chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 33.0
Sex: F
Vaccine: TDAP
Symptoms: Pyrexia, Sinus tachycardia
Clinical narrative: Vaccine received at 27 weeks 2 days pregnant. Baby's due date is 10/27/2018. This is my second pregnancy. I had this same vaccine during my first pregnancy with no reactions. I did receive the vaccine a few weeks later with pregnancy #1 around 32 weeks I believe. I have also had this vaccine when I was not pregnant previously with no reactions. I woke up 7/31/18 with body aches, chills, low grade fever 99.1 orally, fatigue, and overall just feeling miserable and flu like. I took Tylenol about every 4 hours and the symptoms subsided. These flu symptoms were gone the next day. However, I developed different symptoms later in the day. Later that same day 7/31/18 around 5pm I noticed I was increasing fatigued (more than the morning) and winded with very minimal activity. My heart rate would increase to about 130 and I was short of breath/winded with very light activity such as walking 15 feet at a very slow pace. I would have to stop and sit down and rest for a few mins and my heart rate would come down and I could start again. Activity such as doing a load of laundry or washing the dishes caused in increase in HR/SOB as well which was not the case prior even being pregnant. 8/1/18 the elevated heart rate and shortness of breath continued and prompted a trip to the ED. After multiple tests it was determined I had a likely inflammatory reaction to the Tdap vaccine. These symptoms finally subsided 8/12/2018. I was told to increase hydration and take it easy. If it would have persisted a beta blocker was the next step but I did not need that.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product reconstitution quality issue
Clinical narrative: This spontaneous report was received from a registered nurse who refers to a patient of unknown age and gender. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On 31-JUL-2018, the patient was vaccinated with VARIVAX lot # R003301, expiration date 01-FEB-2020 (dose and route of administration were not reported) which was reconstituted with sterile diluent (STERILE DILUENT) (lot # and expiration date were not reported) for prophylaxis. The VARIVAX was administered 40 minutes after reconstitution. No adverse effects were reported.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash, Skin lesion
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 16-JAN-2015, the patient received the ZOSTAVAX (lot number, dosage and route of administration not provided), for its intended purpose the prevention of shingles. On 02-OCT-2016, the patient suffered from a shingles outbreak, in addition to chronic pain, rash and lesions to various parts of his body as a direct result of the ZOSTAVAX. As a direct result of ZOSTAVAX vaccine, the patient suffered mental and emotional distress due to resulting physical limitations and seriousness of his condition. The patient has suffered serious, progressive, permanent, and incurable injuries, as well as conscious pain and suffering, mental and emotional distress, loss of enjoyment of life, physical impairment and injury. The patient has incurred medical expenses and other economic harm as a direct result of ZOSTAVAX use. The outcome of the event was unknown. Causality assessment was related. The event of shingles outbreak was considered disabling. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Pain, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 14-OCT-2013, the patient was inoculated with the ZOSTAVAX vaccine as recommended for routine adult health maintenance for prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. On or about 05-OCT-2016, the patient was treated for a blistering vesicular outbreak that was diagnosed as severe herpes zoster. The patient was prescribed famciclovir for management of his painful symptoms and chronic pain. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 31-OCT-2007, the patient was inoculated with the ZOSTAVAX vaccine as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot number not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. On or about 19-OCT-2016, the patient was treated for a blistering vesicular outbreak that was diagnosed as severe herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown.  Causality assessment was related. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: HIBV, MENB, MNQ, PPV
Symptoms: Fatigue, Hypotension, Injection site erythema, Respiratory rate increased, Tachycardia
Clinical narrative: Generalized fatigue and hypotension at home. The patient states her blood pressure has been running 80s/50s. She denies any fevers or chills. The patient does have a history of ovarian cancer. She has erythema noted to the right upper arm. Her inital vital signs show the patient is tachycardic, hypotensive and increased respiration. Sepsis protocol was initated. The patient is given ROCEPHIN and vancomycin in the ED. Her vital signs improved after fluids.
