chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 26-APR-2018, the patient was vaccinated with an improperly stored dose of LIQUID PEDVAXHIB, lot # N022167, expiration date: 08-FEB-2020 (dose and route of administration were not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 47 to 77 degrees Fahrenheit for 5 hours. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1806USA001505: US-009507513-1806USA009026: US-009507513-1806USA009027: US-009507513-1806USA009028: US-009507513-1806USA009030: US-009507513-1806USA009031: US-009507513-1806USA009032: US-009507513-1806USA009033: US-009507513-1806USA009034: US-009507513-1806USA009035: US-009507513-1806USA009036: US-009507513-1806USA009037: US-009507513-1806USA009038: US-009507513-1806USA009039: US-009507513-1806USA009040: US-009507513-1806USA009041: US-009507513-1806USA009042: US-009507513-1806USA009043: US-009507513-1806USA009044: US-009507513-1806USA009045: US-009507513-1806USA009046: US-009507513-1806USA009047: US-009507513-1806USA009048: US-009507513-1806USA009049: US-009507513-1806USA009050: US-009507513-1806USA009051: US-009507513-1806USA009052: US-009507513-1806USA009053: US-009507513-1806USA009054: US-009507513-1806USA009055: US-009507513-1806USA009056:
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 27-APR-2018, the patient was vaccinated with an improperly stored dose of PEDVAXHIB, lot # N022167, expiration date: 08-FEB-2020 (dose and route of administration were not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 47 to 77 degrees Fahrenheit for 5 hours. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1806USA001505: US-009507513-1806USA009026: US-009507513-1806USA009027: US-009507513-1806USA009028: US-009507513-1806USA009029: US-009507513-1806USA009031: US-009507513-1806USA009032: US-009507513-1806USA009033: US-009507513-1806USA009034: US-009507513-1806USA009035: US-009507513-1806USA009036: US-009507513-1806USA009037: US-009507513-1806USA009038: US-009507513-1806USA009039: US-009507513-1806USA009040: US-009507513-1806USA009041: US-009507513-1806USA009042: US-009507513-1806USA009043: US-009507513-1806USA009044: US-009507513-1806USA009045: US-009507513-1806USA009046: US-009507513-1806USA009047: US-009507513-1806USA009048: US-009507513-1806USA009049: US-009507513-1806USA009050: US-009507513-1806USA009051: US-009507513-1806USA009052: US-009507513-1806USA009053: US-009507513-1806USA009054: US-009507513-1806USA009055: US-009507513-1806USA009056.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 27-APR-2018, the patient was vaccinated with an improperly stored dose of LIQUID PEDVAXHIB, lot # N022167, expiration date: 08-FEB-2020 (dose and route of administration were not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 47 to 77 degrees Fahrenheit for 5 hours. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1806USA001505: US-009507513-1806USA009026: US-009507513-1806USA009027: US-009507513-1806USA009028: US-009507513-1806USA009029: US-009507513-1806USA009030: US-009507513-1806USA009032: US-009507513-1806USA009033: US-009507513-1806USA009034: US-009507513-1806USA009035: US-009507513-1806USA009036: US-009507513-1806USA009037: US-009507513-1806USA009038: US-009507513-1806USA009039: US-009507513-1806USA009040: US-009507513-1806USA009041: US-009507513-1806USA009042: US-009507513-1806USA009043: US-009507513-1806USA009044: US-009507513-1806USA009045: US-009507513-1806USA009046: US-009507513-1806USA009047: US-009507513-1806USA009048: US-009507513-1806USA009049: US-009507513-1806USA009050: US-009507513-1806USA009051: US-009507513-1806USA009052: US-009507513-1806USA009053: US-009507513-1806USA009054: US-009507513-1806USA009055: US-009507513-1806USA009056:
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 30-APR-2018, the patient was vaccinated with an improperly stored dose of PEDVAXHIB, lot # N022167, expiration date: 08-FEB-2020 (dose and route of administration were not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 47 to 77 degrees Fahrenheit for 5 hours. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1806USA001505: US-009507513-1806USA009026: US-009507513-1806USA009027: US-009507513-1806USA009028: US-009507513-1806USA009029:US-009507513-1806USA009030: US-009507513-1806USA009031: US-009507513-1806USA009033: US-009507513-1806USA009034: US-009507513-1806USA009035: US-009507513-1806USA009036: US-009507513-1806USA009037: US-009507513-1806USA009038: US-009507513-1806USA009039: US-009507513-1806USA009040: US-009507513-1806USA009041: US-009507513-1806USA009042: US-009507513-1806USA009043: US-009507513-1806USA009044: US-009507513-1806USA009045: US-009507513-1806USA009046: US-009507513-1806USA009047: US-009507513-1806USA009048: US-009507513-1806USA009049: US-009507513-1806USA009050: US-009507513-1806USA009051: US-009507513-1806USA009052: US-009507513-1806USA009053: US-009507513-1806USA009054: US-009507513-1806USA009055: US-009507513-1806USA009056.
