chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.75
Sex: M
Vaccine: FLU4
Symptoms: Pyrexia, Rash
Clinical narrative: Fever, Rash
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Dizziness, Eye irritation, Injection site pain, Ocular hyperaemia
Clinical narrative: burning, red eyes; burning, red eyes; dizziness; soreness at injection site; This spontaneous report was received from a registered nurse, and refers to a 11 year old male patient with attention deficit/hyperactivity disorder (ADHD). Concomitant therapies included methylphenidate hydrochloride(QUILLIVANT). The patient had not known allergies. Information about the patient's pertinent medical history was not provided.       On 07-MAY-2019 at 16:50, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (Lot No. R029117 has been verified to be a valid lot number for GARDASIL 9, expiration date not reported, but upon internal validation established as XX-10-JUL-2021), via intramuscular route of administration, in the left arm, for prophylaxis (strength, dose and frequency were not provided); on the same date at the same time, the patient was also vaccinated with the sixth dose of diphtheria toxoid, pertussis acellular 5-component vaccine, tetanus toxoid(ADACEL) (lot #U6214AA) via intramuscular route of administration, in the right arm, for prophylaxis (strength, dose, expiration date and frequency were not provided) and with the first dose of meningococcal acyw conj vaccine (dip toxoid)(MENACTRA) (lot # u6346aa) via intramuscular route of administration, in the left arm, for prophylaxis (strength, dose, expiration date and frequency were not provided).     On 08-MAY-2019 at 09:00, the patient's parent called reporting that the patient was experiencing dizziness, burning (ocular hyperaemia), red eyes (eye irritation) and soreness at Injection sites (injection site pain).      At the time of reporting, the outcome of eye irritation, injection site pain, dizziness and ocular hyperaemia was unknown.  Causality assessment was not provided.
Sex: F
Vaccine: FLU3
Symptoms: No adverse event, Overdose, Product administered to patient of inappropriate age
Clinical narrative: patient aged 64 received Fluzone high dose/ no AE; patient aged 64 received Fluzone high dose/ no AE; Initial information received on 04-Dec-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves a 64 years old female patient who received  0.5 ml dose of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] lot UJ274AB (Expiry date 26-May-2020) via intramuscular route in the left deltoid on 21-Oct-2019.  The patient's medical history and concomitant medications were not reported.  It was an actual medication error case due to inappropriate age at vaccine administration and overdose.   At a time of reporting 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.
Age: 68.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Injected limb mobility decreased, Injection site bruising, Injection site swelling, Pain in extremity, Pyrexia
Clinical narrative: Flu shot given and injection site instantly swelled. Within 3 hrs. arm was swollen, sharp pains, could not move or lift up. Vomiting & fever. Swelling in arm, shoulder & neck, bruising  Went back to Dr. office on 12-23-2019 was given Baclofen 10mg. Also given Meloxicam 15mg. Help a little. Went back to Dr. office on 1-8-2020. Did nothing. Still to date have had fever off & on. My arm is very weak and almost numb in the mornings. If I try & move it in the wrong way it's still painful and is very sore.
Age: 68.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Vomiting
Clinical narrative: Flu shot given and injection site instantly swelled. Within 3 hrs. arm was swollen, sharp pains, could not move or lift up. Vomiting & fever. Swelling in arm, shoulder & neck, bruising  Went back to Dr. office on 12-23-2019 was given Baclofen 10mg. Also given Meloxicam 15mg. Help a little. Went back to Dr. office on 1-8-2020. Did nothing. Still to date have had fever off & on. My arm is very weak and almost numb in the mornings. If I try & move it in the wrong way it's still painful and is very sore.
Age: 68.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Contusion, Injection site swelling, Mobility decreased, Muscular weakness, Pain
Clinical narrative: Flu shot given and injection site instantly swelled. Within 3 hrs. arm was swollen, sharp pains, could not move or lift up. Vomiting & fever. Swelling in arm, shoulder & neck, bruising  Went back to Dr. office on 12-23-2019 was given Baclofen 10mg. Also given Meloxicam 15mg. Help a little. Went back to Dr. office on 1-8-2020. Did nothing. Still to date have had fever off & on. My arm is very weak and almost numb in the mornings. If I try & move it in the wrong way it's still painful and is very sore.