Age: 5.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth, Local reaction
Clinical narrative: Mom called to say that patient received his Var shot on Thursday and now his leg was red, raised, hard, and warm to the touch. Mom brought patient in and was evaluated. Encourage to ice the site and bathing with Ecson salt. Informed mom that the reaction is local. Mom to keep an eye out for signs of infection. Reaction did not seemed to bother the patient. No fever or other symptoms reported.
Age: 2.0
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Irritability, Pyrexia, Skin discolouration
Clinical narrative: Guardian of pt. says symptoms began 8/25/18 with increased irritability, discoloration of skin on his back and a fever of 102. Patient was given BENADRYL for his back and TYLENOL for temperature. Says today he is back to normal.
Age: 19.0
Sex: M
Vaccine: VARCEL
Symptoms: Blister
Clinical narrative: This spontaneous report was received from a nurse and refers to a 19-year-old male patient. The patient had no pertinent medical history, drug reactions or allergies and there was no concomitant medications. On 18-JUL-2018, the patient was vaccinated with a dose of VARIVAX (lot # R002507, expiration date: 25-JAN-2020, dose, site and route of administration were not provided) for prevention of chickenpox. On 27-JUL-2018, the patient experienced an outbreak of vesicles over his torso. The patient was isolated and treated with calamine lotion. No lab diagnostics/studies were performed. The outcome of an outbreak of vesicles over the patient's torso was reported as not recovered. The relatedness between an outbreak of vesicles over the patient's torso and VARIVAX was not reported.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Product storage error
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to 4 year old female patient. There was no information about concurrent condition, concomitant medication and historical medication. On 01-AUG-2018, the patient was vaccinated with Oka-Merck PROQUAD lot # R002935 dose 1, subcutaneous in the left arm for prophylaxis. Other suspect therapies included KINRIX. Medication error occurred at the time of storage in clinical practice (Product storage error). Digital data logger was involved. This is one of several reports received from the same reporter.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist refers to a patient of unknown age and gender. The patient's concomitant medications, pertinent medical history, drug reactions or allergies were not reported. In November 2017, the patient was vaccinated with first dose of GARDASIL 9 (lot #, expiration date, dose, strength and route of administration were not provided) for prophylaxis. On 07-AUG-2018, the patient was vaccinated with the second dose of GARDASIL 9 (lot # R010596, expiration date 11-DEC-2020) (dose, strength and route of administration were not provided) for prophylaxis. No adverse effect was reported.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous case was reported from a nurse concerning a 18 years old, patient of unknown gender. The patient's concurrent, historical conditions, concomitant medications and drug reactions or allergies were not provided. The patient was vaccinated with the first dose of GARDASIL 9 series for prophylaxis (dose, route, anatomical side of injection, lot#, date of expiration were not reported) on unspecified dates, outside the recommended dosing schedule according to the prescribing information. No adverse effects were reported.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse 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 21-AUG-2018, the patient was inadvertently vaccinated with PROQUAD therapy, lot # R008196, expiration date 16-SEP-2019 (dose nd route of administration were not reported). The vaccine was reconstituted with properly stored sterile diluent (lot# and expiration date were not provided). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion between 6 to 14 degrees Fahrenheit for 6 hours and between 15 to 46 degrees Fahrenheit for 5 hours and 45 minutes. Data logger was not involved. It was not reported if there were any previous excursions. No product quality complaint (PQC) was involved.