Age: 64.0
Sex: M
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Initial information received on 17-Jun-2018 regarding an unsolicited valid non-serious case received from a Nurse. This case involves a 64-year-old male patient who received a dose of FLUZONE HIGH DOSE and he was not yet 65 years old. This is an actual medication error case due to inappropriate age at vaccine administration. No medical history was reported. No details of concomitant therapy were reported. On 16-Jan-2018, the patient received a dose of 0.5 ml FLUZONE HD (batch number: UI883AA, expiry date: 25-May-2018 route and site of administration not reported). Caller states that the patient indicated on his paperwork that he was 65 years old but he was actually only 64 at the time. Caller asking about safety/efficacy of the vaccine if given prior to age 65 and is also asking for reimbursement for the vaccine. It was not reported if the patient experienced any adverse event. Lab data and corrective treatment: not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Impaired work ability, Nausea
Clinical narrative: Chills, nausea, trouble going to work.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Injection site pain, Injection site swelling, Myalgia
Clinical narrative: Initial soreness and swelling at injection site, next day fatigue, nausea, headache, muscle pain.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea
Clinical narrative: Initial soreness and swelling at injection site, next day fatigue, nausea, headache, muscle pain.
Age: 61.0
Sex: M
Vaccine: PNC13, TDAP, VARZOS
Symptoms: Peripheral swelling, Swelling face
Clinical narrative: CAME IN 06/20/2018 8:30PM WITH A LITTLE SWELLING OF THE FACE AND SWELLING OF THE FEET. NOT SURE WHY HE WAITED SO LONG TO COME IN? I TOLD HIM TO GO HOME AND ELEVATE THE FEET AND I WOULD REEVALUATE HIM ON 06/21/2018.  HE HAS NOT SEEN THE DR FOR THIS YET.
Age: 17.0
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Bradycardia, Eye movement disorder, Nausea, Pallor, Tremor
Clinical narrative: After vaccines pt turned pale, felt nauseated, pt had eyes roll back into his head, both arms trembled and raised up and pt slumped over. Pt improved after lying down. Had brief bradycardia but normal BP and O2 sat throughout episode. Pt had frequent vital checks, and drank 16oz of Pedialyte with improvement in symptoms. Pt observed for 45 minutes.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Back pain, Dizziness, Nausea, Rash, Rash erythematous
Clinical narrative: Back pain, nausea, dizziness x 2-3 days. Followed by itchy, erythematous, maculopapular rash, confluent in areas, started on his chest spreading down abdomen to genitals up the neck, to the chin and started to erupt on the arms.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash maculo-papular, Rash pruritic
Clinical narrative: Back pain, nausea, dizziness x 2-3 days. Followed by itchy, erythematous, maculopapular rash, confluent in areas, started on his chest spreading down abdomen to genitals up the neck, to the chin and started to erupt on the arms.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Chills, Fatigue, Musculoskeletal pain, Neck pain
Clinical narrative: Fatigue. Neck, shoulder, back aches. Chills and fever.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Fatigue. Neck, shoulder, back aches. Chills and fever.
