chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 16.0
Sex: U
Vaccine: MNQ
Symptoms: Expired product administered
Clinical narrative: Caller reporting giving an expired dose of Menactra; Initial information received on 22-Aug-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a16 years old patient who received an expired dose of vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HPV VACCINE (HPV VACCINE) for Immunisation; and HPV VACCINE VLP RL1 9V (YEAST) (GARDASIL 9) for Immunisation.  On 21-Aug-2019, the patient received a 0.5 ml single dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE lot U594AC (expiry date: 14-AUG-2019) via unknown route in the right deltoid.  It was of actual medication error case due to expired vaccine used.  It was not reported whether adverse event was experienced by the patient 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: HIBV
Symptoms: No adverse event, Product preparation error, Product preparation issue
Clinical narrative: a nurse administered an Act-Hib vaccine which was reconstituted with sterile water instead of the provided 0.4 percent saline; Initial information received on 22-Aug-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 15 months old patient who was administered a 0.5ml fourth dose of vaccine HIB (PRP/T) VACCINE [ACT-HIB] which was reconstituted with sterile water instead of the provided 0.4 percent saline lot UJ119AA, expiry date: 11-Dec-2020  via intramuscular route in the right vastus lateralis on 21-Aug-2019.  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) and HEPATITIS B VACCINE (HEPATITIS B VACCINE).  It was an actual medication error due to inappropriate reconstitution technique.  Adverse 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 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: 10.0
Sex: M
Vaccine: DTAP, TDAP
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Daptacel was inadvertently administered to a 10 year patient instead of Adacel/no AE; Daptacel was inadvertently administered to a 10 year patient instead of Adacel/no AE; Initial information received on 21-Aug-2019 regarding an unsolicited non-valid non-serious case received from a Physician.  This case concerns a 10-year-old male patient who received a single 0.5 ml booster dose of DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE (DAPTACEL) (lot: C5207AA/C5307AA) via intramuscular route in left deltoid instead of DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE (ADACEL) on 21-Aug-2019.  Patient's medical history and concomitant therapy were not reported.   It was of actual medication error case due to wrong vaccine administered and Inappropriate age at vaccine administration.  It was reported that no adverse event was experienced by the patient.  Information on the batch number was requested (for ADACEL).  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: MNQ
Symptoms: Extra dose administered
Clinical narrative: patient was administered Menactra at age 11 years and then 10 months later; Initial information received on 21-Aug-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to cases 2019SA240611 and 2019SA240612 (same reporter).  This case involves a 11 years old patient who received vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (lot number and Exp. Date not reported) via unknown route in unknown administration site, in Oct-2019 and again 10 months later.  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 extra dose administered.  It was reported that triplets were administered Menactra at age 11 years and then 10 months later.   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 holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Information on the batch number was requested.  List of documents held by sender: none.
Sex: U
Vaccine: IPV
Symptoms: No adverse event, Product storage error
Clinical narrative: was already opened and stored at 51.2F for 1 hour and 16 minutes with no AE; Initial information received on 21-Aug-2019 regarding an unsolicited valid non-serious case received from other health professional.  This case is linked to cases 2019SA237576 and 2019SA237575 (same reporter).  This case involves a patient of unknown age who received vaccine IPV (VERO) [IPOL] and reported that vaccine was already opened and stored at 51.2f for 1 hour and 16 minutes with no AE.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  Concomitant medications included VARICELLA ZOSTER VACCINE (VARICELLA VACCINE); MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR); and DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DAPTACEL).  On 20-Aug-2019, the patient received 4th dose of suspect IPV (VERO) lot P1A242M and expiry date: 26-Apr-2020 via unknown route in the left thigh.  It was a case of actual medication error due to incorrect product storage.  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: IPV
Symptoms: No adverse event, Product storage error
Clinical narrative: patient recieved already opened and stored vaccine at 51.2F for 1 hour and 16 minutes with no AE; Initial information received on 21-Aug-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked to cases 2019SA237576 and 2019SA237574 (same reporter).  This case involves a 5 year old male patient of unknown age who received vaccine IPV (VERO) [IPOL] and reported that vaccine was already opened and stored at 51.2 Fahrenheit for 1 hour and 16 minutes with no AE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS A VACCINE (HEPATITIS A); MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR); VARICELLA ZOSTER VACCINE (VARICELLA VACCINE); and DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DAPTACEL).  On 21-Aug-2019, the patient received 4th dose of suspect IPV (VERO) lot P1A242M and expiry date: 26-Apr-2020 via unknown route in the left thigh.  It was a case of actual medication error due to incorrect product storage.  No adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Sex: F
