chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
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 21-NOV-2011 the patient was vaccinated with zoster vaccine live(ZOSTAVAX) (dose, route, lot# and expiration date were unknown) by a healthcare provider for the long-term prevention of shingles and/or zoster-related conditions (for prophylaxis). Subsequent to inoculation, the patient was treated for shingles.  As a direct and proximate result of patient's use of the zoster vaccine live(ZOSTAVAX) vaccine, patient 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.  Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse events.; patient received improperly stored dose of vaccine; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. Information about pertinent medical history, drug reaction/allergy and concomitant medication was not provided. Concomitant therapy included sterile diluent (MERCK STERILE DILUENT).         On 02-JAN-2020, the patient was vaccinated with improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (strength, vaccine dosage detail and route of administration were not reported, lot # S012536, expiration date 20-OCT-2020) for prophylaxis(product storage error). The measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) was reconstituted with properly stored sterile diluent (MERCK STERILE DILUENT). The storage temperature of the vaccine was 6 Fahrenheit degrees to 14 Fahrenheit degrees (-14 Celsius degrees to -10 Celsius degrees (5.5 Fahrenheit degrees) for 35 minutes. Previous temperature excursion was 6 Fahrenheit degrees to 14 Fahrenheit degrees (-14 Celsius degrees to -10 Celsius degrees (7 Fahrenheit degrees) for 35 minutes. No additional adverse events. Data logger was involved.
Sex: F
Vaccine: VARCEL
Symptoms: Antibody test abnormal, Rash
Clinical narrative: antibodies "at the 140 level, below the expected level of 160 or above."; a rash of 12 dots; This spontaneous report was received from a patient's mother and refers to a female patient of unknown age. No information regarding the her pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 20-SEP-2019, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) injection, subcutaneous, (dose, lot # and expiration date were not reported) for vaccination.  On the same date, she experienced rash of 12 dots at an unspecified location, which resolved on an unknown date in approximately 2019, provided as "shortly after the vaccine was given".  On 06-DEC-2019, reported as eleven weeks after the dose, the patient had varicella titers test drawn, showing antibodies at the 140 level, below the expected level of 160 or above (units not provided). On an unknown date patient sought medical attention and contacted a physician. The outcome of the event of antibodies at the 140 level was reported as recovered (date unspecified). The relatedness between the events and the suspect vaccine was not provided.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This spontaneous report has been received from a lawyer regarding a case in litigation, referring to a female patient of unknown age. The patient's medical history, concurrent condition and concomitant medication were not reported.    In 2015 the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, route, strength, batch/lot# and expiration date were not reported) for the long-term prevention of shingles and/or zoster-related conditions. At the time of the patient's vaccination, the patient relied on the warning label affixed to zoster vaccine live (ZOSTAVAX), and the information relayed through the patient's healthcare provider(s) that zoster vaccine live (ZOSTAVAX) was effective in preventing shingles on a permanent basis and did not carry any significant risk of adverse effects, which induced the patient to be vaccinated. Alternatively, in 2015, the patient'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 that it did not carry any significant risks of adverse effects.   On an unknown date, reported as subsequent to the patient's zoster vaccine live (ZOSTAVAX) inoculation, the patient experienced shingles and was treated. As a direct and proximate result of the patient's use of the zoster vaccine live (ZOSTAVAX) vaccine, the patient 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 outcome of shingles was unknown. The reporter considered shingles to be related to zoster vaccine live (ZOSTAVAX).  The reporter considered the event shingles to be serious due to hospitalization and life threatening.
Sex: U
Vaccine: HPV9
Symptoms: Product storage error
Clinical narrative: a dose ofGARDASIL9 that experienced a temperatme excursion.; Patient did not experience any symptoms; This spontaneous report has been received from a nurse, referring to a patient of unknown age and gender. Information about the patient's pertinent medical history, concurrent conditions, concomitant medications and previous drug reactions and allergies were not provided.  On 06-JAN-2020, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), by intramuscular route, lot number S008154, and expiration date 20-NOV-2021 for prophylaxis (strength, dose and frequency were not provided) that experienced a temperature excursion (product storage error). The patient did not experience any symptoms.   The temperature was for 2 celsius degrees (°C) (-5.7 degrees (C)) for a timeframe of 16 minutes and a previous temperature excursion of above 9 celsius degrees (°C) (10.7C) for a timeframe of 45 minutes. The call was due to data logger.