Age: 75.0
Sex: F
Vaccine: TDAP
Symptoms: Rash
Clinical narrative: Rash on arm of injection which spread to left side of body and right side.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Pain
Clinical narrative: Chills and aches.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Hypersomnia
Clinical narrative: The day after the shot he felt extreme fatigue. He said he required 1 week of sleep over the 2 days following the shot
Age: 65.0
Sex: M
Vaccine: PNC13
Symptoms: Blood test, Electromyogram, Fall, Gait inability, Guillain-Barre syndrome
Clinical narrative: Arms and hands affected on 4/30, legs the next day. Started falling and unable to walk, went to my Dr. and he diagnosed a herniated disc in cervical spine. Condition worsened and went to ER. They couldn't figure it out. Transported by ambulance next day to a different hospital and diagnosed with Guillain- Barre Syndrome. Treated with IV/IG for 5 days and started to improve. 12 days at hospital then 10 more in-patient rehab. Home now but still affected.
Age: 65.0
Sex: M
Vaccine: PNC13
Symptoms: Immunoglobulin therapy, Intervertebral disc protrusion, Lumbar puncture, Nuclear magnetic resonance imaging brain, Nuclear magnetic resonance imaging spinal
Clinical narrative: Arms and hands affected on 4/30, legs the next day. Started falling and unable to walk, went to my Dr. and he diagnosed a herniated disc in cervical spine. Condition worsened and went to ER. They couldn't figure it out. Transported by ambulance next day to a different hospital and diagnosed with Guillain- Barre Syndrome. Treated with IV/IG for 5 days and started to improve. 12 days at hospital then 10 more in-patient rehab. Home now but still affected.
Age: 0.83
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Febrile convulsion, Pyrexia
Clinical narrative: Patient with fever starting 6 hours vaccines and then at 4:00 with febrile seizure less than 5 min and fever documented in ED to 104. Fever gone after 36 hours. Normal exam with no other symptoms.
Age: 63.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: Patient experienced excrutiating pain in the right arm after receiving the flu shot. They were unable to raise their arm even after a month since receiving the shot. Patient is currently still seeking medical help.
Age: 33.0
Sex: F
Vaccine: RAB
Symptoms: Injection site erythema, Injection site oedema, Injection site pain, Injection site pruritus, Temperature regulation disorder
Clinical narrative: After 2nd rabies vaccination in R deltoid - pruritic, edematous area extending approximately 10 cm around anterior R arm, with some associated erythema, tenderness, poikilothermia.
Age: 2.0
Sex: F
Vaccine: DTAP
Symptoms: Erythema, Feeling hot, Induration, Swelling
Clinical narrative: Erythema, swelling, heat, firm.
Age: 11.0
Sex: F
Vaccine: DTAPIPV, HPV9, MNQ
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Was notified by administration that she should not have gotten a Quadracel, should have gotten her ADACEL for school. The immunization records that I looked at did not list a 4th IPV injection, so I administered the DTaP IPV Quadracel to bring her up to date. I did not realize that the school system will not accept this in place of an ADACEL so we called the parents and told them she needed to come back in and get her ADACEL to be able to start school on time, and that we would not charge her for this as it was our mistake. There were no reactions to the vaccines that were given, she just needed to get the ADACEL instead.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. During 2015, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 15-JUL-2015, the patient was treated by a physician for a vesicular outbreak which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX, for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 18-DEC-2009, the patient was inoculated with ZOSTAVAX at a clinic as recommended for routine adult health maintenance and for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster. On or about 11-FEB-2013, she was treated by a physician at the same clinic for a vesicular outbreak, which was diagnosed as shingles. The patient was prescribed acyclovir for management of her painful symptoms and chronic pain. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 25-NOV-2014, the patient was inoculated with the ZOSTAVAX vaccine as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain condition of herpes zoster. On or about 08-JUL-2016, she was treated at a physician office for a blistering vesicular outbreak, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Age: 26.0
Sex: U
Vaccine: MMRV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a physician assistant refers to a 26 year old patient of unknown gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 13-JUN-2018, the patient was inadvertently vaccinated with one dose of PROQUAD (strength and route of administration were unknown) with lot # R001541 and expiration date of 15-JUL-2019 for prophylaxis. No adverse effects were reported.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information has been received regarding the patient's past medical history, concurrent conditions, or concomitant medication. In 2015, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided), at a medical center/health care facility (by an unspecified healthcare professional) as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster. Later in 2015, the patient was treated (by an unspecified health care professional) at another medical center/hospital for a blistering vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The reporter considered the events to be related to ZOSTAVAX. The outcome of the events is unknown. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HEPA, TDAP
Symptoms: Haemoptysis
Clinical narrative: Coughing up blood.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Confusional state, Dizziness, Fall, Fatigue
Clinical narrative: 12 hours after vaccine administration: fatigue, chills/shivering, sweats followed by dizziness, falling x3, confusion in the middle of the night was oriented to person, place time per husband seen in the office at 3PM the following day, symptoms improved but not not completely resolved.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Hyperhidrosis
Clinical narrative: 12 hours after vaccine administration: fatigue, chills/shivering, sweats followed by dizziness, falling x3, confusion in the middle of the night was oriented to person, place time per husband seen in the office at 3PM the following day, symptoms improved but not not completely resolved.
