chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: 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 2012, the patient was inoculated with the ZOSTAVAX vaccine as recommended for routine adult health maintenance and for the long term prevention of shingles (dose, route, and lot number not provided). The vaccine did not prevent shingles and the patient subsequently contracted a persistent strain of herpes zoster or shingles. In 2016, the patient was treated by a physician for the onset of a severe vesicular rash, which was diagnosed as 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 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: 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 provided regarding the patient's past medical history, concurrent conditions, or concomitant medication. In 2013, 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 and for the long-term prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster or shingles. In 2014, the patient was treated by a physician for the onset of a severe vesicular rash, which was diagnosed as herpes zoster or shingles. Later in 2014, the patient sought subsequent treatment from the same physician for another episode of a severe vesicular rash, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the 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. The outcome of the events was unknown. Causality assessment was related.    Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: 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 2011, the patient was inoculated with the ZOSTAVAX vaccine at a pharmacy as recommended for routine adult health maintenance and for the 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 or shingles. On or about 30-JAN-2014, the patient was treated at a medical center for a vesicular outbreak, which was diagnosed as 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. Additional information has been requested
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, 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. In 2015, the patient was inoculated with the ZOSTAVAX vaccine at a pharmacy as recommended for routine adult health maintenance and for the 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 or shingles. In 2016, the patient was treated at a medical center for a vesicular outbreak, which was diagnosed as 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. Additional information has been requested.
Sex: M
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 male patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2008, the patient was inoculated with ZOSTAVAX at a medical center as recommended for routine adult health maintenance for the 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 condition of herpes zoster. Later in 2008, the patient was treated by a physician for a blistering vesicular outbreak which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the 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 01-AUG-2011, the patient was inoculated with ZOSTAVAX at a pharmacy as recommended for routine adult health maintenance for the 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 condition of herpes zoster. On or about 17-JAN-2012, the patient was treated by a physician at a family medical center for a blistering vesicular outbreak which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the 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: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report has been received from a medical assistant referring to an unspecified number of patients of unknown age and gender. Information regarding the patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications was not reported. On an unknown date, the patients were vaccinated with an improperly stored doses of M-M-R II, lot # N023024 with expiration date in 23-AUG-2019, and lot # N025895 with expiration date in 19-SEP-2018 (strength, dose, frequency, route of administration, lot number and expiration date were not provided) for prophylaxis. The vaccines was reconstituted with properly stored Merck sterile diluent. No adverse effects were reported. The vaccines were exposed to a temperature range between 47 degrees F to 77 degrees F during a time frame of 54.15 minutes, which was called by a data logger. No previous temperature excursions.
Sex: U
Vaccine: HEPA, TYP
Symptoms: No adverse event, Syringe issue
Clinical narrative: Initial information received on 03-Oct-2018 regarding an unsolicited valid non-serious case received from Other health professional (Medical assistant). This case involves a 41 years old patient who experienced received vaccine TYPHIM VI. The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included HEPATITIS A VACCINE (HEPATITIS A VACCINE). On 15-May-2018, the patient received a 0.5ml dose of suspect TYPHOID VI POLYSACCHARIDE VACCINE lot number N1K911M, expiry date 27-Oct-2019 via intramuscular route in the right deltoid. It was a case of actual medication error due to syringe issue and vaccine underdose. It was reported that there were no problems with the needle going on. Medical assistant stated that she tightened the needle down tight. The vaccine came out as it was being injected where the needle joins the syringe. MA stated that when she tightened the needle the little area where you put the needle on seemed a little loose. The patient did not experience any adverse reaction after the injection. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Follow up information was received from  Other health professional (Medical assistant) and Quality department regarding PTC on 08-Oct-2018. Lot number and expiry date updated. PTC investigation was in process. List of documents held by sender- none
Sex: F
Vaccine: FLUR4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Initial information received on 02-Oct-2018 regarding an unsolicited valid non-serious case received from a Nurse. This case involves a 16 years old female patient who received vaccine FLUBLOK QIV at inappropriate age. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication was none. On an unknown date (reported as today), the patient received a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE lot QFAA1810 via unknown route in the right deltoid. It was a case of actual medication error due to inappropriate age at vaccine administration. It was not reported that if any adverse event occurred or not. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Sex: U