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 concomitant medications, concurrent conditions or medical history. On or about 2014, the pt was inoculated with the zoster vaccine live (ZOSTAVAX) vaccine at a health department as recommended for routine adult health maintenance and for the prevention of shingles (dose, route, and lot # not provided). Subsequently, pt. vaccination the pt, was treated by a health care for shingles,( date unspecified date). As a direct and proximate result of zoster vaccine live (ZOSTAVAX)vaccine, and/or despite receiving zoster vaccine live (ZOSTAVAX) for long-term prevention of shingles, the pt suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the pt had suffered and would continue to suffer significant medical expenses, including but not limited to costs for hospitalization (unknown date), physician care, monitoring, treatment, medications and supplies and suffered ongoing injuries, pain and other damages. The outcome of the event was considered not recovered.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles; This 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 medical history, concurrent conditions, or concomitant medications. On 17-FEB-2014, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) for the long-term prevention of shingles and/or zoster related conditions (the dosage regimen information was not reported). Subsequently, the patient was treated by a physician for shingles. As a direct and proximate result of patient's use of zoster vaccine live (ZOSTAVAX), the patient had and would continue suffer ongoing injuries, included 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.
Sex: U
Vaccine: HEP
Symptoms: Expired product administered, No adverse event
Clinical narrative: no additional adverse effect; a patient was administered a dose of RECOMBIVAX after its labeled expiration date. RECOMBIVAX expired on 08-NOV-2019; This spontaneous report was received from an office manager referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not reported.  On 19-NOV-2019, the patient was vaccinated with an expired dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) thiomersal free (lot # N006321 and expiration date: 08-NOV-2019) via unknown route for prophylaxis (expired product administered). No additional adverse effects were reported. No product quality complaint (PQC) was involved.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This spontaneous report has been received from a lawyer regarding a case in litigation, referring to a female patient of unknown age. The patient's medical history, concurrent condition and concomitant medication were not reported.    On or about 24-JAN-2011 the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, route, strength, batch/lot# and expiration date were not reported) for the long-term prevention of shingles and/or zoster-related conditions. At the time of the patient's vaccination, the patient relied on the warning label affixed to zoster vaccine live (ZOSTAVAX), and the information relayed through the patient's healthcare provider(s) that zoster vaccine live (ZOSTAVAX) was effective in preventing shingles on a permanent basis and did not carry any significant risk of adverse effects, which induced the patient to be vaccinated. On or about 24-JAN-2011, the patient'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 that it did not carry any significant risks of adverse effects.   On an unknown date, reported as subsequent to the patient's zoster vaccine live (ZOSTAVAX) inoculation, the patient experienced shingles and was treated. As a direct and proximate result of the patient's use of the zoster vaccine live (ZOSTAVAX) vaccine, the patient 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 outcome of shingles was unknown. The reporter considered shingles to be related to zoster vaccine live (ZOSTAVAX).  The reporter considered the event shingles to be serious due to hospitalization and life threatening.
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 of unspecified age. Information about the patient's concurrent condition, concomitant medication or medical history was not provided. In 2016 the patient was vaccinated with zoster vaccine live(ZOSTAVAX) (strength, dose, route, lot # and expiration date were not reported) as prescribed and/or administered by a healthcare provider for the long-term prevention of shingles and/or zoster-related conditions. At the time of patient's vaccination, patient relied on the warning label affixed to zoster vaccine live(ZOSTAVAX), and the information relayed through patient's healthcare provider(s) that zoster vaccine live(ZOSTAVAX) was effective in preventing shingles on a permanent basis and did not carry any significant risk of adverse effects, which induced patient to be vaccinated. On an unspecified date (reported as subsequent to zoster vaccine live(ZOSTAVAX) inoculation), patient was treated a doctor for shingles. As a direct and proximate result of patient's use of the zoster vaccine live(ZOSTAVAX) vaccine, patient 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 outcome of shingles was not provided. The lawyer considered shingles to be related to zoster vaccine live(ZOSTAVAX).
