chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 86.0
Sex: F
Vaccine: VARZOS
Symptoms: Inflammation, Injection site erythema, Injection site inflammation, Injection site pruritus
Clinical narrative: Day after immunization her arm became red and itchy at the injection site. The area of inflammation grew to about a 8" circle and continued to itch. No treatment was required. Patient came into the pharmacy on 4/27 and the redness and itching is subsiding.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: 6 cm x 7 cm area of redness and swelling at injection site. Painful to touch. Began within 24 hours of injection. Saw provider 3 days after injection.
Age: 1.25
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Gait disturbance, Injection site cellulitis, Injection site erythema, Injection site mass, Injection site swelling
Clinical narrative: Swelling and redness at site of DTaP and HIB vaccine that occurred the night after getting vaccines. Patient went to ED next day because of worsening redness and adx with cellulitis and started on BACTRIM. Mom states area has improved. Patient is ambulating well with no issues. Did have 101 fever Tuesday night and 102 fever 24 hrs ago, but no other fevers. Mom states redness had spread to almost entire thigh, but not beyond knee and hip joints. APPEARS TO BE LOCALIZED REACTION TO DTAP VACCINE, NOT ALLERGIC REACTION. REDNESS AND MASS HAS DECREASED, PER MOTHER. ED DX WITH CELLULITIS, WHICH IS POSSIBLE, BUT NOT PROBABLE. TOLD MOM TO CONTINUE ANTIBIOTIC THAT WAS RX'D AND REASSURED THAT REDNESS SHOULD CONTINUE TO IMPROVE. TOLD HER THAT CYSTIC MASS SHOULD ALSO IMPROVE, BUT MORE SLOWLY AND MAY TAKE WEEKS TO MONTHS TO COMPLETELY RESOLVE. RTC FOR WORSENING, PERSISTENT FEVER, REFUSAL TO WALK. WILL REPORT REACTION TO VAERS.
Age: 1.25
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Local reaction, Pyrexia
Clinical narrative: Swelling and redness at site of DTaP and HIB vaccine that occurred the night after getting vaccines. Patient went to ED next day because of worsening redness and adx with cellulitis and started on BACTRIM. Mom states area has improved. Patient is ambulating well with no issues. Did have 101 fever Tuesday night and 102 fever 24 hrs ago, but no other fevers. Mom states redness had spread to almost entire thigh, but not beyond knee and hip joints. APPEARS TO BE LOCALIZED REACTION TO DTAP VACCINE, NOT ALLERGIC REACTION. REDNESS AND MASS HAS DECREASED, PER MOTHER. ED DX WITH CELLULITIS, WHICH IS POSSIBLE, BUT NOT PROBABLE. TOLD MOM TO CONTINUE ANTIBIOTIC THAT WAS RX'D AND REASSURED THAT REDNESS SHOULD CONTINUE TO IMPROVE. TOLD HER THAT CYSTIC MASS SHOULD ALSO IMPROVE, BUT MORE SLOWLY AND MAY TAKE WEEKS TO MONTHS TO COMPLETELY RESOLVE. RTC FOR WORSENING, PERSISTENT FEVER, REFUSAL TO WALK. WILL REPORT REACTION TO VAERS.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site erythema, Injection site swelling
Clinical narrative: Patient stated that she experienced redness and swelling at the site of injection and also a headache and possible fever (patient did not measure temperature). Patient sought prescriber assistance. Prescriber referred patient to the pharmacy. I counseled the patient that these are not unusual side effects of the vaccination. I also instructed the patient to take some TYLENOL for the pain, fever, and call us if the adverse symptoms do not improve or worsen. Patient stated understanding and was satisfied with the counseling received. Patient also stated that there was some improvement in the adverse reaction from yesterday 4/26/18 to today 4/27/18.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Cold sweat, Decreased appetite, Dyspnoea, Fatigue, Headache
Clinical narrative: Arm pain, extreme fatigue - sleeping, sweating/clammy, headache, nausea, loss of appetite, mild shortness of breath upon exertion like climbing stairs.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Hyperhidrosis, Nausea, Pain in extremity
Clinical narrative: Arm pain, extreme fatigue - sleeping, sweating/clammy, headache, nausea, loss of appetite, mild shortness of breath upon exertion like climbing stairs.
Age: 64.0
Sex: M
Vaccine: FLU4
Symptoms: Coma, Guillain-Barre syndrome
Clinical narrative: Patient was unable to get out of bed for three days, reports being comatose, similar to Guillain Barre reaction.