Vaccine: FLU4
Symptoms: Incorrect route of product administration
Clinical narrative: Initial information received on 05-Oct-2018 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a patient (age and gender not reported) who was vaccinated with the vaccine FLUZONE QUADRIVALENT via intravenous route on an unknown date. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications were not reported. It was a case of actual medication error due to inappropriate route of vaccination because the patient was administered via intravenous route instead of intramuscular route. 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 Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
Sex: U
Vaccine: FLU4
Symptoms: No adverse event, Underdose
Clinical narrative: Initial unsolicited report received from nurse on 05-Oct-2018. This case is linked to cases 2018SA279275, 2018SA279268, 2018SA279274 and 2018SA279276 (same reporter and same suspect). This case involves a eight years old patient was vaccinated with a 0.25 ml dose of FLUZONE QUADRIVALENT (Batch number: UT6259KA, expiration date: 30-Jun-2019, route and site of administration was not reported) on an unknown date. The patient's medical history and concomitant medications were not reported. It was a case of actual medication error due to vaccine underdose (gave the FLUZONE QUADRIVALENT of 0.25ml that needed the 0.5ml and gave incorrect dose /No AE). No Adverse Events have been noted at time of the call. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Sex: U
Vaccine: FLU4
Symptoms: No adverse event, Underdose
Clinical narrative: Initial information received on 05-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to cases 2018SA279268, 2018SA279273, 2018SA279275 and 2018SA279276 (same reporter). This case involves a four years old patient of an unknown gender who was vaccinated with a 0.25 ml dose of suspect FLUZONE QUADRIVALENT (batch number UT6259KA and expiration date 30-JUN-2019) via unknown route in unknown administration site on an unspecified date.  The patients past medical history, concomitant medication and family history were not provided. It was an actual medication error due to vaccine underdose. It was reported that the patient received FLUZONE QUADRIVALENT of 0.25ML that needed the 0.5ml. No Adverse Events have been noted at time of the call. 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.
Sex: U
Vaccine: FLU4
Symptoms: No adverse event, Underdose
Clinical narrative: Initial information received on 05-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to cases 2018SA279268, 2018SA279273, 2018SA279274 and 2018SA279276 (same reporter). This case involves a five years old patient (gender not reported) who was vaccinated with a 0.25 ml dose instead of 0.5ml dose of FLUZONE QUADRIVALENT (batch number UT6259KA and expiration date 30-JUN-2019) via unknown route in unknown administration site on an unspecified date. The patients medical history and concomitant medications were not reported. It was an actual medication error due to vaccine underdose. No adverse event had been reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive and Module VI of the 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: No adverse event, Underdose
Clinical narrative: Initial information received on 05-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case was linked with 2018SA279268, 2018SA279274, 2018SA279275 and 2018SA279273 (same reporter). This case involves a 4 years old patient who experienced patient vaccinated with 0.25 ml dose, no adverse event, while he/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 0.25ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot UT6259KA, Expiry date-30-JUN-2019 via unknown route. It was a case of actual medication error due to Vaccine underdose. No Adverse Events have been noted at time of the call. 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: 1.0
Sex: F
Vaccine: HIBV, PNC13
Symptoms: Expired product administered
Clinical narrative: Initial information received on 05-Oct-2018 regarding an unsolicited valid non-serious case from a consumer/non-HCP. This case involves a 12 months old female patient who was given an expired dose of ActHib, while she received ACT-HIB. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PCV 13) for immunization on 05-Oct-2018. On 05-Oct-2018, the patient received a fourth 0.5 ml once dose of suspect HIB (PRP/T) VACCINE lot UI806AA via intramuscular route in the right thigh. It was also reported lot number Box UI806AAA Expiry date 30-Sep-2018 and Diluent lot number U5871AA, Expiry date-04-Oct-2018. It was a case of actual medication error due to expired vaccine used. The patient outcome was Not Applicable for gave an expired dose of ACTHIB. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Sex: F
Vaccine: FLUR4
Symptoms: Feeling abnormal, Muscle tightness, Nausea, Nervousness, Sensation of foreign body
Clinical narrative: Initial information received on 05-Oct-2018 regarding an unsolicited valid non-serious case received from a consumer also received additional information on 05 Oct 2018. This case involves Adult female patient who experienced i feel funny and am sick to my stomach, feel shaky like i've had too much caffeine, my muscles are tense, i am nauseated and i have a lump in my throat, while she received vaccine FLUBLOK QIV. It was reported that, patient's had an Alpha Gal allergy. On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE lot number not reported in the right arm. On an unknown date, 15 min post vaccination patient developed a non-serious i feel funny and am sick to my stomach (feeling abnormal), i feel funny and am sick to my stomach (abdominal discomfort), feel shaky like i've had too much caffeine (nervousness), muscles are tense (muscle tightness), i am nauseated (nausea), i have a lump in my throat (sensation of foreign body). Final diagnosis was i have a lump in my throat, i am nauseated, my muscles are tense, feel shaky like i've had too much caffeine, i feel funny and am sick to my stomach and i feel funny and am sick to my stomach. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for i feel funny and am sick to my stomach, as Unknown for i feel funny and am sick to my stomach, as Unknown for feel shaky like i've had too much caffeine, as Unknown for my muscles are tense, as Unknown for i am nauseated and as Unknown for i have a lump in my throat.