Age: 85.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Son called reporting patients are was warm, red and swollen around injection site and down arm. No fever reported.
Age: 20.0
Sex: F
Vaccine: MENB
Symptoms: Discomfort, Headache, Insomnia, Mobility decreased, Pain in extremity
Clinical narrative: Patient went in for a sports physical. She received Bexsero. Within 5 hours had such severe arm pain she can not lift her arm. Can not function due to pain/no comfortable position. Pain continues even when resting and not moving. Vaccine also caused headache and fever of 100%. None of the symptoms have resolved 24 hours later. Pain was intolerable. Unable to sleep overnight. Not just mild pain and swelling, but extreme pain.
Age: 20.0
Sex: F
Vaccine: MENB
Symptoms: Pyrexia, Swelling
Clinical narrative: Patient went in for a sports physical. She received Bexsero. Within 5 hours had such severe arm pain she can not lift her arm. Can not function due to pain/no comfortable position. Pain continues even when resting and not moving. Vaccine also caused headache and fever of 100%. None of the symptoms have resolved 24 hours later. Pain was intolerable. Unable to sleep overnight. Not just mild pain and swelling, but extreme pain.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Haemoglobin decreased, Transfusion
Clinical narrative: Patient's hemoglobin dropped from 8 to 6. She was hospitalized from 6/14 to 6/18. As of 6/21 she stated that her hemoglobin is continuing to drop. She received two transfusions in the hospital.  She is not necessarily claiming that the vaccine caused this, but we decided to file a VAERS report.
Age: 17.0
Sex: M
Vaccine: HPV9, MENB, MNQ
Symptoms: Dizziness, Syncope
Clinical narrative: Patient fainted 5 minutes or longer after vaccine was administered. Patient was waiting in the hallway until sibling had vaccines completed and when entering the room he became lightheaded and fainted. Patient was assisted to the floor and was aware of surroundings and walked to another room with assistance at side. Patient remained in room for 15 additional minutes and was offered juice and crackers. Patient tolerated fluids and was able to sit up and ambulate on own. Patient was released and left with sibling and mother.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: Hives remained until Wednesday. After taking BENADRYL, MEDROL dosepak and applying BENADRYL cream, patient has recovered drastically but there are mild case of hives still remains.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, HEPA
Symptoms: Injection site urticaria
Clinical narrative: Hives on left thigh.
Age: 3.0
Sex: F
Vaccine: DTAPIPVHIB, HEPA, MMR, PNC13, VARCEL
Symptoms: Eye swelling, Injection site bruising, Injection site nodule
Clinical narrative: Mom reported the following; noticed swelling under eyes of child at approximately 1:45 pm today 6/21/2018, eyes are "half shut", daughter did not realize eyes were swollen, denied child having difficulty breathing, eating, talking, daughter is running and playing as usual. Mom reports that vaccination sites on right leg are slightly bruised and have small "knot" at site. No difficulties reported with left leg vaccination sites.  Mom denies daughter having any allergies, no insect or other bites, no different or usual foods.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Fatigue, Nausea, Rash
Clinical narrative: Weak, fatigue, nausea, large rash.