Age: 49.0
Sex: F
Vaccine: TDAP
Symptoms: Dizziness, Fatigue, Nausea
Clinical narrative: Patient received the Tdap vaccine this morning and called us this afternoon reporting that upon driving home, she began feeling nauseous, lightheaded and tired. It has continued throughout the day today. This is the second report from a patient of these exact symptoms after receiving a Tdap vaccine within the last week. Reassured Patient that although these side effects are not common, they are not unheard of and could be a result of receiving the vaccine. Informed her that we have reported the adverse reaction and to rest and push fluids.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Burning sensation, Rash erythematous
Clinical narrative: Patient developed a red, burning rash on head around temple area and over head.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Hypersensitivity, Pain in extremity, Rash
Clinical narrative: Patient developed a red, burning rash on head around temple area and over head.
Age: 53.0
Sex: F
Vaccine: UNK
Symptoms: Loss of personal independence in daily activities, Mobility decreased, Pain, Pain in extremity, Sleep disorder
Clinical narrative: From the day of the shot there was some soreness that I thought was normal. However, within a few days the pain had progressed into shooting pain down my arm with pulsating pain when at rest. At two weeks the pain had progressed and was causing me to wake up at night and causing me difficulty in turning over. The pain has increased over the last three months. When at rest it still hurts and during the night I often have to lift the sore arm with my other hand in order to turn over to my other side.  The pain experience is much worse when I cross my arm over my body or when lifting out to the side making it difficult to perform normal lifting task at work.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Patient had a warm red area where shot was given. She went to MD and they gave her an antibiotic.
Age: 8.0
Sex: F
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a licensed practiced nurse refers to a 8 year old female patient. The patient's concurrent conditions, medical history, drug reactions and allergies were not reported. Concomitant therapies included sterile diluent (MRK INJ). On 10-APR-2018, the patient was vaccinated with improperly stored PROQUAD (dose, units and frequency not reported) (lot # N023969 and expiration date: 28-FEB-2018) subcutaneously at the temperature from -14 degree Celsius (C) to -10 C (-14 C) for 1 hour. There was no previous temperature excursion. Digital data logger was involved. No adverse effects were reported. No product quality complaint was involved. This is one of the report received from the same reporter. Sender's Comments: US-009507513-1804USA006162: US-009507513-1804USA006161.
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a licensed practiced nurse refers to a 4 year old female patient. The patient's concurrent conditions, medical history, drug reactions and allergies were not reported. Concomitant therapies included sterile diluent. On 10-APR-2018, the patient was vaccinated with improperly stored PROQUAD (dose, units and frequency not reported) (lot # N023969 and expiration date: 28-FEB-2018) subcutaneously at the temperature from -14 degree Celsius (C) to -10 C (-14 C) for 1 hour. There was no previous temperature excursion. Digital data logger was involved. No adverse effects were reported. No product quality complaint was involved. This is one of the report received from the same reporter. Sender's Comments: US-009507513-1804USA005654: US-009507513-1804USA006162.
Age: 1.5
Sex: F
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a licensed practiced nurse refers to a 18 months old female patient. The patient's concurrent conditions, medical history, drug reactions and allergies were not reported. Concomitant therapies included sterile diluent (MRK). On 10-APR-2018, the patient was vaccinated with improperly stored PROQUAD (dose, units and frequency not reported) (lot # N023969 and expiration date: 28-FEB-2018) subcutaneously at the temperature from -14 degree Celsius (C) to -10 C (-14 C) for 1 hour. There was no previous temperature excursion. Digital data logger was involved. No adverse effects were reported. No product quality complaint was involved. This is one of the report received from the same reporter. Sender's Comments: US-009507513-1804USA005654: US-009507513-1804USA006161.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site pruritus
Clinical narrative: This is a spontaneous report from a contactable Nurse, reporting for herself. This 65-year-old female patient received PREVNAR 13 Lot Number: T85621 Expiry date: 31Mar2020, intramuscular in right deltoid on 02Feb2018 14:30 PM at single dose for immunisation. Medical history included breast cancer from Jun2016 to an unknown date, diabetes mellitus from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient experienced itch at the injection site. There is no redness or swelling, but it itches every day from 16Feb2018 and worsened. The outcome was not recovered.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Feeling abnormal, Injection site hypersensitivity, Injection site reaction, Injection site swelling
Clinical narrative: The patient started to experience a low grade fever, joint pain, and nausea starting the morning after receiving the vaccination. The low grade fever was around 99 degrees and ended the evening of the 26th. The joint pain and nausea is still continuing as of the 27th. She also stated that her arm is red and swollen around the injection site. In addition to these she experienced feeling disconnected in a manner similar to a light switch flicking on and off. She said she feels something similar when withdrawing from her venlafaxine (she stated that she is still taking the venlafaxine daily, so it is not from actual withdrawal). She went to the doctors on the morning of the 27th and was told to take some BENADRYL for the allergic reaction on her arm and to take TYLENOL or Ibuprofen for the joint pain whichever she preferred.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pyrexia
Clinical narrative: The patient started to experience a low grade fever, joint pain, and nausea starting the morning after receiving the vaccination. The low grade fever was around 99 degrees and ended the evening of the 26th. The joint pain and nausea is still continuing as of the 27th. She also stated that her arm is red and swollen around the injection site. In addition to these she experienced feeling disconnected in a manner similar to a light switch flicking on and off. She said she feels something similar when withdrawing from her venlafaxine (she stated that she is still taking the venlafaxine daily, so it is not from actual withdrawal). She went to the doctors on the morning of the 27th and was told to take some BENADRYL for the allergic reaction on her arm and to take TYLENOL or Ibuprofen for the joint pain whichever she preferred.