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 of unspecified age. Information about the patient's concurrent condition, concomitant medication or medical history was not provided. In 2015 the patient was vaccinated with zoster vaccine live(ZOSTAVAX) (strength, dose, route, lot # and expiration date were not reported) as prescribed and/or administered by a healthcare provider for the long-term prevention of shingles and/or zoster-related conditions. At the time of patient's vaccination, patient relied on the warning label affixed to zoster vaccine live(ZOSTAVAX), and the information relayed through patient's healthcare provider(s) that zoster vaccine live(ZOSTAVAX) was effective in preventing shingles on a permanent basis and did not carry any significant risk of adverse effects, which induced patient to be vaccinated. On an unspecified date (reported as subsequent to zoster vaccine live(ZOSTAVAX) inoculation), patient was treated for shingles. As a direct and proximate result of patient's use of the zoster vaccine live(ZOSTAVAX) vaccine, patient 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 outcome of shingles was not provided. The lawyer considered shingles to be related to zoster vaccine live(ZOSTAVAX).
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 10-OCT-2017 the patient was vaccinated with zoster vaccine live(ZOSTAVAX) (dose, route, lot# and expiration date were unknown) by a pharmacist for the long-term prevention of shingles and/or zoster-related conditions (for prophylaxis). Subsequent to inoculation, the patient was treated for shingles.  As a direct and proximate result of patient's use of the zoster vaccine live(ZOSTAVAX) vaccine, patient 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.  Additional information has been requested.
Sex: M
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 male patient of unspecified age. Information about the patient's concurrent condition, concomitant medication or medical history was not provided. In 2016 the patient was vaccinated with zoster vaccine live(ZOSTAVAX) (strength, dose, route, lot # and expiration date were not reported) as prescribed and/or administered by a healthcare provider for the long-term prevention of shingles and/or zoster-related conditions. At the time of patient's vaccination, patient relied on the warning label affixed to zoster vaccine live(ZOSTAVAX), and the information relayed through patient's healthcare provider(s) that zoster vaccine live(ZOSTAVAX) was effective in preventing shingles on a permanent basis and did not carry any significant risk of adverse effects, which induced patient to be vaccinated. On an unspecified date (reported as subsequent to zoster vaccine live(ZOSTAVAX) inoculation), patient was treated for shingles. As a direct and proximate result of patient's use of the zoster vaccine live(ZOSTAVAX) vaccine, patient 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 outcome of shingles was not provided. The lawyer considered shingles to be related to zoster vaccine live(ZOSTAVAX).
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This 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 medical history, concurrent conditions, or concomitant medications. In 2011, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) for the long-term prevention of shingles and/or zoster related conditions (the dosage regimen information was not reported). Subsequently, the patient was treated by a nurse practitioner for shingles. As a direct and proximate result of patient's use of zoster vaccine live (ZOSTAVAX), the patient had and would continue suffer ongoing injuries, included 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.
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 concomitant medications, concurrent conditions or medical history. On or about 13-NOV-2014, the pt was inoculated with the zoster vaccine live (ZOSTAVAX) vaccine at a health department as recommended for routine adult health maintenance and for the prevention of shingles (dose, route, and lot # not provided). Subsequently, pt. vaccination the pt, was treated by physician for shingles,( date unspecified date). As a direct and proximate result of zoster vaccine live (ZOSTAVAX)vaccine, and/or despite receiving zoster vaccine live (ZOSTAVAX) for long-term prevention of shingles, the pt suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the pt had suffered and would continue to suffer significant medical expenses, including but not limited to costs for hospitalization (unknown date), physician care, monitoring, treatment, medications and supplies and suffered ongoing injuries, pain and other damages. The outcome of the event was considered not recovered.
