chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Pain in extremity, Pyrexia
Clinical narrative: Arm soreness, bruising, large rash at injection site thsg got bigger overnight, headache, fever (102 F), chills, fatigue, swollen lymph node in left collarbone,
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Gait disturbance, Muscular weakness, Pyrexia
Clinical narrative: On the 9th day after receiving the 2nd vaccine, my legs became very weak. By the 10th day, I could barely walk. It is now two weeks after the 2nd vaccine, and I can walk only about 700 steps at a time at a pace less than 2 mph. I previously could walk over 3 miles at 4 mph.  I've also had a low grade fever (99.4-99.6) off and on since the day after the vaccine.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Gait disturbance, Muscular weakness
Clinical narrative: On the 9th day after receiving the 2nd vaccine, my legs became very weak. By the 10th day, I could barely walk. It is now two weeks after the 2nd vaccine, and I can walk only about 700 steps at a time at a pace less than 2 mph. I previously could walk over 3 miles at 4 mph.  I've also had a low grade fever (99.4-99.6) off and on since the day after the vaccine.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: 104.1 fever for 6 hrs
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: ?Covid Arm?: swelling, redness, heat at site 1 week after vaccine was administered.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Paraesthesia, Vertigo
Clinical narrative: I?m three weeks post vaccine #2.  During weeks 2 and 3 I have had vertigo off and on and almost fainted once.  It wasn?t clear that it was related to the vaccine until my husband started having the same symptom. I also had some leg tingling which may or may not be related. My blood pressure is normal. 70s / 120s.  I am still currently having these symptoms and have not contacted my doctor.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Tremor
Clinical narrative: Shaking / chills
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Angiogram, Blood test abnormal, Chest X-ray, Chest pain, Fibrin D dimer increased
Clinical narrative: Headache, chest pain , muscle pain, high blood pressure
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hypertension, Myalgia, Urine analysis abnormal
Clinical narrative: Headache, chest pain , muscle pain, high blood pressure
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Menstrual disorder, Muscle spasms
Clinical narrative: Very heavy period since second vaccine, extremely painful cramps. Very unusual and not what i am used to. Definitely feels different.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Pruritus, Rash
Clinical narrative: Swollen painful lymph nodes in left armpit and groin Rash on upper extremities and chest - not raised, no heat, very itchy Itchy scalp
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Headache, Lymphadenopathy, Pyrexia
Clinical narrative: Fever for 12 days, headache, rash, painful joints, swollen glands, chills,
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Fever for 12 days, headache, rash, painful joints, swollen glands, chills,
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Rash
Clinical narrative: low grade temp 4/28, tylenol x 2 doses,  shingles rash on rt forehead, onset 4/30/2021 seen by me 5/3/2021, rx valtrex
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Injection site erythema, Injection site warmth, Malaise
Clinical narrative: Headache began approximately 8 hours after injection accompanied by fatigue, general malaise, and mild body aches. Left arm began to hurt approximately 10 hours after injection. Left arm became red and hot to the touch between shoulder and bicep approximately 14 hours after injection. The general malaise and mild body aches continued for approximately 72 hours. Left arm redness and heat increased quickly from hour 14 through hour 19, continued at that level until approximately 72 hours after injection, and then gradually decreased until approximately 96 hours after injection. Left arm pain increased steadily for the first 72 hours, but continued gradually decreasing until approximately 144 hours after injection. The headache and fatigue worsened from hour 8 through approximately hour 72, stabilized from hours 72 through 96, and then the fatigue quickly decreased between 96 and 100 hours after injection. The headache did not decrease or disappear until approximately 318 hours after injection.  No further symptoms or side effects continued after that.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity
Clinical narrative: Headache began approximately 8 hours after injection accompanied by fatigue, general malaise, and mild body aches. Left arm began to hurt approximately 10 hours after injection. Left arm became red and hot to the touch between shoulder and bicep approximately 14 hours after injection. The general malaise and mild body aches continued for approximately 72 hours. Left arm redness and heat increased quickly from hour 14 through hour 19, continued at that level until approximately 72 hours after injection, and then gradually decreased until approximately 96 hours after injection. Left arm pain increased steadily for the first 72 hours, but continued gradually decreasing until approximately 144 hours after injection. The headache and fatigue worsened from hour 8 through approximately hour 72, stabilized from hours 72 through 96, and then the fatigue quickly decreased between 96 and 100 hours after injection. The headache did not decrease or disappear until approximately 318 hours after injection.  No further symptoms or side effects continued after that.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Myalgia, Nausea, Nervousness
Clinical narrative: Fever  Chills Nausea Muscle pain Muscle aches  Joint pain  Shaking  Nervousness  Tremors
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Tremor
Clinical narrative: Fever  Chills Nausea Muscle pain Muscle aches  Joint pain  Shaking  Nervousness  Tremors
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac flutter, Choking, Dizziness, Ear discomfort, Head discomfort
Clinical narrative: 4 days after the first shot I was feeling very very dizzy.   My ears felt full enough that I thought maybe they were just full of wax.  I bought an over the counter ear cleaning kit.  That didn't relieve any symptoms.  I never get headaches, but a couple days later the front top of my head was throbbing.  The area just above my forehead.  It was not sinus pressure, my face didn't feel any pressure or pain.  My throat also felt like I was being slightly choked.  Not my airway, but just my jugulars.  It began in the evenings.  It would feel like I had been hanging upside down for a while.  My head felt full of blood, like it was going to pop, like my eyes were bugging out.  By a week to 10 days later, my upper arms felt weak, my toes were tingling, and my heart would flutter for just a few seconds occasionally.  I was still dizzy, still felt like I was choking, except I was feeling this way all the time now.  The symptoms only seemed to be staying the same or getting worse.  I have NEVER gone to the doctor on my own in my life to get something checked, but this had me disconcerted enough to check in and see if I should get my second shot at all.  My appointment was to see my doctor was the morning of the same day I was scheduled to get my second Pfizer shot.  My doctor had not heard of these symptoms being associated with the Pfizer shot and chalked my symptoms up to stress.  I am not a stressful person and very much err on the side of "waiting to see what happens" if I feel sick.  I never feel sick.  But I accepted the explanation and took the second shot that day anyway.  It should be noted that the second shot made my left armpit swell up quite a bit.  I did feel dizzy again, but not nearly as much.  The other symptoms seemed to not be as bad either.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Muscular weakness, Paraesthesia, Stress
Clinical narrative: 4 days after the first shot I was feeling very very dizzy.   My ears felt full enough that I thought maybe they were just full of wax.  I bought an over the counter ear cleaning kit.  That didn't relieve any symptoms.  I never get headaches, but a couple days later the front top of my head was throbbing.  The area just above my forehead.  It was not sinus pressure, my face didn't feel any pressure or pain.  My throat also felt like I was being slightly choked.  Not my airway, but just my jugulars.  It began in the evenings.  It would feel like I had been hanging upside down for a while.  My head felt full of blood, like it was going to pop, like my eyes were bugging out.  By a week to 10 days later, my upper arms felt weak, my toes were tingling, and my heart would flutter for just a few seconds occasionally.  I was still dizzy, still felt like I was choking, except I was feeling this way all the time now.  The symptoms only seemed to be staying the same or getting worse.  I have NEVER gone to the doctor on my own in my life to get something checked, but this had me disconcerted enough to check in and see if I should get my second shot at all.  My appointment was to see my doctor was the morning of the same day I was scheduled to get my second Pfizer shot.  My doctor had not heard of these symptoms being associated with the Pfizer shot and chalked my symptoms up to stress.  I am not a stressful person and very much err on the side of "waiting to see what happens" if I feel sick.  I never feel sick.  But I accepted the explanation and took the second shot that day anyway.  It should be noted that the second shot made my left armpit swell up quite a bit.  I did feel dizzy again, but not nearly as much.  The other symptoms seemed to not be as bad either.