Vaccine: IPV
Symptoms: No adverse event, Product storage error
Clinical narrative: was already opened and stored at 51.2F for 1 hour and 16 minutes with no AE; Initial information received on 21-Aug-2019 regarding an unsolicited valid non-serious case received from other health professional.  This case is linked to cases 2019SA237574 and 2019SA237575 (same reporter).  This case involves a female patient of unknown age who received vaccine IPV (VERO) [IPOL] and reported that vaccine was already opened and stored at 51.2f for 1 hour and 16 minutes with no AE.  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 (DAPTACEL); MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR); and HEPATITIS A VACCINE (HEPATITIS A).  On 21-Aug-2019, the patient received 4th dose of suspect IPV (VERO) lot P1A242M and expiry date: 26-Apr-2020 via subcutaneous route in the right thigh.  It was a case of actual medication error due to incorrect product storage.  No adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Sex: U
Vaccine: MNQ
Symptoms: Extra dose administered
Clinical narrative: patient was administered Menactra at age 11 years and then 10 months later; Initial information received on 21-Aug-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to cases 2019SA236741 and 2019SA240612 (same reporter).  This case involves an 11 years old patient who received vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] and reported that patient was administered Menactra at age 11 years and then 10 months later.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  In October 2018, the patient received a dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE lot number not reported via unknown route in unknown administration site.  It was a case of actual medication error due to extra dose administered.  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 holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Information on the batch number was requested.  List of documents held by sender: none.
Sex: U
Vaccine: MNQ
Symptoms: Extra dose administered
Clinical narrative: patient was administered Menactra at age 11 years and then 10 months later; Initial information received on 21-Aug-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to cases 2019SA240611 and 2019SA236741 (same reporter).   This case involves an 11 years old patient who received vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] and reported that patient was administered Menactra at age 11 years and then 10 months later.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  In October 2018, the patient received a dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE lot number not reported via unknown route in unknown administration site.  It was a case of actual medication error due to extra dose administered.  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 holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Information on the batch number was requested.  List of documents held by sender: none.
Age: 2.0
Sex: M
Vaccine: HEPA
Symptoms: Computerised tomogram head normal, Pyrexia, Seizure
Clinical narrative: Approximately 2 days after getting vaccination, pt got a fever and seizure. Pt was taken to the ER. Pt had a normal head CT at that time. pt has done fine since that time.
Age: 44.0
Sex: F
Vaccine: TD
Symptoms: Mass, Pruritus, Rash, Skin warm
Clinical narrative: Pt woke on 8/31/19 with rash about 1-2 inches which became hot, itchy, and spread to 5-6 inches with lump. Pt applied OTC antibiotic ointment.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Lip swelling, Swelling face, Urticaria
Clinical narrative: Patient experience facial swelling, lip swelling, and hives on the back of the head. Patient stated she did not feel like she had any trouble breathing. Patient was advised to take Benadryl or Claritin and follow up with PCP if symptoms did not resolve. Upon follow-up several days later, patient stated that all her symptoms had resolved.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, HEPA, MMRV
Symptoms: Injection site cellulitis, Injection site rash
Clinical narrative: Patient developed cellulitis rash on right arm.  Patient was taken to ER by mother and was told to just keep an eye on rash. No treatment was given in ER.
Age: 12.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Dizziness, Loss of consciousness
Clinical narrative: Pt to clinic for immunizations.  Pt received two immunizations to L deltoid. After receiving second immunization pt lost consciousness for approximately 3 to 5 seconds. Pt positioned on exam table in semi sitting position with feet elevated. Pt remained in exam room for approximately 5 minutes and stated she felt light headed and lost consciousness again for 3 to 5 seconds.. Pt drank a box of juice and ate a pack of peanut butter crackers. Pt stated she did not feel dizzy or light headed. Mother and pt advised to see pediatrician today for evaluation. Mother stated she would take child to pediatrician after leaving clinic today.
Age: 70.0
Sex: F
Vaccine: UNK
Symptoms: Arthralgia, Headache, Injection site erythema, Injection site swelling, Muscle fatigue
Clinical narrative: Fever,  severe head ache, muscle and joint aches, redness and swelling in muscle beneath injection site for 36 hrs Swelling and itching in arm lasted 6 days with muscle fatigue so great that arm would. It support a hair dryer. Minor Muscle fatigue in arm continues with stiffness and some pain  17 days later.
