chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: FLU4
Symptoms: Expired product administered, No adverse event
Clinical narrative: 4 patients were inadvertently given the expired vaccine, NO AE; Initial information received on 24-Sep-2019 regarding an unsolicited valid non-serious case received from a pharmacist.   This case involves four patients of an unknown demographics who received an expired vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] on an unknown date.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was a case of actual medication error due to expired vaccine used.  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 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.
Age: 89.0
Sex: F
Vaccine: FLU3
Symptoms: No adverse event, Product storage error
Clinical narrative: vaccines that are administered but have been deemed not suitable for use, the vaccines were on the truck on thursday but did not arrive to them until around 11 am / No AE; Initial information received on 24-Sep-2019 regarding an unsolicited valid non-serious case received from a consumer (office staff).  This case is linked to cases 2019SA267341, 2019SA267342, 2019SA267344, 2019SA267345 and 2019SA267346 (same reporter).  This case involves a 89 years old female patient who received 0.5mL dose of vaccines INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [FLUZONE] (lot UJ223AA, expiry-30-06-2020) via intramuscular route in the right deltoid.  It was a case an actual medication error due to incorrect product storage.  Caller is saying the vaccines were on the truck on Thursday but didn't arrive to them until around 11 AM but they did not hear until late in the day not to use them stating they received a message around 4:20 PM. Caller states as soon as they arrived she started giving injections and feels they should have been told earlier in the day that the vaccines shouldn't have been given.  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.  List of documents held by sender: none.
Sex: M
Vaccine: FLU4
Symptoms: No adverse event, Product storage error
Clinical narrative: vaccines that are administered but have been deemed not suitable for use, the vaccines were on the truck on thursday but didn't arrive to them until around 11 am/No AE; Initial information received on 24-Sep-2019 regarding an unsolicited valid non-serious case received from a consumer (office staff).  This case is linked to cases 2019SA267336, 2019SA267342, 2019SA267344, 2019SA267345 and 2019SA267346 (same reporter).  This case involves a 73 years old male patient who received 0.5mL dose of vaccines INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [FLUZONE] (lot UJ223AA, expiry-30-06-2020) via intramuscular route in the left deltoid.  It was a case an actual medication error due to incorrect product storage.  Caller is saying the vaccines were on the truck on Thursday but didn't arrive to them until around 11 AM but they did not hear until late in the day not to use them stating they received a message around 4:20 PM. Caller states as soon as they arrived she started giving injections and feels they should have been told earlier in the day that the vaccines shouldn't have been given.  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.  List of documents held by sender: none.
Age: 59.0
Sex: M
Vaccine: FLU3
Symptoms: No adverse event, Product storage error
Clinical narrative: vaccines that are administered but have been deemed not suitable for use, the vaccines were on the truck on thursday but didn't arrive to them until around 11 am/No AE; Initial information received on 24-Sep-2019 regarding an unsolicited valid non-serious case received from a consumer (office staff).  This case is linked to cases 2019SA267341, 2019SA267336, 2019SA267344, 2019SA267345 and 2019SA267346 (same reporter).  This case involves a 59 years old male patient who received 0.5mL dose of vaccines INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [FLUZONE] (lot UJ223AA, expiry-30-06-2020) via intramuscular route in the right deltoid on 23-Sep-2019.  It was a case an actual medication error due to incorrect product storage.  Caller is saying the vaccines were on the truck on Thursday but didn't arrive to them until around 11 AM but they did not hear until late in the day not to use them stating they received a message around 4:20 PM. Caller states as soon as they arrived she started giving injections and feels they should have been told earlier in the day that the vaccines shouldn't have been given.  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.  List of documents held by sender: none.