Age: 0.33
Sex: U
Vaccine: HIBV
Symptoms: Product storage error
Clinical narrative: PEDVAXHIB had a temperature excursion and was administered; This spontaneous report was received from a nurse referring to a 4 months old patient of unknown gender. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not reported.  On 19-FEB-2021, the patient was vaccinated with improperly stored haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (strength, dose, anatomical location, and route of administration were not reported, lot # T020614, expiration date 12-MAR-2023) for prophylaxis (product storage error).         The vaccine was stored in a temperature of 34.5 degrees Fahrenheit (F) for 29 minutes as recorded by a data logger. There were previous temperature excursions of 34.2 F and 35.4 F for 15 minutes.  No product quality complaint (PQC) was reported.  This is one of the several reports reported by the same reporter.; Sender's Comments:  US-009507513-2104USA001304: US-009507513-2104USA001350: US-009507513-2104USA001312: US-009507513-2104USA001282:
Age: 50.0
Sex: U
Vaccine: MMRV
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: No side effects reported/ No additional adverse events reported; Patient was given Proquad today instead of MMR; Patient was given Proquad today instead of MMR; This spontaneous report was received from a licensed practical nurse, referring to a 50-year-old patient of an unknown gender. Information regarding the patient's historical conditions, concurrent conditions, concomitant therapies, drug reactions and allergies were not reported.  On 19-APR-2021, the patient was intending to get a measles, mumps, and rubella (manufacturer unknown) booster dose; however, the patient was given a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) for prophylaxis (lot # T027294 was determined to be valid, expiration date reported and validated as 08-FEB-2021) (frequency scheme, route of administration and anatomical injection site were not reported) instead (wrong product administered and product administered to patient of inappropriate age). No side effects reported. No additional adverse events reported.
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: Patient uncooperative, Underdose
Clinical narrative: patient moving; patient was administered approximately 0.4ml of VARlVAX; This spontaneous report has been received from a nurse referring to a 12-month-old patient of unknown gender. The patient's pertinent medical history, drug reactions/allergies and concomitant medication were not reported.  On 21-APR-2021, the patient was vaccinated an invalid dose of varicella virus vaccine live (oka/merck) (VARIVAX) one time dose (strength and route of administration were unknown, lot # T017684 has been verified to be a valid lot number, expiration date was 21-MAY-2022) for prophylaxis. Nurse reported that the patient was administered approximately 0.4 ml of varicella virus vaccine live (oka/merck) (VARIVAX) (incorrect dose administered) due to patient moving (patient uncooperative). The outcome of the event of patient uncooperative was unknown.  The relationship between the event of patient uncooperative and the varicella virus vaccine live (oka/merck) (VARIVAX) was unknown.
Sex: M
Vaccine: HPV9
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient has not reported any additional adverse experiences as a result.; a patient was accidentally given a fourth dose of HPV (Confirmed as GARDASIL 9).; This spontaneous report was received from a physician assistant, referring to a 17-year-old male patient. The patient's pertinent medical history, concurrent conditions, previous drug reactions or allergies, and concomitant medications were not reported.   On 09-APR-2021, 8 months after his series was completed and the third dose administered, the patient was accidentally given a fourth dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) as prophylaxis (strength, route of administration, and anatomical location was not reported; lot number 1687291 has been verified to be a valid lot number for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) prefilled syringe, expiration date reported and upon internal validation established as 11-SEP-2022) (extra dose administered). The patient had not reported any additional adverse experiences as a result. The reporter stated the patient received the complete 3 dose hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) vaccine series on time according to his age of 15 at the time of his first dose. 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: 1687291; expirationdate: 11-SEP-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: F
Vaccine: HPV9
Symptoms: Syringe issue, Underdose
Clinical narrative: no additional AE; the pharmacist that injected her did not do it properly and "a large drip came down the syringe after the injection".; Caller is unsure if she got the full recommended dosage of the vaccine; This spontaneous report was received from a female patient of unknown age reporting on herself. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On 23-APR-2021, the patient was vaccinated with her second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (exact dose, route of administration, anatomical location, lot # and expiration date were not reported) as it was recommended by gynecologists. The patient reported that the pharmacist that injected her the vaccine did not do it properly and a large drip came down the syringe after the injection. The patient was unsure if she got the full recommended dosage of the vaccine. The patient did not seek medical attention. No additional adverse event was reported.
