chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 55.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood test normal, Tinnitus
Clinical narrative: After 5 days Taking the Vaccine I started to have ringing of the ears.; This is a spontaneous report receive from two contactable consumer (one is patient). A 55-year-old male patient received first dose BNT162B2 (COMIRNATY, PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection, Lot number; unknown) via intramuscularly on the left arm on 07Feb2021 at 9.30 am (at the age of 55-years-old) at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient reported that, after 5 days taking the vaccine, on 12Feb2021 at 12:00 AM I started to have ringing of the ears. I never experienced this and it has occurred for the past 2 days in both ears. I need to know if I should hold off on the second doses and if this ringing of the ears has been reported for other patients taking your Vaccine. I am scheduled for my 2nd shot on 28Feb2021. Patient did not receive other vaccine in four weeks. Patient did not have covid prior vaccination. Patient did not tested covid post vaccination. No treatment was received for the event. Outcome of event was not recovered.  Information on the lot/batch number has been requested.
Age: 55.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Tinnitus
Clinical narrative: After 5 days Taking the Vaccine I started to have ringing of the ears.; This is a spontaneous report receive from two contactable consumer (one is patient). A 55-year-old male patient received first dose BNT162B2 (COMIRNATY, PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection, Lot number; unknown) via intramuscularly on the left arm on 07Feb2021 at 9.30 am (at the age of 55-years-old) at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient reported that, after 5 days taking the vaccine, on 12Feb2021 at 12:00 AM I started to have ringing of the ears. I never experienced this and it has occurred for the past 2 days in both ears. I need to know if I should hold off on the second doses and if this ringing of the ears has been reported for other patients taking your Vaccine. I am scheduled for my 2nd shot on 28Feb2021. Patient did not receive other vaccine in four weeks. Patient did not have covid prior vaccination. Patient did not tested covid post vaccination. No treatment was received for the event. Outcome of event was not recovered.  Information on the lot/batch number has been requested.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Malaise, Pain, Pyrexia, Rash erythematous, Tenderness
Clinical narrative: Rash that started 8 days post-vaccination at site of vaccination, lasted 4 days followed by bilateral swollen lymph nodes in axilla and inguinal regions 12 days post vaccination that lasted 2 days.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site rash, Lymphadenopathy
Clinical narrative: Rash that started 8 days post-vaccination at site of vaccination, lasted 4 days followed by bilateral swollen lymph nodes in axilla and inguinal regions 12 days post vaccination that lasted 2 days.
Age: 18.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Seizure like phenomena
Clinical narrative: Within 15 minute waiting period after vaccine administration, patient's mother alerted staff that patient had just had a seizure-like episode after becoming light headed. Patient started flaring with flexion and shaking of upper extremities, nonverbal during event. Staff examined patient and found no signs of a seizure. Patient was sent to the emergency room for further evaluation. Mother states that patient had a similar episode at age 8, but no further details provided. Patient was stable and discharged from the emergency room with a referral to follow-up with primary care physician.
Age: 18.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Aphasia, Dizziness, Seizure, Tremor
Clinical narrative: Within 15 minute waiting period after vaccine administration, patient's mother alerted staff that patient had just had a seizure-like episode after becoming light headed. Patient started flaring with flexion and shaking of upper extremities, nonverbal during event. Staff examined patient and found no signs of a seizure. Patient was sent to the emergency room for further evaluation. Mother states that patient had a similar episode at age 8, but no further details provided. Patient was stable and discharged from the emergency room with a referral to follow-up with primary care physician.
Age: 36.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Anxiety, Dizziness, Hyperhidrosis, Loss of consciousness
Clinical narrative: After sitting down in post vaccination area, client became lightheaded and diaphoretic and fell to the floor.  No injuries noted.  VSS - BP 117/82 lying; 149/92 sitting; 146/93 standing.  Pulse 78.  Oxygen Saturation 97% on RA.  Client states he passes out every time he has to give blood.  Refused any further treatment.
Age: 36.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Fall, Hyperhidrosis
Clinical narrative: After sitting down in post vaccination area, client became lightheaded and diaphoretic and fell to the floor.  No injuries noted.  VSS - BP 117/82 lying; 149/92 sitting; 146/93 standing.  Pulse 78.  Oxygen Saturation 97% on RA.  Client states he passes out every time he has to give blood.  Refused any further treatment.
