chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
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. The patient's healthcare provider recommended, and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On 07-MAR-2007, a health care provider administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On 02-SEP-2015, the patient was treated by a healthcare provider for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death; aggravation of preexisting conditions and activation of latent conditions (unspecified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information was provided regarding the patient's concurrent conditions, medical history or concomitant medications. On 16-NOV-2018, the patient was vaccinated with an expired dose of VAQTA lot # N026997 for prophylaxis (dose and route of administration were not reported). However, no adverse effects were reported.
Sex: U
Vaccine: HEPA, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This Non-valid spontaneous report was received from a nurse and refers to a multiple unspecified patients of unknown age and gender. The patients' concurrent conditions, medical history, historical drugs and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of VAQTA Lot/Exp: N020689, 22-OCT-2018; Lot/Exp: N030287, 22-JAN-2019; N026997, 11-OCT-2018, and ROTATEQ Lot/Exp: N024294 26-FEB-2019; Lot/Exp: unknown, 28-MAY-2019 (dose, frequency and route were not reported) for prophylaxis. No adverse effects reported. The Nurse confirmed that VAQTA lot# N020689, expiration date 22-OCT-2018 and lot# N026997, expiration date 10-NOV-2018 were not administered after their expiration dates. The temperature involved was: VAQTA Lot: N020689; Temperature/Time frame: 47 degrees F to 77 degrees F (48.6 F) for 1 hour. ROTATEQ: Lot: N024294; Temperature/Time frame:47 degrees F to 77 degrees F (48.6 F) for 1 hour and: VAQTA: Lot: N030287; N026997; Temperature/Time frame: 47 degrees F to 77 degrees F (multiple excursions) for 7 hours. ROTATEQ: Lot: unknown; Temperature/Time frame: 47 degrees F to 77 degrees F (multiple excursions) for 7 hours. There was no previous excursion. A data logger was involved, specifically because of audit.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
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 concurrent conditions, medical history, or concomitant medications. On 18-MAY-2011, a healthcare provider at a medical group administered ZOSTAVAX to the patient to obtain permanent prevention and protection against shingles and zoster-related injuries (dose, route, and lot # not provided). In 2013, the patient was treated by a healthcare provider at an urgent care for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with ZOSTAVAX, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of ZOSTAVAX, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was not recovered. Causality assessment was related. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Ophthalmic herpes zoster
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. The patient's healthcare provider recommended and/or prescribed the ZOSTAVAX vaccine to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On 10-MAY-2013, a healthcare provider at a pharmacy administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On 21-FEB-2014 and 18-APR-2016, the patient was treated by healthcare providers for shingles and herpes zoster keratitis, respectively. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions (unspecified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Upon internal review, herpes zoster keratitis was determined to be medically significant. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
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 concurrent conditions, medical history, or concomitant medications. On or about 16-AUG-2013, a pharmacist at a pharmacy administered ZOSTAVAX to the patient to obtain permanent prevention and protection against shingles and zoster-related injuries (dose, route, and lot # not provided). On or about 24-FEB-2016, the patient was treated by a physician for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with ZOSTAVAX, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of ZOSTAVAX, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was not recovered.  Causality assessment was related. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
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 concurrent conditions, medical history, or concomitant medications. In 2008, a healthcare provider administered ZOSTAVAX to the patient to obtain permanent prevention and protection against shingles and zoster-related injuries (dose, route, and lot # not provided). On or about 27-AUG-2015, the patient was treated by a Dermatologist for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with ZOSTAVAX, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of ZOSTAVAX, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was not recovered.  Causality assessment was related. Additional information has been requested.
Age: 48.0
Sex: F
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: This spontaneous report as received from a 48 year old female patient regarding herself. The patient's pertinent medical history, drug reactions/allergies and concomitant medications were not reported. The patient reported that she was prescribed with GARDASIL 9 by her physician and received the first dose of GARDASIL 9 (lot, expiry date and route of administration were not reported) 0.5 milliliter for prophylaxis, at her pharmacy. There was no adverse reaction reported. No product quality complaint was filed.