Sex: F
Vaccine: HPV9
Symptoms: Complication of pregnancy
Clinical narrative: They both received the GARDASIL 9 vaccine as adolescents. As adults, they both had trouble conceiving; Eventually they both were able to conceive and did have children; This spontaneous retrospective pregnancy report was received from a registered nurse via field representative and refers to adult female patient of unknown age. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On an unknown date (when the patient was adolescent), she was vaccinated with HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (exact dose, route of administration, anatomical location, lot # and expiration date were not reported) indication reported as vaccine.  On an unknown date (when the patient was adult), she had trouble conceiving. Eventually the patient became pregnant. Date of last menstrual period (LMP) and estimated due date (EDD) were unknown. The pregnancy outcome was live birth (as it was reported that the patient eventually did have child). It was unknown whether the patient received any treatment. The outcome of the event was unknown.   The causal relationship between HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) and the event was not reported.  This is one of two reports received from the same reporter.
Sex: F
Vaccine: PPV
Symptoms: Wrong product administered
Clinical narrative: she was supposed to have received a vaccine called "PNEUMOCOCAL ADULT ". She thinks she may have received Merck's PNEUMOVAX 23 vaccine instead; she was supposed to have received a vaccine called "PNEUMOCOCAL ADULT ". She thinks she may have received Merck's PNEUMOVAX 23 vaccine instead; This spontaneous report was received from a female patient of unknown age reporting on herself. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On 19-NOV-2007, the patient was supposed to have received a vaccine called "PNEUMOCOCAL ADULT " lot # reported as 0601F  but the patient thought she might have received pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) instead (dose, route of administration, anatomical location, lot # and expiration date were not reported) for prophylaxis due to product confusion.
Sex: F
Vaccine: HPV9
Symptoms: Infertility female
Clinical narrative: They both received the GARDASIL 9 vaccine as adolescents. As adults, they both had trouble conceiving; Eventually they both were able to conceive and did have children; This spontaneous retrospective pregnancy report was received from a registered nurse via field representative and refers to adult female patient of unknown age. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On an unknown date (when the patient was adolescent), she was vaccinated with HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (exact dose, route of administration, anatomical location, lot # and expiration date were not reported) indication reported as vaccine.  On an unknown date (when the patient was adult), she had trouble conceiving. Eventually the patient became pregnant. Date of last menstrual period (LMP) and estimated due date (EDD) were unknown. The pregnancy outcome was live birth (as it was reported that the patient eventually did have child). It was unknown whether the patient received any treatment. The outcome of the event was unknown.   The causal relationship between HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) and the event was not reported.  This is one of two reports received from the same reporter.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Ill-defined disorder
Clinical narrative: Shingles; including any and all of its sequelae.; This spontaneous report as received from a lawyer and refers to a 66 year old female patient.     In 2018, the patient was vaccinated with zoster vaccine live(ZOSTAVAX) for prophylaxis.   As a result of her receipt of  zoster vaccine live(ZOSTAVAX), in 2018, was caused to suffer Shingles, including any and all of its sequelae (ill-defined disorder).  As well as other severe and personal injuries which are permanent and lasting in nature, physical pain and mental anguish, including diminished enjoyment of life, as well as the need for lifelong medical treatment, monitoring and/or medications.  Plaintiff required and/or will require more health care and services and did incur medical, health, incidental and related expenses. Plaintiff alleged that Plaintiff will in the future be required to obtain further medical and/or hospital care, attention, and services.  The outcome of herpes zoster and ill-defined disorder was considered as not recovered.   The reporter considered herpes zoster and ill-defined disorder to be related to Zoster Vaccine Live(ZOSTAVAX).     Upon internal review, herpes zoster and ill-defined disorder were considered as disabling.
Age: 58.0
Sex: U
Vaccine: VARZOS
Symptoms: Balance disorder, Rash
Clinical narrative: rash; balance problems; This spontaneous report was received from a lawyer rand refers to a currently 66 year old patient.  The patient's relevant medical history, drug reactions/allergies and concomitant medication were not reported.    On 17-SEP-2013, 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, the patient was treated for the following injuries resulting from Plaintiff's zoster vaccine live(ZOSTAVAX) use: balance problems and rash.      The outcome of rash and balance disorder was unknown. The reporter considered rash and balance disorder to be related to Zoster Vaccine Live(ZOSTAVAX).