Age: 53.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: CSF protein increased, CSF white blood cell count, Guillain-Barre syndrome, Muscular weakness, Paraesthesia
Clinical narrative: Patient had progressive weakness in lower extremities and was found to have Gilliam Barré 2 days after receiving the second dose of Moderna
Age: 53.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Computerised tomogram head, Computerised tomogram spine, Guillain-Barre syndrome, Laboratory test, Lumbar puncture
Clinical narrative: Patient had progressive weakness in lower extremities and was found to have Gilliam Barré 2 days after receiving the second dose of Moderna
Age: 53.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Angiogram cerebral, Arteriogram carotid, Computerised tomogram head, Condition aggravated, Electromyogram
Clinical narrative: Patient had progressive weakness in lower extremities and was found to have Gilliam Barré 2 days after receiving the second dose of Moderna
Age: 53.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Guillain-Barre syndrome, Muscular weakness
Clinical narrative: Patient had progressive weakness in lower extremities and was found to have Gilliam Barré 2 days after receiving the second dose of Moderna
Age: 84.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Feeling abnormal, Incoherent, Muscular weakness, Pain
Clinical narrative: CLIENT HAD SEVERE TREMORS FOLLOWED BY TOTAL DISORENTATION, COULDN'T STAND OR WALK. UNRESPONSIVE FOR ABOUT 12 HOURS.  FOLLOWED UP 3/23/2021 WITH PRIMARY DOCTOR.  DR FELT SHE HAD AN EXTREME AUTO IMMUNE RESPONSE.  WILL RECHECK ON 4/08/2021
Age: 84.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Somnolence, Tremor
Clinical narrative: CLIENT HAD SEVERE TREMORS FOLLOWED BY TOTAL DISORENTATION, COULDN'T STAND OR WALK. UNRESPONSIVE FOR ABOUT 12 HOURS.  FOLLOWED UP 3/23/2021 WITH PRIMARY DOCTOR.  DR FELT SHE HAD AN EXTREME AUTO IMMUNE RESPONSE.  WILL RECHECK ON 4/08/2021
Age: 84.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Autoimmune disorder, Disorientation, Dysstasia, Gait disturbance, Tremor
Clinical narrative: CLIENT HAD SEVERE TREMORS FOLLOWED BY TOTAL DISORENTATION, COULDN'T STAND OR WALK. UNRESPONSIVE FOR ABOUT 12 HOURS.  FOLLOWED UP 3/23/2021 WITH PRIMARY DOCTOR.  DR FELT SHE HAD AN EXTREME AUTO IMMUNE RESPONSE.  WILL RECHECK ON 4/08/2021
Age: 84.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Unresponsive to stimuli
Clinical narrative: CLIENT HAD SEVERE TREMORS FOLLOWED BY TOTAL DISORENTATION, COULDN'T STAND OR WALK. UNRESPONSIVE FOR ABOUT 12 HOURS.  FOLLOWED UP 3/23/2021 WITH PRIMARY DOCTOR.  DR FELT SHE HAD AN EXTREME AUTO IMMUNE RESPONSE.  WILL RECHECK ON 4/08/2021
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cough, Dyspnoea
Clinical narrative: Anaphylaxis.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anaphylactic reaction
Clinical narrative: Anaphylaxis.
Age: 21.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anxiety, Dyspnoea, Vomiting, Wheezing
Clinical narrative: i received my vaccine right about 12:30 that money and while waiting in the 15 minute clinic at the center i felt relatively fine aside for a dry mouth which i didn't even thing was a adverse reaction at the time. i processed to continue with my day and head to my 2pm class and while sitting in my class my throat which at this point was pretty itchy and felt like it was to some extent tightening. I also started to cough and wheeze profusely which is something im use to as an asthma patient but usually something has to induce that and at this point i was literally just sitting in class. i left the class and at this point it was getting extremely hard for me to breath i was coughing and wheezing essentially in a full on asthma attack. i drove to the clinic where they first gave me an albuterol nebulizer and then tried to give me a Claritin but just a few minutes after i threw up we tried again with a Benadryl and while i was able to keep that in longer i also threw up after taking that medicine. After my breathing calmed down a bit i was released to go home but there i had a fever and headache, body chills, extreme fatigue, exhaustion. nausea and  abdominal oain in my lower left side and right below my breast bone. for the rest of the night and even into today (march 23). i continued to take both Benadryl and the nebulizer over night and that has worked to help releeve symptoms but i still feel significantly unwell.
