chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Dry mouth, Dry throat, Fatigue, Feeling hot, Gait disturbance
Clinical narrative: Day 1 (day of vaccination): Within 15 minutes of receiving the jab i experienced heart palpitations, fever, dizziness, a dry mouth/throat and heat in my head/upper body. After being discharged from recovery an hour later i returned home but felt very anxious all night. Heart palpitations continued on and off. Day 2: Severe cramp/pain started in my arm, neck and shoulders. Headache. Sweating. Days 3 & 4: Flu symptoms; headache, shivers/fever, runny nose, sore throat, cough, severe muscle and joint pain. Skin was so sensitive to touch i could not wash. Muscles hurt so much i could not move around. Extreme fatigue. Days 5 & 6: Cold symptoms started to resolve. Muscle and joint pain still very severe - difficulty walking/moving around, stiffness and aches  in every part of my body. Extreme fatigue. Days 7, 8 & 9: Cold symptoms gone. Muscle and joint pain still severe. Extreme fatigue. Day 10: Pain in muscles started to resolve but not in joints. Fatigue still present. Day 11: Fatigue starting to resolve, joints still very sore.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hyperhidrosis, Influenza like illness, Myalgia, Neck pain
Clinical narrative: Day 1 (day of vaccination): Within 15 minutes of receiving the jab i experienced heart palpitations, fever, dizziness, a dry mouth/throat and heat in my head/upper body. After being discharged from recovery an hour later i returned home but felt very anxious all night. Heart palpitations continued on and off. Day 2: Severe cramp/pain started in my arm, neck and shoulders. Headache. Sweating. Days 3 & 4: Flu symptoms; headache, shivers/fever, runny nose, sore throat, cough, severe muscle and joint pain. Skin was so sensitive to touch i could not wash. Muscles hurt so much i could not move around. Extreme fatigue. Days 5 & 6: Cold symptoms started to resolve. Muscle and joint pain still very severe - difficulty walking/moving around, stiffness and aches  in every part of my body. Extreme fatigue. Days 7, 8 & 9: Cold symptoms gone. Muscle and joint pain still severe. Extreme fatigue. Day 10: Pain in muscles started to resolve but not in joints. Fatigue still present. Day 11: Fatigue starting to resolve, joints still very sore.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Pain, Pain in extremity, Palpitations, Pyrexia
Clinical narrative: Day 1 (day of vaccination): Within 15 minutes of receiving the jab i experienced heart palpitations, fever, dizziness, a dry mouth/throat and heat in my head/upper body. After being discharged from recovery an hour later i returned home but felt very anxious all night. Heart palpitations continued on and off. Day 2: Severe cramp/pain started in my arm, neck and shoulders. Headache. Sweating. Days 3 & 4: Flu symptoms; headache, shivers/fever, runny nose, sore throat, cough, severe muscle and joint pain. Skin was so sensitive to touch i could not wash. Muscles hurt so much i could not move around. Extreme fatigue. Days 5 & 6: Cold symptoms started to resolve. Muscle and joint pain still very severe - difficulty walking/moving around, stiffness and aches  in every part of my body. Extreme fatigue. Days 7, 8 & 9: Cold symptoms gone. Muscle and joint pain still severe. Extreme fatigue. Day 10: Pain in muscles started to resolve but not in joints. Fatigue still present. Day 11: Fatigue starting to resolve, joints still very sore.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Rhinorrhoea, Sensitive skin
Clinical narrative: Day 1 (day of vaccination): Within 15 minutes of receiving the jab i experienced heart palpitations, fever, dizziness, a dry mouth/throat and heat in my head/upper body. After being discharged from recovery an hour later i returned home but felt very anxious all night. Heart palpitations continued on and off. Day 2: Severe cramp/pain started in my arm, neck and shoulders. Headache. Sweating. Days 3 & 4: Flu symptoms; headache, shivers/fever, runny nose, sore throat, cough, severe muscle and joint pain. Skin was so sensitive to touch i could not wash. Muscles hurt so much i could not move around. Extreme fatigue. Days 5 & 6: Cold symptoms started to resolve. Muscle and joint pain still very severe - difficulty walking/moving around, stiffness and aches  in every part of my body. Extreme fatigue. Days 7, 8 & 9: Cold symptoms gone. Muscle and joint pain still severe. Extreme fatigue. Day 10: Pain in muscles started to resolve but not in joints. Fatigue still present. Day 11: Fatigue starting to resolve, joints still very sore.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Diarrhoea, Gingival bleeding, Haematoma, Headache