Age: 1.58
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; product storage error; This spontaneous report was received from a nurse, referring to a 19-month-old patient. Information regarding the patient's pertinent medical history, historical drugs, concurrent conditions, concomitant therapies, and previous drug reactions or allergies was not reported.   On 26-APR-2021, the patient was vaccinated with an improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live, recombinant human albumin (rha) (M-M-R II) lot # S020160, expiration date 30-JUN-2021, at a dose of 0.5 milliliter once for prophylaxis (route of administration and anatomical site of vaccination were not reported).   The vaccine was stored in a temperature above 46 degree Fahrenheit (°F) (67.6°F) for 8 hours 30 minutes as recorded by a data logger. There was no previous temperature excursion reported.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Post herpetic neuralgia
Clinical narrative: post herpetic neuralgia; herpes zoster outbreaks; Information has been received regarding a case in litigation from a lawyer and refers to a patient of unknown age and gender.  No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 11-JAN-2016, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route, lot # and expiration date was not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). After receiving zoster vaccine live (ZOSTAVAX) vaccine (date not reported), the patient suffered multiple outbreaks of herpes zoster and postherpetic neuralgia. As a result of these symptoms, the patient was seen and treated by medical providers and still under their care. 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 vaccine. The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of patient's condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), patient sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live (ZOSTAVAX), 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, the patient had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events was considered not recovered. Multiple outbreaks of herpes zoster and postherpetic neuralgia were considered to be related to zoster vaccine live (ZOSTAVAX) and disability events.
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Product storage error
Clinical narrative: No additional adverse events reported; improperly stored doses of GARDASIL 9 was administered; This spontaneous report was received from a medical assistant referring to a 11-year-old female patient. No information regarding the patients' medical history, concurrent conditions or concomitant medications was provided.  On 20-JAN-2021, the patient was vaccinated with improperly stored HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (0.5 milliliter, lot # 1621929, expiration date 06-DEC-2021 intramuscularly in left arm; conflicting information, previous dose was 3) for prophylaxis (product storage error). The administered dose was exposed to the temperature of 10.13 degrees Celsius (C) for 1 hour. There were previous temperature excursions reported as 9.17 C for 15 minutes and 8.59 C for 15 minutes. The call was because of a digital data logger. The patient did not experience an adverse reaction.  This is one of several reports received from the same reporter. 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: 1621929; expirationdate: 06-DEC-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other;  followupadditionalinfo :Yes; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2104USA007465:
Age: 1.0
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Contraindicated product administered, No adverse event
Clinical narrative: No additional adverse events reported; a dose of PROQUAD anda dose of VARlVAX were administered concomitantly to a 12 month old today; a dose of PROQUAD anda dose of VARlVAX were administered concomitantly to a 12 month old; This spontaneous report was received from a physician and refers to a 12-month-old patient of unknown gender. No information regarding the patient's medical history, drug reactions, allergies or concomitant therapies was provided.  On 27-APR-2021, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD), 0.5 ml (route of administration, lot # and expiration date were not provided) for prophylaxis. On the same day, the patient concomitantly received varicella virus vaccine live (oka/merck) (VARIVAX), 0.5 ml (route of administration, lot # and expiration date were not provided) for prophylaxis. No adverse events were reported.
Sex: U
Vaccine: VARZOS
Symptoms: Dupuytren's contracture, Herpetic radiculopathy, Neuritis, Pain, Post herpetic neuralgia
Clinical narrative: Dupuytren's contracture; Herpes Zoster Radiculitis; Post Herpetic Neuralgia; Post herpetic neuritis; chronic pain; Information has been received regarding a case in litigation from a lawyer and refers to a patient of unknown age and gender.  No information was provided regarding medical history, concurrent conditions, or concomitant medications. In or around 08-NOV-2013, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route, lot # and expiration date was not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving zoster vaccine live (ZOSTAVAX) vaccine (date not reported), the patient suffered from and had been diagnosed with Herpes Zoster Radiculitis, Post Herpetic Neuralgia, Post-herpetic neuritis, chronic pain, and Dupuytren's contracture. The patient experienced recurrent herpetic rashes, pain, and symptoms related to her injuries, which have been ongoing for eight years. 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 vaccine. The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of patient's condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), patient sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live (ZOSTAVAX), 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, the patient had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events was considered not recovered. All the events were considered to be related to zoster vaccine live (ZOSTAVAX).  Herpes Zoster Radiculitis, Post Herpetic Neuralgia, Post-herpetic neuritis, chronic pain, and Dupuytren's contracture were considered to be disability events. Upon internal review, Dupuytren's contracture was considered to be medically significant.