Sex: M
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a physician and refers to a male patient of unknown age. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On an unknown date, the patient was subcutaneously vaccinated with an improperly stored dose of Oka-Merck PROQUAD therapy type rHA (recombinant human albumin), lot # N015622, expiration date 15-NOV-2019 (dose was not reported). The vaccine was reconstituted with sterile diluent (lot# N030413, expiration date 05-JUL-2020). No adverse effect reported. Administered dose of vaccine experienced the temperature excursion between 6 to 14 degrees Fahrenheit for 24 hours. Data logger was involved. There were no previous excursions reported. No product quality complaint (PQC) was involved.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2013, the patient was inoculated with the ZOSTAVAX vaccine as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot number not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. In 2014, the patient was treated for a blistering vesicular outbreak that was diagnosed as severe herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 27-FEB-2013, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided), as recommended for routine adult health maintenance for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. On or about 21-DEC-2015, the patient was treated for a blistering vesicular outbreak that was diagnosed as severe herpes zoster or shingles. The outcome of the events is unknown. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for the long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received on 23-AUG-2018 regarding a case in litigation from a lawyer and a female consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. On or about 10-DEC-2014, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route at a healthcare facility as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. In 2015, the patient was treated by a physician at a medical center for a blistering vesicular outbreak, which was diagnosed as severe herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX and/or despite receiving the ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses and pain and suffering and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received on 23-AUG-2018 regarding a case in litigation from a lawyer and a female consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. In 2013, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route by a physician as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. On or about 23-OCT-2016, the patient was treated by a medical group for a blistering vesicular outbreak, which was diagnosed as severe herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX and/or despite receiving the ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses and pain and suffering and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On an unknown date in 2011, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided) at a pharmacy, as recommended for routine adult health maintenance for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. On an unknown date in 2016, the patient was treated by a physician for a blistering vesicular outbreak that was diagnosed as severe herpes zoster or shingles. The outcome of the events is unknown. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for the long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: U
Vaccine: PNC13
Symptoms: Local reaction
Clinical narrative: This is a spontaneous report from a contactable other HCP received via a sales representative. A patient of unspecified age and gender received PREVNAR 13 (batch/lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient had a local reaction with pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein) on an unspecified date thus would like to discuss if PNEUMO 23 was contraindicated. The outcome of the event was unknown. The information on the batch/lot number and expiration date has been requested.
Sex: M
Vaccine: HEP, MENB
Symptoms: Rash
Clinical narrative: This is a spontaneous report from a contactable consumer (medical assistant) via a Pfizer sales representative. A male patient of an unspecified age received TRUMENBA, hepatitis b vaccine (HBV), both via an unspecified route of administration on the same arm on an unspecified date at single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient experienced rash after concomitant administration with HBV on the same arm on an unspecified date with outcome of unknown.
Sex: F
Vaccine: DTAPIPV, HEPA
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Initial information received on 08-Aug-2018 regarding an unsolicited valid non-serious case received from a non-hcp (Office Staff). This case involves a two-years-old female patient for whom the doctor ordered DTaP and polio vaccine separately, but QUADRACEL was inadvertently administered, no adverse event. The patient's past vaccination(s) included three doses of PENTACEL vaccine. The patient's past medical history, medical treatment(s) and family history were not provided. Concomitant medications included a dose of HAVRIX for Immunisation. On 03-Aug-2018, the patient received 0.5 ml dose of suspect QUADRACEL lot c5248aa, exp date: 21-August-2019 via intramuscular route in the left thigh. This is the case of medication error due to wrong vaccine administered and inappropriate age at vaccine administration. No adverse event or symptoms were noted. 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: 0.5
Sex: U
Vaccine: DTAPIPV, PNC13
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Initial information received on 10-Aug-2018 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 6 months old patient (gender not reported) who was vaccinated with a 0.5 ml dose of QUADRACEL (Batch number: B5325BA) via intramuscular route in the left thigh on 09-May-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included PREVENAR for Immunisation; and CINNARIZINE for Product used for unknown indication on an unknown date. It was a case of actual medication error due to inappropriate age at vaccine administration because QUADRACEL given to a six-month old baby child. No adverse event symptoms have been 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 the sender: None.