Clinical narrative: severe headache; severe neck pain; severe arm pain; fever at 103 degrees F; Swollen lymph node; bleeding gums; small hematomas on legs; extremely hot diarrheas; horrible burning sensation; This is a spontaneous report from a contactable nurse (patient herself). A 46-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection; lot number; EJ1686, expiration date was unknown), via an unspecified route of administration on the left arm on 08Jan2021 at 14:15 at a single dose for COVID-19 immunization administered at the hospital. She received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection; lot number; EK5730, expiration date was unknown) via an unspecified route of administration on the left arm on 18Dec2020. Relevant medical history included known allergies to shellfish. There were no concomitant medications. The patient was not pregnant at the time of vaccination. The patient had no COVID prior vaccination. On 09Jan2021 at 12:00 AM, the patient experienced severe headache, severe neck pain, severe arm pain, fever at 103 degrees Fahrenheit (F), swollen lymph node, bleeding gums, small hematomas on legs, and extremely hot diarrheas that she had this horrible burning sensation. The patient did not receive any treatment for the adverse events (AE). The patient underwent further lab tests and procedures, which included COVID test via nasal swab post vaccination on 13Jan2021, which resulted negative. The patient was recovering from all the events.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Neck pain, Pain in extremity, Pyrexia, SARS-CoV-2 test negative
Clinical narrative: severe headache; severe neck pain; severe arm pain; fever at 103 degrees F; Swollen lymph node; bleeding gums; small hematomas on legs; extremely hot diarrheas; horrible burning sensation; This is a spontaneous report from a contactable nurse (patient herself). A 46-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection; lot number; EJ1686, expiration date was unknown), via an unspecified route of administration on the left arm on 08Jan2021 at 14:15 at a single dose for COVID-19 immunization administered at the hospital. She received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection; lot number; EK5730, expiration date was unknown) via an unspecified route of administration on the left arm on 18Dec2020. Relevant medical history included known allergies to shellfish. There were no concomitant medications. The patient was not pregnant at the time of vaccination. The patient had no COVID prior vaccination. On 09Jan2021 at 12:00 AM, the patient experienced severe headache, severe neck pain, severe arm pain, fever at 103 degrees Fahrenheit (F), swollen lymph node, bleeding gums, small hematomas on legs, and extremely hot diarrheas that she had this horrible burning sensation. The patient did not receive any treatment for the adverse events (AE). The patient underwent further lab tests and procedures, which included COVID test via nasal swab post vaccination on 13Jan2021, which resulted negative. The patient was recovering from all the events.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Depression, Head discomfort, Muscle spasms, Paraesthesia, Respiration abnormal
Clinical narrative: Uncontrolled short rhythmic breathing; brief electric shock sensation; little sporadic back spasms; strong head pressure sensation; depression symptoms; This is a spontaneous report from a contactable Other HCP reporting for self. A 54-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 07Jan2021 09:00 at single dose for covid-19 immunisation. The patient medical history was not reported. Patient received first dose of bnt162b2 on 17Dec2020 09:00. The patient's concomitant medications were not reported. The patient experienced Uncontrolled short rhythmic breathing, brief electric shock sensation and little sporadic back spasms, strong head pressure sensation, depression symptoms currently persistent and decreasing gradually on 09Jan2021. Patient had Nasal Swab on 12Jan2021 with negative result. Outcome of events was recovering. Patient received treatment for all events.