Sex: U
Vaccine: VARZOS
Symptoms: Rash vesicular
Clinical narrative: Dupuytren's contracture; Herpes Zoster Radiculitis; Post Herpetic Neuralgia; Post herpetic neuritis; chronic pain; Information has been received regarding a case in litigation from a lawyer and refers to a patient of unknown age and gender.  No information was provided regarding medical history, concurrent conditions, or concomitant medications. In or around 08-NOV-2013, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route, lot # and expiration date was not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving zoster vaccine live (ZOSTAVAX) vaccine (date not reported), the patient suffered from and had been diagnosed with Herpes Zoster Radiculitis, Post Herpetic Neuralgia, Post-herpetic neuritis, chronic pain, and Dupuytren's contracture. The patient experienced recurrent herpetic rashes, pain, and symptoms related to her injuries, which have been ongoing for eight years. 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 vaccine. The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of patient's condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), patient sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live (ZOSTAVAX), 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, the patient had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events was considered not recovered. All the events were considered to be related to zoster vaccine live (ZOSTAVAX).  Herpes Zoster Radiculitis, Post Herpetic Neuralgia, Post-herpetic neuritis, chronic pain, and Dupuytren's contracture were considered to be disability events. Upon internal review, Dupuytren's contracture was considered to be medically significant.
Sex: U
Vaccine: HPV9
Symptoms: Papilloma viral infection, Squamous cell carcinoma
Clinical narrative: treatment or prevention of recurrent squamous cell carcinoma as the pharmacist received the prescription; no additional AE; This spontaneous report was received from a pharmacist concerning a 54-years old patient of unknown gender. The patient's concurrent condition included recurrent squamous cell carcinoma. Concomitant medications, drug allergies and historical conditions were not reported.   Pharmacist received a prescription for treatment or prevention of recurrent squamous cell carcinoma for a 3 series vaccination with 1st dose followed by second dose at 1 month and a 3rd dose at 6 months (product prescribing issue). Therefore, the pharmacist contacted the physician who stated that they had tried other treatments with the patient and the carcinoma was caused by a strain of human papillomavirus. It was stated that the patient has not yet received the vaccine due to just received the COVID 19 vaccine and they were waiting 14 days. No additional ad verse events reported.  The outcome of the event was unknown.
Age: 46.0
Sex: M
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, Product administered to patient of inappropriate age
Clinical narrative: GARDASIL 9 was used in a 46 years old male patient; misuse adverse event / she had a prescription for the patient; No additional AEs; This spontaneous report was received from a doctor of pharmacy and refers to a 46-years-old male patient. There was no information regarding his medical history, current conditions nor concomitant therapies provided.  On an unspecified date, the patient received the first dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) 0.5 ml (route of administration, anatomical location, lot # and expiration date were not provided). The second dose was administered at 1 month and the third dose was administered at 6 months from the first vaccination (details not provided). The pharmacist was not sure what the indication was as the vaccination schedule was not the normal 0, 2 and 6 month series. The reporter stated a colleague informed her she had a prescription for the patient (event was also reported as misuse) (product prescribing issue). No adverse events (AEs) were reported.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Impaired work ability, Insomnia, Loss of consciousness, Myalgia
