration interval too short and circumstance or information capable of leading to medication error. On an unknown date, the outcome of the influenza, pain in arm, pain, tiredness, headache and spaced out were recovered/resolved and the outcome of the drug dose administration interval too short and circumstance or information capable of leading to medication error were unknown.   It was unknown if the reporter considered the influenza, pain in arm, pain, tiredness, headache and spaced out to be related to Shingrix.  Additional details were reported as follows: Health care provider was also the patient.  Asking about receiving the second dose of Shingrix before 2 months.  Also reported feeling mildly fluish, very sore arm, headache, tired, "out of it" the next day. AE reported for the possibility of early dose administered, which led to shortening of the vaccination schedule and or information capable of leading to medication error.  The patient or HCP did not state that they would be receiving the second dose early, this was a near miss.   No lot number or expiry date of vaccine available since nothing had been administered. The reporter did not give consent to follow up.
Age: 0.33
Sex: U
Vaccine: DTAPIPVHIB, HEP, PNC
Symptoms: Rash, Urticaria
Clinical narrative: Rash; Hives/broke out in an urticarial hive/raised welts; Inappropriate schedule of vaccine; This case was reported by a physician via call center representative and described the occurrence of rash in a 4-month-old patient who received HBV (Engerix B) for prophylaxis.   Co-suspect products included PNEUMOCOCCAL VACCINE (PREVNAR) for prophylaxis and PENTACEL for prophylaxis.   On an unknown date, the patient received the 2nd dose of Engerix B, PREVNAR at an unknown dose and PENTACEL at an unknown dose. On an unknown date, less than a year after receiving Engerix B, the patient experienced rash, hives and drug dose administration interval too long. On an unknown date, the outcome of the rash and hives were recovered/resolved and the outcome of the drug dose administration interval too long was unknown.   It was unknown if the reporter considered the rash and hives to be related to Engerix B.  Additional details were received as follows: MD reported that a 4 month old received the second dose of Hep B 4 months after the first dose was received as a newborn.  Second dose of Hep B was administered at the MD's office. This led to lengthening of vaccination schedule. The physician stated that he is not certain of the vaccine used for the first dose, unsure of the vaccine used for the second dose, but he was pretty sure that the second dose was Engerix-B.  After the infant received the Hep B vaccination, they broke out in an urticarial hive rash around the back of its neck and behind its ear, raised welts.  The rash lasted a couple of days, infant is doing fine now.  Infant also received Pentacel and Prevnar. Physician was not at the office, unable to provide vaccine name or lot/exp, no patient information available. The reporter consented to follow up.
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation issue
Clinical narrative: 5 months old female patient who received DTaP-IPV diluent separately and did not receive ACT-HIB powder portion of pentacel, no AE; Initial information received on 12-Sep-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to cases 2019SA257163 and 2019SA261801 (same reporter).   This case involves a 5 months old female patient who received DTaP-IPV diluent separately and did not receive ACT-HIB powder portion of vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [Pentacel] (lot: UJ060AA, expiry vdate: 04-Oct-2020, the outer carton is lot: UJ060AAA, expiry date: 04-Oct-2020) via unknown route in the left thigh, on 27-Aug-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant vaccinations included ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) and PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13).  It was a case of actual medication error due to inappropriate reconstitution technique.  At a time of reporting 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.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation issue
Clinical narrative: patient who received only the DTaP-IPV diluent portion of the Pentacel vaccine and not of ActHIB powder, no AE; Initial information received on 12-Sep-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to cases 2019SA257163 and 2019SA261800 (same reporter).   This case involves a 4 months old female patient who received DTaP-IPV diluent separately and did not receive ACT-HIB powder portion of vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [Pentacel] (lot: UJ060AA, expiry vdate: 04-Oct-2020, the outer carton is lot: UJ060AAA, expiry date: 04-Oct-2020) via unknown route in the left thigh, on 28-Aug-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant vaccinations included ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) and PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13).  It was a case of actual medication error due to inappropriate reconstitution technique.  At a time of reporting 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: FLU4
Symptoms: Chills, Dizziness, Influenza like illness, Night sweats, Pyrexia
Clinical narrative: flu like symptoms; chills; dizziness; fever; night sweats; Initial information received on 12-Sep-2019 regarding an unsolicited valid non-serious case received from a other non health care professional (Pharmacy-Other).  This case involves a female patient who experienced night sweats (night sweats), flu like symptoms (influenza like illness), chills (chills), dizziness (dizziness), fever (pyrexia), while she received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient's past medical history, medical treatment(s), and family history were not provided. It was reported that she has never had a reaction over the last 20 plus years of getting the flu shot.   On an unknown date, the patient received 0.5 ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot UT6647MA, exp date: 30 June 2020 via unknown route in unknown administration site.  On an unknown date, the patient had night sweats (night sweats), flu like symptoms (influenza like illness), chills (chills), dizziness (dizziness), fever (pyrexia) in the evening same day following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  Lab data was not reported.  Final diagnosis was fever, dizziness, chills, flu like symptoms and night sweats.   It was not reported if the patient received a corrective treatment.  The patient was recovered from all the events on an unspecified date.  List of document held by sender: none.