Age: 68.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Pain in extremity, Peripheral swelling, Pyrexia, Swelling, Vomiting
Clinical narrative: Flu shot given and injection site instantly swelled. Within 3 hrs. arm was swollen, sharp pains, could not move or lift up. Vomiting & fever. Swelling in arm, shoulder & neck, bruising  Went back to Dr. office on 12-23-2019 was given Baclofen 10mg. Also given Meloxicam 15mg. Help a little. Went back to Dr. office on 1-8-2020. Did nothing. Still to date have had fever off & on. My arm is very weak and almost numb in the mornings. If I try & move it in the wrong way it's still painful and is very sore.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Formication, Pain in extremity, Skin warm
Clinical narrative: pt called 1/13/20 reporting pain in arm, heat and redness, also feeling like areas is crawling, no fever. since injection on 1/7/20. consulted pt to take nsaid, benadry to reduce symptoms, and follow up with pcp if symptom dont resolve after 1-2 days from now. pt mentioned she will ice area as well. and to call us tomorrow to follow up on improvement.
Age: 57.0
Sex: M
Vaccine: HEP
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Adult patient received a peds dose of the Hep B instead of an adult dose.  Dose in medical record needs to be documented as invalid.  pt will be contacted.   No adverse event occurred  Pt did also receive a correct dose of Hep A adult the same day. No adverse event occurred.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE information provided; the patient was administered an improperly stored dose of PEDVAXHIB; This spontaneous report was received from a licensed practical nurse referring to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not reported.  On 02-JAN-2020, the patient was vaccinated an improperly stored dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (PEDVAXHIB) (lot# S007079, expiration date 24-JAN-2022; dose and route were unknown) for prophylaxis (product storage error).   Temperature excursion of this vaccine was 8.64 Celsius degrees for 30 minutes. There was no previous temperature excursion. No additional adverse event was reported. Data logger was involved.
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.   On 21-OCT-2014 the patient was vaccinated with zoster vaccine live(ZOSTAVAX) (dose, route, lot# and expiration date were unknown) 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: 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 (pt) of an unknown age. The pt's concurrent conditions, medical history and concomitant medications were not reported. On an unknown date in 2013, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (exact dose, site and route of administration, lot# and expiration date were not provided) as prescribed and/or administered by a pharmacist for long-term prevention of shingles and/or zoster-related conditions. Subsequent to the pt's zoster vaccine live (ZOSTAVAX) inoculation, she was treated by a healthcare provider for shingles. As a direct and proximate result of the pt's use of zoster vaccine live (ZOSTAVAX) vaccine, she 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 not recovered. the relatedness between the event and zoster vaccine live (ZOSTAVAX) was related.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. On or about 03-OCT-2012, the patient was vaccinated with zoster vaccine live(ZOSTAVAX) (lot#, expiration date, dosage and route of administration were not provided) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, subsequent to inoculation, the pt was treated for shingles. The pt had and would continue suffering 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. At the time of the report, the outcome of shingles was unknown. The reporter considered shingles to be related to Zoster Vaccine Live(ZOSTAVAX).
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Post herpetic neuralgia
Clinical narrative: post herpetic neuralgia; Shingles; Information has been received from a lawyer regarding a case in litigation concerning a female of unknown age. The patient's pertinent medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not provided. On about 19-FEB-2016, the patient was inoculated with Zoster Vaccine Live (ZOSTAVAX) at the pharmacy (dose, frequency, lot number, expiration date and anatomical location were not provided), for the long-term prevention of shingles and/or zoster-related conditions. Subsequently, after Zoster Vaccine Live (ZOSTAVAX) inoculation, the pt was treated on unspecified date for shingles and postherpetic neuralgia. As a direct and proximate result of patient's use of Zoster Vaccine Live (ZOSTAVAX), the patient had and would continue to 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, physical 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. At the reporting time the patient had not recovered from the events. The reporter considered the events to be related.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: The patient was treated for shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation referring to a female patient of unknown age. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. On an unspecified date in 2008, the patient was vaccinated with zoster vaccine live(ZOSTAVAX) (lot#, expiration date, dosage and route of administration were not provided) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, subsequent to inoculation, the pt was treated for shingles. The pt had and would continue suffering 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. At the time of the report, the outcome of shingles was unknown. The reporter considered shingles to be related to Zoster Vaccine Live(ZOSTAVAX).