Age: 11.0
Sex: U
Vaccine: HPV9
Symptoms: Product storage error
Clinical narrative: No additional adverse events reported; a dose of GARDASIL9 was administered during a temperature excursion; This spontaneous report was received from a medical assistant and refers to a 11-year-old patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.      On 18-DEC-2020, the patient was vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot # S033308, expiration date 08-APR-2022, 0.5 milliliter (exact dose, anatomical location and route of administration were not reported) for prophylaxis.    Digital Data logger was not involved. The vaccine was stored at the temperature that was reported as 8.5 degrees of Celsius for 3 minutes. There was no previous temperature excursion reported.  No additional adverse events reported. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: S033308; expirationdate: 08-APR-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE reported; the patient was administered PROQUAD on 06-JAN-2021 that had a labeled expiry of 05-JAN-2021; This spontaneous report as received from a registered nurse and other health care professional refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On 06-JAN-2021, the patient was vaccinated with an expired dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (albumin status rHA)(PROQUAD) lot # S021324, expiration date: 05-JAN-2021, 0.5 ml (route of administration and anatomical location were not reported) for prophylaxis. No adverse event was reported. Additionally, information regarding re-vaccination recommendations was requested by the reporter.
Age: 13.0
Sex: U
Vaccine: HPV9
Symptoms: Product storage error
Clinical narrative: NO additional AE details are available; Incorrect product storage; This spontaneous report was received from a medical assistant and refers to a 13-year-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On an unknown date in January 2021, the patient was vaccinated with a 0.5 ml, improperly stored dose of dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot# R029900, expiration date 23-JUL-2021 (site and route of administration were not reported) for prophylaxis. On 07-JAN-2021, the reporter checked the thermometer in the morning and it was fine and in the afternoon when she checked a wire was loose from the thermometer and it had some readings that were extremely out of range. It stated -199 with no specification of Celsius or Fahrenheit. The reporter stated she believed it was a data logger/temperature probe malfunction. Caller unable to provide further details but did advise the product had been administered once since the possible excursion. There was no previous temperature excursion. Data logger was involved. No additional adverse events were reported. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.  devicelotnumber: R029900; expirationdate: 23-JUL-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: No other AE reported; Patient given a dose of expired Varivax.; This spontaneous report was received from a pharmacist, who refers to a patient of unknown age and gender. Information regarding the patient's drug reactions or allergies, concomitant therapies and pertinent medical history was not provided. On 07-JAN-2021, the patient was vaccinated with expired dose of varicella virus vaccine live (oka/merck)(VARIVAX) lot # R027989, expiration date 01-OCT-2020, dose reported as 0.5 milliliter, for prophylaxis (formulation, concentration, dose number, route of administration, frequency were not reported). No additional adverse event reported. No product quality complaint (PQC) was involved. The pharmacists needed to know if the dose needed to be repeated and were there any adverse reactions the reporter needed to look for.
Age: 1.0
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: No additional AE reported, and no further information provided/ Patient did not have any known adverse reaction; was inadvertently administered after its labeled expiry date; This spontaneous report was received from a nurse and a licensed practical nurse and refers to a 12-month-old female patient. No information regarding the patient's medical history, concurrent conditions, drug reactions or allergies was provided. Her historical vaccine included hib conj vaccine (tet toxoid)(ACTHIB). Her concomitant vaccines included varicella virus vaccine live (oka/merck)(VARIVAX) and hib conj vaccine (tet toxoid)(ACTHIB).  On 11-JAN-2021, the patient was inadvertently vaccinated with expired dose of hepatitis a vaccine, inactivated (VAQTA) injection, first dose, 25U/0.5ML, 1 dose, intramuscularly in the right thigh, lot # T008149 (lot number T008149 has been verified to be a valid lot number for hepatitis a vaccine, inactivated (VAQTA) formulation vial), expiration date: 06-JAN-2021 for prophylaxis.  The patient did not have any known adverse reaction. No treatment was prescribed. There were no known temperature excursions involved. The licensed practical nurse reported that the patient was not going to be revaccinated.