Age: 21.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain, Asthma, Chest pain, Chills, Cough
Clinical narrative: i received my vaccine right about 12:30 that money and while waiting in the 15 minute clinic at the center i felt relatively fine aside for a dry mouth which i didn't even thing was a adverse reaction at the time. i processed to continue with my day and head to my 2pm class and while sitting in my class my throat which at this point was pretty itchy and felt like it was to some extent tightening. I also started to cough and wheeze profusely which is something im use to as an asthma patient but usually something has to induce that and at this point i was literally just sitting in class. i left the class and at this point it was getting extremely hard for me to breath i was coughing and wheezing essentially in a full on asthma attack. i drove to the clinic where they first gave me an albuterol nebulizer and then tried to give me a Claritin but just a few minutes after i threw up we tried again with a Benadryl and while i was able to keep that in longer i also threw up after taking that medicine. After my breathing calmed down a bit i was released to go home but there i had a fever and headache, body chills, extreme fatigue, exhaustion. nausea and  abdominal oain in my lower left side and right below my breast bone. for the rest of the night and even into today (march 23). i continued to take both Benadryl and the nebulizer over night and that has worked to help releeve symptoms but i still feel significantly unwell.
Age: 21.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dry mouth, Dyspnoea, Fatigue, Headache, Malaise
Clinical narrative: i received my vaccine right about 12:30 that money and while waiting in the 15 minute clinic at the center i felt relatively fine aside for a dry mouth which i didn't even thing was a adverse reaction at the time. i processed to continue with my day and head to my 2pm class and while sitting in my class my throat which at this point was pretty itchy and felt like it was to some extent tightening. I also started to cough and wheeze profusely which is something im use to as an asthma patient but usually something has to induce that and at this point i was literally just sitting in class. i left the class and at this point it was getting extremely hard for me to breath i was coughing and wheezing essentially in a full on asthma attack. i drove to the clinic where they first gave me an albuterol nebulizer and then tried to give me a Claritin but just a few minutes after i threw up we tried again with a Benadryl and while i was able to keep that in longer i also threw up after taking that medicine. After my breathing calmed down a bit i was released to go home but there i had a fever and headache, body chills, extreme fatigue, exhaustion. nausea and  abdominal oain in my lower left side and right below my breast bone. for the rest of the night and even into today (march 23). i continued to take both Benadryl and the nebulizer over night and that has worked to help releeve symptoms but i still feel significantly unwell.
Age: 21.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nausea, Pyrexia, Throat tightness, Vomiting, Wheezing
Clinical narrative: i received my vaccine right about 12:30 that money and while waiting in the 15 minute clinic at the center i felt relatively fine aside for a dry mouth which i didn't even thing was a adverse reaction at the time. i processed to continue with my day and head to my 2pm class and while sitting in my class my throat which at this point was pretty itchy and felt like it was to some extent tightening. I also started to cough and wheeze profusely which is something im use to as an asthma patient but usually something has to induce that and at this point i was literally just sitting in class. i left the class and at this point it was getting extremely hard for me to breath i was coughing and wheezing essentially in a full on asthma attack. i drove to the clinic where they first gave me an albuterol nebulizer and then tried to give me a Claritin but just a few minutes after i threw up we tried again with a Benadryl and while i was able to keep that in longer i also threw up after taking that medicine. After my breathing calmed down a bit i was released to go home but there i had a fever and headache, body chills, extreme fatigue, exhaustion. nausea and  abdominal oain in my lower left side and right below my breast bone. for the rest of the night and even into today (march 23). i continued to take both Benadryl and the nebulizer over night and that has worked to help releeve symptoms but i still feel significantly unwell.