Age: 12.0
Sex: F
Vaccine: FLUR4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Initial information received on 05-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 12 years old female patient who received vaccine FLUBLOK QIV. The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. No other vaccines given at the time. On 05-Oct-2018, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (lot number: QFAA1820 and expiry date: 30-Jun-2019) (dose in series was not reported) 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: 17.0
Sex: F
Vaccine: FLUR4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Initial information received on 05-Oct-2018 regarding an unsolicited valid non-serious case received from an other health care professional. This case involves a 17 years old female patient who was vaccinated with a 0.5 ml dose of FLUBLOK QIV (batch number R013859 and expiration date 14-JUN-2019) via unknown route in the right deltoid on 20-Sep-2018. The patient's medical history and concomitant medications were not reported. No concomitant vaccines were given. It was an actual medication error due to inappropriate age at vaccine administration. No information reported 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: FLU3
Symptoms: Exposure via skin contact, Syringe issue, Underdose
Clinical narrative: Initial information received on 05-Oct-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves an unknown demographic patient who vaccinated with FLUZONE HIGH DOSE (lot UJ038AB and Exp. date 03 May 2019) via unknown route in the left deltoid on 05-Oct-2018. The patient's medical history and concomitant medications were not reported. It is an actual medication error case due to vaccine underdose. It is also a case of syringe issue and exposure via skin contact. It was reported that, pharmacist screwed on the needle and it was tight and sealed but there must be a crack or something because it was leaking out when she was giving it. She had an irate patient because it leaked all over him. No information reported 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 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: 0.42
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Product preparation issue
Clinical narrative: Initial information received on 05-Oct-2018 regarding an unsolicited valid non-serious case received from an other care health professional. This case involves a 6 months old female patient who was vaccinated with a 0.5 ml dose of PENTACEL via unknown route in the left thigh on 05-Oct-2018. It was reported that, Vial: Lot# C5427BA, Exp date: 13-Oct-19 NDC 49281-560-05. Lypholized powder: Lot# C5573AA Exp date: 13-Oct-19 NDC 49281-545-15. Box: Lot# C5573AA, exp date: 13-Oct-19. Concomitant medications included HEPATITIS B VACCINE (HEPATITIS B VACCIN); PREVNAR 13 and ROTATEQ for Immunization. The patient's medical history was not reported. It was an actual medication error due to inappropriate reconstitution technique. (gave Pentacel liquid vial (DTaP and IPV) but did not give the ActHib lypholized powder vial to a 6 months old female.) No information reported 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: HEPA, IPV, TDAP
Symptoms: Product storage error
Clinical narrative: Initial unsolicited report received from nurse on 05-Oct-2018. This case is linked to case 2018SA279686. This case involves an eight years old (unknown gender) patient who was vaccinated with a 0.5 ml dose of IPOL (Batch number: N1K92, expiration date: 14-NOV-2019, route: subcutaneous and site of administration: left thigh) on 24-Sep-2018. Concomitant medications included TDAP and HEPATITIS A VACCINE. The patient's medical history was not reported. It was an actual medication error due to incorrect product storage (vaccinated with an IPOL multi-dose vial that was out of temperature range for 30 minutes). 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: 59.0
Sex: M
Vaccine: FLUR4
Symptoms: Product storage error
Clinical narrative: Initial information received on 03-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to cases 2018SA279741, 2018SA279742, 2018SA279748, 2018SA279744, 2018SA279745, 2018SA279746, 2018SA279747, 2018SA279743 and 2018SA277209 (same reporter). This case involves a 59 years old male patient who was vaccinated with 0.5 ml dose of FLUBLOK QIV (lot QFAA1829 and expiry date: 30-Jun-2019) via intramuscular route in the left deltoid. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications were not reported. It was a case of actual medication error due to incorrect product storage. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
Age: 11.0
Sex: U
Vaccine: FLU4, TDAP
Symptoms: Expired product administered
Clinical narrative: Initial information received on 05-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 11 years old patient who received 0.5 mL dose of vaccine ADACEL lot U5458BA, expiration date: 28-Sep-18 via intramuscular route in the right deltoid on 02-Oct-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included FLUZONE QUADRIVALENT for Immunisation. It was an actual medication error due to expired vaccine used. It was reported that patient received ADACEL that was three days expired. It was unknown whether patient experienced any adverse reaction after 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: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: No adverse event, Product storage error