Clinical narrative: Loss of consciousness; single  syncopal episode; tried to get ready for work; did not sleep much that night; pain/body aches; Tired; Awoke nauseated; This case was received via VAERS on 27-Apr-2021 and was forwarded to Moderna on 27-Apr-2021.    This regulatory authority case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of LOSS OF CONSCIOUSNESS (Loss of consciousness) and SYNCOPE (single  syncopal episode) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Multiple organ dysfunction syndrome. Concurrent medical conditions included COPD and Asthma. Concomitant products included FLUTICASONE FUROATE, VILANTEROL TRIFENATATE (BREO ELLIPTA) and FLUTICASONE for an unknown indication.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced LOSS OF CONSCIOUSNESS (Loss of consciousness) (seriousness criterion medically significant), SYNCOPE (single  syncopal episode) (seriousness criterion medically significant), IMPAIRED WORK ABILITY (tried to get ready for work), INSOMNIA (did not sleep much that night), MYALGIA (pain/body aches), FATIGUE (Tired) and NAUSEA (Awoke nauseated ). At the time of the report, LOSS OF CONSCIOUSNESS (Loss of consciousness), SYNCOPE (single  syncopal episode), IMPAIRED WORK ABILITY (tried to get ready for work), INSOMNIA (did not sleep much that night), MYALGIA (pain/body aches), FATIGUE (Tired) and NAUSEA (Awoke nauseated ) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient has done a telehealth visit with physician  couple hours after the events.  No further treatment was rendered. Treatment information  was not provided.  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Patient's hx of multiple organ dysfunction syndrome is a confounding factor that may play a possible contributory role.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Patient's hx of multiple organ dysfunction syndrome is a confounding factor that may play a possible contributory role.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Syncope
Clinical narrative: Loss of consciousness; single  syncopal episode; tried to get ready for work; did not sleep much that night; pain/body aches; Tired; Awoke nauseated; This case was received via VAERS on 27-Apr-2021 and was forwarded to Moderna on 27-Apr-2021.    This regulatory authority case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of LOSS OF CONSCIOUSNESS (Loss of consciousness) and SYNCOPE (single  syncopal episode) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Multiple organ dysfunction syndrome. Concurrent medical conditions included COPD and Asthma. Concomitant products included FLUTICASONE FUROATE, VILANTEROL TRIFENATATE (BREO ELLIPTA) and FLUTICASONE for an unknown indication.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced LOSS OF CONSCIOUSNESS (Loss of consciousness) (seriousness criterion medically significant), SYNCOPE (single  syncopal episode) (seriousness criterion medically significant), IMPAIRED WORK ABILITY (tried to get ready for work), INSOMNIA (did not sleep much that night), MYALGIA (pain/body aches), FATIGUE (Tired) and NAUSEA (Awoke nauseated ). At the time of the report, LOSS OF CONSCIOUSNESS (Loss of consciousness), SYNCOPE (single  syncopal episode), IMPAIRED WORK ABILITY (tried to get ready for work), INSOMNIA (did not sleep much that night), MYALGIA (pain/body aches), FATIGUE (Tired) and NAUSEA (Awoke nauseated ) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient has done a telehealth visit with physician  couple hours after the events.  No further treatment was rendered. Treatment information  was not provided.  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Patient's hx of multiple organ dysfunction syndrome is a confounding factor that may play a possible contributory role.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Patient's hx of multiple organ dysfunction syndrome is a confounding factor that may play a possible contributory role.