Sex: F
Vaccine: FLU4
Symptoms: No adverse event, Product storage error
Clinical narrative: vaccines that are administered but have been deemed not suitable for use. the vaccines were on the truck on Thursday but didn't arrive to them until around 11 AM / No AE; Initial information received on 24-Sep-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case is linked to cases 2019SA267341, 2019SA267342, 2019SA267336, 2019SA267345 and 2019SA267346 same reporter.  This case involves female patient who received 0.5mL dose of vaccines INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [FLUZONE] (lot UJ223AA, expiry-30-06-2020) via intramuscular route in the left deltoid.  It was a case of actual medication error due to incorrect product storage. Caller is saying the vaccines were on the truck on Thursday but didn't arrive to them until around 11 AM but they did not hear until late in the day not to use them stating they received a message around 4:20 PM. Caller states as soon as they arrived she started giving injections and feels they should have been told earlier in the day that the vaccines shouldn't have been given.  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: M
Vaccine: FLU3
Symptoms: No adverse event, Product storage error
Clinical narrative: vaccines that are administered but have been deemed not suitable for use. the vaccines were on the truck on Thursday but didn't arrive to them until around 11 AM / No AE; Initial information received on 24-Sep-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.   This case is linked to cases 2019SA267341, 2019SA267342, 2019SA267344, 2019SA267336 and 2019SA267346 same reporter.  This case involves 60 years male patient who received 0.5mL dose of vaccines INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [FLUZONE] (lot UJ223AA, expiry-30-06-2020) via intramuscular route in the left deltoid but have been deemed not suitable for use.  It was a case of actual medication error due to incorrect product storage. Caller is saying the vaccines were on the truck on Thursday but didn't arrive to them until around 11 AM but they did not hear until late in the day not to use them stating they received a message around 4:20 PM. Caller states as soon as they arrived she started giving injections and feels they should have been told earlier in the day that the vaccines shouldn't have been given.  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.
Age: 42.0
Sex: M
Vaccine: FLU4
Symptoms: No adverse event, Product storage error
Clinical narrative: vaccines that are administered but have been deemed not suitable for use. the vaccines were on the truck on Thursday but didn't arrive to them until around 11 AM / 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 to cases 2019SA267341, 2019SA267342, 2019SA267344, 2019SA267345 and 2019SA267336 same reporter.  This case involves 42 years male patient who received 0.5mL dose of vaccines INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [FLUZONE] (lot UJ223AA, expiry-30-06-2020) via intramuscular route in the right deltoid but have been deemed not suitable for use.  Patient past medial history, vaccination, treatment and family history not reported.  No other vaccine was given.  It was a case of actual medication error due to Product storage error.  Caller is saying the vaccines were on the truck on Thursday but didn't arrive to them until around 11 AM but they did not hear until late in the day not to use them stating they received a message around 4:20 PM. Caller states as soon as they arrived she started giving injections and feels they should have been told earlier in the day that the vaccines shouldn't have been given.  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.
Age: 11.0
Sex: F
Vaccine: FLU3, FLUR4, HPV4
Symptoms: Extra dose administered, No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: patient received 2 flu vaccines Flublok and Fluzone Quadrivalent, It was intended that the patient receive Gardasil with an influenza vaccine/ No AE; Patient received 2 flu vaccines Flublok and Fluzone Quadrivalent, It was intended that the patient receive Gardasil with an influenza vaccine. They were picked back up, a Flublok syringe was picked up in place of the Gardasil syringe/ No AE; 11 year old patient received 2 flu vaccines Flublok and Fluzone Quadrivalent, It was intended that the patient receive Gardasil with an influenza vaccine/ 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 involves a 11 years old female patient who received vaccines INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] lot QFAA1903, expiry May-2020 via unknown route in the right arm and INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [FLUZONE] lot UJ223AA via unknown route in the left arm On 23-Sep-2019. The patient received FLUBLOK QIV instead of HPV VACCINE VLP RL1 4V (YEAST) [GARDASIL].   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  No other vaccines received. Notes: The patient does not have an egg allergy   It was a case of actual medication error due to Extra dose administered, Inappropriate age at vaccine administration and wrong vaccine administered. It was intended for the patient to receive influenza vaccine and Gardasil. Two medical assistants were working with the same physician. The Medical Assistant laid the shots down after they were prepared, and then when they were picked back up, a Flublok prefilled syringe was picked up in place of the Gardasil prefilled syringe. The caller stated that the patient "weighs a lot" and she was hoping that the weight of the patient might mitigate any adverse effect of receiving a double dose of influenza vaccine  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: U
Vaccine: TDAP
Symptoms: Extra dose administered
Clinical narrative: 11 year old child received Adacel, 8 months later, received second immunization/ NO AE; Initial information received on 23-Sep-2019 regarding an unsolicited valid non-serious case received from a other health professional. Additional information was received on 24-Sep-2019   This case involves a 11 year old received DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL], 8 months later, received second immunization but not received previous DTAP.  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 1  dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot number not reported via intramuscular route. 1 other doses were administered on unknown dates for suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE.  It was a case of actual medication error due to extra dose administered.  It was not reported 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.