Clinical narrative: Initial information received on 05-Oct-2018 regarding an unsolicited valid non-serious case received from a non-healthcare professional. This case is linked to cases 2018SA279973, 2018SA281633, 2018SA281638, 2018SA281635, 2018SA281636, 2018SA281637, 2018SA281634, 2018SA281632, 2018SA279979, 2018SA281687 and 2018SA281692. (Same reporter). This case involves an 11 years old male patient who he received vaccines MENACTRA and ADACEL which were in below freezing for 4 hours from 11-Sep-2018 through 13-Sep-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication was not reported. On 11-Sep-2018, the patient received a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot U5875AB expiry date: 14-Feb-2020 via unknown route in the left deltoid. On 11-Sep-2018, the patient received a dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE lot U6015AA Expiry date: 06-Oct-2019 via unknown route in the right deltoid. It was case of actual medication error due to incorrect product storage. No adverse event was experienced. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Age: 11.0
Sex: F
Vaccine: TDAP
Symptoms: No adverse event, Product storage error
Clinical narrative: Initial information received on 05-Oct-2018 regarding an unsolicited valid non-serious case received from a Non-healthcare professional. This case is linked to cases 2018SA279967, 2018SA279973, 2018SA281633, 2018SA281638, 2018SA281635, 2018SA281636, 2018SA281637, 2018SA281634, 2018SA281632, 2018SA279979, 2018SA281687, 2018SA281692 and 2018SA279967. (Same reporter). This case involves an 11 years old female patient who received vaccine ADACEL, lot U5798AB via unknown route in the left deltoid on an unknown date. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication was not reported. It was a case of actual medication error due to incorrect product storage. It was reported that vaccines given between 11-Sep-2018 to 13-Sep-2018 after temperature was at 30 F for 4 hours: They were below freezing. No adverse event was reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Sex: M
Vaccine: FLU3
Symptoms: Extra dose administered, Syringe issue, Underdose
Clinical narrative: Initial information received on 05-Oct-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case is linked to case 2018SA279805 (Same reporter). This case involves a male patient (age reported as 65 year old) who he received vaccine FLUZONE HIGH DOSE lot UJ038AB expiry date: 03-May-2019 via unknown route on 03-Oct-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication was not reported. It was case of actual medication error due to vaccine under dose and extra dose administered. It was reported that reporter screwed on the needle and it was tight and sealed but there must be a crack or something because it was leaking out when she was giving it. The shot leaked and she administered another FLUZONE injection at the time. It was also a case of needle issue. It was not reported that if any adverse event was occurred or not. 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 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: 13.0
Sex: U
Vaccine: FLU4, PNC13
Symptoms: Injection site erythema
Clinical narrative: Patient received PREVNAR 13 on 10/3/18 on Left arm and developed redness at the site of injection (Left arm). She also received flu-shot same day on right arm - No reaction occurred.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Herpes zoster
Clinical narrative: A case of shingles broke out in the usual location - my low back. The vaccine was given in my left outer arm. This was the booster (the second of two parts).
Age: 1.08
Sex: F
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: Developed acute onset of urticarial/hives on trunk and extremities a couple of hours after receiving the shot.
Age: 81.0
Sex: M
Vaccine: FLUA3
Symptoms: Blood test, Computerised tomogram, Dysarthria, Eyelid ptosis, Facial paralysis
Clinical narrative: Patient noticed facial paralysis starting on 10/8/2018 with facial droop, slurred speech, eye drooping.
Age: 81.0
Sex: M
Vaccine: FLUA3
Symptoms: Nuclear magnetic resonance imaging
Clinical narrative: Patient noticed facial paralysis starting on 10/8/2018 with facial droop, slurred speech, eye drooping.
Age: 66.0
Sex: F
Vaccine: FLUA3, PNC13
Symptoms: Injection site pain, Pain
Clinical narrative: Patient complains of pain in right arm where flu shot was given. Patient stated symptoms started the day after vaccination and is still ongoing. Pain/discomfort is in right arm and hurts when moving/rotating. Pain begins on the top of arm and extends to halfway down her upper arm (in between shoulder and elbow). Patient reports no pain on left arm from PREVNAR vaccine. Patient has tried icing the arm as well as taking Ibuprofen with little relief. Patient will be consulting with PCP to discuss reaction and further treatment options.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Anaphylactic reaction, Dizziness, Injection site pruritus, Tricuspid valve incompetence, Upper airway obstruction
Clinical narrative: Itchy (severe itchy sensation of the arm at site of injection), shortly patient felt dizzy, followed by stridor. Management upper airway obstruction in view of anaphylaxis/called 911. Tx: Epinephrine Antihistamine/BENADRYL Corticosteroid.