Sex: U
Vaccine: HIBV
Symptoms: Extra dose administered
Clinical narrative: was given the invalid ActHIB also asked how many hours is the vaccine viable for use after mixed and drawn up in syringe/ no AE; Initial information received on 18-Sep-2019 regarding an unsolicited valid non-serious case received from a non-hcp (Office Staff).  This case involves a 4 months old patient who was administered HIB (PRP/T) VACCINE [ACT-HIB] lot UJ176AA (Expiry date unknown) via intramuscular route in the right vastus lateralis, on 12-Sep-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13), ROTAVIRUS VACCINE (ROTAVIRUS VACCINE),ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ) and DIPHTHERIA VACCINE TOXOID, HEPATITIS B VACCINE RHBSAG (YEAST), PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, POLIO VACCINE INACT 3V (VERO), TETANUS VACCINE TOXOID (PEDIARIX) .   It was an actual medication error case due extra dose administered.   It was reported that child that was given the invalid ActHIB was 4 months old and this was a Well Child Check Up in live follow up reported that She also asked how many hours is the vaccine viable for use after mixed and drawn up in syringe and stored properly in refrigerator?  It was unknown whether the patient had any adverse reactions.  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: FLU3
Symptoms: Liquid product physical issue, Underdose
Clinical narrative: unable to draw up 0.5 mL of Fluzone (multi-dose vial) while administering it to a nine years old patient they cannot administer the whole product into the skin because they feel pressure when they press down/No AE; unable to draw up 0.5 mL of Fluzone (multi-dose vial) while administering it to a nine years old patient they cannot administer the whole product into the skin because they feel pressure when they press down/No AE; Initial information received on 18-Sep-2019 and additional information received on 23-Sep-2019 regarding an unsolicited valid non-serious case received from a consumer.  This case involves a nine years old patient (gender unknown).  In this case it was reported that they were unable to draw up 0.5 ml of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [FLUZONE] (multi-dose vial) while administering it to the patient, they cannot administer the whole product into the skin because they feel pressure when they press down lot number: UJ237AB, expiry date: 30-Jun-2020 via unknown route in unknown administration site on an unknown date.  It was a case of vaccine underdose and liquid product flow abnormal.  It was unknown whether patient experienced any adverse event following vaccination.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization 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.
Age: 20.0
Sex: F
Vaccine: FLU4
Symptoms: Expired product administered, No adverse event
Clinical narrative: a female patient received a 0.5 ml dose of Fluzone Quadrivalent which was already expired on 30Jun2019/No AE; Initial information received on 18-Sep-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case is linked to cases 2019SA263392, 2019SA263393 and 2019SA263394 (same reporter).  This case involves a 20 years old female patient who received a 0.5 ml dose of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] Prefilled syringes which was already expired on 30-Jun-2019 lot UJ041AB via unknown route in the left deltoid on 17-Sep-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 expired vaccine used.  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization 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.