Sex: F
Vaccine: FLUR4
Symptoms: Exposure during pregnancy, Headache, Heart rate decreased, Hypertension, Neuropathy peripheral
Clinical narrative: left side swelling neuropathy; high Blood pressure; low Heart rate; severe headache; 38 weeks pregnant female received Flublok QIV; Initial information received on 24-Sep-2019 regarding an unsolicited valid serious case received from a nurse.  This case involves female patient of an unknown age who experienced left side swelling neuropathy (neuropathy peripheral), high Blood pressure (hypertension), low Heart rate (heart rate decreased) and severe headache (headache) and was 38 weeks pregnant, while she received vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV].   Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known.   The date of last menstrual period was not reported.  The estimated due date was not reported.  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 INFLUENZA QUADRIVALENT RECOMBINANT VACCINE lot number not reported via intramuscular route in unknown administration site.  On an unknown date, the patient developed a serious left side swelling neuropathy (neuropathy peripheral), high Blood pressure (hypertension), low Heart rate (heart rate decreased) and severe headache (headache) (Unknown latency) following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE. The patient was hospitalized for this event.  It was also the case of Vaccine exposure during pregnancy.  (Other relevant tests included no lab data.)  Final diagnosis was severe headache, low Heart rate, high Blood pressure and left side swelling neuropathy.  It was not reported if the patient received a corrective treatment.  The outcome of the event was reported as Unknown for all the events.  Pregnancy outcome was unknown at the time of report.  Information on the batch number was requested  Documents held by sender: none.; Sender's Comments: Patient experienced peripheral neuropathy, high blood pressure, decreased heart rate, severe headache after vaccination. Time to onset is unknown. However, further information including patient's medical history, concomitant medications, previous vaccination and tolerance, laboratory investigations excluding other etiology would be needed to fully assess this case. Based on available information the role of vaccine cannot be assessed.
Sex: F
Vaccine: FLUR4
Symptoms: Swelling
Clinical narrative: left side swelling neuropathy; high Blood pressure; low Heart rate; severe headache; 38 weeks pregnant female received Flublok QIV; Initial information received on 24-Sep-2019 regarding an unsolicited valid serious case received from a nurse.  This case involves female patient of an unknown age who experienced left side swelling neuropathy (neuropathy peripheral), high Blood pressure (hypertension), low Heart rate (heart rate decreased) and severe headache (headache) and was 38 weeks pregnant, while she received vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV].   Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known.   The date of last menstrual period was not reported.  The estimated due date was not reported.  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 INFLUENZA QUADRIVALENT RECOMBINANT VACCINE lot number not reported via intramuscular route in unknown administration site.  On an unknown date, the patient developed a serious left side swelling neuropathy (neuropathy peripheral), high Blood pressure (hypertension), low Heart rate (heart rate decreased) and severe headache (headache) (Unknown latency) following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE. The patient was hospitalized for this event.  It was also the case of Vaccine exposure during pregnancy.  (Other relevant tests included no lab data.)  Final diagnosis was severe headache, low Heart rate, high Blood pressure and left side swelling neuropathy.  It was not reported if the patient received a corrective treatment.  The outcome of the event was reported as Unknown for all the events.  Pregnancy outcome was unknown at the time of report.  Information on the batch number was requested  Documents held by sender: none.; Sender's Comments: Patient experienced peripheral neuropathy, high blood pressure, decreased heart rate, severe headache after vaccination. Time to onset is unknown. However, further information including patient's medical history, concomitant medications, previous vaccination and tolerance, laboratory investigations excluding other etiology would be needed to fully assess this case. Based on available information the role of vaccine cannot be assessed.