Age: 48.0
Sex: M
Vaccine: MMR
Symptoms: Wrong technique in product usage process
Clinical narrative: no additional adverse events reported; dose of MMR II via intramuscular route instead of subcutaneous route.; This spontaneous report was received from a medical assistant referring to a 48 year old male patient. The patient's concurrent conditions, medical history and concomitant medications were not reported.  On 01-MAR-2021, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) 0.5 milliliter, intramuscular instead of subcutaneous route for prophylaxis (lot# reported as S035111 established as invalid lot #, expiration date on 03-MAY-2021). No further information was provided. No additional adverse events were reported. No product quality complaint.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, Product storage error
Clinical narrative: expired product (VAQTA) administered with previous temperature excursion; expired product (VAQTA) administered with previous temperature excursion; This spontaneous report as received from a medical assistant refers to a 24-year-old patient of unknown gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 15-JAN-2021, the patient was vaccinated with an expired of hepatitis a vaccine, inactivated (VAQTA) 1.0 ml, lot # S034296, expiration date 09-JAN-2021 (route of administration and anatomical location was not reported) for prophylaxis. The administered dose of hepatitis a vaccine, inactivated (VAQTA) experienced previous temperature excursion.  This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S034296; expirationdate: 09-JAN-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; Sender's Comments:  US-009507513-2103USA001667:
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: No additional adverse event reported; Temperature excursion/ VARIVAX was administered to a patient; This spontaneous report as received from an office manager to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 20-FEB-2021, the patient was vaccinated with an improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) 1 time dose, lot # T022315, expiration date 30-JUN-2022 (dose and route of administration were not reported) for prophylaxis. The administered dose of vaccine experienced temperature excursion of 5.5 degrees Celsius for 21 hours. There was no previous temperature excursion. Digital data logger was not involved. There was no adverse event reported.   This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-2103USA005929:
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Post herpetic neuralgia
Clinical narrative: post herpetic neuralgia; herpes zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient (pt) of unknown age and gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On an unknown date, the pt was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, lot # and expiration date were not specified) for routine health maintenance and the prevention of shingles (herpes zoster). On an unspecified date, shortly after receiving zoster vaccine live (ZOSTAVAX) the pt suffered outbreaks of herpes zoster and post herpetic neuralgia. As a result of these symptoms, the pt was seen and treated by medical providers and still was under their care. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, the pt's symptoms resulted in physical limitations not present prior to using the vaccine. The pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of the pt's condition. As a result of the zoster vaccine live (ZOSTAVAX), the pt sustained severe and permanent personal injuries. Further, as a tragic consequence, the pt suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of the vaccine, the pt suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The patient did not recover from the reported events. The lawyer considered the events to be related to zoster vaccine live (ZOSTAVAX).   The events of herpes zoster and post herpetic neuralgia were considered to be disabling.
Sex: U
Vaccine: HEPA, UNK
Symptoms: Incorrect dose administered
Clinical narrative: No additional AE reported; a 15-month-old child received an adult dose of VAQTA; a 15-month-old child received an adult dose of VAQTA; This spontaneous report was received from a certified medical assistant and refers to a 15-month-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not provided.  On 26-FEB-2021, the patient was vaccinated with the first, 1 ml, adult dose of hepatitis a vaccine, inactivated (VAQTA) (lot # T014589, expiration date 25-OCT-2021; site and route of administration were not reported) for prophylaxis. No additional adverse events had been reported since dose was administered.
Age: 51.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Anogenital warts, Inappropriate schedule of product administration