Age: 36.0
Sex: F
Vaccine: FLU4
Symptoms: Expired product administered, No adverse event
Clinical narrative: a female patient received a 0.5 ml dose of Fluzone Quadrivalent which was already expired on 30Jun2019/No AE; Initial information received on 18-Sep-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case is linked to cases 2019SA263367, 2019SA263393 and 2019SA263394 (same reporter).  This case involves a 36 years old female patient who received a 0.5 ml dose of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] Prefilled syringes which was already expired on 30-Jun-2019 lot UJ041AB via unknown route in the right deltoid on 17-Sep-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 expired vaccine used.  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization 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.
Age: 20.0
Sex: F
Vaccine: FLU4
Symptoms: Expired product administered, No adverse event
Clinical narrative: a female patient received a 0.5 ml dose of Fluzone Quadrivalent which was already expired on 30Jun2019/No AE; Initial information received on 18-Sep-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case is linked to cases 2019SA263392, 2019SA263367 and 2019SA263394 (same reporter).  This case involves a 20 years old female patient who received a 0.5 ml dose of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] Prefilled syringes which was already expired on 30-Jun-2019 lot UJ041AB via unknown route in the right deltoid on 17-Sep-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 expired vaccine used.  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization 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: F
Vaccine: FLU4
Symptoms: Expired product administered, No adverse event
Clinical narrative: patient received a 0.5 ml dose of Fluzone Quadrivalent which was already expired on 30Jun2019/No AE; Initial information received on 18-Sep-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case is linked to cases 2019SA263392, 2019SA263393 and 2019SA263367.  This case involves a female patient (age unknown) received a 0.5 ml dose of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] Prefilled syringes which was already expired on 30-Jun-2019 lot UJ041AB via unknown route in the left deltoid 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 due to expired vaccine used.  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization 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: Incorrect product formulation administered, Product preparation error, Product preparation issue
Clinical narrative: reconstituted the dry lyophilized component of the Hib vaccine with a sterile diluent and not the diluent provided in the packaging, no AE; Initial information received on 18-Sep-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves an unknown demographic patient who was vaccinated with a dose of DIPHTHERIA/TETANUS/2 AC PERTUSSIS/IPV (VERO)/HIB (PRP/T) VACCINE [PENTAXIM] reconstituted with a sterile diluent instead of diluent provided, lot number not reported via unknown route in an unknown administration site on an unknown date.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It is an actual medication error case due to inappropriate reconstitution technique. It was reported that the they reconstituted the dry lyophilized component of the Hib vaccine vial in the Pentacel packaging with a sterile diluent and not the diluent provided in the packaging.  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in 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, HEP, PNC13
Symptoms: Rash
Clinical narrative: Rash broke out in flat rashes in the back of his neck and right ear; Initial information received on 20-Sep-2019 regarding an unsolicited valid non-serious case received from a physician.  This case involves an infant patient who experienced rash broke out in flat rashes in the back of his neck and right ear (rash), while he/she received vaccines HEPATITIS B VACCINE, PREVNAR 13 and DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL].  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 via unknown route in the right thigh, a dose of suspect PREVNAR 13 not produced by Sanofi Pasteur lot number not reported via unknown route in the right thigh and a dose of suspect HEPATITIS B VACCINE not produced by Sanofi Pasteur lot number not reported via unknown route in the right thigh.  On an unknown date, the patient developed a non-serious rash broke out in flat rashes in the back of his neck and right ear (rash) 15 min following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE, PREVNAR 13 and HEPATITIS B VACCINE.  Other relevant tests were not reported.  Final diagnosis was rash broke out in flat rashes in the back of his neck and right ear.  It was not reported if the patient received a corrective treatment.  The patient outcome is reported as Unknown for the event.  Information on the batch number was requested  List of documents held by sender: none.
Sex: F
Vaccine: TD, TDAP
Symptoms: Inappropriate schedule of product administration, No adverse event, Wrong product administered
Clinical narrative: student requesting Adacel inadvertently received Tenivac, patient received 1st dose of Tenivac on 07/08/2019 and 2nd on 09/20/2019/ No AE; student requesting Adacel inadvertently received Tenivac/ No AE; Initial information received on 23-Sep-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves a 21 years old female patient who inadvertently received 0.5 mL dose vaccines DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC] on 08-Jul-2019 and 20-Sep-2019 (lot U6101AA, expiry date-23-10-2020 via intramuscular route in the left deltoid) instead of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  no other vaccines received.   It was a case of actual medication error due to wrong vaccine administered and inappropriate schedule of vaccine administered.  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Documents held by sender: none.