Age: 70.0
Sex: F
Vaccine: UNK
Symptoms: Musculoskeletal stiffness, Myalgia, Pain in extremity, Peripheral swelling, Pruritus
Clinical narrative: Fever,  severe head ache, muscle and joint aches, redness and swelling in muscle beneath injection site for 36 hrs Swelling and itching in arm lasted 6 days with muscle fatigue so great that arm would. It support a hair dryer. Minor Muscle fatigue in arm continues with stiffness and some pain  17 days later.
Age: 70.0
Sex: F
Vaccine: UNK
Symptoms: Pyrexia
Clinical narrative: Fever,  severe head ache, muscle and joint aches, redness and swelling in muscle beneath injection site for 36 hrs Swelling and itching in arm lasted 6 days with muscle fatigue so great that arm would. It support a hair dryer. Minor Muscle fatigue in arm continues with stiffness and some pain  17 days later.
Age: 3.0
Sex: M
Vaccine: IPV
Symptoms: Dyspnoea
Clinical narrative: Patient seemed to be experiencing air hunger. Taking big breaths roughly 30 - 60 seconds  apart for over an hour
Age: 11.0
Sex: F
Vaccine: HEPA, MMR, MNQ, VARCEL
Symptoms: Loss of consciousness
Clinical narrative: Pt to clinic for immunizations. Pt received three immunizations in left arm, after last immunization pt eyes closed and she lost consciousness for approximately 2 to 3 seconds. Pt was positioned in a semi sitting position with feet elevated on exam table with mother at side. Pt remained in clinic room for approximately 40 minutes and drank a box of juice.  Pt then received last immunization in right arm w/o incident. Pt remained in clinic for approximately 15 minutes post last immunization and stated she did not feel light headed or dizzy. Pt was allowed to leave clinic with mother.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Pyrexia
Clinical narrative: Fever, weak, chills
Age: 1.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Incorrect route of product administration, Injection site erythema, Product preparation issue
Clinical narrative: Toe Patient's left arm is red; The VARIVAX was inadvertently reconstituted with VAQTA and administered together subcutaneously to a 1 year old in her left arm.; This spontaneous report was received from a medical assistant and refers to a 1-year-old female patient. Her concurrent conditions included ear infection. Concomitant therapies included antibiotics. No information regarding the patient's pertinent medical history and drug reactions or allergies was provided.  On 13-AUG-2019, the patient inadvertently received varicella virus vaccine live (oka/merck) (VARIVAX) lot # S006018, expiration date: 27-FEB-2021, and hepatitis a vaccine, inactivated (VAQTA) vial 25/0.5, lot # S002505, expiration date: 04-APR-2020 mixed together and administered subcutaneously in the left arm as prophylaxis (childhood immunizations, the child was due for both vaccines). No sterile diluent was used to reconstitute varicella virus vaccine live (oka/merck) (VARIVAX); just hepatitis a vaccine, inactivated (VAQTA). The patient's left arm was red and she received acetaminophen (TYLENOL) and a cool arm wrap for the redness. The outcome of the event was reported as recovering.   The relatedness between the event and varicella virus vaccine live (Oka/Merck) (VARIVAX) and hepatitis a vaccine, inactivated (VAQTA) was not reported.