Clinical narrative: Genital warts; The patient was administered Pneumovax in February 2005 and October 2005; This spontaneous report has been received from other healthcare professional via a medical records from a case in litigation for zoster vaccine live (ZOSTAVAX)(2102USA003524), concerning a 52-year-old female patient (pt). The pt was a smoker. She was allergic to codeine, cephalexin and sulfa drugs. Her concurrent conditions included transverse sinus thrombosis, hypercoagulation with anticoagulant therapy, depression, astroesophageal reflux (GE) disease, lumbar spinal stenosis (LLS), obesity, hirsutism, allergic rhinitis, pernicious anaemia, iron deficiency anemia- malabsorption. The pt's family history included coronary artery disease (CAD) and cystic fibrosis. The PT' medical history included pain in left elbow, gastric bypass, anxiety, peptic ulcer disease (PUD), peripheral edema, furuncle, chronic low blood pressure, left lower extremity (LLE) radiculopathy, cholelithiasis, jaundice and rotator cuff strain. The patient received doses of unspecified influenza vaccines on unspecified dates in: November 1992; September 1993; October 1994; November 1995; November 1996; October 1999; November 2000; November 2001; October 2002; September 2003. It was also reported that the pt was vaccinated in the past with tetanus (+) diphtheria (+) pertussis (Tdap) vaccine (on 01-AUG-2003).  On an unknown date in February 2005, the pt was vaccinated with first dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX). On an unknown date in October 2005, the pt was vaccinated with the second dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX) for prophylaxis (dose, route of administration, anatomical location, lot# and expiration date were not provided for both)(inappropriate schedule of vaccine administration). On an unknown date in November 2005, the pt experienced genital warts. The outcome of the event of genital warts was not reported.  The causality assessment between the event of genital warts and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX) was not provided.  All available medical records will be provided upon request.  This is the one of two cases regarding the same patient (linked: MARRS#2102USA008735).; Sender's Comments:  US-009507513-2102USA003524:
Age: 51.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Genital warts; The patient was administered Pneumovax in February 2005 and October 2005; This spontaneous report has been received from other healthcare professional via a medical records from a case in litigation for zoster vaccine live (ZOSTAVAX)(2102USA003524), concerning a 52-year-old female patient (pt). The pt was a smoker. She was allergic to codeine, cephalexin and sulfa drugs. Her concurrent conditions included transverse sinus thrombosis, hypercoagulation with anticoagulant therapy, depression, astroesophageal reflux (GE) disease, lumbar spinal stenosis (LLS), obesity, hirsutism, allergic rhinitis, pernicious anaemia, iron deficiency anemia- malabsorption. The pt's family history included coronary artery disease (CAD) and cystic fibrosis. The PT' medical history included pain in left elbow, gastric bypass, anxiety, peptic ulcer disease (PUD), peripheral edema, furuncle, chronic low blood pressure, left lower extremity (LLE) radiculopathy, cholelithiasis, jaundice and rotator cuff strain. The patient received doses of unspecified influenza vaccines on unspecified dates in: November 1992; September 1993; October 1994; November 1995; November 1996; October 1999; November 2000; November 2001; October 2002; September 2003. It was also reported that the pt was vaccinated in the past with tetanus (+) diphtheria (+) pertussis (Tdap) vaccine (on 01-AUG-2003).  On an unknown date in February 2005, the pt was vaccinated with first dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX). On an unknown date in October 2005, the pt was vaccinated with the second dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX) for prophylaxis (dose, route of administration, anatomical location, lot# and expiration date were not provided for both)(inappropriate schedule of vaccine administration). On an unknown date in November 2005, the pt experienced genital warts. The outcome of the event of genital warts was not reported.  The causality assessment between the event of genital warts and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX) was not provided.  All available medical records will be provided upon request.  This is the one of two cases regarding the same patient (linked: MARRS#2102USA008735).; Sender's Comments:  US-009507513-2102USA003524:
Sex: U
Vaccine: VARZOS
Symptoms: Herpes simplex, Post-traumatic neuralgia
Clinical narrative: nerve irritation; herpes zoster; herpes simplex; postherpetic neuralgia; Information has been received from a lawyer and a consumer regarding a case in litigation referring to a patient (pt) of unknown age or gender. The pt's concurrent conditions, medical history and concomitant medications were not reported. On or about 10-JAN-2013 and 21-NOV-2013, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dosage regimen, route of administration, anatomical location, lot number and expiration date were not provided)at the health center for the long-term prevention of shingles and zoster-related conditions. Subsequently, the pt was treated by health care providers for the following injuries resulting from the use of zoster vaccine live (ZOSTAVAX): herpes zoster, postherpetic neuralgia, herpes simplex and nerve irritation. The outcome of the claimed events was not provided, and causal relationship was reported as related to zoster vaccine live (ZOSTAVAX).