Sex: U
Vaccine: HPV9
Symptoms: Unevaluable event
Clinical narrative: patient received first dose of GARDASIL in Oct 2014 and second dose October 2020; This spontaneous report was received from a consumer and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On an unknown date in October 2014, 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) (exact dose, site and route of administration, lot# and expiration date were not provided) for prophylaxis. On an unknown date in October 2020, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9).
Age: 6.0
Sex: F
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AEs; PROQUAD was administered on 24 SEP 2020 however, it expired on 16 SEP 2020.; This spontaneous report was received from a medical assistant, who refers to a 6-year-old female patient. On 22-SEP-2015, when the patient was "a little over 1 years old", she received a dose of measles (+) mumps (+) rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) (lot # K024035, expiration date 26-NOV-2016). Information regarding the patient's drug reactions or allergies, concomitant therapies and her other pertinent medical history was not provided. On 24-SEP-2020, the patient was vaccinated with expired measles (+) mumps (+) rubella (+) varicella (oka-merck) virus vaccine live(rHA) (PROQUAD) vial, first dose, 1 dosage form, for prophylaxis, lot # S008573, expiration date 16-SEP-2020 (concentration, route of administration, frequency were not reported). The fact the patient received an expired dose of vaccine was discovered during an internal audit. The medical assistant would like information regarding revaccination to provide to the physicians. No additional adverse event reported. No product quality complaint (PQC) was involved.
Sex: U
Vaccine: VARZOS
Symptoms: Deafness neurosensory, Sudden hearing loss
Clinical narrative: sudden sensorineural hearing loss; This initial spontaneous report was received from a lawyer regarding a case in litigation concerning a patient of unknown age and gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In or around 07-MAY-2012, the patient was inoculated with zoster vaccine live (ZOSTAVAX) for routine adult health maintenance and for its intended purpose: the prevention of shingles. On an unknown date, shortly after vaccination, the patient suffered sudden left side hearing loss and was diagnosed with left sudden sensorineural hearing loss. As a direct and proximate result of the zoster vaccine live (ZOSTAVAX), the patient's symptoms have resulted in physical limitations not present prior to vaccination, also experienced mental and emotional distress due to resulting physical limitations and seriousness of his condition. Patient sustained severe and permanent personal injuries and 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. At the time of this report, the patient had not recovered from the event. The reporter assessed that the event was related to zoster vaccine live (ZOSTAVAX).   The reporter considered left sudden sensorineural hearing loss to be a disabling event. Upon internal review, it was considered a medically significant event.
Sex: U
Vaccine: VARZOS
Symptoms: Deafness, Herpes zoster
Clinical narrative: hearing loss; zoster; ill defined disorder; This spontaneous report was received from a lawyer referring to a patient of unknown age and gender.  The patient's relevant medical history, drug reactions/allergies and concomitant medication were not reported.  In 2012, the patient was vaccinated with zoster vaccine live(ZOSTAVAX) for the long-term prevention of shingles and zoster-related conditions (strength, route, dosage schedule, lot number and expiration date were not reported).         On an unknown date, was treated for hearing loss and other zoster-related conditions. As a direct and proximate result the patient had and will 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, 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.   Upon internal review, hearing loss was considered medically significant.
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: No other AE; VARIVAX Improperly stored and administered; This spontaneous report was received from a certified medical assistant and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not provided.  On 19-JAN-2021, the patient was vaccinated with an improperly stored varicella virus vaccine live (Oka/Merck) (VARIVAX) 1 dose, lot # was reported as T010309 and was confirmed to be valid, expiry date was reported as 24-MAR-2022 and upon internal validation process it was confirmed to be correct (dose number, route of administration and anatomical location were not reported) for prophylaxis. The administered dose of vaccine was exposed to the temperature of -12.8 Celsius degrees (C) for 9 hours and 6 minutes. There was no previous temperature excursions. Digital data logger was involved. The patient did not experienced any other adverse events.