Sex: F
Vaccine: SMALL
Symptoms: Skin ulcer
Clinical narrative: Skin lesion on right upper extremity; Possible contact transmission of smallpox; This case was obtained on 22APR2021 from the review of scientific literature.    A 27-year-old female presented to health clinic with a 7-day lesion on her right upper extremity. She disclosed that her boyfriend was a marine and was vaccinated against smallpox two weeks prior to her developing the skin lesion. The specific smallpox vaccine that he received is unknown and her boyfriend did not cover the vaccine site as instructed. The patient's skin lesion was non-itchy, approximately 5 millimeter (mm) blister like rash that ulcerated with a grayish, white center and had a surrounding red border. She denied any fever, chills, pets at home, insect bites or trauma to the area. While at the health clinic, the patient's skin lesion was unroofed, and a sample was sent to Laboratory of Public Health for identification. The sample returned positive for Orthopoxvirus DNA by polymerase chain reaction (PCR). The patient was instructed to cover the area while at work, keep the lesion open to air at home, and to avoid skin-to-skin contact. The clinic also reported the event to Department of Health for possible contact transmission of smallpox. The outcomes of the events of possible contact transmission of smallpox and lesion on her right upper extremity was not reported.  The patient's medical history includes asthma. Concomitant medications include unspecified nebulizers for asthma.  Author's Comment: Recipients of smallpox vaccine have a potential for autoinoculation and inoculation of close contacts. Hence, the vaccine recipients should be well educated about proper care of the vaccination site for preventing possible contact transmission of the virus. These include covering the vaccination site, proper hand washing after bandage changes, and avoiding skin-to-skin contact.  Company Comment: The suspected drug as described, was possible ACAM2000. ACAM2000 is a live vaccinia virus that can be transmitted to persons who have close contact with the vaccinee. In this case, the female presented a lesion that was confirmed to be Orthopoxvirus. The lesion is consistent with a contamination due to a secondary transmission from the male who was recently vaccinated; therefore, the lesions are considered related to ACAM2000.  The case is an adverse event of special interest (AESI) and considered medically important for the purpose of submission to the FDA as required commitment.; Sender's Comments: The suspected drug as described, was possible ACAM2000. ACAM2000 is a live vaccinia virus that can be transmitted to persons who have close contact with the vaccinee. In this case, the female presented a lesion that was confirmed to be Orthopoxvirus. The lesion is consistent with a contamination due to a secondary transmission from the male who was recently vaccinated; therefore, the lesions are considered related to ACAM2000.  The case is an adverse event of special interest (AESI) and considered medically important for the purpose of submission to the FDA as required commitment.
Sex: U
Vaccine: VARZOS
Symptoms: Balance disorder, Herpes zoster, Muscle atrophy, Pain, Vaccination failure
Clinical narrative: Even with the shot, you can get it again, but it won't be as bad/ Suspected vaccination failure; Even with the shot, you can get it again, but it won't be as bad; still have the pain a year later / is the most painful thing I have ever had / so painful; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included chickenpox.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure and shingles were unknown and the outcome of the pain was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.  Additional details were reported as follows: The case was reported by patient. The age at vaccination was not reported. The age group was not reported but was captured as adult as per vaccine indication.  The patient stated that if you have chickenpox, then you have virus in you that's what comes out later as shingles. It was so painful more than a chickenpox. The patient stated that he/she had been on medication for a year and still had a pain. Side effects were not good. The patient tried to take less medications. The patient stated that event after receiving shot you can get the shingles but it won't be as bad. The patient was on Gemopatin and did not like side effects. The patient still had a pain a year later. The patient stated that it was most painful thing he/she ever had. This case was considered as suspected vaccination failure as details regarding vaccination schedule, time to onset for target disease and laboratory confirmation were unknown at the time of reporting. No other information was reported. The follow-up would not possible, as no contact details were available. The events weight gain, muscle loss, dizziness, balance and its driving him/her crazy was captured only in narrative since it was seems to be developed after medication which was taken in past.
Sex: U
Vaccine: VARZOS
Symptoms: Weight increased
Clinical narrative: Even with the shot, you can get it again, but it won't be as bad/ Suspected vaccination failure; Even with the shot, you can get it again, but it won't be as bad; still have the pain a year later / is the most painful thing I have ever had / so painful; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included chickenpox.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure and shingles were unknown and the outcome of the pain was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.  Additional details were reported as follows: The case was reported by patient. The age at vaccination was not reported. The age group was not reported but was captured as adult as per vaccine indication.  The patient stated that if you have chickenpox, then you have virus in you that's what comes out later as shingles. It was so painful more than a chickenpox. The patient stated that he/she had been on medication for a year and still had a pain. Side effects were not good. The patient tried to take less medications. The patient stated that event after receiving shot you can get the shingles but it won't be as bad. The patient was on Gemopatin and did not like side effects. The patient still had a pain a year later. The patient stated that it was most painful thing he/she ever had. This case was considered as suspected vaccination failure as details regarding vaccination schedule, time to onset for target disease and laboratory confirmation were unknown at the time of reporting. No other information was reported. The follow-up would not possible, as no contact details were available. The events weight gain, muscle loss, dizziness, balance and its driving him/her crazy was captured only in narrative since it was seems to be developed after medication which was taken in past.