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE's.; GARDASIL 9 that underwent a temperature excursion; Information has been received from a registered medical assistant reporting on a patient of unknown age and gender. There was no information about the patient's concurrent conditions, medical history or concomitant medication.  On 11-MAR-2021, 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) for prophylaxis, lot number 1687292 and expiration date 25-AUG-2022 (dose and route of administration were not reported). No adverse event.  On an unknown date, the vaccine underwent a temperature excursion between 36 and 46 Fahrenheit degree for 30 minutes; another temperature excursion between 36 and 46 Fahrenheit degree for 30 minutes was confirmed. No previous temperature excursions were reported. The call was placed because a digital data logger 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: 1687292; expirationdate: 25-AUG-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash, Scab
Clinical narrative: The appearance was of shingles; Rash along the medial aspect of my left breast / small amount on the lateral left breast; Rash has more of a scabbed appearance; This case was reported by a nurse and described the occurrence of shingles in a 53-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 8th February 2021, the patient received the 1st dose of Shingrix. On 13th February 2021, 5 days after receiving Shingrix and an unknown time after starting Valtrex, the patient experienced shingles and rash. In February 2021, the patient experienced scab. The patient was treated with valaciclovir hydrochloride (Valtrex). On an unknown date, the outcome of the shingles and rash were recovering/resolving and the outcome of the scab was unknown.   It was unknown if the reporter considered the shingles, rash and scab to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported but it could be 52 or 53 years old. The patient received the first dose of the Shingrix vaccine on 8th February 2021 (Monday). On the following Saturday (13th February 2021), she noted a rash along the medial aspect of left breast with a small amount also on the lateral left breast. As the reporter was a nurse who worked with breast cancer patients and, hence had concerns of inflammatory breast cancer, she went to see a breast specialist on 16th February 2021 (Tuesday). The breast specialist reassured her that the appearance was not that of inflammatory breast cancer but was rather of shingles.  The patient was prescribed Valtrex which she was taking and was on day 6 on the reporting date. The rash was clearing up but was still present at the time of reporting and had more of a scabbed appearance at that time. The reporter was wondering if this had been noted in any other patients with Shingrix and was also inquiring if she should receive the second dose. The reporter consented to follow -up.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Feeling abnormal, Feeling cold, Hyperhidrosis, Malaise
Clinical narrative: felt like a freezing / dog; felt like a / soaking, whipped dog; felt like a freezing, soaking, whipped dog; This case was reported by a consumer and described the occurrence of feeling cold in a male 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 feeling cold, feeling unwell and chills. On an unknown date, the outcome of the feeling cold, feeling unwell and chills were recovered/resolved.   The reporter considered the feeling cold, feeling unwell and chills to be possibly related to Shingrix.   Additional details were provided as follows: Age at vaccination was not reported. The patient felt like a freezing, soaking, whipped dog for a day or two after each shot. For tolerability of 2nd dose refer the case US2021AMR053984. No further information reported.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR053984:2nd dose
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Feeling cold, Malaise, Vaccine positive rechallenge
Clinical narrative: felt like a freezing / dog; felt like a / soaking, whipped dog; felt like a freezing, soaking, whipped dog; This case was reported by a consumer and described the occurrence of feeling cold in a male 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 feeling cold, feeling unwell and chills. On an unknown date, the outcome of the feeling cold, feeling unwell and chills were recovered/resolved.   The reporter considered the feeling cold, feeling unwell and chills to be possibly related to Shingrix.   Additional details were provided as follows: Age at vaccination was not reported. The patient felt like a freezing, soaking, whipped dog for a day or two after each shot. For tolerability of 2nd dose refer the case US2021AMR053984. No further information reported.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR053984:2nd dose
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Feeling abnormal, Feeling cold, Hyperhidrosis, Malaise
Clinical narrative: felt like a freezing / dog; felt like a / soaking, whipped dog; felt like a freezing, soaking, whipped dog; This case was reported by a consumer and described the occurrence of feeling cold in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of feeling cold (For the tolerability of 1st dose, refer case US2021AMR053974, reported for same patient.).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced feeling cold, feeling unwell and chills. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the feeling cold, feeling unwell and chills were recovered/resolved.   The reporter considered the feeling cold, feeling unwell and chills to be possibly related to Shingrix.  Additional details were provided as follows: Age at vaccination was not reported. The patient felt like a freezing, soaking, whipped dog for a day or two after each shot. No further information reported.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR053974:2nd dose