Age: 30.0
Sex: F
Vaccine: MMRV
Symptoms: Drug administered to patient of inappropriate age, Immunisation, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 30 year old female patient. The patient's concurrent conditions and medical history were not reported. Concomitant therapies included sterile diluent. On an unspecified date in May 2018 (reported as "last month"), the patient was vaccinated with a dose of PROQUAD (strength, dose, route of administration, lot number and expiration date were unknown) for prophylaxis to vaccinate to attend college. On 08-JUN-2018, the patient was revaccinated with M-M-R II with lot number N014635 and expiration date of 11-MAY-2019 (strength, dose and route of administration were unknown) and VARIVAX with lot number M032495 and expiration date of 06-JUL-2018. No adverse effects were reported.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information has been received regarding the patient's past medical history, concurrent conditions, or concomitant medication. In 2006 (date as reported), the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided), at a health care facility/office (by an unspecified healthcare professional) as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster. Later in 2016, the patient was treated (by an unspecified health care professional) at a health care facility/office for a severe vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The reporter considered the events to be related to ZOSTAVAX. The outcome of the events is unknown. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2014, the patient was inoculated with the ZOSTAVAX vaccine by a physician as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain condition of herpes zoster.  In 2015, she was treated by a physician for a blistering vesicular outbreak, which was diagnosed as herpes zoster, or shingles.  As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Erythema, Herpes zoster, Pain in extremity, Pruritus
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shingles in a 66-year-old male patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGLES VACCINE (received 4 years ago) and Pneumonia vaccine (received couple of years ago). Concomitant products included PNEUMOCOCCAL VACCINE and Aspirin (Baby). On 31st May 2018, the patient received the 1st dose of SHINGRIX. On 11th June 2018, 11 days after receiving SHINGRIX, the patient experienced shingles, skin swelling and blister. In June 2018, the patient experienced pain in arm, pruritus and erythema of extremities. On an unknown date, the outcome of the shingles, pruritus, skin swelling and blister were not recovered/not resolved and the outcome of the pain in arm and erythema of extremities were recovered/resolved. The reporter considered the shingles, pain in arm, pruritus, erythema of extremities, skin swelling and blister to be probably related to SHINGRIX. Additional details were provided as follows: The patient reported that he had the shingles vaccine four years ago but he could not recall the name of the vaccine. Concomitant product included Vitamin D. At 1:42 PM, the patient received SHINGRIX. The patient was experienced sore and red on his arm for three days later. The patient experienced a red circle the size of a baseball after injection with soreness that resolved after four days. This past weekend the patient experienced itchiness and this morning he had shingles. The patient claimed that on one side he had an inch long streak and then another streak that was about 4 to 5 inches in length with swelling and blisters on his right side of his body.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Skin swelling
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shingles in a 66-year-old male patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGLES VACCINE (received 4 years ago) and Pneumonia vaccine (received couple of years ago). Concomitant products included PNEUMOCOCCAL VACCINE and Aspirin (Baby). On 31st May 2018, the patient received the 1st dose of SHINGRIX. On 11th June 2018, 11 days after receiving SHINGRIX, the patient experienced shingles, skin swelling and blister. In June 2018, the patient experienced pain in arm, pruritus and erythema of extremities. On an unknown date, the outcome of the shingles, pruritus, skin swelling and blister were not recovered/not resolved and the outcome of the pain in arm and erythema of extremities were recovered/resolved. The reporter considered the shingles, pain in arm, pruritus, erythema of extremities, skin swelling and blister to be probably related to SHINGRIX. Additional details were provided as follows: The patient reported that he had the shingles vaccine four years ago but he could not recall the name of the vaccine. Concomitant product included Vitamin D. At 1:42 PM, the patient received SHINGRIX. The patient was experienced sore and red on his arm for three days later. The patient experienced a red circle the size of a baseball after injection with soreness that resolved after four days. This past weekend the patient experienced itchiness and this morning he had shingles. The patient claimed that on one side he had an inch long streak and then another streak that was about 4 to 5 inches in length with swelling and blisters on his right side of his body.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Dizziness, Oropharyngeal pain, Pain, Pyrexia