Age: 69.0
Sex: F
Vaccine: FLU4
Symptoms: Decreased appetite, Electrocardiogram, Fatigue, Hyperaesthesia, Hypotension
Clinical narrative: Extreme fatigue. Low Blood Pressure. Loss of appetite. Extreme sensitivity at vaccination site, whenever my immune system is compromised. Loss of weight.
Age: 69.0
Sex: F
Vaccine: FLU4
Symptoms: Vaccination site reaction, Weight decreased
Clinical narrative: Extreme fatigue. Low Blood Pressure. Loss of appetite. Extreme sensitivity at vaccination site, whenever my immune system is compromised. Loss of weight.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Altered state of consciousness, Chills, Dizziness, Nausea
Clinical narrative: Per pt's report: She went home after receiving her vaccine and took some TYLENOL about 9:30 pm. She was awoken by shaking chills at 2:00 am. This lasted until about 5:00 am. She proceeded to go to work but felt nauseous and dizzy ("almost passed out"). She felt much better toward the end of the day and back to her normal self the following day.
Age: 35.0
Sex: F
Vaccine: FLU4
Symptoms: Limb discomfort, Peripheral swelling, Swelling, Tenderness
Clinical narrative: Received annual influenza vaccination 10/10/2018 at 0630 AM in left deltoid IM. Awoke on 10/11/2018 of 0500AM with left upper arm and under arm into left chest swelling with tenderness to touch, took Ibuprofen p.o. this morning still experiencing an odd uncomfortable feeling in arm. Swelling decreasing slowly.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Patient has 6 cm diameter area, firm induration increased warmth with erythema and increased warmth on right deltoid.
Age: 17.0
Sex: F
Vaccine: FLU4, MENB
Symptoms: Diarrhoea, Nausea, Pyrexia, Vomiting
Clinical narrative: High fever, diarrhea, N/V.
Sex: M
Vaccine: VARZOS
Symptoms: Eye infection viral, Necrotising retinitis, Varicella
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 05-JUN-2012, the patient was inoculated with the ZOSTAVAX vaccine at a pharmacy as recommended for routine adult health maintenance and for the 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 or shingles. On or about 20-OCT-2015, the patient was treated at an ophthalmology specialty hospital emergency room for a severe viral infection of the retina that may lead to significant vision loss, which was diagnosed as varicella associated acute retinal necrosis. The patient was prescribed valacyclovir hydrochloride (VALTREX) and difluprednate (DUREZOL) and received an injection of intravitreal foscarnet sodium in the left eye. On or about 04-NOV-2015, the patient sought subsequent treatment from a physician at an ophthalmology clinic for a follow up appointment for his diagnosis of acute retinal necrosis. The patient was prescribed atropine and was to continue valacyclovir hydrochloride (VALTREX) and difluprednate (DUREZOL) and has to wear Polycarbonate lenses to protect the left eye. On or about 04-DEC-2015, the patient had further treatment from a physician at an ophthalmology and surgery office for an additional follow up appointment for his diagnosis of acute retinal necrosis. The patient was prescribed a double dose of valacyclovir hydrochloride (VALTREX). As a direct and proximate result of zoster 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. Upon internal review, the event of varicella associated acute retinal necrosis was considered medically significant. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: 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 06-APR-2009, the patient was inoculated with ZOSTAVAX at a pharmacy as recommended for routine adult health maintenance and for the 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 condition of herpes zoster or shingles. Later in 2009, the patient was treated by Nurse Practitioner for a vesicular outbreak which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the 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: Herpes zoster, Rash vesicular
Clinical narrative: Information was received from a lawyer regarding a case in litigation involving a female patient, age and medical history not provided. On or about 07-JAN-2014 the patient was inoculated with ZOSTAVAX vaccine at a pharmacy for routine adult health maintenance and the prevention of shingles. The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain condition of herpes zoster. In 2016 the patient was treated by a physician for a vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX r despite receiving ZOSTAVAX for 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, pain, suffering and other damages. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, 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 05-DEC-2013, the patient was inoculated with ZOSTAVAX at a medical center as recommended for routine adult health maintenance and for the long-term 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 or shingles. In 2016, the patient was treated at the same medical center for a severe vesicular outbreak which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the 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.