Age: 32.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Injection site erythema, Injection site induration, Injection site mass, Injection site swelling
Clinical narrative: Occupational health nurse at patient's worksite (hospital) called to report patient's right arm had two hard red lumps about halfway down the upper arm at the site of the varicella injection. The site of the injection is the smaller reddened raised hard area that looks to be approximately 1 inch in diameter, with a 21/2 inch diameter area adjacent to it. Patient told the Occupation Nurse that her entire arm was red and swollen yesterday and that it is better today with just the two noted areas of redness.
Age: 32.0
Sex: F
Vaccine: VARCEL
Symptoms: Peripheral swelling
Clinical narrative: Occupational health nurse at patient's worksite (hospital) called to report patient's right arm had two hard red lumps about halfway down the upper arm at the site of the varicella injection. The site of the injection is the smaller reddened raised hard area that looks to be approximately 1 inch in diameter, with a 21/2 inch diameter area adjacent to it. Patient told the Occupation Nurse that her entire arm was red and swollen yesterday and that it is better today with just the two noted areas of redness.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain, Pyrexia, Rash, Rash generalised, Rash pruritic
Clinical narrative: Initially, as expected - mild fever, soreness. Then developed diffuse rash over body - none on face. Slightly raised and intermittently pruritic. Concentrated to arms and lower legs. Plan: Monitoring.
Age: 55.0
Sex: M
Vaccine: HEPA, VARZOS
Symptoms: Chills, Disorientation, Gait disturbance, Headache, Injection site pain
Clinical narrative: After receiving vaccine (4/24/18) for HAVRIX and SHINGRIX pt reports being disoriented for almost 2 days. Around 9PM after vaccine was given patient developed sudden chills, intense nausea, intense headache, teeth chattering, and disorientation. Reports being unable to sleep and violently tossing and turning. Reports being so disoriented that he lost 2 days of time. Unable to brush teeth or do normal daily activities of living. He reports that he was so disoriented he had trouble walking. Reports that wife said he had a fever, but cannot recall what the number was. Today (4/27) pt reports waking up and feeling fine. Did not seek outside treatment and feels fine now, however did have some arm pain and feeling of warmth at injection site today.
Age: 55.0
Sex: M
Vaccine: HEPA, VARZOS
Symptoms: Injection site warmth, Insomnia, Loss of personal independence in daily activities, Nausea, Poor quality sleep
Clinical narrative: After receiving vaccine (4/24/18) for HAVRIX and SHINGRIX pt reports being disoriented for almost 2 days. Around 9PM after vaccine was given patient developed sudden chills, intense nausea, intense headache, teeth chattering, and disorientation. Reports being unable to sleep and violently tossing and turning. Reports being so disoriented that he lost 2 days of time. Unable to brush teeth or do normal daily activities of living. He reports that he was so disoriented he had trouble walking. Reports that wife said he had a fever, but cannot recall what the number was. Today (4/27) pt reports waking up and feeling fine. Did not seek outside treatment and feels fine now, however did have some arm pain and feeling of warmth at injection site today.
Age: 55.0
Sex: M
Vaccine: HEPA, VARZOS
Symptoms: Pyrexia
Clinical narrative: After receiving vaccine (4/24/18) for HAVRIX and SHINGRIX pt reports being disoriented for almost 2 days. Around 9PM after vaccine was given patient developed sudden chills, intense nausea, intense headache, teeth chattering, and disorientation. Reports being unable to sleep and violently tossing and turning. Reports being so disoriented that he lost 2 days of time. Unable to brush teeth or do normal daily activities of living. He reports that he was so disoriented he had trouble walking. Reports that wife said he had a fever, but cannot recall what the number was. Today (4/27) pt reports waking up and feeling fine. Did not seek outside treatment and feels fine now, however did have some arm pain and feeling of warmth at injection site today.