Clinical narrative: This case was reported by a consumer via out of hour services and described the occurrence of pain in a 71-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included shingles (developed shingles in December of 2017). Previously administered products included ZOSTAVAX, Swine flu shot (received in 1976), Chemotherapy and flu shots. On 4th June 2018, the patient received the 1st dose of SHINGRIX .5 ml. On 4th June 2018, less than a day after receiving SHINGRIX, the patient experienced pain. On 7th June 2018, the patient experienced chills and fever. On 8th June 2018, the patient experienced light headedness. On 9th June 2018, the patient experienced sore throat. On an unknown date, the outcome of the pain was recovered/resolved and the outcome of the light headedness and fever were unknown and the outcome of the sore throat and chills were recovering/resolving. The reporter considered the pain to be related to SHINGRIX. It was unknown if the reporter considered the light headedness, sore throat, chills and fever to be related to SHINGRIX. Additional details were provided as follows: The patient stated that, she had another shingles shot years before the date of reporting and developed shingles in December of 2017. On 4th June 2018 Monday, at 14:09 the patient received SHINGRIX. The patient experienced a sharp pain above her elbow while driving home. On 5th June 2018, Tuesday, the patient was fine. On 6th June 2018, Wednesday, 2 days after vaccination, the patient woke up in the morning with some soreness. On 7th June 2018, Thursday, 3 days after vaccination, in evening the patient had some chills but she did not feel sick and at first thought her air conditioning was too low but then developed a fever of 101.5, her temperature usually runs around 97.4. On 8th June 2018, Friday, 4 days after vaccination, the patient started to experience some lightheadedness. On 9th June 2018, Saturday, 5 days after vaccination, one side of the patient's throat was sore. She said when she first woke up, her temperature was normal but then it was spiked later in the day. The patient did not have a fever so far on the reporting date. The patient was not sure if she wanted to provide the name of her physician so a letter should be sent to her. Lab Comments: The patient's body temperature usually runs around 97.4.
Age: 22.0
Sex: F
Vaccine: MENB, TTOX
Symptoms: Injection site pain, Injection site swelling, Mycobacterium tuberculosis complex test, Nodule, Pyrexia
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of fever in a 22-year-old female patient who received BEXSERO for prophylaxis. Concurrent medical conditions included menorrhagia. Concomitant products included TETANUS TOXOID and OCELLA. On 5th June 2018, the patient received the 1st dose of BEXSERO (intramuscular). On 5th June 2018, less than a day after receiving BEXSERO, the patient experienced injection site tenderness. On 6th June 2018, the patient experienced fever. On 7th June 2018, the patient experienced nodule on extremity, injection site swelling and skin eruption. In June 2018, the outcome of the fever and injection site swelling were recovered/resolved and the outcome of the injection site tenderness was recovering/resolving. On an unknown date, the outcome of the nodule on extremity and skin eruption were not recovered/not resolved. It was unknown if the reporter considered the fever, nodule on extremity, injection site tenderness, injection site swelling and skin eruption to be related to BEXSERO. Additional information was received as follows: The patient also received Tetanus booster (unknown manufacturer) on the same day of vaccination on the left arm but above the injection site for BEXSERO. The patient also received Purified protein derivative (PPD) injection to test for TB on her forearm. The patient's mother reported that the patient received BEXSERO the Tuesday before the day of reporting and experienced a low grade fever the next day. The reporter reported that 48 hours after administration of BEXSERO, the patient experienced swelling on left arm around the injection site that lasted for approximately 48 hours. After 48 hours of receiving BEXSERO, the patient had two nodules on her left arm, distal to the injection site, that was erupted and then the patient had a new nodule that erupted a day before reporting day. On the same day of vaccination, the patient experienced tenderness on her left arm around the injection site. The patient has denied permission to contact their physician. The reporter stated that they do not intend to give the next dose in the series due to the adverse event experienced after dose 1. The caller stated that this patient's twin received the same series of vaccines on the same day and did not experience the same reaction (refer case US2018104366).