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Expired vaccine ROTATEQ administered to patient.; This spontaneous report was received from a medical assistant concerning to a patient of unknown age and gender. The patient's concurrent conditions, medical history, concomitant therapies, and previous drugs reactions and allergies were not reported.  On 21-JAN-2021, the patient was vaccinated with an expired rotavirus vaccine, live, oral, pentavalent (ROTATEQ), by oral route, lot # S012679, expiration date reported as 17-JAN-2021, but upon internal validation established as 07-JAN-2021; for prophylaxis (expired product administered). Additionally, the vaccine did not experience a temperature excursion. No adverse event.    The outcome of expired product administered and no adverse event was unknown.
Sex: M
Vaccine: HPV9
Symptoms: No adverse event, Product dose omission issue
Clinical narrative: No additional AE reported; he has not been able to go to his physician's office and receive the third dose/he was supposed to receive the third dose approximately 1 year ago but never received it; This spontaneous report was received from a consumer of unknown age referring to himself. The patient's concomitant medication, pertinent medical history and drug reactions and allergies were not reported.     On an unknown date, the patient was vaccinated with the first two doses of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (strength, dose, route, lot# and expiration date were not reported) for prophylaxis according to the dosing schedule.         The patient stated he was supposed to receive the third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) in approximately 1 year ago, but was not able to go to his physician's office and receive the third dose due to Coronavirus disease (COVID-19) pandemic (inappropriate schedule of vaccine administration). The patient inquired about when to receive the third dose. No additional adverse event (AE) reported (no adverse event). No product quality complaint (PQC).
Sex: U
Vaccine: HPV9
Symptoms: Expired product administered
Clinical narrative: No adverse event; Expired vaccine administered; This spontaneous report was received from a certified medical assistant referring to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications.  On 25-JAN-2021, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot # R005341  that expired on 06-DEC-2020 for prophylaxis (dose, route of administration were not reported). The reporter stated that this product did not have a temperature excursion. No additional adverse events were reported.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles; other zoster related conditions; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of an unknown age and gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about  05-APR-2013, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot #, expiration date, dose, dose # and route not specified) for the long-term prevention of singles and zoster-related conditions. Subsequently on an unknown date, the patient was treated for singles and other zoster related conditions. As a direct and proximate result of the patient's receipt of zoster vaccine live (ZOSTAVAX), the patient continued 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 medical losses and costs included 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 will continue to suffer such losses, and damages in the future. The outcome of singles was not recovered. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).
Age: 51.0
Sex: F
Vaccine: VARCEL
Symptoms: Inappropriate schedule of product administration
Clinical narrative: No additional AE was reported.; The consumer reported receiving her first dose of VARlVAX on 7/5/2020, and has yet to receive her 2nd dose. The AE awareness date is 8/30/2020, because that would be exactly 8 weeks (max allotted time) from the first dose.; This spontaneous report as received from a 52-year-old female patient referring to herself. The patient's pertinent concurrent conditions, medical history and concomitant medications were not reported.  On 05-JUL-2020, the patient was vaccinated with first dose of varicella virus vaccine live (oka/merck)(VARIVAX), 1 dose as prophylaxis (concentration, route of administration, anatomical location, lot number and expiration date were not reported.     On 30-AUG-2020 (8 weeks maximum time allowed), It was reported that the patient had not received yet the second dose of varicella virus vaccine live (oka/merck)(VARIVAX) (inappropriate schedule of product administration). The patient did not report any side effects.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE; Administered after labeled expiry date; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. No information regarding the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant medications was provided.  On 18-JAN-2021, the patient was inadvertently vaccinated with an expired dose of Hepatitis A Vaccine, Inactivated (VAQTA) 25 U/25 ml, 1 dose, lot # S032359 was confirmed to be valid, expiration date 11-JAN-2021, (route and site of administration were not reported) for prophylaxis. There were no known temperature excursions on vaccine. The nurse inquired about need for revaccination. No additional adverse event was reported. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S032359; expirationdate: 11-JAN-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: F
Vaccine: VARZOS
Symptoms: Bell's palsy
Clinical narrative: bell's palsy; This initial spontaneous report was received on from a lawyer regarding a case in litigation and refers to a female patient of unknown age. The patient's concurrent conditions, medical history and concomitant medication were not provided.   On an unspecified date in or around 2016, the patient was vaccinated with a dose zoster vaccine live (ZOSTAVAX) (strength, dose, route of administration, lot # and expiration date were not reported) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster).  On an unspecified date, shortly after receiving the vaccine, the patient suffered Bell's Palsy. As a direct and proximate result of the plaintiff's symptoms had resulted in physical limitations not present prior to using the vaccine. Plaintiff also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), plaintiff sustained severe and permanent personal injuries. Further, as a tragic consequence of Merck's wrongful conduct, Plaintiff 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.   The reporter considered the event Bell's Palsy to be related to zoster vaccine live (ZOSTAVAX).  Upon internal review, Bell's Palsy was determined to be medically significant.