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site pain, Injection site swelling, Injection site warmth, Mobility decreased, Myalgia
Clinical narrative: 03-13-2018: Left arm pain, swelling, hot injection site, muscle pain and limited mobility shoulder to elbow, left arm, 03-13-2018: MOTRIN, ice and heat 03-14-2018: Same as above and vomiting. 03-14-2018: Appointment with MD.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Pt had immunization on 4/25/18 and had a rash on same arm on 4/27/18.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Depression, Discomfort, Dizziness
Clinical narrative: Uncontrollable chills and fever for almost 24 hours. Dizzy and lightheaded. Weak, tired hurt all over.  Leg and feet cramps. Was afraid to be alone...I was feeling very depressed and just didn't want to be alone. I got the shot the shot in the morning and by 7:30 PM my problems started. 2 days later I am feeling 85% better but still not comfortable. I know that you have the side effects listed, but it is still very scary when you do not have other health issues. I did reach out to my dr. I will NOT be taking the 2nd shot. This reaction is very scary and to be honest not worth it to me.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Feeling abnormal, Muscle spasms, Pain, Pyrexia
Clinical narrative: Uncontrollable chills and fever for almost 24 hours. Dizzy and lightheaded. Weak, tired hurt all over.  Leg and feet cramps. Was afraid to be alone...I was feeling very depressed and just didn't want to be alone. I got the shot the shot in the morning and by 7:30 PM my problems started. 2 days later I am feeling 85% better but still not comfortable. I know that you have the side effects listed, but it is still very scary when you do not have other health issues. I did reach out to my dr. I will NOT be taking the 2nd shot. This reaction is very scary and to be honest not worth it to me.
Age: 61.0
Sex: M
Vaccine: PPV
Symptoms: Mobility decreased, Myalgia, Pain in extremity, Pyrexia, Rash erythematous
Clinical narrative: Patient developed fever with a MAXIMUM TEMPERATURE of 102 approximately 5 hours after immunization was given. Along with this he had soreness of the arm, difficulty moving the arm for 2 days, myalgias, and red rash distal to the injection site. Fever did abate 2 days after injection. He was examined in the office 3 days after the injection with ongoing presence of warmth and rash circumferentially distal to the injection site of the right arm. There were no symptoms of anaphylaxis.
Age: 61.0
Sex: M
Vaccine: PPV
Symptoms: Skin warm
Clinical narrative: Patient developed fever with a MAXIMUM TEMPERATURE of 102 approximately 5 hours after immunization was given. Along with this he had soreness of the arm, difficulty moving the arm for 2 days, myalgias, and red rash distal to the injection site. Fever did abate 2 days after injection. He was examined in the office 3 days after the injection with ongoing presence of warmth and rash circumferentially distal to the injection site of the right arm. There were no symptoms of anaphylaxis.
Age: 24.0
Sex: F
Vaccine: HEPA
Symptoms: Immediate post-injection reaction, Injection site pruritus, Injection site rash
Clinical narrative: Immediate rash appeared around injection site, and some itching was reported. The patient took Benadryl after she got home, and when I checked on her at 5pm, she said it was "much better".
Age: 73.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Mobility decreased, Myalgia
Clinical narrative: Patient has been experiencing constant muscle pain in the left arm for the last 7 days since vaccination was received. Pt has stated she has trouble moving arm backwards. Will be seeking or scheduling appointment with her doctor.
Age: 73.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Injection site swelling, Myalgia, Pain, Pain in extremity
Clinical narrative: Patient has been experiencing constant muscle pain in the left arm for the last 7 days since vaccination was received. Pt has stated she has trouble moving arm backwards. Will be seeking or scheduling appointment with her doctor.
Age: 73.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Blood creatine phosphokinase, C-reactive protein, Differential white blood cell count, Full blood count, Impaired work ability
Clinical narrative: Patient has been experiencing constant muscle pain in the left arm for the last 7 days since vaccination was received. Pt has stated she has trouble moving arm backwards. Will be seeking or scheduling appointment with her doctor.
Age: 73.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Injected limb mobility decreased, Loss of personal independence in daily activities, Musculoskeletal pain, Neck pain, Pain in extremity
Clinical narrative: Patient has been experiencing constant muscle pain in the left arm for the last 7 days since vaccination was received. Pt has stated she has trouble moving arm backwards. Will be seeking or scheduling appointment with her doctor.
Age: 73.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Red blood cell sedimentation rate, X-ray limb
Clinical narrative: Patient has been experiencing constant muscle pain in the left arm for the last 7 days since vaccination was received. Pt has stated she has trouble moving arm backwards. Will be seeking or scheduling appointment with her doctor.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Rash occurred 2 days after injection on the same arm that was vaccinated.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient has redness and swelling from his deltoid to elbow area. Started with just redness to deltoid area on 4/26/18 and spread to elbow area by 4/27/218. Patient to use warm and cold compress on and off and administer TYLENOL as needed for pain. Provider ordered antibiotics for patient. Patient to return on Monday 4/30/18.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea
Clinical narrative: Patient started having severe diarrhea on Sunday, April 22 after receiving the first SHINGRIX vaccination on April 20th. The diarrhea lasted for 2 days before the patient decided to go to the ER. There she was given LOMOTIL to stop the diarrhea. She started feeling better on the Wednesday following the vaccination.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient started having redness by the next day and it slowly increased in size and became a raised spot on the arm where the vaccine was given. The spot is warm to the touch.