Sex: F
Vaccine: HPV9
Symptoms: Oedema peripheral, Pain
Clinical narrative: edema of the injection arm, and the arm was very painful to move.; edema of the injection arm, and the arm was very painful to move.; edema of the injection arm, and the arm was very painful to move.; edema of the injection arm, and the arm was very painful to move.; This spontaneous report was received from a physician (patient's mother) via a company representative referring to a female patient of unknown age. The patient's concomitant medication, concurrent condition, pertinent medical history, drug reaction/allergies were not reported.  On an unspecified date in February 2019 (reported as about 6 months ago), the patient was vaccinated with the first dose of series of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, unit, route of administration, lot# and expiration date were not reported) by the patient's pediatrician for prophylaxis.  The patient subsequently experienced edema of the injection arm, and the arm was very painful to move on an unspecified date in 2019. She received ibuprofen and ice packs were put on the arm, and the patient recovered two days later.  Causality between events rash and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not provided.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 03-JUN-2008, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (lot number, dosage and route of administration not provided), for the long term prevention of shingles and zoster related conditions. Subsequently, the patient was treated for shingles on unspecified date. As a direct and proximate result of the patient's use of zoster vaccine live (ZOSTAVAX) vaccine, the patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; 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 include care for hospitalization (on an unknown date), physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of the event was considered as not resolved. The causality between shingles and zoster vaccine live (ZOSTAVAX) was considered as related.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; 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. In 2011 , the patient was inoculated with zoster vaccine live (ZOSTAVAX) (lot number, dosage and route of administration not provided), at a pharmacy for the long term prevention of shingles and zoster related conditions. Subsequently, the patient was treated in a hospital for shingles on unspecified date. As a direct and proximate result of the patient's use of zoster vaccine live (ZOSTAVAX) vaccine, the patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; 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 include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future. The outcome of the event was considered as not resolved. The causality between shingles and zoster vaccine live (ZOSTAVAX) was considered as related.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This initial spontaneous report has been received from a lawyer regarding a case in litigation referring to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history.    On 04-SEP-2013, the patient was inoculated with the zoster vaccine live (ZOSTAVAX) vaccine for the long-term prevention of shingles (dose, route, and lot number not provided). On an unknown date, the patient experience shingles. Subsequently, the patient was treated by a healthcare provider. The outcome of the event was unknown. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, the patient had and would suffered ongoing injuries, including but not limited to: mental and physical pain and suffering; 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 cost include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Subsequent to Plaintiff's ZOSTAVAX inoculation, Plaintiff was treated by M.D. at the Office of M.D. for shingles.; Information has been received from a lawyer regarding a case in litigation concerning a female patient (pt) of unknown age. No information was received regarding the pt's past medical history, concurrent conditions, or concomitant medication. In 2008, the pt was inoculated with the zoster vaccine live (ZOSTAVAX) (lot number, dosage and route of administration not provided), as prescribed and/or administered by a healthcare provider, for the long-term prevention of shingles and zoster-related conditions. Alternatively, in 2008, the pt's healthcare providers, relied on the warning label affixed to the zoster vaccine live (ZOSTAVAX) vaccine, believed that it was effective in preventing shingles on a long-term or permanent basis, and believed that it did not carry any significant risks of adverse effects. Subsequent to pt's zoster vaccine live (ZOSTAVAX) inoculation, pt was treated by physician, at the Office, for shingles. As a direct and proximate result of pt's use of the zoster vaccine live (ZOSTAVAX) vaccine, pt had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; 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 include care for hospitalization (date unspecified), physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided.  In 2011, the patient (pt) was vaccinated with zoster vaccine live (ZOSTAVAX), (lot#, dosage and route unknown) for long-term prevention of shingles and zoster-related conditions.  Subsequent to zoster vaccine live (ZOSTAVAX) inoculation, the pt experienced shingles (date unspecified) and was treated by a healthcare provider at a clinic and was hospitalized due to the event (date unspecified). As a direct and proximate result of pt use of the zoster vaccine live (ZOSTAVAX) vaccine, the pt had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; 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 include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of the event was considered as not resolved. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; Information has been received from a lawyer and the patient regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided.  On or about 14-JUN-2013, the patient (pt) was vaccinated with zoster vaccine live (ZOSTAVAX), (lot# and expiration date, route unknown) for long-term prevention of shingles and zoster-related conditions.  Subsequent to zoster vaccine live (ZOSTAVAX) inoculation, the pt experienced shingles (onset date unspecified) and was treated by a physician at his office; and was hospitalized due to the event (date unspecified). As a direct and proximate result of pt use of the zoster vaccine live (ZOSTAVAX) vaccine, the pt had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; 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 include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future. The outcome of the event was reported as not resolved.  The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Neuropathy peripheral
Clinical narrative: neuropathy; shingles; This initial spontaneous report was received from a lawyer and the patient regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or around 18-FEB-2015, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) at pharmacy, for the long-term prevention of shingles and zoster-related conditions. Subsequently, on an unspecified date, the patient was treated by a healthcare professional  for shingles and neuropathy (neuropathy peripheral). As a direct and proximate result of the patient's use of zoster vaccine live (ZOSTAVAX) vaccine, the patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; 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 include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of the events was not provided and the causality of the events was related.  Upon internal review, the event neuropathy peripheral was determined to be medically significant.