Sex: U
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: I've gotten sicker than a dog; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a adult 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. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced sickness. On an unknown date, the outcome of the sickness was unknown.   It was unknown if the reporter considered the sickness to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: The age vaccination was not reported. The patient received Influenza vaccine Quadrivalent unspecified season and experienced sick. The age group was not reported but taken as adult as per vaccie indication. The patient stated that vaccine comes out I'm not going to get it because every time I've got the flu shot I've got sicker than a dog so why would  take the chance of getting a brand-spanking-new vaccine that's been rushed out. The information regarding consent to follow up was not reported.
Sex: U
Vaccine: FLUX
Symptoms: Palpitations
Clinical narrative: it brought on heart palpitations; This case was reported by a consumer via interactive digital media and described the occurrence of palpitation in a patient who received Flu unspecified (Flu vaccine) for prophylaxis.   On an unknown date, the patient received Flu vaccine. On an unknown date, unknown after receiving Flu vaccine, the patient experienced palpitation. On an unknown date, the outcome of the palpitation was unknown.   It was unknown if the reporter considered the palpitation to be related to Flu vaccine.  Additional details were reported as follows: The age at vaccination was not reported. The patient received flu shot two years before the date of reporting and it brought on heart palpitations that did not fully subside for a full year. The reporter reported that some people's bodies could not tolerate some of the ingredients. Take a look at this vaccine excipient summary. This case has been linked with the case US2020AMR242083, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR242083:same reporter
Sex: F
Vaccine: HPVX
Symptoms: Back pain, Polycystic ovaries
Clinical narrative: haD PCOS; Lower back pain; This case was reported by a consumer via interactive digital media and described the occurrence of polycystic ovarian syndrome in a female patient who received HPV 16-18 (HPV vaccine) for prophylaxis.   On an unknown date, the patient received HPV vaccine. On an unknown date, unknown after receiving HPV vaccine, the patient experienced polycystic ovarian syndrome and low back pain. On an unknown date, the outcome of the polycystic ovarian syndrome and low back pain were unknown.   It was unknown if the reporter considered the polycystic ovarian syndrome and low back pain to be related to HPV vaccine.  Additional details were reported as follows: The age at vaccination was not reported. The patient experienced PCOS and lower back pain. This case has been linked with the case US2020AMR247394, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR247394:same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Body temperature, Pain, Pyrexia
Clinical narrative: Fever of 102; Pain; This case was reported by a consumer and described the occurrence of fever in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date).   On 13th December 2020, the patient received the 2nd dose of Shingrix. On 14th December 2020, 1 days after receiving Shingrix, the patient experienced fever and pain. On an unknown date, the outcome of the fever and pain were not recovered/not resolved.   It was unknown if the reporter considered the fever and pain to be related to Shingrix.  Additional details were reported as follows: This case was reported by patient's husband. The age at vaccination was not reported. A day before reporting, the patient received Shingrix and on the day of reporting the patient experienced fever of 102 degrees F and pain.