Age: 2.0
Sex: F
Vaccine: DTAP, HEPA, HIBV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Redness, swelling and warm around injection site, for a few days.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Injection site pain, Nausea, Pain
Clinical narrative: Developed fever, chills and body aches, which peaked at 101.3° by the following morning. Severe headache. Nausea, no eating for over 24 hours. Symptoms began to resolve at about 5 PM the following day with resolution at 6:30 PM on April 27, 2018. Muscle soreness at site of injection. Symptoms managed with aspirin.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Developed fever, chills and body aches, which peaked at 101.3° by the following morning. Severe headache. Nausea, no eating for over 24 hours. Symptoms began to resolve at about 5 PM the following day with resolution at 6:30 PM on April 27, 2018. Muscle soreness at site of injection. Symptoms managed with aspirin.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Asthenia, Feeling hot, Influenza like illness, Injection site pain, Peripheral swelling
Clinical narrative: I never experienced any reaction to flu shots or any other immunizations, but after the PPSV23 shot was given on April 24th, 2018, at 2:30pm, I noticed symptoms developing about 2 or 3 hours after the injection, I developed flu-like symptoms and pain in the right arm where the shot was given. For 3 days now, I have taken 800mg of Ibuprofen and 1000mg of acetaminophen for the pain and fever. Also, ice packs every few hours for the heat/swelling in my arm. Today/Friday April 27th, I am feeling a little better, but still have a little weakness and reduced amount of pain in the right arm at injection site. I have thought of going to the ER, but my symptoms have improved so I have not gone.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: I never experienced any reaction to flu shots or any other immunizations, but after the PPSV23 shot was given on April 24th, 2018, at 2:30pm, I noticed symptoms developing about 2 or 3 hours after the injection, I developed flu-like symptoms and pain in the right arm where the shot was given. For 3 days now, I have taken 800mg of Ibuprofen and 1000mg of acetaminophen for the pain and fever. Also, ice packs every few hours for the heat/swelling in my arm. Today/Friday April 27th, I am feeling a little better, but still have a little weakness and reduced amount of pain in the right arm at injection site. I have thought of going to the ER, but my symptoms have improved so I have not gone.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Nausea, Pain, Peripheral swelling, Pyrexia
Clinical narrative: The patient received the vaccination at 2:30 pm on Tues 4/24/2018. About 24 hours later the patient experienced red swelling in the arm from the shoulder down to the elbow, nausea, vomiting, low grade fever and body aches. The red swelling lesion was described as one long continuous patch, raised and swollen, tender like a bee sting bite. The nausea, vomiting, aches, and fever subsided within 48 hours but the red lesion remains.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin lesion, Tenderness, Vomiting
Clinical narrative: The patient received the vaccination at 2:30 pm on Tues 4/24/2018. About 24 hours later the patient experienced red swelling in the arm from the shoulder down to the elbow, nausea, vomiting, low grade fever and body aches. The red swelling lesion was described as one long continuous patch, raised and swollen, tender like a bee sting bite. The nausea, vomiting, aches, and fever subsided within 48 hours but the red lesion remains.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Fatigue, Injection site pain, Malaise, Nausea
Clinical narrative: Site of injection was sore for 4 days; day after injection (4/19/18) had malaise, fatigue, lightheaded, nausea, scintillating scotoma. On 5th day, 4/23/18, experienced another episode of scintillating scotoma. At the height of GCA last year (2017) I had several episodes of scintillating scotoma prior to treatment.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Scintillating scotoma
Clinical narrative: Site of injection was sore for 4 days; day after injection (4/19/18) had malaise, fatigue, lightheaded, nausea, scintillating scotoma. On 5th day, 4/23/18, experienced another episode of scintillating scotoma. At the height of GCA last year (2017) I had several episodes of scintillating scotoma prior to treatment.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Swelling
Clinical narrative: Large swelling lasting 3 days and still swollen, fever.
Age: 67.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Pruritus, Urticaria
Clinical narrative: Patient's daughter called to report patient was experiencing hives on trunk and face with extreme itching. Stated the only new thing was the SHINGRIX shot, and the reaction began approximately 48-72 hours post exposure. Patient's daughter stated she had used hydrocortisone cream, pharmacist on duty (not the one who administered) recommended oral BENADRYL and cold compresses. Recommended going to ER if developing systemic symptoms such as itchy or closing throat.
Age: 1.08
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Blood heavy metal increased, Metal poisoning, Motor dysfunction, Posture abnormal, Seizure
Clinical narrative: Patient began having seizures after the vaccine and lost motor control of his head. Before the vaccine he was able to sit, he lost that ability when vaccinated and has not recovered it. Patient was hospitalized days after the vaccine for two nights.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Patient had injection site reaction about the size of the palm of your hand in a circle around the injection site on her arm. It was very red and itchy.