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: The patient was treated for shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation referring to a female patient of unknown age. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. On an unspecified date in 2011, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dosage and route of administration were not provided) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, subsequent to inoculation, the pt was treated for shingles. The pt had and would continue suffering 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. At the time of the report, the outcome of shingles was unknown. The reporter considered shingles to be related to Zoster Vaccine Live (ZOSTAVAX).
Sex: M
Vaccine: MMRV
Symptoms: Exposure via eye contact, Occupational exposure to product
Clinical narrative: a couple drops of PROQUAD splashed directly into his eye; a couple drops of PROQUAD splashed directly into his eye.; a couple drops of PROQUAD splashed directly into his eye.; This spontaneous report was received from a physician referring to a male employee of unknown age. Information about medical history, concurrent conditions and concomitant therapies was not provided.  On 07-JAN-2020, when the employee was preparing measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) (before reconstitution) to administer to a patient (dose, strength, route, lot# and expiration date were not provided) for prophylaxis, a couple drops of preparing measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) splashed directly into the employee's eye (occupational exposure to product, accidental exposure to product and exposure via eye contact). The eye was rinsed with water. Medical attention had been sought.
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.   On 14-FEB-2008 the patient was vaccinated with zoster vaccine live(ZOSTAVAX) (dose, route, lot# and expiration date were unknown) for the long-term prevention of shingles and/or zoster-related conditions (for prophylaxis). Subsequent to inoculation, the patient was treated for herpes zoster .  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; Information has been received from a lawyer and a male patient of unknown age regarding a case in litigation. Information about concurrent condition, medical history and concomitant medication was not reported. In 2011, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, lot# and route unknown) for the long-term prevention of shingles and/or zoster-related conditions. Subsequent to the inoculation (date not reported), the patient was treated by a physician at a physician office for shingles. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), 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 the event shingles was not recovered. The lawyer considered the event shingles 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 regarding a case in litigation concerning a female patient(pt) of unknown age. The pt's medical history, concurrent conditions and concomitant medications were not provided. On or about 02-NOV-2016, the pt was vaccinated with zoster vaccine live(ZOSTAVAX) (dose, route of administration, anatomical location, lot#, expiration date were unknown) by a pharmacist at a 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 zoster vaccine live(ZOSTAVAX), 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.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: The patient was treated for shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. On an unspecified date in 2012, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dosage and route of administration were not provided) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, subsequent to inoculation, the pt was treated for shingles. The pt had and would continue suffering 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. At the time of the report, the outcome of shingles was unknown. The reporter 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 to a male patient of an unknown age. The patient's concurrent conditions, medical history, historical drugs and concomitant therapies were not reported.   On or about 05-JUL-2013, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, route, anatomical application, lot number and expiration date were not reported) for the long-term prevention of shingles and or zoster-related conditions.   On an unknown date, subsequent to the patient's zoster vaccine live (ZOSTAVAX) inoculation, the patient experienced shingles, and he was treated by a health care professional. The patient had and would continue suffer ongoing injuries; significant medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications and supplies.   The causal relationship between shingles and zoster vaccine live (ZOSTAVAX) was related.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; Information has been received from a lawyer regarding a case in litigation concerning to a female patient of an unknown age. The patient's concurrent conditions, medical history, historical drugs and concomitant therapies were not reported.   In 2015, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, route, anatomical application, lot number and expiration date were not reported) for the long-term prevention of shingles and or zoster-related conditions.   On an unknown date, subsequent to the patient's zoster vaccine live (ZOSTAVAX) inoculation, the patient experienced shingles, and she was treated by a physician. The patient had and would continue suffer ongoing injuries; significant medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications and supplies.   The causal relationship between shingles and zoster vaccine live (ZOSTAVAX) was related.