Age: 20.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Diarrhoea, Dizziness, Feeling abnormal, Flushing
Clinical narrative: Initial information received on 04-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 19 years old female patient who experienced dizziness, weakness, diarrhea, lost conscientiousness briefly twice, has a feeling of floating, thoughts not clear and cheeks are flushed, while she received vaccine FLUZONE QUADRIVALENT. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient had not known allergies. Her last period was the third week of September. On 10-Apr-2018, the patient received a single dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot U6293DA; expiry date: 30-Jun-2019 via intramuscular route in the left deltoid. On an unknown date, the patient developed a non-serious dizziness, weakness (asthenia), diarrhea (diarrhoea), lost conscientiousness briefly twice (loss of consciousness), a feeling of floating (feeling abnormal), thoughts not clear (thinking abnormal) and flushed (flushing) three-hours following the administration of INFLUENZA QUADRIVAL A-B VACCINE. No lab data reported. Final diagnosis was cheeks are flushed, thoughts not clear, has a feeling of floating, lost conscientiousness briefly twice, diarrhea, weakness and dizziness. It was not reported if the patient received a corrective treatment. The patient outcome is reported as unknown for all the events.
Age: 20.0
Sex: F
Vaccine: FLU4
Symptoms: Loss of consciousness
Clinical narrative: Initial information received on 04-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 19 years old female patient who experienced dizziness, weakness, diarrhea, lost conscientiousness briefly twice, has a feeling of floating, thoughts not clear and cheeks are flushed, while she received vaccine FLUZONE QUADRIVALENT. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient had not known allergies. Her last period was the third week of September. On 10-Apr-2018, the patient received a single dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot U6293DA; expiry date: 30-Jun-2019 via intramuscular route in the left deltoid. On an unknown date, the patient developed a non-serious dizziness, weakness (asthenia), diarrhea (diarrhoea), lost conscientiousness briefly twice (loss of consciousness), a feeling of floating (feeling abnormal), thoughts not clear (thinking abnormal) and flushed (flushing) three-hours following the administration of INFLUENZA QUADRIVAL A-B VACCINE. No lab data reported. Final diagnosis was cheeks are flushed, thoughts not clear, has a feeling of floating, lost conscientiousness briefly twice, diarrhea, weakness and dizziness. It was not reported if the patient received a corrective treatment. The patient outcome is reported as unknown for all the events.
Sex: F
Vaccine: FLU3
Symptoms: Cardiac assistance device user, Cardiac disorder
Clinical narrative: Initial information received on 06-Nov-2018 regarding an unsolicited valid serious case received from a consumer. This case involves a female patient (age not reported) who experienced flu shot with the chemicals took out her heart and she almost died, while she received vaccine FLUZONE HIGH DOSE. The patients past vaccination(s) included pneumonia vaccine and got bronchitis. The patients past medical history, medical treatment(s) and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot number and Exp. Date not reported via unknown route in unknown administration site. On an unknown date, the patient experienced flu shot with the chemicals took out her heart and she almost died (cardiac disorder) following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. This event was assessed as life-threatening. Reporter stated that the flu shot has aluminum, formaldehyde, and mercury in the shot. She had a defibrillator now. She had given the flu shot herself. Details of lab data not provided. Final diagnosis was (Life-threatening) cardiac disorder. It was not reported whether the patient received a corrective treatment. The event outcome was not reported. List of documents held by sender: none. Sender's Comments: This case concerns a female of unknown of age who presented with cardiac disorder (unspecified) after vaccination with FLUZONE HIGH DOSE and reported that she almost died due to the event. The time to onset is unknown. Moreover, there is no information regarding patient's age, past history, medical condition at time of vaccination, details of the event and lab tests ruling out alternate etiologies. Based upon the reported information, the role of the vaccine cannot be assessed.