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 concomitant medications, concurrent conditions or medical history. On or about 2018, the pt was inoculated with the zoster vaccine live (ZOSTAVAX) vaccine at a health department as recommended for routine adult health maintenance and for the prevention of shingles (dose, route, and lot # not provided). Subsequently, pt. vaccination the pt, was treated by  healt care professional for shingles,( date unspecified date). As a direct and proximate result of zoster vaccine live (ZOSTAVAX)vaccine, and/or despite receiving zoster vaccine live (ZOSTAVAX) for long-term prevention of shingles, the pt suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the pt had suffered and would continue to suffer significant medical expenses, including but not limited to costs for hospitalization (unknown date), physician care, monitoring, treatment, medications and supplies and suffered ongoing injuries, pain and other damages. The outcome of the event was considered not recovered/not resolved.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; The patient was inadvertently administered a dose of VARIVAX (Lot#N034558/Exp: 12/5/2019), that was expired; This spontaneous report was received from a certified medical assistant refers to a patient of an unknown age and gender. The patient's pertinent medical history, concomitant medication and drug reactions or allergies were not reported.  On 08-JAN-2020, the patient was inadvertently vaccinated with a dose of varicella virus vaccine live (oka/merck) (VARIVAX) injection, lot # N034558 (expiration date: 05-DEC-2019) for prophylaxis (strength, route and anatomical location not reported), that was expired. The patient had no additional adverse event. No product quality complaint (PQC) was involved.
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: he patient received an improperly stored; This spontaneous report was received from a nurse, concerning a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions and drug reactions or allergies were not reported. The patient's concomitant therapies included a sterile diluent.   On 30-DEC-2019, the patient received an improperly stored dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), for prophylaxis, lot number S021327 with an expiration date on 05-JAN-2021 (strength and dose were not reported).   The vaccine was stored at a temperature range between -9° Celsius degrees (C) to 8°C (-3°C) for the time frame of 30 minutes. There was no previous temperature excursion and the call was because of a data logger.
Sex: U
Vaccine: RV5
Symptoms: Regurgitation
Clinical narrative: The patient regurgitated; This spontaneous report was received from an office manager referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies, and concomitant medication was not reported.  On 09-JAN-2020, the patient was administered a dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral route for prophylaxis (strength, dose, frequency were not reported) (lot # S004400 had been verified to be a valid number; expiration date 14-NOV-2020), and the patient regurgitated (regurgitation). The outcome of regurgitation were not reported.        The causality assessment between the vaccine rotavirus vaccine, live, oral, pentavalent (ROTATEQ), and the aforementioned event was not reported.
Age: 13.0
Sex: U
Vaccine: MMRV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: According to the nurse, a 13 years old patient was administered the first dose of PROQUAD; Information has been received from a registered nurse referring to a 13-year-old patient of unknown gender. There was no information about the patient's concurrent conditions, medical history or concomitant medication.  On 09-JAN-2020, the 13-year-old patient was administered the first dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live rHA (PROQUAD) with sterile diluent for prophylaxis (dose and route of administration were not reported) lot number S021619 and expiration date 09-JAN-2021.
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: Nurse reported the patient received an improperly stored dose of PROQUAD; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent conditions, concomitant and historical drugs, drug reactions and allergies was not provided.  On 07-JAN-2020, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) lot # S021327 expiration date 05-JAN-2021 (dose, route and anatomical location were not provided) for prophylaxis. The vaccine was exposed to a temperature of - 9 degree celsius to 8 degree celsius (-3 degree celsius) during 30 minutes. There was not previous temperature excursion. It was reported that digital data logger was involved. Additionally, the vaccine was reconstituted with sterile diluent lot # R032353 expiration date reported as 10-JAN-2021, but upon internal validation established as 10-JUN-2021.
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: The patient received the second dose of Gardasil 9 one month after being vaccinated instead of the recommended two months; no adverse event; This spontaneous report as received from a consumer refers to a female patient of unknown age. On an unknown date, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) for prophylaxis. On an unknown date, the patient received the second dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) one month after being vaccinated instead of the recommended two months (inappropriate schedule of product administration). There was no adverse event. The outcome of inappropriate schedule of product administration was unknown.
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: patient received an improperly stored dose of VARIVAX; This spontaneous report was received from a registered nurse concerning to a patient of unknown age and gender. No information was provided regarding the patients' medical history, concurrent conditions or concomitant medications.  On 09-JAN-2020, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) lot number S002396 with expiration date on 23-JAN-2021 (dosage schedule, route and anatomical location were not reported) for prophylaxis.  Administered doses of vaccine experienced temperature excursion of 15 to 46 degrees Fahrenheit (F) (22.6 F) for an unknown time frame. There was no previous temperature excursion. Digital data logger was involved.