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy
Clinical narrative: Initial information received on 16-Aug-2018 regarding an unsolicited valid non-serious case received from a consumer. This case involves female patient who received ADACEL (batch number, expiry date, route and site of administration were not reported) on an unspecified date. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The last menstrual period and estimated date of delivery was not reported. At the time of vaccination the patient was pregnant. Lab data not reported. It was unknown if any adverse event occurred. Documents held by sender: none.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PPV, RUB
Symptoms: Product preparation issue
Clinical narrative: Initial information received on 17-Aug-2018 regarding an unsolicited valid non-serious case received from an other health professional. This case involves a 4 months old female patient who was vaccinated with Dtap-IPV portion (0.5 ml second dose) of PENTACEL (lot C5455AA and expiry date: 18-Dec-2018) in the right thigh (route of administration were not reported) on 24-Jul-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included Pneumococcal 13 Valent Vaccine for Immunisation; and Rubella Vaccine  for Immunisation on an unknown date. It was a case of actual medication error due to inappropriate reconstitution technique because child received Dtap-IPV but not the HIB of vaccine. It was unknown if any adverse event was occurred or not following the vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization 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 the sender: None.
Age: 0.58
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Incorrect product formulation administered, Product preparation issue
Clinical narrative: Initial information received on 17-Aug-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 2 months old male patient who was vaccinated with only liquid portion of a 0.5 ml first dose of PENTACEL (Batch number: C5408AB and expiry date: 06-Oct-2019) via intramuscular route in right thigh on 10-Aug-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. No concomitant medications given. It was a case of actual medication error due to inappropriate reconstitution technique because only liquid portion of PENTACEL given, HIB portion not given due to error. It was unknown if any adverse event was occurred or not following the vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by the sender: None.
Sex: U
Vaccine: HPV4, MNQ, TDAP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Initial information received on 20-Aug-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 11 years old patient who received a dose of ADACEL (lot number, expiry date, dose, route and site of administration were not reported) on 16-Oct-2017 also received a 0.5 mL second dose of same vaccine lot C5446AA via intramuscular route in the left deltoid on 21-Jun-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included GARDASIL: and MENACTRA. It was a case of actual medication error due to Inappropriate schedule of vaccine administered. It was not reported if the patient experienced any adverse event or not. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization 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: 73.0
Sex: F
Vaccine: TYP
Symptoms: Syringe issue, Underdose
Clinical narrative: Initial information received on 20-Aug-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 73 years old female patient who didn't get the full dose as she had a hard time getting the needle on the syringe and if fell off during injection, while she received vaccine TYPHIM VI. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 20-Aug-2018, the patient received a single dose of suspect TYPHIM VI lot NIK81, expiry date- 19-Oct-2019 via unknown route in unknown administration site. It was a case of actual medication error due to vaccine underdose and syringe issue. (Other relevant tests included no lab data.) Final diagnosis was she had a hard time getting the needle on the syringe and if fell off during injection and the patient didn't get the full dose. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Not Applicable for she had a hard time getting the needle on the syringe and if fell off during injection and as Not Applicable for the patient didn't get the full dose. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: M
Vaccine: RAB
Symptoms: Expired product administered, No adverse event
Clinical narrative: Initial information received on 20-Aug-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a three years old male patient who was vaccinated with an expired dose of IMOVAX RABIES (batch number M12962M, expiration date 12-JUN-2018) (dose, route and site of administration was not reported for vaccine) on 20-Aug-2018. The patient's medical history and concomitant medications were not reported. It was an actual medication error due to expired vaccine used. The patient did not experience any symptoms. 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: Product storage error
Clinical narrative: Initial information received on 20-Aug-2018 regarding an unsolicited valid non-serious case received from Other health care professional. This case involves a patient (age and gender not reported) who was vaccinated with FLUZONE HIGH DOSE (batch number, expiration date, dose, route and site of administration was not reported for vaccine) on an unspecified date. The patient's medical history and concomitant medications were not reported. It was an actual medication error due to incorrect product storage as product which was too long in transit was given to a patient. It was unknown whether the patient had any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization 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: FLU3
Symptoms: Product storage error