Sex: F
Vaccine: HPV4
Symptoms: Lip injury, Syncope
Clinical narrative: fainted after receiving the vaccine as well as hit the floor and suffered a cut on her lip; fainted after receiving the vaccine as well as hit the floor and suffered a cut on her lip; This spontaneous report was received from a licensed practical nurse via field employee regarding a 14 years old female patient. The patient's medical history, concurrent conditions, concomitant therapies and drug reactions/allergies were not provided.  On an unspecified date in 2016 (reported as 3 years ago), the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) (dose, batch/lot#, expiration date and route were not reported) for prophylaxis. On an unspecified date in 2016, the patient experienced fainted after receiving the vaccine as well as hit the floor and suffered a cut on her lip. The patient received unspecified treatment for the events and she sought medical attention and the cut was treated. On the same day, she recovered from the events.  Causality between the events and quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) was not reported.  Upon internal review, event syncope was determined to be medically significant.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient (pt) of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 12-APR-2011, pt was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, and route of administration were not specified), as prescribed and/or administered by a healthcare provider at pharmacy for the long-term prevention of shingles and/or zoster-related conditions. Subsequent to pt's zoster vaccine live (ZOSTAVAX) inoculation, pt was treated by a physician for shingles. As a direct and proximate result of pt's use of the zoster vaccine live (ZOSTAVAX) vaccine, pt has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; 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 include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: adult patient received unspecified dose of VARIVAX that was improperly stored; No adverse effects reported; This spontaneous report has been received from an office manager concerning an adult patient of unknown age and gender. The patient's medical history, drug allergies, concurrent conditions were not reported. Concomitant therapies included sterile diluent (DILUENT MRK).  On 21-AUG-2019 (also reported as "in the last few days"), the patient was administered  a dose of varicella virus vaccine live (oka/merck) (VARIVAX) with lot # R035222 and expiration date on 04-DEC-2020 (strength, dose, dose number, route of administration and anatomical location were not provided), for prophylaxis.  It was reported that on an unspecified date, the vaccine was exposed to a temperature of 46 Fahrenheit degrees for 6 months. There was no previous temperature excursion. The call was placed because of a Digital Data logger report. No adverse effects were reported.
Sex: U
Vaccine: HIBV, RV5
Symptoms: Product storage error
Clinical narrative: improperly stored vaccine; This spontaneous report was received from a medical assistant concerning to a patient of unknown age and gender. No information was provided regarding the patients' medical history, concurrent conditions or concomitant medications.  On 25-APR-2019, the patient was vaccinated with improperly stored dose of Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) one dose, lot number R021078 with expiration date on 12-JUN-2021; and Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) lot number R028189 with expiration date on 06-JUN-2020. Dosage schedule, route and anatomical location were not reported for non of the vaccines, and all of them were administered for prophylaxis.  The administered doses experienced temperature excursion up to 52.5 degrees Fahrenheit (F) for 4 hours and 40 minutes. There was no previous temperature excursion. Digital data logger was involved.
Sex: U
Vaccine: HEPA
Symptoms: Product storage error
Clinical narrative: A patient received improperly stored vaccine; This spontaneous report as received from a medical assistant concerning a patient of unknown age and gender. There was no information regarding the patient's medical history, concurrent conditions or concomitant medications.  On 23-APR-2019, the patient was vaccinated with a dose of improperly stored hepatitis a vaccine, inactivated(VAQTA) lot # S002459 with expiration date of 15-MAY-2020 (route of administration and anatomical location were not reported),  for prophylaxis, which was stored in the range of 52.5 Fahrenheit degrees for 4 hours and 40 minutes. There was no previous temperature excursion.  Digital data logger was involved.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; patient received improperly stored vaccine; This spontaneous report was received from a medical assistant regarding a patient of unknown demographics. Information on patient's pertinent medical history, concurrent conditions and concomitant medications were not reported. On 25-APR-2019, the patient was vaccinated with improperly stored Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) (lot # R021078, expiry date: 12-JUN-2021), dose details, route, strength of all the vaccines were unknown) for prophylaxis. The vaccine was stored at a temperature range of (52.5 degree fahrenheit) for time frame of 4 hour 40 minutes. No previous temperature excursion involved. The digital data logger was involved. No adverse effects reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; a patient was administered a dose of improperly stored VARIVAX; Information has been received from medical assistant referring to a patient of unknown age. The patient's pertinent medical history, concurrent condition and concomitant therapy were not reported.     On 26-AUG-2019, the patient was vaccinated with a dose of improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) (lot # S004554, expiration date: 14-FEB-2021, strength and route were not reported) for prophylaxis (improper storage of product in use). The vaccine was stored in temperature range from -14 degrees Celsius to -10 degrees Celsius for 18 minutes. The data logger was involved. The excursion was due to calibration for data-logger. There was no previous temperature excursion. No adverse effect reported.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect; patient was administered a dose of improperly stored PROQUAD; This spontaneous report was received from a medical assistant refers to a patient of unknown age. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On 22-AUG-2019, the patient was vaccinated with a dose of improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) (lot # S003863, expiry date:08-AUG-2020, anatomical location and route was not reported) for prophylaxis (product storage error). The vaccine was exposed to a temperature range of -14 C to-10 C ( -14.4C) for a time frame of 18 minutes which was due to calibration for data-logger. There were no previous temperature excursions noted. No adverse effect reported. No PQC was filed.