Age: 39.0
Sex: F
Vaccine: VARZOS
Symptoms: Adverse event, Product administered to patient of inappropriate age
Clinical narrative: Reaction; Inappropriate Age at Vaccine Administration; This case was reported by a physician via call center representative and described the occurrence of adverse event in a 39-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced adverse event and inappropriate age at vaccine administration. On an unknown date, the outcome of the adverse event was recovered/resolved and the outcome of the inappropriate age at vaccine administration was unknown.   It was unknown if the reporter considered the adverse event to be related to Shingrix.  Additional details were provided as follows: The patient received 1st dose at 39 years old which led to inappropriate age at vaccine administration and had a reaction. This was a medication error with adverse event No further details were provided. For tolerance with 2nd dose of Shingrix, refer linked case US2020000969.
Sex: U
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: gave the liquid component of Menveo only to a patient; Inappropriate dose of vaccine administered; This case was reported by a consumer via sales rep and described the occurrence of inappropriate reconstitution technique in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo at an unknown dose. On an unknown date, unknown after receiving Menveo, the patient experienced inappropriate reconstitution technique and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate reconstitution technique and inappropriate dose of vaccine administered were unknown.  Additional details were received as follows: The age at vaccination was not reported. One of their offices they gave the liquid component of Menveo only to the patient, which led to inappropriate reconstitution technique and inappropriate dose of vaccine. The reported corrected her and showed her there are 2 components. She said she followed up with the practice and they will correct the mal administration and educate the new MA on how to give Menveo.
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Malaise, Pain, Pyrexia
Clinical narrative: Fever; achiness; exhaustion; Sick; This case was reported by a consumer via call center representative and described the occurrence of fever in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, 1 day after receiving Shingrix, the patient experienced fever, pain, exhaustion and sickness. On an unknown date, the outcome of the fever, pain, exhaustion and sickness were recovered/resolved.   It was unknown if the reporter considered the fever, pain, exhaustion and sickness to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter was the patient. The patient received dose of Shingrix about 2 to 3 years ago. The patient got sick, next day after vaccination. The patient experienced fever, extreme achiness, and exhaustion for 12 hours. No other information provided.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Influenza like illness, Nausea, Pain
Clinical narrative: Nausea; Body ache; Flu Like Symptoms; Upset Stomach; This case was reported by a consumer via call center representative and described the occurrence of nausea in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than 4 months after receiving Shingrix, the patient experienced nausea, general body pain, influenza-like symptoms and upset stomach. On an unknown date, the outcome of the nausea, general body pain, influenza-like symptoms and upset stomach were recovered/resolved.   It was unknown if the reporter considered the nausea, general body pain, influenza-like symptoms and upset stomach to be related to Shingrix.  Additional details were provided as follows: The patient received dose of Shingrix 3 to 4 months ago. After vaccination, the patient experienced nausea, body aches, flu like symptoms and upset stomach that lasted for 4 days. No further details were provided The reporter did not consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Sore; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 weeks after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was not recovered/not resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not provided. The reporter stated that, 2 weeks after vaccination her arm became sore. The reporter was unwilling to provide any additional details.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache
Clinical narrative: headache; This case was reported by a consumer via call center representative and described the occurrence of headache in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included headache (had headaches). Concurrent medical conditions included chronic pain.   On 13th December 2019, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than 3 weeks after receiving Shingrix, the patient experienced headache. On an unknown date, the outcome of the headache was recovered/resolved.   It was unknown if the reporter considered the headache to be related to Shingrix.  Additional details were provided as follows: The patient received dose of Shingrix in the left arm. The reporter stated that, after vaccination, had headach that lasted for approximately 1 day. The reporter did not consent to follow up.