Sex: U
Vaccine: VARZOS
Symptoms: Back pain, Spinal pain
Clinical narrative: Back spinal pain; Back pain; This case was reported by a consumer and described the occurrence of pain in spine in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in spine and back pain. On an unknown date, the outcome of the pain in spine and back pain were unknown.   It was unknown if the reporter considered the pain in spine and back pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported.  The age group was not reported but was captured as adult as per vaccine indication.  After receiving dose of Shingrix, the patient experienced back spine pain and back pain. The reporter did not consent to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: fever; pain; This case was reported by a other health professional and described the occurrence of fever in a adult 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 fever and pain. On an unknown date, the outcome of the fever and pain were unknown.   It was unknown if the reporter considered the fever and pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported.  The age group was not reported but was captured as adult as per vaccine indication.  The reporter said that should a patient had to administer another dose of Shingrix. After receiving 1st dose of Shingrix, the patient experienced fever and pain. The reporter said that should a patient had to administer another dose of Shingrix. The reporter did not consent to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Extensive swelling of vaccinated limb, Injection site erythema, Injection site induration, Injection site infection, Injection site swelling
Clinical narrative: Injection site infection; Injection site swelling measuring 8 inches by 4 inches; Injection site redness; Injection site heat; Injection site hardness; This case was reported by a pharmacist and described the occurrence of injection site infection in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced injection site infection, extensive swelling of vaccinated limb, injection site erythema, injection site warmth and injection site induration. On an unknown date, the outcome of the injection site infection, extensive swelling of vaccinated limb, injection site erythema, injection site warmth and injection site induration were unknown.   It was unknown if the reporter considered the injection site infection, extensive swelling of vaccinated limb, injection site erythema, injection site warmth and injection site induration to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The reporter stated that he had at least 100 patients this year who had experienced similar reactions like injection site redness, heat, hardness and swelling measuring 8 inches by 4 inches (extensive swelling of vaccinated limb) after receiving the Shingrix vaccine. It was unknown what lot numbers, location or treatment was given to the 100 patients. The reporter consented to follow-up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020250657:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Injection site warmth
Clinical narrative: Injection site infection; Injection site swelling measuring 8 inches by 4 inches; Injection site redness; Injection site heat; Injection site hardness; This case was reported by a pharmacist and described the occurrence of injection site infection in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced injection site infection, extensive swelling of vaccinated limb, injection site erythema, injection site warmth and injection site induration. On an unknown date, the outcome of the injection site infection, extensive swelling of vaccinated limb, injection site erythema, injection site warmth and injection site induration were unknown.   It was unknown if the reporter considered the injection site infection, extensive swelling of vaccinated limb, injection site erythema, injection site warmth and injection site induration to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The reporter stated that he had at least 100 patients this year who had experienced similar reactions like injection site redness, heat, hardness and swelling measuring 8 inches by 4 inches (extensive swelling of vaccinated limb) after receiving the Shingrix vaccine. It was unknown what lot numbers, location or treatment was given to the 100 patients. The reporter consented to follow-up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020250657:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Arthralgia
Clinical narrative: achy joints/ knee joints are starting to get really achy; This case was reported by a consumer and described the occurrence of knee pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17th December 2020, the patient received the 2nd dose of Shingrix. On 17th December 2020, 4 hrs after receiving Shingrix, the patient experienced knee pain. On an unknown date, the outcome of the knee pain was not recovered/not resolved.   It was unknown if the reporter considered the knee pain to be related to Shingrix.  Additional details were provided as follows: The reporter was patient. The age at vaccination was not reported. The patient just had the 2nd dose of Shingrix about 4 hours ago and knee joints of the patient had started to get really achy. The reporter wanted to know if achy joints were a side effect of the 2nd dose of Shingrix vaccine. The reporter did not consent to follow-up as they were not comfortable to provide the contact details.
Sex: U
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Myalgia, Pyrexia
Clinical narrative: Fever; Chills; Myalgias; Weakness; This case was reported by a other health professional and described the occurrence of fever in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced fever, chills, myalgia and weakness. On an unknown date, the outcome of the fever, chills, myalgia and weakness were recovered/resolved.   It was unknown if the reporter considered the fever, chills, myalgia and weakness to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was captured as an adult as per vaccine indication. The patient had adverse events to Shingrix like fever, chills, myalgias, weakness and was evaluated in Emergency Room and symptoms had resolved in 24 hours.  The patient had asked if there was risk for same reaction for future vaccines like coronavirus vaccine. The reporter consented to follow-up.