Sex: U
Vaccine: VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: no adverse affects; extra dose administered; This spontaneous report was received from an administrator refers to a patient of unknown demographics. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On 27-AUG-2019, the patient was vaccinated with extra dose of varicella virus vaccine live (oka/merck)(VARIVAX) (strength, route of administration, anatomical location were unknown) of lot # R027995 and expiration date 01-OCT-2020 for prophylaxis (extra dose administered). No adverse effects reported. The outcome of extra dose administered was unknown. No product quality complaint reported.
Sex: U
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Rash on chest; This case was reported by a consumer and described the occurrence of rash in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 22nd August 2019, the patient received the 1st dose of Shingrix. In August 2019, less than a week after receiving Shingrix, the patient experienced rash. On an unknown date, the outcome of the rash was unknown.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per the vaccine indication. The patient had a rash on chest. The patient asked could the shot cause a rash in other areas of the body.
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Dyspnoea, Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Arm pain at injection site; Injection site redness; Injection site warmth; Felt like coming down with something; Body aches; Out of breath; Weak; This case was reported by a nurse via sales rep and described the occurrence of injection site pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix .5 ml. On an unknown date, 1 day after receiving Shingrix, the patient experienced injection site pain, injection site erythema, injection site warmth, feeling unwell, general body pain, shortness of breath and weakness. On an unknown date, the outcome of the injection site pain, injection site erythema, injection site warmth, feeling unwell, general body pain, shortness of breath and weakness were recovered/resolved.   The reporter considered the injection site pain, injection site erythema, injection site warmth, feeling unwell, general body pain, shortness of breath and weakness to be possibly related to Shingrix.  Additional details were provided as follows: The patient received Shingrix on right deltoid. The reporter stated that local side effects on 1st day after vaccination as arm pain, redness and warmth at injection site. Less than 2 years after vaccination, the patient had systemic effects like felt like coming down with something which included body aches for several days, out of breath and weak. The patient was not hospitalized. The reporter indicated suspected link to vaccine. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Malaise, Pain
Clinical narrative: Arm pain at injection site; Injection site redness; Injection site warmth; Felt like coming down with something; Body aches; Out of breath; Weak; This case was reported by a nurse via sales rep and described the occurrence of injection site pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix .5 ml. On an unknown date, 1 day after receiving Shingrix, the patient experienced injection site pain, injection site erythema, injection site warmth, feeling unwell, general body pain, shortness of breath and weakness. On an unknown date, the outcome of the injection site pain, injection site erythema, injection site warmth, feeling unwell, general body pain, shortness of breath and weakness were recovered/resolved.   The reporter considered the injection site pain, injection site erythema, injection site warmth, feeling unwell, general body pain, shortness of breath and weakness to be possibly related to Shingrix.  Additional details were provided as follows: The patient received Shingrix on right deltoid. The reporter stated that local side effects on 1st day after vaccination as arm pain, redness and warmth at injection site. Less than 2 years after vaccination, the patient had systemic effects like felt like coming down with something which included body aches for several days, out of breath and weak. The patient was not hospitalized. The reporter indicated suspected link to vaccine. The reporter consented to follow up.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Lethargy, Pyrexia
Clinical narrative: Fever 101.5; Lethargy; Chills; This case was reported by a pharmacist via call center representative and described the occurrence of fever in a 73-year-old female patient who received Herpes zoster (Shingrix) (batch number 9JG52, expiry date 27th September 2021) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, less than 4 months after receiving Shingrix, the patient experienced fever, lethargy and chills. On an unknown date, the outcome of the fever, lethargy and chills were recovered/resolved.   It was unknown if the reporter considered the fever, lethargy and chills to be related to Shingrix.  Additional information received were as follows: The age at vaccination was not reported. The pharmacist called and reported that the patient had fever of 101.5 degree F., lethargy, and chills for one day. The reporter consented to follow up.