Age: 22.0
Sex: F
Vaccine: MENB, TTOX
Symptoms: Rash
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of fever in a 22-year-old female patient who received BEXSERO for prophylaxis. Concurrent medical conditions included menorrhagia. Concomitant products included TETANUS TOXOID and OCELLA. On 5th June 2018, the patient received the 1st dose of BEXSERO (intramuscular). On 5th June 2018, less than a day after receiving BEXSERO, the patient experienced injection site tenderness. On 6th June 2018, the patient experienced fever. On 7th June 2018, the patient experienced nodule on extremity, injection site swelling and skin eruption. In June 2018, the outcome of the fever and injection site swelling were recovered/resolved and the outcome of the injection site tenderness was recovering/resolving. On an unknown date, the outcome of the nodule on extremity and skin eruption were not recovered/not resolved. It was unknown if the reporter considered the fever, nodule on extremity, injection site tenderness, injection site swelling and skin eruption to be related to BEXSERO. Additional information was received as follows: The patient also received Tetanus booster (unknown manufacturer) on the same day of vaccination on the left arm but above the injection site for BEXSERO. The patient also received Purified protein derivative (PPD) injection to test for TB on her forearm. The patient's mother reported that the patient received BEXSERO the Tuesday before the day of reporting and experienced a low grade fever the next day. The reporter reported that 48 hours after administration of BEXSERO, the patient experienced swelling on left arm around the injection site that lasted for approximately 48 hours. After 48 hours of receiving BEXSERO, the patient had two nodules on her left arm, distal to the injection site, that was erupted and then the patient had a new nodule that erupted a day before reporting day. On the same day of vaccination, the patient experienced tenderness on her left arm around the injection site. The patient has denied permission to contact their physician. The reporter stated that they do not intend to give the next dose in the series due to the adverse event experienced after dose 1. The caller stated that this patient's twin received the same series of vaccines on the same day and did not experience the same reaction (refer case US2018104366).
Age: 22.0
Sex: F
Vaccine: MENB, TTOX
Symptoms: Injection site pain, Mycobacterium tuberculosis complex test, Pyrexia
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of fever in a 22-year-old female patient who received BEXSERO for prophylaxis. Concurrent medical conditions included heavy periods. Concomitant products included Tetanus Booster. On 5th June 2018, the patient received the 1st dose of BEXSERO (intramuscular). On 5th June 2018, less than a day after receiving BEXSERO, the patient experienced injection site tenderness. On 6th June 2018, the patient experienced fever. In June 2018, the outcome of the fever was recovered/resolved. On an unknown date, the outcome of the injection site tenderness was recovering/resolving. It was unknown if the reporter considered the fever and injection site tenderness to be related to BEXSERO. Additional information was received as follows: The patient also received Tetanus booster (unknown manufacturer) on the same day of vaccination on the left arm but above the injection site for BEXSERO. The patient also received Purified protein derivative (PPD) injection to test for TB on her forearm. The patient's mother reported that the patient received BEXSERO the Tuesday before the day of reporting and experienced a low grade fever the next day. On the same day of vaccination, the patient experienced tenderness on her arm around the injection site. The patient also received Tetanus booster (unknown manufacturer) on the same day of vaccination on the same arm but above the injection site for BEXSERO. The patient also received PPD injection to test for TB on her forearm. The reporter did not wanted to give the next dose in the series due to the adverse event experienced after 1st dose. The patient had denied permission to contact their physician. The call center representative states that patient were twin, received the same series of vaccines on the same day and did not experience the same reaction. The reporter could not provide all details for this report. The patient has denied permission to contact their physician. The reporter stated that they do not intend to give the next dose in the series due to the adverse event experienced after dose 1. The caller stated that this patient's twin received the same series of vaccines on the same day and did not experience the same reaction (refer case US2018104364). Lab Comments: The patient received Purified protein derivative (PPD) injection to test for TB on her forearm.