Age: 34.0
Sex: F
Vaccine: FLU4
Symptoms: Expired product administered, Exposure during pregnancy, No adverse event
Clinical narrative: consumer was given Fluzone Quadrivalent 0.5 mL that was expiredwho was 35-weeks pregnant, no AE; consumer was given Fluzone Quadrivalent 0.5 mL that was expired, no AE; Initial information received on 24-Sep-2019 regarding an unsolicited valid non-serious case received from non-healthcare professional.  This case involves a 34 years old female patient who received 0.5 ml dose of expired vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (lot U63O2AA, Exp. Date 30-Jun-2019) via intramuscular route in the left deltoid, on 24-Sep-2019 and was 35 weeks pregnant.   Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known. The gestation period at onset was reported as 35 weeks. The date of last menstrual period was not reported. The estimated due date is 27-Oct-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing gestational diabetes.  It was a case of actual medication error due to expired vaccine used.  It was also a case of vaccine exposure during pregnanacy.  It was reported that a consumer was given Fluzone Quadrivalent 0.5 mL that was expired. The caller reported that the consumer received the dose on the morning of 24-Sep-2019, the vaccine expiration was on 30-Jun-2019. The consumer is 35-weeks pregnant.  At the time of reporting, no adverse reactions were reported.  Additionally, at time of reporting, the outcome of the pregnancy was unknown.  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: 26.0
Sex: F
Vaccine: FLU4
Symptoms: Exposure during pregnancy, Syringe issue, Underdose
Clinical narrative: 26 years old pregnant patient recieved Fluzone Quadrivalent, no AE; while needle in the patients arm, pushed the plunger, and liquid leaked where the needle meets the syringe, no AE; vaccine leaked while injecting, patient received partial dose, no AE; Initial information received on 24-Sep-2019 regarding an unsolicited valid non-serious case received from a Nurse.  This case involves a 26 years old female patient who was pregnant and received partial dose of vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (lot UJ212AB, Exp. Date 30-Jun-2020) via intramuscular route in the left deltoid, on 24-Sep-2019 .  Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known. The patient was exposed to INFLUENZA QUADRIVAL A-B VACCINE at 8 weeks of pregnancy, during first pregnancy trimester for INFLUENZA QUADRIVAL A-B VACCINE. The date of last menstrual period was reported as 29-Jul-2019. The estimated due date is 13-May-2020. 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 vaccine underdose.  It was a case of vaccine exposure during pregnancy, syringe leak.  It was reported that vaccine leaked while injecting the patient with pre-filled 0.5 mL syringe. When asked how nurse connected the needle to syringe, she stated she twisted needle. She stated it appeared normal until pushing the plunger while needle in patients arm. Patient received partial dose, caller stated liquid leaking from multiple areas around syringe where needle meets syringe.  At the time of reporting, no adverse reactions were reported.  Additionally, at time of reporting, the outcome of the pregnancy was unknown.  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: FLU3
Symptoms: Exposure via breast milk, No adverse event
Clinical narrative: administered Fluzone High-Dose to a breastfeeding mother, no AE; Initial information received on 19-Sep-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case is linked to case 2019SA263295 (mother case).  This case involves infant patient who was exposed to 0.5 ml dose of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] (lot number: UJ238AB Expiry date 14-Apr-2020) at the time of lactation, via transmammary route, on 19-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 case due to vaccine exposure via breast milk.   At a time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Sex: F
Vaccine: TDAP
Symptoms: Limb deformity, Peripheral swelling
Clinical narrative: permanent swelling on her arm which permanently deformed on her arm related to the Adacel vaccine.; permanent swelling on her arm which permanently deformed on her arm related to the Adacel vaccine.; Initial information received on 25-Sep-2019 regarding an unsolicited valid serious case received from a consumer/non-hcp.  This case involves a female patient (unknown age) who experienced swelling on her arm which permanently deformed on her arm (peripheral swelling) (Arm deformity), while she received vaccine 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.   On an unknown date (5 years ago), the patient received a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot number not reported via unknown route in unknown administration site.  On an unknown date, the patient had swelling on her arm which permanently deformed on her arm (peripheral swelling) (Arm deformity) (Unknown latency) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE. These events was considered as medically significant.  Lab data was not reported.  Final diagnosis was peripheral swelling and Arm deformity.   It was not reported if the patient received a corrective treatment.  The patient was not recovered from the swelling on arm and Arm deformity.  Information on batch number is requested.  List of document held by sender: none.; Sender's Comments: This case concerns a female patient who had limb deformity and peripheral swelling, following the vaccination with ADACEL. The time to onset was unknown. The patient's past medical history, concomitant medications, conditions at the time of vaccination and lab data ruling out other etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of the vaccine cannot be assessed.