Age: 39.0
Sex: F
Vaccine: VARZOS
Symptoms: Product administered to patient of inappropriate age, Pruritus
Clinical narrative: Itching; Inappropriate Age at Vaccine Administration; This case was reported by a physician via call center representative and described the occurrence of pruritus in a 39-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of adverse event (1st dose received on an unknown date, refer linked case US2020AMR002254).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, 1 week after receiving Shingrix, the patient experienced pruritus and inappropriate age at vaccine administration. On an unknown date, the outcome of the pruritus and inappropriate age at vaccine administration were unknown.   It was unknown if the reporter considered the pruritus to be related to Shingrix.  Additional details were provided as follows: The patient received 2nd dose at 39 years old, which led to inappropriate age at vaccine administration. The patient experienced itching after receiving 2nd dose of Shingrix. This was a medication error with adverse event No further details were provided.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Product administered to patient of inappropriate age
Clinical narrative: Shingles after first dose; Inappropriate age at vaccine administration; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 43-year-old female patient who received Herpes zoster (Shingrix) (batch number 4749N, expiry date 14th November 2020) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced shingles and inappropriate age at vaccine administration. On an unknown date, the outcome of the shingles and inappropriate age at vaccine administration were unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows:  The age at vaccination was not reported. The patient experienced shingles after receiving 1st dose of Shingrix. The patient received 1st dose before the recommended age at vaccination, which led to inappropriate age at vaccine administration. The reporter requested information about administering the 2nd dose of Shingrix. This was a medication error with adverse event. Consent to follow up was provided.
Age: 0.83
Sex: U
Vaccine: FLU4
Symptoms: Incomplete course of vaccination, No adverse event
Clinical narrative: 10 month old patient that did not received the second dose of fluzone quadrivalent in 28 days / no AE; Initial information received on 02-Dec-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 10 months old patient who received first 0.25 mL dose of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (lot number and Expiry date unknown) via unknown route in unknown administration site on an unknown date.  The patients past medical history, medical treatments, vaccinations and family history were not provided.   It was an actual medication error case due to Incomplete course of vaccination as 10 months old patient that did not received the second dose of fluzone quadrivalent in 28 days.   At the time of reporting no adverse reaction 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.
Sex: U
Vaccine: FLU4
Symptoms: Syringe issue, Underdose
Clinical narrative: during administration, the needle on the syringe wasn't tight; during administration, some of the vaccine leaked out/No AE; Initial information received on 10-Dec-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves patient with unknown demographic who received INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT]. During administration some of the vaccine leaked out (underdose), and the needle on the syringe wasn't tight (syringe issue).  Medical history, medical treatment, vaccination and family history were not provided.   On 09-Dec-2019, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE [lot number and other dosing details were not reported] via unknown route in unknown administration site.  It was actual medication error case due to vaccine leaked out (underdose).  It was also the case of Syringe issue.  It was unknown whether the vaccines were administered.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Information on the batch number was requested.
Sex: U
Vaccine: FLU3
Symptoms: Exposure via skin contact, Syringe issue, Underdose
Clinical narrative: pushed down the fluid leaked out of the syringe around the hub and onto the patient's arm / no AE; pushed down the fluid leaked out of the syringe around the hub and onto the patient's arm / no AE; plunger was pushed down the fluid leaked out of syringe / no AE; Initial information received on 04-Nov-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves a patient of an unknown demographics who had an incomplete vaccination of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] (lot UJ288AA, Expiry date unknown) via unknown route in unknown administration site.  It was an actual medication error case due to vaccine underdose.  It was also a case of syringe leak and Exposure via skin contact.  The patient was given injection and when plunger was pushed down the fluid leaked out of the syringe around the hub and onto the patient's arm. Syringe was disposed of after injection.  At the time of reporting no adverse reaction 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 and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Exposure via skin contact, Syringe issue, Underdose
Clinical narrative: drip of the medication on the patient's arm  / no AE; drip of the medication on the patient's arm, Vaccine leaking/no AE; leaking from Luer-Lok adapter area where the needle connects to the syringe / no AE; Initial information received on 07-Nov-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves a 65 years old female patient who had an incomplete vaccination of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] (lot UJ288AB, Expiry date unknown) via intramuscular route in the left deltoid on 02-Nov-2019.  It was an actual medication error case due to vaccine underdose and syringe leak.  It was also a case of Exposure via skin contact.  It was reported that she noticed a drip of the medication on the patients arm.  Vaccine leaking from the Luer Lok adapter area where the needle connects to the syringe.  At the time of reporting no adverse reaction 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.
Sex: U
Vaccine: FLU3
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient received two doses of Fluzone HD in one season, No AE; Initial information received on 16-Dec-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves patient who was vaccinated with two doses of vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] in one season (lot number: UJ308AA and expiration date: 30-Jun-2020) first dose on October and on 16-Dec-2019.  Medical history and concomitant medication was not reported.  This was an actual medication error case due to extra dose administered.  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.