Sex: F
Vaccine: FLU4
Symptoms: Injection site reaction
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of injection site reaction in a adult female patient who received Influenza vaccine Quadrivalent for prophylaxis. On an unknown date, the patient received Influenza vaccine Quadrivalent. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent, the patient experienced injection site reaction. On an unknown date, the outcome of the injection site reaction was unknown. It was unknown if the reporter considered the injection site reaction to be related to Influenza vaccine Quadrivalent. Additional details were provided as follows: The caller was the patient's mother. The age at vaccination was not reported. The caller stated that the patient experienced an injection site reaction following the flu vaccine (unknown manufacturer) two years ago before the time of reporting. The reporter did not have time to provide any additional information regarding this event during the call. The patient had denied permission to contact their physician.
Age: 71.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Pruritus, Rash
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shingles in a 71-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included shingles (previous diagnosis of shingles in August 2017). Previously administered products included ZOSTAVAX (previous ZOSTAVAX vaccination prior to August 2017). On 6th June 2018, the patient received the 1st dose of SHINGRIX .5 ml. On 9th June 2018, 3 days after receiving SHINGRIX, the patient experienced shingles and rash. In June 2018, the patient experienced pruritus. The patient was treated with acyclovir. On an unknown date, the outcome of the shingles, rash and pruritus were recovering/resolving. It was unknown if the reporter considered the shingles, rash and pruritus to be related to SHINGRIX. Additional details were provided as follows: Less than a week after receiving vaccination, the patient had an itchy back that she was told was shingles. This itching started several days prior to 9th June 2018, but the patient unsure when exactly that started. On 9th June 2018, Shingles rash was visible to the patient and then she went to the emergency room, where she was diagnosed with shingles and given 800 mg of acyclovir, then started on 400 mg of acyclovir three times a day for 30 days as treatment. The patient stated her PA told her this was due to the SHINGRIX vaccine, while her pharmacist disagreed, and stated this could not be from the SHINGRIX and it was not a live vaccine. The patient did not provide full demographics for herself or the pharmacy where the injection was given. The patient did not wish to participate in answering the questions within this report. No further adverse event information was provided.
Age: 71.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Musculoskeletal pain, Neck pain, Pruritus, Rash
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shingles in a 71-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included shingles (previous diagnosis of shingles in August 2017). Previously administered products included ZOSTAVAX (previous ZOSTAVAX vaccination prior to August 2017). On 6th June 2018, the patient received the 1st dose of SHINGRIX .5 ml. On 9th June 2018, 3 days after receiving SHINGRIX, the patient experienced shingles and rash. In June 2018, the patient experienced pruritus. The patient was treated with acyclovir. On an unknown date, the outcome of the shingles, rash and pruritus were recovering/resolving. It was unknown if the reporter considered the shingles, rash and pruritus to be related to SHINGRIX. Additional details were provided as follows: Less than a week after receiving vaccination, the patient had an itchy back that she was told was shingles. This itching started several days prior to 9th June 2018, but the patient unsure when exactly that started. On 9th June 2018, Shingles rash was visible to the patient and then she went to the emergency room, where she was diagnosed with shingles and given 800 mg of acyclovir, then started on 400 mg of acyclovir three times a day for 30 days as treatment. The patient stated her PA told her this was due to the SHINGRIX vaccine, while her pharmacist disagreed, and stated this could not be from the SHINGRIX and it was not a live vaccine. The patient did not provide full demographics for herself or the pharmacy where the injection was given. The patient did not wish to participate in answering the questions within this report. No further adverse event information was provided.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Rash
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of blister in a 70-year-old female patient who received SHINGRIX (batch number ML532, expiry date 13th July 2020) for prophylaxis. On 16th May 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 17th May 2018, 1 days after receiving SHINGRIX, the patient experienced blister. On an unknown date, the patient experienced rash. On an unknown date, the outcome of the blister was unchanged and the outcome of the rash was not recovered/not resolved. It was unknown if the reporter considered the blister and rash to be related to SHINGRIX. Additional information was reported as follows: The patient received SHINGRIX on the left arm. The next day after receiving SHINGRIX, the patient had water filled blisters on her belly, she did not think it was shingles. The rash came and went but was not resolved till the date of reporting.