Sex: F
Vaccine: VARZOS
Symptoms: Blindness, Deafness unilateral, Retinal artery occlusion, Retinal degeneration, Retinal tear
Clinical narrative: central retinal aitery occlusion; atrophic retinal hole; sudden hearing loss in her left ear; Information has been received from a lawyer regarding a case in litigation and referring to a female patient of unspecified age. No information was provided regarding medical history, concurrent conditions, or concomitant medications.   On or around 03-JUN-2017, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (strength, dose, route, lot#, expiration date were not reported) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unspecified date (reported as shortly after receiving zoster vaccine live (ZOSTAVAX)), the patient suffered sudden vision loss and was diagnosed with central retinal artery occlusion and an atrophic retinal hole. She also suffered sudden hearing loss in her left ear. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient's symptoms have resulted in physical limitations not present prior to using the product. The patient also experiences mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of the zoster vaccine live (ZOSTAVAX), the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of the zoster vaccine live (ZOSTAVAX), the patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events were considered not recovered. The events were considered related to zoster vaccine live (ZOSTAVAX).  Central retinal artery occlusion, an atrophic retinal hole and sudden hearing loss were considered to be disabling.   Upon internal review, central retinal artery occlusion, an atrophic retinal hole and sudden hearing loss were considered to be medically significant.
Sex: F
Vaccine: VARZOS
Symptoms: Sudden hearing loss
Clinical narrative: central retinal aitery occlusion; atrophic retinal hole; sudden hearing loss in her left ear; Information has been received from a lawyer regarding a case in litigation and referring to a female patient of unspecified age. No information was provided regarding medical history, concurrent conditions, or concomitant medications.   On or around 03-JUN-2017, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (strength, dose, route, lot#, expiration date were not reported) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unspecified date (reported as shortly after receiving zoster vaccine live (ZOSTAVAX)), the patient suffered sudden vision loss and was diagnosed with central retinal artery occlusion and an atrophic retinal hole. She also suffered sudden hearing loss in her left ear. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient's symptoms have resulted in physical limitations not present prior to using the product. The patient also experiences mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of the zoster vaccine live (ZOSTAVAX), the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of the zoster vaccine live (ZOSTAVAX), the patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events were considered not recovered. The events were considered related to zoster vaccine live (ZOSTAVAX).  Central retinal artery occlusion, an atrophic retinal hole and sudden hearing loss were considered to be disabling.   Upon internal review, central retinal artery occlusion, an atrophic retinal hole and sudden hearing loss were considered to be medically significant.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: No adverse events; Inadvertently administered a dose of proquad via the intramuscular route rather than the subcutaneous route; This spontaneous report was received from a nurse refers to a 4-year-old patient of unknown gender. The patient's pertinent medical history, concurrent conditions and drug reactions/allergies were not reported. Concomitant therapies included sterile diluent.   On 11-DEC-2019, the patient was vaccinated with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (strength, dose number and anatomical location were not reported) lot # R030801 with expiration date: 22-APR-2020; via intramuscular route rather than the subcutaneous route for prophylaxis (incorrect route of product administration). No adverse symptoms reported (no adverse event). No product quality complaint (PQC) was involved.
Sex: M
Vaccine: HPV9
Symptoms: No adverse event, Product administered at inappropriate site
Clinical narrative: No adverse effect reported; Route of Administration:  intramuscular in "right upper outer gluteal muscle"; This spontaneous report was received from a nurse, concerning a male patient between 11-12-year-old. His pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not reported.   In approximately October 2019 (also reported as "about 3 month ago"), the patient was vaccinated with the first dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9), intramuscular, right upper outer gluteal muscle (product administered at inappropriate site) (strength, dose, lot number and expiration date were not reported).  No adverse effects reported from that first dose.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: The patient did not experience any symptoms; The patient was administered one dose of expired MMR II on 1/9/2020; This spontaneous report was received from a nurse, referring to a patient of unknown age and gender. The patient's concurrent conditions, past medical history and concomitant medications were not reported.  On 09-JAN-2020, the patient was vaccinated with one expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) lot # R000550 and expiration date 08-JAN-2020 (dose, frequency, route and anatomical location were not provided) for prophylaxis (expired product administered). The patient did not experience any symptoms.
Sex: U
Vaccine: VARZOS
Symptoms: Decreased appetite, Gingival pain
Clinical narrative: Gums are so sensitive to temperature; Barely eat; This case was reported by a consumer via call center representative and described the occurrence of sensitivity of gums in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced sensitivity of gums and decreased appetite. On an unknown date, the outcome of the sensitivity of gums and decreased appetite were unknown.   It was unknown if the reporter considered the sensitivity of gums and decreased appetite to be related to Shingrix.  Additional details were received as follows: The age at vaccination was not reported. The patient stated that after vaccination the gums were so sensitive to temperature and can barely eat. The patient asked if there is a known reaction to teeth and gums after a shingrix shot. The patient stated that this could be a coincidence and asked have heard of this problem before.