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Product preparation issue
Clinical narrative: a patient was administered the liquid only portion of the Pentacel vaccine which was the Dtap and polio and it was never reconstituted with Hib powder/No AE; Initial information received on 17-Sep-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to case 2019SA262075.  This case involves a 8 weeks old female (also reported as two months) patient who was administered the liquid only portion of the DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] vaccine which was the dtap and polio and it was never reconstituted with hib powder lot number and expiry date not reported via intramuscular route in the left thigh on 13-Sep-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS B VACCINE (HEPATITIS B VACCINE), PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVENAR 13) and ROTAVIRUS VACCINE (ROTAVIRUS VACCINE).  It was an actual medication error due to inappropriate reconstitution technique.  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization 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: U
Vaccine: DT, DTAP
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Vaccine tdap was given to a 9 ½ year old patient; Tdap or pediatric DTaP is inadvertently administered to a child, no adverse event; Initial information received on 23-Sep-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 9 years 6 months old patient who received fourth 0.5 mL vaccine DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE produced by unknown manufacturer lot U62772AA, expiry date-26-04-2021 via intramuscular route in the right deltoid on 23-Sep-2019, instead of DIPHTHERIA AND TETANUS TOXOIDS.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was a case of actual medication error due to inappropriate age at vaccine administration and wrong vaccine administered.   The reported queried that What should be give between the ages of 7-10 for Tetanus and Diphtheria. Reportedly Tdap or pediatric DTaP is inadvertently administered to a child aged 7-9 years instead of Td.  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Query for batch number reconfirmation was sent.  Documents held by sender: none.
Age: 6.0
Sex: U
Vaccine: TD
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Tenivac was given to a 6 year old in error, no AE; Initial information received on 24-Sep-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 6 years old patient who was vaccinated with a dose of DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC] lot number not reported via unknown route in an unknown administration site on an unknown date.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It is an actual medication error case due to Inappropriate age at vaccine administration. It was reported that the Tenivac was given to a 6 year old in error.  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Information on the batch number was requested  List of documents held by sender: none.
Age: 5.0
Sex: M
Vaccine: DTAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired Daptacel was given to the patient, no AE; Initial information received on 24-Sep-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 5 years old male patient who was inadvertently vaccinated with an expired fourth dose of 0.5 mL DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] lot C5254AA, expiry date: 18-Sep-2019 via intramuscular route in the right thigh on 23-Sep-2019.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included POLIO VACCINE INACT 3V (VERO) (IPOL [POLIO VACCINE INACT 3V (VERO)]) for Immunisation; and MEASLES VACCINE LIVE (ENDERS-EDMONSTON), MUMPS VACCINE LIVE (JERYL LYNN), RUBELLA VACCINE LIVE (WISTAR RA 27/3), VARICELLA ZOSTER VACCINE LIVE (OKA/MERCK) (PROQUAD) for Immunisation.  It is an actual medication error case due to expired vaccine used.  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Age: 11.0
Sex: F
Vaccine: FLU4, FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: 11 years old received Flublok instead of prescribed Fluzone Quadrivalent/ NO AE; 11 years old received Flublok instead of prescribed Fluzone Quadrivalent/ NO AE; Initial information received on 24-Sep-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp (Office Staff).  This case is linked with 2019SA267180, 2019SA267186, 2019SA267188 (same reporter)  This case involves a 11 years 6 months old female patient who was vaccinated with dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] instead of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 12 Sep 2019, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE , Frequency = once, lot QFAA1903, exp date: 19 May 2020 intramuscularly in left arm instead of prescribed dose of INFLUENZA QUADRIVAL A-B VACCINE lot number not reported.  It was a case of actual medication error due to inappropriate age at vaccine administration and wrong vaccine administered.  At the time of the report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error  List of documents held by the sender: none