Age: 48.0
Sex: M
Vaccine: FLU3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 48 years old patient was accidentally administered Fluzone High Dose on 24Sep2019, no AE; 48 years old patient was accidentally administered Fluzone High Dose on 24Sep2019, no AE; Initial information received on 25-Sep-2019 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 48 years old male patient who was accidentally administered with a 0.5 mL dose of vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] (lot UJ221AB, expiry date: 01-Apr-2020) via intramuscular route in the left deltoid on 24-Sep-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was a case of actual medication error due to inappropriate age at vaccine administration and overdose.  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.  Documents held by sender: none.
Age: 54.0
Sex: M
Vaccine: RAB
Symptoms: No adverse event, Product administered at inappropriate site
Clinical narrative: gave Imovax in the gluteal area, NO AE; Initial information received on 25-Sep-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves an 54 year old male patient who was vaccinated with dose of RABIES (HDC) VACCINE [IMOVAX RABIES] in the gluteal area.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 24-Sep-2019, the patient received a 1 ml first dose of suspect RABIES (HDC) VACCINE lot N1L13, exp date: Nov 14, 2019 via unknown route in the gluteal area due to bat exposure.  It was a case of actual medication error due to Vaccine administered at inappropriate site.  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
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain, Swelling
Clinical narrative: pt reported symptoms of swelling, redness, soreness, and nausea that began the day prior to receiving the vaccine.
Age: 30.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity
Clinical narrative: Arm pain since given the shot on 9/18
Age: 84.0
Sex: F
Vaccine: FLUA3
Symptoms: Dry mouth, Feeling cold, Thirst
Clinical narrative: Patient reports she became extremely cold the evening of her vaccine and has remained cold constantly since then. In addition, patient states she has developed a very dry mouth and extreme thirst. Patient states there has been no fever or other symptoms during this period. Patient reports no new medications or changes in routine outside of the flu vaccine. Patient was referred to her doctor for evaluation. Patient was convinced these symptoms were from the vaccine and requested we report as an adverse event on her behalf.
Age: 66.0
Sex: F
Vaccine: UNK
Symptoms: Chest discomfort, Cough, Secretion discharge, Wheezing
Clinical narrative: Within a half hour the patient could feel a tightness in her bronchial passageway. She does not feel like it was life threatening. In about half an hour after onset of symptoms, the patient began to cough. In the evening she began wheezing with little bits of mucous. Patient sought treatment from pharmacist via phone and primary care physician after hours via phone (nurse practitioner provided phone support). Nurse advised that the patient visit urgent care. Patient declined. Patient took ibuprofen.
Age: 39.0
Sex: M
Vaccine: FLUC4, TDAP
Symptoms: Malaise, Nausea, Pyrexia, Vomiting
Clinical narrative: Patient called about 5-6 hours after vaccination stating he was not feeling well. He had fever, nausea and vomiting. Went to ER, but they measured his blood pressure and it was normal, they just sent him home. Followed-up with the patient the next morning, he stated his symptoms are much better now and are resolving.
Age: 19.0
Sex: F
Vaccine: JEV1
Symptoms: Diarrhoea, Nausea, Urticaria, Vomiting
Clinical narrative: Patient had nausea, vomiting several hours after getting vaccine. The morning after receiving the vaccine she awoke with "hives" that resolved. She then presented to the emergency room with only symptoms of vomiting/diarrhea
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injection site erythema, Pyrexia
Clinical narrative: Low grade fever ~100 degrees;  erythema extending in a 2 inch radius from injection site.; chills
Age: 58.0
Sex: F
Vaccine: TDAP
Symptoms: Ecchymosis, Periorbital oedema
Clinical narrative: Periorbital edema and ecchymosis- patient woke up the day after the vaccine with this. Presented to office 2 days after the vaccine. treatment- cool compresses, antihistamine.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Site of injection became swollen, red, hot to touch a few hours after injection.  Redness and heat spread to several inches and remained >24 hours.  Saw occupational health nurse and MD who provided zyrtec and pepcid to reduce histamine reaction.  48 later area is still red, swollen, and warm to touch but improving.