Age: 38.0
Sex: F
Vaccine: RAB
Symptoms: Peripheral swelling, Pruritus, Rash, Swelling
Clinical narrative: On 04/13/2018, during her annual physical, the donor reported to center medical staff: On 03/27/2018, the day after receiving her second Rabies vaccination, the donor experienced a rash on the right side of her neck. Two days after, she experienced an onset of swelling and itchiness on bilateral arms. Due to the symptoms, the donor took over-the-counter medication ? BENADRYL. The donor went to see her PMD, due to the swelling on her arms and the itching on her neck. She was prescribed Hydroxyzine Hydrochloride 50 mg (to be taken orally once every six hours) and Cetirizine Hydrochloride 10 mg (to be taken orally once daily). On 04/09/2018, the same day as her third Rabies vaccination, and a few hours afterward, the donor experienced the onset of itching and swelling on her neck, extending to her shoulders. No medication was taken at that time. The following morning, all symptoms had cleared. Due to the information provided by the donor on 04/13/2018 about the adverse events described above, she was removed from the Rabies immunization program.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Burning sensation, Feeling hot, Headache, Insomnia, Mobility decreased
Clinical narrative: Pt reported that almost immediately after receiving the shot, he felt a warm/burning sensation, that did not go away. By 10pm when the pt went to try to sleep for the night, the pain in his arm was intense to the point that he was unable to move it, and he also started feeling a headache (pt reports that he doesn't normally get headaches). At midnight he was unable to sleep and took 2 ANACIN. At 9AM the next morning, pt took 2 TYLENOL. At 3pm he reported a fever of 100.1 F and he also experienced a slight amount of nausea, not to the point that he felt like vomiting, but rather just a queasiness feeling. By the time I spoke with pt 3 days later, the pt report that he was feeling no nausea, no fever, and while his arm still ached, it was no longer the unbearable pain, but now a level he could tolerate.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Nausea, Pain in extremity, Pyrexia
Clinical narrative: Pt reported that almost immediately after receiving the shot, he felt a warm/burning sensation, that did not go away. By 10pm when the pt went to try to sleep for the night, the pain in his arm was intense to the point that he was unable to move it, and he also started feeling a headache (pt reports that he doesn't normally get headaches). At midnight he was unable to sleep and took 2 ANACIN. At 9AM the next morning, pt took 2 TYLENOL. At 3pm he reported a fever of 100.1 F and he also experienced a slight amount of nausea, not to the point that he felt like vomiting, but rather just a queasiness feeling. By the time I spoke with pt 3 days later, the pt report that he was feeling no nausea, no fever, and while his arm still ached, it was no longer the unbearable pain, but now a level he could tolerate.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Rash, Rash erythematous
Clinical narrative: The evening of 4/26/18 patient reported having flu-like symptoms. 4/27/18 around 4pm the patient reported a red rash on arms, legs, chest and back. Not itchy just red.
Age: 86.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Swelling of injection site, redness, pain and itching.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction, Rash pruritic, Rash vesicular
Clinical narrative: Patient states she had a circular, blistering, itchy rash at the injection site. She states it came on 2 days after the injection and lasted for about 2 days.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Injection site erythema, Injection site pain, Myalgia, Pyrexia
Clinical narrative: Extremely painful injection site. Redness. Fatigue/muscle aches/fever like symptoms.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Dyspnoea, Neck pain, Pain, Pain in extremity
Clinical narrative: 6 HOURS AFTER EVENT, PT STARTED FEELING A LOT OF PAIN ON ARM SHOT WAS GIVEN. PT WENT TO BED. THE NEXT MORNING, PAIN WOKE HER UP AND EXTENDED TO ALL OVER HER BODY. SO PT STARTED TAKING IBUPROFEN. PAIN WAS SEVERE IN HER NECK AND COULD NOT BREATHE PROPERLY SO SHE TOOK A SUDAFED. AFTER AN HOUR LATER, PAIN WAS A LITTLE MORE MANAGEABLE. PT TOOK MORE IBUPROFEN AND PAIN IS STILL THERE. PT WILL MONITOR HER PAIN AND WILL SEE HER DOCTOR IN THE MORNING IF PAIN HAS NOT SUBSIDED.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Pain in extremity
Clinical narrative: My left arm was so painful I took 2 oxycodone. The first did nothing, the second relieved the pain. The next day, 4/24/18 I had chills so badly I wore four layers of clothing: turtle neck, silk/cotton sweater, yak sweater, vest.