Sex: M
Vaccine: FLUR4, MNQ
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Initial information received on 12-Nov-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 16 years old male patient who was injected FLUBLOK while he received vaccine FLUBLOK QIV. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date (also reported as 12-Nov-2019), the patient received a 0.5 ml once dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE lot QFAA1814, expiry date- 30-Jun-2019 via unknown route in the left deltoid. Concomitant medication includes MENVEO received on the same day. It was a case of actual medication error due to inappropriate age at vaccine administration. There were not side effects. 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: FLU4
Symptoms: Incorrect dose administered
Clinical narrative: Initial information received on 12-Nov-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 22-months old patient who was vaccinated with 0.5 ml dose of FLUZONE QUADRIVALENT, lot UJ088AB in the left thigh on 12-Nov-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was actual medication error due to overdose. It was unknown if 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
Symptoms: Underdose
Clinical narrative: Initial information received on 12-Nov-2018 regarding an unsolicited valid non-serious case received from other healthcare professional. This case involves a 62 years old patient, who was vaccinated with FLUZONE QUADRIVALENT and where couple of drops dripped, lot number not reported via unknown route in unknown administration site. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was as actual medication error case due to vaccine underdose. It was unknown whether the patient had any adverse reactions. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Sex: F
Vaccine: FLU4
Symptoms: Incorrect route of product administration, Injection site erythema, Injection site pruritus
Clinical narrative: Initial information received on 13-Nov-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a female patient (age not reported) who experienced local reaction at injection site of itching and redness, while she received vaccine FLUZONE QUADRIVALENT. 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 Quadrival A-B Vaccine lot number not reported via transdermal route in unknown administration site. On an unknown date, the patient developed a non-serious local reaction at injection site of itching and redness (vaccination site erythema) (vaccination site pruritus) (Unknown latency) following the administration of Influenza Quadrival A-B Vaccine. It was an actual medication error due to inappropriate route of vaccination. It was reported that the patient was vaccinated with FLUZONE QUADRIVALENT transdermally. (Other relevant tests included No lab data.) Final diagnosis was local reaction at injection site of itching and redness, local reaction at injection site of itching and redness. It was not reported if the patient received a corrective treatment. The patient outcome is reported as unknown for local reaction at injection site of itching and redness. 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: 3.0
Sex: U
Vaccine: FLU4
Symptoms: Incorrect dose administered
Clinical narrative: Initial information received on 13-Nov-2018 regarding an unsolicited valid non-serious case received from a Nurse. This case involves an unknown gender 36 months (reported as more than three years) old patient who was vaccinated with a 0.25ml dose of FLUZONE QUADRIVALENT (Batch number: UT6315TA, expiration date: 30-Jun-2019, and site of administration: left thigh was not reported) on 09-Nov-2018 instead of 0.5 ml. The patients' medical history were not reported. No other vaccines given at that time. It was an actual medication error due to vaccine underdose. It was unknown whether patient experienced any adverse event following vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Age: 3.0
Sex: M
Vaccine: FLU4
Symptoms: Incorrect dose administered
Clinical narrative: Initial information received on 13-Nov-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 40 months old male patient who was administered a 0.25 ml first dose of FLUZONE QUADRIVALENT, lot number: UT6259MA, expiry date: 30-Jun-2019, via intramuscular route in the right thigh on 07-Nov-2018. The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided. It is an actual medication error due to vaccine underdose. It was unknown whether patient experienced any adverse event following vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Sex: U
Vaccine: FLUX
Symptoms: Injection site erythema
Clinical narrative: Initial information received on 12-Nov-2018 regarding an unsolicited valid non-serious case received from a physician. This case involves unknown gender and age of patient who experienced injection site redness, while he/she received vaccine Influenza Vaccine. The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided. At the time of the event, the patient had ongoing Food allergy (egg allergy).  On an unknown date (last year), the patient received a dose of suspect Influenza Vaccine produced by unknown manufacturer lot number not reported via unknown route in unknown administration site. On an unknown date, patient developed a non-serious injection site redness (injection site erythema) unknown latency following the administration of Influenza Vaccine. Lab data was not reported. Final diagnosis was injection site redness. It was not reported if the patient received a corrective treatment. The outcome of event of injection site redness was not reported. Documents held by sender: none.