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Feeling cold, Malaise, Vaccine positive rechallenge
Clinical narrative: felt like a freezing / dog; felt like a / soaking, whipped dog; felt like a freezing, soaking, whipped dog; This case was reported by a consumer and described the occurrence of feeling cold in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of feeling cold (For the tolerability of 1st dose, refer case US2021AMR053974, reported for same patient.).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced feeling cold, feeling unwell and chills. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the feeling cold, feeling unwell and chills were recovered/resolved.   The reporter considered the feeling cold, feeling unwell and chills to be possibly related to Shingrix.  Additional details were provided as follows: Age at vaccination was not reported. The patient felt like a freezing, soaking, whipped dog for a day or two after each shot. No further information reported.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR053974:2nd dose
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Injection site pain, Injection site swelling, Malaise, Pain
Clinical narrative: Pain in my arm at the injection site / persisted these past 6 months / forcing / to seek medical attention; Injured by the Shingrix vaccine / Pain / has continued on for over 6 months; Swelling; Feeling unwell / malaise; Fatigue; This case was reported by a consumer and described the occurrence of injection site pain in a 53-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 14th August 2020, the patient received the 1st dose of Shingrix. On 14th August 2020, 1 day after receiving Shingrix, the patient experienced injection site pain, pain, swelling, feeling unwell and fatigue. On an unknown date, the outcome of the injection site pain, pain, swelling, feeling unwell and fatigue were unknown.   It was unknown if the reporter considered the injection site pain, pain, swelling, feeling unwell and fatigue to be related to Shingrix.   Additional details were reported as follows: Reported A description of the possible side effect itself, such as the signs and symptoms experienced, date the possible side effect started and the result of the possible side effect. The vaccine received by patient on 14-AUG-2021, that day patient started the pain, swelling, rash, fatigue and malaise. Patient stated that the pain side effect forcing her to seek medical attention. Her doctor has ordered an MRI to rule out what damage present in her arm.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Pain in my arm at the injection site / persisted these past 6 months / forcing / to seek medical attention; Injured by the Shingrix vaccine / Pain / has continued on for over 6 months; Swelling; Feeling unwell / malaise; Fatigue; This case was reported by a consumer and described the occurrence of injection site pain in a 53-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 14th August 2020, the patient received the 1st dose of Shingrix. On 14th August 2020, 1 day after receiving Shingrix, the patient experienced injection site pain, pain, swelling, feeling unwell and fatigue. On an unknown date, the outcome of the injection site pain, pain, swelling, feeling unwell and fatigue were unknown.   It was unknown if the reporter considered the injection site pain, pain, swelling, feeling unwell and fatigue to be related to Shingrix.   Additional details were reported as follows: Reported A description of the possible side effect itself, such as the signs and symptoms experienced, date the possible side effect started and the result of the possible side effect. The vaccine received by patient on 14-AUG-2021, that day patient started the pain, swelling, rash, fatigue and malaise. Patient stated that the pain side effect forcing her to seek medical attention. Her doctor has ordered an MRI to rule out what damage present in her arm.
Sex: U
Vaccine: VARZOS
Symptoms: Burning sensation, Hypersensitivity, Pyrexia, Rash
Clinical narrative: Burning rash from the top of my shoulders all the way to my finger tips; Blisters; Burning rash from the top of my shoulders all the way to my finger tips; Wanted to scratch the skin off of my body so much; Fever of 102; Terrible allergies; This case was reported by a consumer via interactive digital media and described the occurrence of burning sensation in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (Family History) (patient's sister got Shingles and was sick for weeks). Previously administered products included Shingles vaccine (1st dose received on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced burning sensation, blister, rash, scratch, fever and allergy. On an unknown date, the outcome of the burning sensation, blister, rash, scratch and allergy were unknown and the outcome of the fever was recovering/resolving.   It was unknown if the reporter considered the burning sensation, blister, rash, scratch, fever and allergy to be related to Shingles vaccine.  Additional details were provided as follows: The reporter was the patient. 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's mother and sister got Shingles and were sick for weeks. The patient was okay with the first shot but felt that the second shot was a nightmare. The patient had a burning rash from the top of the shoulders all the way to the finger tips. The patient had never wanted to scratch the skin off of the body so badly, then the rash became blisters. The patient also had fever of 102 degree Fahrenheit which subsided later. The patient also had terrible allergies. The patient was not sorry that they had the vaccine, however was worried about the Covid vaccine which they were going to get. The patient was questioning if one should take the chances or not but unfortunately did not have the answer for that but the patient stated that they would still get the vaccine.