Age: 85.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash pruritic
Clinical narrative: Itchy rash on left gluteal and hamstring areas. Patient says the rash started two days after the vaccine was administered. The rash lasted about 1 week. She visited a prescriber. The prescriber said the rash was of unknown origin.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Disorientation, Hallucination, Myalgia, Nightmare, Pyrexia
Clinical narrative: Patient states that when she went home the evening that she got the shot that she had severe muscle soreness and a fever that kept fluctuating. The next day she began to become disorientated and started having hallucinations. She also complains of having nightmare. These symptoms persisted for 3 days after the vaccination.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Pyrexia
Clinical narrative: Patient experienced fever and chill.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Local reaction, Pain, Product administered at inappropriate site
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of pain in a 62-year-old female patient who received SHINGRIX. On 24th February 2018, the patient received SHINGRIX. On 24th February 2018, less than a day after receiving SHINGRIX, the patient experienced pain, local reaction and drug administered at inappropriate site. The patient was treated with NOS Steroid Injection. On an unknown date, the outcome of the pain and local reaction were recovered/resolved and the outcome of the drug administered at inappropriate site was unknown. It was unknown if the reporter considered the pain and local reaction to be related to SHINGRIX. Additional details were provided as follows: The physician stated that the SHINGRIX vaccine was administered at a weird spot inside the left arm of the patient, which led to vaccine administered via inappropriate site. The patient experienced a very large local reaction that went from her upper arm down to her elbow that measured 5 to 7 centimeters within 24 hours of receiving the SHINGRIX injection. It caused significant pain and the reaction worsened over 72 hours. The patient was concerned and she went to urgent care where she was given a steroid injection and the local reaction resolved within a week. There were no residual symptoms.
Age: 84.0
Sex: F
Vaccine: VARZOS
Symptoms: Contusion, Erythema, Pain in extremity, Peripheral swelling, Pruritus
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of contusion in a 85-year-old female patient who received SHINGRIX (batch number 79N59, expiry date January 2019). Concomitant products included AMBIEN, LYRICA and metoprolol. On 12th April 2018, the patient received the 1st dose of SHINGRIX .5 ml. On 13th April 2018, 1 days after receiving SHINGRIX, the patient experienced contusion, pain in arm, itchy limbs, swelling arm and erythema of extremities. On an unknown date, the outcome of the contusion, pain in arm, itchy upper limbs and erythema of extremities were not recovered/not resolved and the outcome of the swelling arm was recovering/resolving. It was unknown if the reporter considered the contusion, pain in arm, itchy upper limbs, swelling arm and erythema of extremities to be related to SHINGRIX. Additional information was received as follows: At 2:00 p.m. the patient received SHINGRIX on left deltoid. The patient experienced swollen left arm that protruded like the shape of an orange. The day before the date of reporting, the arm was very red, itchy and bruised and very painful to the touch. The swelling had gone down but it was still red and bigger than a softball in the shape of the redness and the area was bruised in the center.
Age: 84.0
Sex: F
Vaccine: VARZOS
Symptoms: Tenderness
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of contusion in a 85-year-old female patient who received SHINGRIX (batch number 79N59, expiry date January 2019). Concomitant products included AMBIEN, LYRICA and metoprolol. On 12th April 2018, the patient received the 1st dose of SHINGRIX .5 ml. On 13th April 2018, 1 days after receiving SHINGRIX, the patient experienced contusion, pain in arm, itchy limbs, swelling arm and erythema of extremities. On an unknown date, the outcome of the contusion, pain in arm, itchy upper limbs and erythema of extremities were not recovered/not resolved and the outcome of the swelling arm was recovering/resolving. It was unknown if the reporter considered the contusion, pain in arm, itchy upper limbs, swelling arm and erythema of extremities to be related to SHINGRIX. Additional information was received as follows: At 2:00 p.m. the patient received SHINGRIX on left deltoid. The patient experienced swollen left arm that protruded like the shape of an orange. The day before the date of reporting, the arm was very red, itchy and bruised and very painful to the touch. The swelling had gone down but it was still red and bigger than a softball in the shape of the redness and the area was bruised in the center.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Eye disorder, Migraine, Neuralgia, Ophthalmic herpes zoster, Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of ophthalmic zoster in a 61-year-old male patient who received SHINGRIX. The patient's past medical history included ophthalmic zoster (in April 2017), migraine headache and corneal lesions. Concomitant products included gabapentin. On 11th April 2018, the patient received SHINGRIX. On 11th April 2018, less than a day after receiving SHINGRIX, the patient experienced pain in arm. On 13th April 2018, the patient experienced ophthalmic zoster (serious criteria GSK medically significant), migraine headache, tingling, neuralgia and eye symptom. The patient was treated with ZOMIG. On an unknown date, the outcome of the ophthalmic zoster and eye symptom were unknown and the outcome of the migraine headache, tingling and neuralgia were not recovered/not resolved and the outcome of the pain in arm was recovered/resolved. The reporter considered the ophthalmic zoster, migraine headache, pain in arm, tingling, neuralgia and eye symptom to be almost certainly related to SHINGRIX. Additional details were provided as follows: The patient reported that he experienced some arm pain after his injection, which had resolved. The patient reported the he experienced a migraine headache 2 days after vaccination. He reported that ZOMIG usually would treat the migraine and the migraine symptoms, such as photophobia, phonophobia, head congestion, and watery eyes, but since the SHINGRIX, the ZOMIG had no effect. After the SHINGRIX vaccination, it felt like he was getting those zoster and ophthalmic symptoms back again which he had experienced in last year. The patient reported that he was experiencing some neuralgia and tingling. The physician contact details were provided.