Age: 15.0
Sex: F
Vaccine: FLUR4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Initial information received on 12-Nov-2018 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional. This case is linked to cases 2018SA315702 and 2018SA315703. This case involves a 15 years old female patient and reported that received a Flublock Quadrivalent that day in her left deltoid, IM, while she received vaccine FLUBLOK QIV. The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. On 12-Nov-2018, the patient received a dose of 0.5 ml suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (lot number: QSAA1804 and expiry date: 01-Jun-2019) via intramuscular route in the left deltoid. It was a case of actual medication error due to inappropriate age at vaccine administration. It was unknown if the patient had any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Age: 12.0
Sex: M
Vaccine: FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Initial information received on 12-Nov-2018 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional. This case is linked with 2018SA315703 and 2018SA315692 (same reporter). This case involves a 12 years old male patient who received a 0.5 mL dose of suspect FLUBLOK QIV (lot number: QSAA1804 and expiry date: 01-Jun-2019) via intramuscular route in the right deltoid on 12-Nov-2018. The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. t was a case of actual medication error due to inappropriate age at vaccine administration. The patient received a FLUBLOCK QUADRIVALENT in his left deltoid who is under the age of 18. There were no side effects. 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: 15.0
Sex: F
Vaccine: FLUR4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Initial information received on 12-Nov-2018 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional. This case is linked to cases 2018SA315702 and 2018SA315692. This case involves a 15 years old female patient and reported that a twin received a FLUBLOCK QUADRIVALENT that day in her right deltoid, IM, while she received vaccine FLUBLOK QIV. The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. On 12-Nov-2018, the patient received a dose of 0.5 ml suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (lot number: QSAA1804 and expiry date: 01-Jun-2019) via intramuscular route in the right deltoid. It was a case of actual medication error due to inappropriate age at vaccine administration. It was unknown if the patient had any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Age: 0.33
Sex: F
Vaccine: FLU4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Initial information received on 12-Nov-2018 regarding an unsolicited valid non-serious case received from a consumer. This case involves four months old female patient who was vaccinated with 0.25ml dose of FLUZONE QUADRIVALENT (Batch number: UT6259NA, expiration date: 30 Jun 2019, dose, route was not reported) in right thigh on 10-Nov-2018. The patient's medical history and concomitant medications were not reported. It was an actual medication error due to inappropriate age at vaccine administration. The baby was kept for 1 hour for monitoring. It was reported that, the patient had no adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization 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
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Initial information received on 12-Nov-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 8 months old patient and reported if a second dose of FLUZONE QD pediatric dose was given early, is it safe to use a third dose from the 20 day lot, while he/she received vaccine FLUZONE QUADRIVALENT. The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. On an unknown date, the patient received a dose of 0.25 ml suspect INFLUENZA QUADRIVAL A-B VACCINE (lot number, expiry date and route was not reported) in the left thigh. It was a case of actual medication error due to inappropriate schedule of product administration. It was unknown if the patient had any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Age: 65.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Bed rest, Malaise, Pyrexia
Clinical narrative: Initial information received on 12-Nov-2018 regarding an unsolicited valid non-serious case received from a non-health care professional. This case involves a 65 years old male patient who reported that patient sick for 3 days, couldn't get out of bed and had a fever, while he received vaccine FLUZONE HIGH DOSE. The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. Concomitant medications included PNEUMOVAX. On 24-Oct-2018, the patient received a dose of 0.5 ml suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE (lot number: UJ0363AB and expiry date: 09-May-2019) (dose in series and route was not reported) in the left deltoid. On an unknown date, the patient developed non-serious sick for 3 days, couldn't get out of bed (malaise) and had a fever (pyrexia), following the vaccination with INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. Relevant tests were not reported. Final diagnosis was sick for 3 days, couldn't get out of bed (malaise) and had a fever. The patient stayed home and did not receive corrective treatment. On an unknown date, the patient was recovered from the events. List of documents held by sender: none.