Age: 69.0
Sex: U
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Multiple sclerosis, Palpitations
Clinical narrative: MS diagnosis; Bounding heartbeat; Headache; Extreme fatigue; This case was reported by a consumer via call center representative and described the occurrence of multiple sclerosis in a 69-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   In November 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced multiple sclerosis (serious criteria GSK medically significant), heart racing, headache and fatigue. On an unknown date, the outcome of the multiple sclerosis, heart racing and headache were unknown and the outcome of the fatigue was recovered/resolved.   It was unknown if the reporter considered the multiple sclerosis, heart racing, headache and fatigue to be related to Shingrix.  Additional details were provided as follows: It was reported that the patient received 1st dose 2 months ago and patient was now due for 2nd dose. The patient experienced bounding heartbeat and headache within 8 hours followed by extreme fatigue 2 days. The patient was also diagnosed with multiple sclerosis. The patient asked if the patient could receive 2nd dose.
Sex: M
Vaccine: FLUX
Symptoms: Influenza, Vaccination failure
Clinical narrative: suspected  vaccination failure; Got the flu; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a 9-year-old male patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2019-2020 season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent 2019-2020 season at an unknown dose. On an unknown date, less than 5 months after receiving Influenza vaccine Quadrivalent 2019-2020 season, the patient experienced vaccination failure (serious criteria GSK medically significant) and influenza. On an unknown date, the outcome of the vaccination failure and influenza were unknown.   It was unknown if the reporter considered the vaccination failure and influenza to be related to Influenza vaccine Quadrivalent 2019-2020 season.  Additional details were provided as follows: The age at vaccination was not reported. The reporter reported that, the patient received dose of Flu vaccine in the fall one year, and experienced fku in the following January. The reporter did not consent to follow up. This case has been linked with cases US2020003242 and US2020AMR003766, reported by same reporter. This case was considered as a suspected vaccination failure case as the time to onset and the lab test confirmation for influenza were unknown.
Sex: U
Vaccine: FLU4, FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age, Product packaging confusion, Wrong product administered
Clinical narrative: 2 patients received Flublock quadrivalent instead of the Fluzone Quadrivalent because the boxes and the syringes are so similar between these two vaccines, no adverse event; 2 patients received Flublock quadrivalent instead of the Fluzone Quadrivalent because the boxes and the syringes are so similar between these two vaccines, no adverse event; 2 patients received Flublock quadrivalent instead of the Fluzone Quadrivalent because the boxes and the syringes are so similar between these two vaccines, no adverse event; Initial information received on 05-Nov-2019 regarding an unsolicited valid non-serious case received from a physician.  This case involves two patients of unknown demography who received INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] instead of the INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] because the boxes and the syringes are so similar between these two vaccines (wrong product administered, product administered to patient of inappropriate age and product packaging confusion).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] dosage unknown (lot not reported) lot number not reported via unknown route in unknown administration site instead of INFLUENZA QUADRIVAL A-B VACCINE.  It was a case of actual medication error due to wrong product administered, Product administered to patient of inappropriate age and Product packaging confusion. 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 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.  Information on the batch number was requested.
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Product preparation issue
Clinical narrative: possible that only the diluent was delivered/no AE; Initial information received on 08-Jan-2020 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a patient who received DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] by incorrect reconstituation.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a 0.5 ml dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot number not reported via intramuscular route in the thigh.  It was of actual medication error due to Inappropriate reconstitution technique.  It was unknown whether adverse event was noticed 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.  The information on the batch number was requested.