Clinical narrative: Initial information received on 20-Aug-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 66 years old female patient who was vaccinated with a 0.5 ml dose of FLUZONE HIGH DOSE (lot no UI9958A and expiration date 01 Mar 2019) via intramuscular route in the left deltoid on an unspecified date. The patient's medical history and concomitant medications were not reported. It was an actual medication error due to incorrect product storage (FLUZONE HD was arrived warm and wasn't stable). It was unknown whether the patient had any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization 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: FLU4, VARZOS
Symptoms: Headache
Clinical narrative: Initial information received on 20-Aug-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves patient (age and gender unknown) who experienced headaches, while received vaccines SHINGRIX and FLUZONE. The patient's past medical history, concomitant medication and family history were not provided. On an unknown date, the patient received injection of suspect INFLUENZA QUADRIVAL A-B VACCINE lot number, expiry date and dose not reported via unknown route in unknown administration site. On an unknown date, the patient received injection of suspect SHINGRIX not produced by Sanofi Pasteur lot number, expiry date and dose not reported via unknown route in unknown administration site. The patient was given FLUZONE and SHINGRIX vaccine at the same time. On an unknown date, the patient developed a non-serious headaches but seems fine otherwise with unknown latency following the administration of INFLUENZA QUADRIVAL A-B VACCINE and following the administration of SHINGRIX. No lab data was provided. Final diagnosis was headaches. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for headaches. List of documents held by sender- none.
Sex: U
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Incorrect product formulation administered, Product preparation issue
Clinical narrative: Initial information received on 20-Aug-2018 regarding an unsolicited valid non-serious case received from a health professional, Nurse. This case involves a 10 months old patient (gender unknown) who received only ACTHIB portion of vaccine PENTACEL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included PREVNAR 13 for Immunisation. On 08-Aug-2018, the patient received a 0.5 ml third dose of suspect Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(MRC5)/HIB(PRP/T) Vaccine, lot C5426AA (expiry date:04-Oct-2019) via intramuscular route in left thigh. It was a case of actual medication error due to Inappropriate reconstitution technique. It was unknown if patient experienced any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Wrong technique in product usage process
Clinical narrative: Initial information received on 20-Aug-2018 regarding an unsolicited valid non-serious case received from a other health professional. This case involves an unknown age patient (gender unknown) who received vaccine PENTACEL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. No concomitant medication reported. On an unknown date, the patient received a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot number not reported. It was a case of actual medication error due to Wrong technique in product usage process. (Improper administration of PENTACEL to a customer). It was unknown whether patient experienced any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Follow-up report received from an-other healthcare professional on 21-Aug-2018. No new information was reported. List of documents held by the sender: None.
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Product preparation issue
Clinical narrative: Initial information received on 20-Aug-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a child patient (gender not reported) who was vaccinated only with HIB portion of PENTACEL which was activated with sterile water diluent 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 inappropriate reconstitution technique. It was not reported whether the patient experienced any adverse events following the vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Initial information received on 20-Aug-2018 in the regarding an unsolicited valid non-serious case received from a nurse. This case involves an 18 years old male patient who was vaccinated with a 0.5 ml second booster dose of MENACTRA (Lot number: U5916AA; expiry date: 27-Jun-2019) via intramuscular route in the left deltoid on 15 Aug 2018. The patient was also vaccinated with a booster dose of MENACTRA on 04-Jun-2018 at another healthcare professional. It was also reported that patient received his first dose of MENACTRA on 02-May-2011. The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient had no concomitant medications. It was a case of actual medication error due to extra dose administered. There were no signs of adverse reaction. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
Age: 28.0
Sex: M
Vaccine: TDAP
Symptoms: Erythema, Inflammation, Swelling, Tenderness
Clinical narrative: Initial information received on 20-Aug-2018 regarding an unsolicited valid non-serious case received from a medical office manager. This case involves a 28 years old male patient who experienced swelling, redness and tenderness in left arm, while he received vaccine ADACEL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient's concomitant medications included TUBERSOL for Tuberculin test (date not reported). On 27-Jul-2018, the patient received a 0.5 ml single dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot U5979AA; expiry date: 13-Jun-2020 via intradermal route in the left forearm. On an unknown date¸ the patient developed a non-serious tenderness in left arm following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE. On an unknown date ¸the patient developed a non-serious redness and swelling in left arm following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE. No lab test reported. Final diagnosis was inflammation in left arm, tenderness in left arm and swelling in left arm. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Recovering / Resolving for swelling in left arm, as Recovering / Resolving for tenderness in left arm and as Recovering / Resolving for inflammation in left arm.