Sex: U
Vaccine: FLU3
Symptoms: Hypersensitivity, Urticaria
Clinical narrative: Initial information received on 12-Nov-2018 regarding an unsolicited valid non-serious case received from a consumer/non-hcp. This case involves patient who experienced the allergic reaction and welt, while he/she received vaccine FLUZONE HIGH DOSE. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 12-Nov-2018, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE (lot number not reported via unknown route in unknown administration site). On an unknown date, the patient developed a non-serious the arm suspected allergic reaction (hypersensitivity) and the patient had a 1 inch welp that grew to about 4 or 5 fingers and is currently about 6 inches on the arm (urticaria) (Unknown latency) following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. (Other relevant tests included No lab data.) Final diagnosis was welt and allergic reaction. It was not reported if the patient received a corrective treatment. On an unknown date, the patient outcome was reported as unknown for all the events. List of document held by sender: None.
Sex: F
Vaccine: RAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Initial information received on 13-Nov-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves an unknown age female patient who received vaccine IMOVAX RABIES. The patients past medical history, concomitant medication and family history were not provided. On 12-Nov-2018, the patient received a first dose 0.5ml of suspect RABIES (HDC) VACCINE lot number, expiry date not reported via intramuscular route in the right deltoid. It was an actual medication error due to inappropriate schedule of vaccine administered. It was reported that patient was one day late for dose 2 in the series of 3 of IMOVAX vaccine. It was unknown whether patient experienced any adverse reaction after the injection. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender- none.
Sex: U
Vaccine: FLUR4
Symptoms: Product administered to patient of inappropriate age, Product packaging confusion, Wrong product administered
Clinical narrative: Initial information received on 12-Nov-2018 regarding an unsolicited valid non-serious case received via an employee via a nurse. This case involves two child patients (age was reported as under 18 years) who was vaccinated with a dose of FLUBLOK QIV instead of FLUZONE (lot number, expiry date, dose, dose in series, route and site of administration was not reported for both the vaccines) 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 wrong vaccine administered and inappropriate age at vaccine administration. The patients were administered with FLUBLOK since the packaging was looking the same as FLUZONE. It was not reported whether the patients 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 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: 0.5
Sex: F
Vaccine: DTAP, FLU3, HIBV, PNC, RV5
Symptoms: Injection site erythema, Product administered to patient of inappropriate age
Clinical narrative: Initial information received on 13-Nov-2018 regarding an unsolicited valid non-serious case received from Office Staff. This case involves a 6 months old female patient who experienced thigh was red at the injection site, while she received vaccine FLUZONE HIGH DOSE. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP) for Immunisation; ACT HIB for Immunisation; PREVNAR for Immunisation; and ROTATEQ for Immunisation. On 30-Oct-2018, the patient received a 0.5 mL dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot UJ042AB, expiry date-19-MAY-2019, via intramuscular route in the right thigh. On an unknown date, the patient developed a non-serious thigh was red at the injection site (vaccination site erythema) following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. It was also the case of actual medication error due to overdose and inappropriate age at vaccine administration. Other relevant tests included no lab data. Final diagnosis was thigh was red at the injection site. It was not reported if the patient received a corrective treatment. The outcome of the event was not reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization 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 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: FLUX
Symptoms: Cardiac arrest
Clinical narrative: Initial information received on 09-Nov-2018 regarding an unsolicited valid serious case received from a non-healthcare professional. This case involves a patient of unknown age and gender who experienced cardiac arrest, while he/she received vaccine INFLUENZA VACCINE. The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site. On an unknown date, the patient developed a serious cardiac arrest, following the administration of INFLUENZA VACCINE. This event was assessed as medically significant. Lab data was not reported. Final diagnosis was cardiac arrest. It was not reported if the patient received a corrective treatment. The outcome of event of cardiac arrest was not reported. Documents held by sender: none. Sender's Comments: Patient of unknown age and gender experienced cardiac arrest after vaccination.Time to onset is unknown. Moreover, 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: FLUX