Sex: U
Vaccine: VARZOS
Symptoms: Pruritus
Clinical narrative: first dose of Shingrix on Dec. 12. / itchy feeling on my body; This case was reported by a consumer via interactive digital media and described the occurrence of generalized pruritus in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12th December 2020, the patient received the 1st dose of Shingrix. On 16th December 2020, 4 days after receiving Shingrix, the patient experienced generalized pruritus. On an unknown date, the outcome of the generalized pruritus was unknown.   It was unknown if the reporter considered the generalized pruritus to be related to Shingrix.  Additional details were reported as follows: This case was reported by patient himself/herself. The age group was not reported but was captured as adult as per vaccine indication. The age at vaccination was not reported. The patient experienced itchy feeling on the body. The patient wanted to know if this could had been caused by the vaccine. The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Feeling abnormal
Clinical narrative: How long do you feel like crap after the second shot; This case was reported by a consumer via interactive digital media and described the occurrence of feeling abnormal in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced feeling abnormal. On an unknown date, the outcome of the feeling abnormal was unknown.   It was unknown if the reporter considered the feeling abnormal to be related to Shingrix.  Additional details were provided 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 received 2nd dose of Shingrix and felt like crap. The patient told that its been 3 days from event occurrence and patient did not counting the day of vaccination.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: shingles from the shingles shot/ Suspected vaccination failure; shingles; This case was reported by a consumer and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   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) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were reported as follows: The age at vaccination was not reported. Until the date of reporting the patient thought that the patient was the only one to get shingles from the shingles shot. This case was considered to be a suspected vaccination failure case, as the details regarding being full vaccination schedule, laboratory confirmation for shingles and exact time to onset were unknown.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Adverse event, Anaemia, Asthenia, Fatigue, Influenza like illness
Clinical narrative: Anemia; "debilitating reaction" / described it as "weakness or tiredness"; "Debilitating reaction" / described it as "weakness or tiredness"; Like when you have the flu; This case was reported by a consumer via call center representative and described the occurrence of weakness in a 77-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Zostavax with an associated reaction of no adverse event (received on 25th September 2007).   On 12th November 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 9 months after receiving Shingrix, the patient experienced weakness, fatigue, influenza-like symptoms and anemia. On an unknown date, the outcome of the weakness, fatigue and influenza-like symptoms were recovered/resolved and the outcome of the anemia was unknown.   It was unknown if the reporter considered the weakness, fatigue, influenza-like symptoms and anemia to be related to Shingrix.  Additional details were provided as follows: The reporter was the patient.  The patient received 1st Shingrix Vaccine dose on the left arm and experienced a debilitating reaction which the patient described as weakness or tiredness. The adverse events of first dose was worse than the second dose and stated it was like when one had the flu. The patient stated that this reaction lasted for 5 days. At the time of reporting the patient took Thyroid medications and not received it when she took the Shingrix Vaccines. The patient also had anemia and fatigue problems. The reporter consented to follow up and also gave consent to follow-up with health care professional. For tolerance to the 2nd dose of Shingrix, refer case US2021AMR048204.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR048204:same reporter
Age: 74.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Hypersensitivity, Incomplete course of vaccination, Injection site erythema, Periorbital swelling
Clinical narrative: Allergic reaction; allergic reaction which included / a red arm / red neck /  her reaction was "semi-bad" reaction; allergic reaction which included puffy eyes /  her reaction was "semi-bad" reaction; She never had Shingrix shot #2 / on 05-Jul-2018 she had the Shingrix shot #1; This case was reported by a consumer via call center representative and described the occurrence of allergic reaction in a 76-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Zostavax (received 2 to 3 years before getting Shingrix shot).   On 5th July 2018, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced allergic reaction, erythema of extremities, puffy eyes and incomplete course of vaccination. On an unknown date, the outcome of the allergic reaction, erythema of extremities, puffy eyes and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the allergic reaction to be related to Shingrix. The reporter considered the erythema of extremities and puffy eyes to be related to Shingrix.  Additional information was provided as follows: This case was reported by patient herself, but initial reporter was her husband who provided his email address. The age at vaccination was not applicable for 2nd dose of Shingrx The patient received 1st dose of Shingrix in arm (unknown) and she had an allergic reaction which included puffy eyes and a red neck and a red arm. According to the family physician her reaction was semi-bad reaction. The patient did not remember when the events were happened to her. It was implied that the red arm was the injected arm. Till the time of reporting, the patient did not receive 2nd dose, which led to Incomplete course of Vaccination. The reporter did not want to provide her physician contact information. The reporter did not consent to follow-up