Age: 81.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Chills, Headache, Pyrexia
Clinical narrative: fever, chills, joint pain, headache
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Back pain, Gastrointestinal pain, Headache, Musculoskeletal pain
Clinical narrative: Headache, intestinal ache, aching in neck, shoulders, back, elbows wrists, hands, hips, knees, feet
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Neck pain, Pain in extremity
Clinical narrative: Headache, intestinal ache, aching in neck, shoulders, back, elbows wrists, hands, hips, knees, feet
Age: 28.0
Sex: F
Vaccine: FLU4, VARCEL
Symptoms: Asthenia, Hyperhidrosis, Immediate post-injection reaction, Injection site pruritus, Pallor
Clinical narrative: weak, sweaty, pale (? vasovagal) immediately after Flu vaccine. Itching at injection site L arm began within 5 minutes and spread to chest. Throat felt tight and lips tingled within 30 minutes.
Age: 28.0
Sex: F
Vaccine: FLU4, VARCEL
Symptoms: Paraesthesia oral, Pruritus, Throat tightness
Clinical narrative: weak, sweaty, pale (? vasovagal) immediately after Flu vaccine. Itching at injection site L arm began within 5 minutes and spread to chest. Throat felt tight and lips tingled within 30 minutes.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect reported; patient received improperly stored PROQUAD; This spontaneous report was received from a medical assistant referring to a patient of unknown age. The patient's pertinent medical history, concurrent conditions and drug reactions/allergies were not provided.   On 05-SEP-2019, the patient was vaccinated with an improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) lot # S002494 (verified to be a valid lot number), expiration date reported and established as 23-JUL-2020, for prophylaxis. The measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) was reconstituted with a properly stored sterile diluent.  The vaccine was improperly stored at a temperature between 6°F to 14°F (10.2°F, multiple) during a time frame of 50 minutes. The call was because of a data logger and no adverse effect neither previous temperature excursions were reported.  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-1909USA005231:
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; a patient was administered an expired MMR Il vaccine; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 11-SEP-2019, the patient was vaccinated with an expired dose of with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) lot # N027779 has been verified to be a valid lot number, expiration date 08-AUG-2019, recombinant Human albumin (exact dose, dose number, route and site of administration were not reported) for prophylaxis. No adverse event was reported. The outcome of the events was unknown.
Age: 0.58
Sex: M
Vaccine: RV5
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: no adverse effect; a 7 month old infant received a first dose of Rotateq on 12-SEP-2019; This spontaneous report was received from a medical assistant and refers to a 7-month-old male patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 12-SEP-2019, the infant was vaccinated with the first dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, 1 dose, orally, lot # R035374 and expiration date 15-SEP-2020 (exact dose was not reported) for prophylaxis, outside of prescribing information. No adverse effect was reported.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse effects reported; expired MMR II (N024703 9/8/2019) was administered to a patient on 9/30/2019; This spontaneous report was received from a medical assistant and refers to an identifiable patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions, allergies or concomitant therapies was provided. On 30-SEP-2019, the patient was vaccinated with expired measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHa) (M-M-R II), lot # N024703, expiration date 08-SEP-2019 (strength, dose, route of administration were not reported) for prophylaxis. It was reconstituted with not expired sterile diluent (lot # S025290, expiration date 20-MAR-2022). There was no temperature excursion for the vaccine and for the diluent. No adverse effect were reported.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; Information has been received from a lawyer concerning a case in litigation and refers to a 61 year old female patient. No information regarding the pt's medical history, concurrent conditions and concomitant medications was reported. On 09-OCT-2014, the pt was vaccinated with zoster vaccine live (ZOSTAVAX) injection (dose, route of administration, vaccination site, lot # and expiry date were not specified) for prophylaxis, at a pharmacy. As a result of her receipt of zoster vaccine live (ZOSTAVAX), on 17-FEB-2015, the pt was caused to suffer shingles, including any and all of its sequelae. As a result of her receipt of zoster vaccine live (ZOSTAVAX), the pt has been caused to suffer severe personal injuries, pain, suffering, and emotional distress, as well as to incur substantial economic damages. As a foreseeable, direct, and proximate consequence of Company's actions, omissions, and misrepresentations, the pt suffered shingles and other related health complications. In addition, the pt required and would continue to require healthcare and services. The pt had incurred and would continue to incur medical and related expenses. The pt also had suffered and would continue to suffer diminished capacity for the enjoyment of life, a diminished quality of life, increased risk of premature death, aggravation of preexisting conditions, activation of latent conditions, and other losses and damages. The pt's direct medical losses and costs include physician care, monitoring, and treatment. The pt had incurred and would continue to incur mental and physical pain and suffering. The outcome of the event was not recovered. The causality was related.  The event of shingles was considered to be disabling.