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13
Symptoms: No adverse event, Product preparation issue
Clinical narrative: Initial information received on 20-Aug-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is related to case- 2018SA236721 (second female child). This case involves a 2 months old male who received inappropriately diluted lyophilized Hib component (first primary dose 0.5ml) of vaccine PENTACEL lot C5439AA, expiry date 20 Oct 2018 via intramuscular route in the left thigh on 17-Aug-2018. The patients past medical history and family history were not provided. Concomitant medications included HEPATITIS B VACCINE and PREVNAR 13 vaccines (Lot number, expiry date, dose and route of administration not provided). It was an actual medication error due to inappropriate reconstitution technique. It was reported that PENTACEL vaccine one full dose was split among two children and one child received invalid HIB. There were no known reports of symptoms or need for treatment. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive and Module VI of the 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: 0.75
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13
Symptoms: Product preparation issue
Clinical narrative: Initial information received on 20-Aug-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is related to case- 2018SA234692 (same reporter). This case involves a nine-months old female who received a 0.5 mL third dose in series of PENTACEL lot C5264AA, expiry date 29-Oct-2018 in right thigh on 20-Aug-2018. The patients past medical history and family history were not provided. Concomitant medications included HEPATITIS B VACCINE and PREVNAR 13 vaccines (Lot number, expiry date, dose and route of administration not provided). It was an actual medication error due to inappropriate reconstitution technique. It was reported that PENTACEL vaccine one full dose was split among two children and patient received only Dtap/IPV component. There were no known reports of symptoms or need for treatment. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender- none.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Gastroenteritis rotavirus, Intussusception
Clinical narrative: Intussusception. Rotaviral enteritis.
Age: 80.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling, Injection site warmth, Tenderness
Clinical narrative: Patient had SHINGRIX #2 8/24/18 at pharmacy. Noticed warmth, swelling, and pain today at injection site on (L) arm. Area 6 cm x 10 cm on (L) arm. Tenderness. No fever or chill. Prescribed prednisone today.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site cellulitis, Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: 8/21 Pt. mother called stating pt. C/O hard, red, warm, and pain (R) thigh. Told to ice, BENADRYL, TYLENOL/ibuprofen for pain. 8/22 Pt. mother called, pt. seen in ER night before, redness worse line drawn around redness, called today redness outside outline from night before. 8/22 Seen in office redness/swelling in (R) thigh worse. Dx cellulitis (R) lower limb given sulfamethoxazole 200 mg - trimethoprim 40 mg/mL. pt. to take 10 mL BID for 7 days. 8/23 seen in office, area of redness increase erythema 16 x 12 cm and induration 9 x 7 cm pt. ask to follow up w/provider next day. 8/24 Pt. into office for F/U visit no change to treatment. Continue BACTRIM, BENADRYL, and warm compresses. Pt. asymptomatic other than local reaction. Pt. father states area not as dark and not painful. Pt's. father told to follow up if any new persistent or worsening symptoms.