Sex: M
Vaccine: DTAPHEPBIP, DTAPIPVHIB
Symptoms: Extra dose administered
Clinical narrative: patient was given pediarix with pentacel at the same time; Initial information received on 08-Jan-2020 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 2 months old male patient who PEDIARIX and DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] and reported that patient was given Pediarix with Pentacel at the same time (extra dose administered).  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) for Immunisation; and ROTAVIRUS VACCINE LIVE ORAL 1V (ROTARIX) for Immunisation.  On 02-Jan-2020, the patient received a dose of suspect 0.5 ml DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot UJ054AA and expiry date: 27-Oct-2020 via intramuscular route in unknown administration site.  It was a case of actual medication error due to extra dose administered.  It was not reported if any adverse event occurred or not.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 26.0
Sex: F
Vaccine: DTAP, TDAP
Symptoms: No adverse event, Wrong product administered
Clinical narrative: a 26 year old female was administered Daptacel by mistake instead of Adacel, no AE.; Initial information received on 08-Jan-2020 regarding an unsolicited valid non-serious case received from an other health professional.  This case involves a 26 years old female patient who was administered with a dose 0.5 ml of vaccine diphtheria-15/tetanus/5 ac pertussis vaccine [daptacel] (lot number C5621AA  and expiration date 23-may-2021) by mistake instead of diphtheria-2/tetanus/5 ac pertussis vaccine [adacel] via intramuscular route in the left deltoid on 31-Dec-2019.  The medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS B VACCINE (HEPATITIS B VACCINE); VARICELLA ZOSTER VACCINE (VARICELLA ZOSTER VACCINE) and MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR VACCIN).  It was an actual medication error case due to wrong product administered.  No adverse event reported at the time of reporting.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 57.0
Sex: F
Vaccine: TDAP
Symptoms: Dizziness, Malaise, Nausea
Clinical narrative: malaise, dizziness, nausea
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Chills, Fatigue, Headache, Pain in extremity
Clinical narrative: sore arm, tired, sick stomach, fever, chills, headache, racing heart
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Palpitations, Pyrexia
Clinical narrative: sore arm, tired, sick stomach, fever, chills, headache, racing heart
Age: 46.0
Sex: M
Vaccine: MMR
Symptoms: Macule
Clinical narrative: macular lesions on R and L arms/forearm (volar aspect), back, R lower leg
Sex: U
Vaccine: FLUX
Symptoms: Influenza, Vaccination failure
Clinical narrative: suspected vaccination failure; got the flu; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season at an unknown dose. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced vaccination failure (serious criteria GSK medically significant) and influenza. On an unknown date, the outcome of the vaccination failure and influenza were unknown.   It was unknown if the reporter considered the vaccination failure and influenza to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: The patient's demographic details were not provided. The patient received dose of flu vaccine and experienced influenza. This case was considered as a suspected vaccination failure case as the time to onset for influenza were unknown.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Musculoskeletal pain, Rash, Vaccination failure
Clinical narrative: Shingles; Rash; vaccination failure; Pain underneath right shoulder blade; This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 26th June 2018, the patient received the 1st dose of Shingrix (intramuscular). On 4th September 2018, the patient received the 2nd dose of Shingrix. In November 2019, less than 6 months after receiving Shingrix and less than 3 months after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shoulder blade pain. On 3rd December 2019, the patient experienced shingles and rash. On an unknown date, the outcome of the vaccination failure, shingles, shoulder blade pain and rash were unknown.   It was unknown if the reporter considered the vaccination failure, shingles, shoulder blade pain and rash to be related to Shingrix and Shingrix.  Additional details were provided as follows: After vaccination with 2nd dose of Shingrix, the patient experienced pain underneath the right shoulder blade in November of 2019. On 3rd December 2019, the patient had strip of rash appeared across the back and right breast. On 26th December 2019, the patient confirmed with shingles. and on 7th January 2019, confirmed by health care provider. No further details were provided. The reporter consented to follow up.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Dizziness, Nausea, Pain, Pyrexia
Clinical narrative: Fever, chills, and body aches the night of the immunization; vertigo, dizziness, and nausea evening two days later.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Vertigo
Clinical narrative: Fever, chills, and body aches the night of the immunization; vertigo, dizziness, and nausea evening two days later.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Product administered at inappropriate site
Clinical narrative: Patient is concerned about where injection was given.  She reports pain at the site of injection and feels it was injected too high in her arm.   She called and PCP and we did also.  She has been seen as a result of her pain.
Age: 60.0
Sex: F
Vaccine: PPV
Symptoms: Incorrect route of product administration
Clinical narrative: Pharmacist injected under skin instead of in deltoid muscle