Sex: F
Vaccine: FLU4
Symptoms: Caesarean section, Cardiovascular insufficiency, Foetal exposure during pregnancy, Low birth weight baby, Premature baby
Clinical narrative: reverse blood flow; babies were in the same sack; Maternal exposure; Low birth weight; premature birth; Live birth; This retrospective pregnancy case was reported by a nurse via call center representative and described the occurrence of cardiovascular insufficiency in a female patient exposed to Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2018-2019 season) (batch number D4E29, expiry date 30th June 2019) in utero. The mother received the product for prophylaxis.   On 26th October 2018, the 23-year-old mother received Fluarix Quadrivalent 2018-2019 season .5 ml. The mother's last menstrual period was on 18th July 2018 and estimated date of delivery was 25th April 2019. The patient was exposed to Fluarix Quadrivalent 2018-2019 season at week 14 of gestation and during the second trimester of pregnancy. At 31 weeks and 1 day, the patient was born via cesarean delivery. The patient was diagnosed with birth weight low, premature birth and live birth. On an unknown date, the patient experienced cardiovascular insufficiency (serious criteria GSK medically significant), monoamniotic twin pregnancy and maternal exposure during pregnancy. On an unknown date, the outcome of the cardiovascular insufficiency, birth weight low, premature birth, live birth, monoamniotic twin pregnancy and maternal exposure during pregnancy were unknown.   It was unknown if the reporter considered the cardiovascular insufficiency and birth weight low to be related to Fluarix Quadrivalent 2018-2019 season. The reporter considered the premature birth to be unrelated to Fluarix Quadrivalent 2018-2019 season.     See case US2018199479 for details regarding the mother case.  Additional details were provided as follows: The patient's mother did not had any known medical history. One hundred and eighteen days after receiving the vaccine to the patient's mother, premature delivery led to premature birth. The Nurse reported that the twin babies were in same sack and one twin did not get adequate blood flow also there was reverse blood flow to one twin. The reporter considered that the event premature birth was not due to the flu shot. It was unknown, if the reporter considered the event cardiovascular insufficiency was related to Flu Seasonal QIV Dresden. The VARS details were updated. This is 1 of 3 cases linked for parent-child cases.
Sex: F
Vaccine: FLU4
Symptoms: Twin pregnancy
Clinical narrative: reverse blood flow; babies were in the same sack; Maternal exposure; Low birth weight; premature birth; Live birth; This retrospective pregnancy case was reported by a nurse via call center representative and described the occurrence of cardiovascular insufficiency in a female patient exposed to Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2018-2019 season) (batch number D4E29, expiry date 30th June 2019) in utero. The mother received the product for prophylaxis.   On 26th October 2018, the 23-year-old mother received Fluarix Quadrivalent 2018-2019 season .5 ml. The mother's last menstrual period was on 18th July 2018 and estimated date of delivery was 25th April 2019. The patient was exposed to Fluarix Quadrivalent 2018-2019 season at week 14 of gestation and during the second trimester of pregnancy. At 31 weeks and 1 day, the patient was born via cesarean delivery. The patient was diagnosed with birth weight low, premature birth and live birth. On an unknown date, the patient experienced cardiovascular insufficiency (serious criteria GSK medically significant), monoamniotic twin pregnancy and maternal exposure during pregnancy. On an unknown date, the outcome of the cardiovascular insufficiency, birth weight low, premature birth, live birth, monoamniotic twin pregnancy and maternal exposure during pregnancy were unknown.   It was unknown if the reporter considered the cardiovascular insufficiency and birth weight low to be related to Fluarix Quadrivalent 2018-2019 season. The reporter considered the premature birth to be unrelated to Fluarix Quadrivalent 2018-2019 season.     See case US2018199479 for details regarding the mother case.  Additional details were provided as follows: The patient's mother did not had any known medical history. One hundred and eighteen days after receiving the vaccine to the patient's mother, premature delivery led to premature birth. The Nurse reported that the twin babies were in same sack and one twin did not get adequate blood flow also there was reverse blood flow to one twin. The reporter considered that the event premature birth was not due to the flu shot. It was unknown, if the reporter considered the event cardiovascular insufficiency was related to Flu Seasonal QIV Dresden. The VARS details were updated. This is 1 of 3 cases linked for parent-child cases.