Symptoms: Immediate post-injection reaction, Nervous system injury, Pain, Quality of life decreased, Resting tremor
Clinical narrative: Initial information received on 14-Nov-2018 regarding an unsolicited valid non-serious case received from a consumer/non-hcp. This case involves a female patient (age not reported) who experienced Immediate post-injection reaction, resting tremor, Nervous system injury and pain while she received vaccine INFLUENZA VACCINE. The patient's past vaccination(s) included a flu vaccine, the patient's past medical history and concomitant medication were not provided, at the time of the event, the patient had ongoing chronic Neutropenia (a week immune system). On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported. On an unknown date, post vaccination, patient developed immediate reaction and spent a few hours in the emergency room  in extreme pain. She stated that the vaccine totally ruined her life, she would woke up at night in pain and felt that her entire body was still under attack and reported that this also happened 21 years ago with an unknown therapy. No lab test was reported. Final diagnosis was Immediate post-injection reaction, resting tremor, Nervous system injury and pain. It was not reported if the patient received a corrective treatment. On an unknown date, patient recovered from the events.
Sex: F
Vaccine: FLUX
Symptoms: Sleep disorder
Clinical narrative: Initial information received on 14-Nov-2018 regarding an unsolicited valid non-serious case received from a consumer/non-hcp. This case involves a female patient (age not reported) who experienced Immediate post-injection reaction, resting tremor, Nervous system injury and pain while she received vaccine INFLUENZA VACCINE. The patient's past vaccination(s) included a flu vaccine, the patient's past medical history and concomitant medication were not provided, at the time of the event, the patient had ongoing chronic Neutropenia (a week immune system). On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported. On an unknown date, post vaccination, patient developed immediate reaction and spent a few hours in the emergency room  in extreme pain. She stated that the vaccine totally ruined her life, she would woke up at night in pain and felt that her entire body was still under attack and reported that this also happened 21 years ago with an unknown therapy. No lab test was reported. Final diagnosis was Immediate post-injection reaction, resting tremor, Nervous system injury and pain. It was not reported if the patient received a corrective treatment. On an unknown date, patient recovered from the events.
Age: 56.0
Sex: F
Vaccine: FLUR4
Symptoms: Product storage error
Clinical narrative: Initial information received on 13-Nov-2018 regarding an unsolicited valid non-serious case received from a other health professional. This case is linked with 2018SA315883, 2018SA315884, 2018SA315886, 2018SA315887, 2018SA315888, 2018SA315882 and 2018SA315885. This case involves a 56 years old female patient who had the vaccines that were exposed to a max temp of  52 f for 27 hours which was inadvertently received by patient, while she received vaccine FLUBLOK QIV. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 07-Nov-2018, the patient received a  0.5ml dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE lot QFAA1815, expiry date- 30-Jun-2019 via intramuscular route in the left deltoid. It was a case of actual medication error due to incorrect product storage. It was unknown if any adverse event occurred. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 60.0
Sex: F
Vaccine: FLUR4
Symptoms: Product storage error
Clinical narrative: Initial information received on 13-Nov-2018 regarding an unsolicited valid non-serious case received from other health care professional. This case is linked to cases 2018SA315884, 2018SA315883, 2018SA315878, 2018SA315885, 2018SA315886, 2018SA315887 and 2018SA315888 (same reporter). This case involves a 60-years old female patient who received 0.5 ml dose of FLUBLOK QIV lot number QFAA1815, expiry date-30-Jun-2019 via intramuscular route in the left deltoid on 07-NOV-2018. 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 incorrect product storage. Vaccines were exposed to a Max temp of 52 F for 27 hours. It was unknown whether patient experienced any adverse event following vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization 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.