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Injection site pain, Pyrexia
Clinical narrative: injection site pain almost immediately; headache; fever; This case was reported by a consumer  and described the occurrence of injection site pain in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 7th December 2020, the patient received the 2nd dose of Shingrix. On 7th December 2020, immediately after receiving Shingrix, the patient experienced injection site pain, headache and fever. On an unknown date, the outcome of the injection site pain, headache and fever were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, headache and fever to be related to Shingrix.  Additional details were provided as follows: The case was reported by the wife of the patient. The age at the vaccination was not reported. The patient received Shingrix and had injection site arm pain almost immediately. The patient developed headache and fever as well and that these symptoms persist. The reporter did not had vaccine information for this adverse event and declined follow up. The reporter did not consent to follow up. This case linked with US2020243295, reporter by same reporter for patient wife.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020243295:Same Reporter
Age: 1.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Inappropriate schedule of product administration, Product administered to patient of inappropriate age
Clinical narrative: vaccinated with Kinrix a 1.5 years old girl.; Inappropriate vaccination schedule; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a infant female patient who received DTPa-IPV (Kinrix) (batch number H9Y52, expiry date 31st January 2022) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 10th December 2020, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration and inappropriate schedule of vaccine administered. On an unknown date, the outcome of the inappropriate age at vaccine administration and inappropriate schedule of vaccine administered were unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The reporter stated that they vaccinated with Kinrix a 1.5 years old girl, which led to inappropriate age at vaccine administration and inappropriate schedule of vaccine administered. The nurse did not realize that the prescribing Information states that Kinrix is indicated for kids aged 4 through 6 years. This was the 3rd dose for DTaP and 3rd dose for IPV series. The reporter consented to follow up. No other information was available.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: redness at injection site; pain; This case was reported by a pharmacist and described the occurrence of injection site erythema in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 2nd December 2020, the patient received the 1st dose of Shingrix. On 3rd December 2020, 1 days after receiving Shingrix, the patient experienced injection site erythema and pain. On an unknown date, the outcome of the injection site erythema was not recovered/not resolved and the outcome of the pain was recovered/resolved.   It was unknown if the reporter considered the injection site erythema and pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but selected as adult as per vaccine indication. The patient received the 1st dose of Shingrix and experienced redness at injection site and pain. A week later the symptoms appeared again. The reporter did not not provided patient identity. The reporter did not  provided lot number and expiry date. No further information was available.
Sex: M
Vaccine: VARZOS
Symptoms: Hyperhidrosis, Injection site erythema, Injection site pruritus, Injection site rash, Pyrexia
Clinical narrative: red, itchy, and a rash at the injection site; rash at the injection site; itchy, and a rash at the injection site.; fever; sweats; This case was reported by a consumer and described the occurrence of injection site erythema in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 18th December 2020, the patient received the 1st dose of Shingrix. On 20th December 2020, 2 days after receiving Shingrix and an unknown time after starting ibuprofen, the patient experienced fever and sweating. On 22nd December 2020, the patient experienced injection site erythema, injection site rash and injection site itching. The patient was treated with ibuprofen. On 21st December 2020, the outcome of the fever and sweating were recovered/resolved. On an unknown date, the outcome of the injection site erythema, injection site rash and injection site itching were not recovered/not resolved.   It was unknown if the reporter considered the injection site erythema, injection site rash, injection site itching, fever and sweating to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient states he received 1st dose of Shingrix and developed fever and sweats. The patient was treated with ibuprofen for fever and sweats. On 22nd December 2020,4 days after vaccination the patient stated that he had red, itchy, and a rash at the injection site. The reporter declined for any other information for Adverse event. The reporter did not consented to follow up.