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Paraesthesia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of ophthalmic zoster in a 61-year-old male patient who received SHINGRIX. The patient's past medical history included ophthalmic zoster (in April 2017), migraine headache and corneal lesions. Concomitant products included gabapentin. On 11th April 2018, the patient received SHINGRIX. On 11th April 2018, less than a day after receiving SHINGRIX, the patient experienced pain in arm. On 13th April 2018, the patient experienced ophthalmic zoster (serious criteria GSK medically significant), migraine headache, tingling, neuralgia and eye symptom. The patient was treated with ZOMIG. On an unknown date, the outcome of the ophthalmic zoster and eye symptom were unknown and the outcome of the migraine headache, tingling and neuralgia were not recovered/not resolved and the outcome of the pain in arm was recovered/resolved. The reporter considered the ophthalmic zoster, migraine headache, pain in arm, tingling, neuralgia and eye symptom to be almost certainly related to SHINGRIX. Additional details were provided as follows: The patient reported that he experienced some arm pain after his injection, which had resolved. The patient reported the he experienced a migraine headache 2 days after vaccination. He reported that ZOMIG usually would treat the migraine and the migraine symptoms, such as photophobia, phonophobia, head congestion, and watery eyes, but since the SHINGRIX, the ZOMIG had no effect. After the SHINGRIX vaccination, it felt like he was getting those zoster and ophthalmic symptoms back again which he had experienced in last year. The patient reported that he was experiencing some neuralgia and tingling. The physician contact details were provided.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood urine present, Injection site erythema, Injection site pain, Injection site swelling, Urinary tract infection
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 63-year-old female patient who received SHINGRIX (batch number CH2X7, expiry date 25th April 2020) and (batch number D3G59, expiry date 25th April 2020). Previously administered products included ZOSTAVAX (patient had received ZOSTAVAX a few years ago). On 17th April 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, the dose was an unknown dose. On 18th April 2018, 1 days after receiving SHINGRIX, the patient experienced injection site erythema (serious criteria disability), injection site swelling (serious criteria disability) and injection site pain (serious criteria disability). On 20th April 2018, the patient experienced blood in urine (serious criteria disability) and urinary tract infection (serious criteria disability). On an unknown date, the outcome of the injection site erythema, blood in urine, urinary tract infection, injection site swelling and injection site pain were not recovered/not resolved. The reporter considered the injection site erythema, injection site swelling and injection site pain to be related to SHINGRIX. The reporter considered the blood in urine and urinary tract infection to be unlikely related to SHINGRIX. Additional details were provided as follows: The patient had redness and swelling at the injection site. The patient was seen at the physician office today due to her whole bicep area being swollen and red. Three days after receiving vaccination, the patient experienced blood in urine and diagnosed with a urinary tract infection. The physician did not believe the blood in the urine and the urinary tract infection were necessarily related to the injection.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Neuralgia, Rash vesicular
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of shingles in a 58-year-old male patient who received SHINGRIX. In April 2018, the patient received SHINGRIX. In April 2018, 5 days after receiving SHINGRIX, the patient experienced shingles, nerve pain and vesicular rash. On an unknown date, the outcome of the shingles, nerve pain and vesicular rash were unknown. the reporter considered the shingles, nerve pain and vesicular rash to be possibly related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient did not have any known immunodeficiency. Approximately a week before the reporting date, the patient received SHINGRIX as per the physician's direction. The patient experienced a vesicular, shingles type rash with burning nerve pain. The rash did not follow a dermatome, but the rash covered multiple different dermatomes and was very closely approximated to the vaccination. It was a classic shingles presentation and the pain was classic shingles. The physician stated that he wanted to be called back. He was surprised because he did not think a patient could get shingles from a non-live vaccine.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Inflammation, Skin warm
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of erythema in a female patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced erythema, skin warm and inflammation. On an unknown date, the outcome of the erythema, skin warm and inflammation were not recovered/not resolved. It was unknown if the reporter considered the erythema, skin warm and inflammation to be related to SHINGRIX. Additional details were provided as follows: The case was received from the District Manager. The patient experienced redness, inflammation and warmth several inches down from the injection site and she thought it was getting bigger.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site irritation
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site irritation in a unspecified number of adult patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site irritation. On an unknown date, the outcome of the injection site irritation was recovered/resolved. The reporter considered the injection site irritation to be related to SHINGRIX. Additional details reported as follows: The age at vaccination was not reported. The health care professional reported that they administered about 20 SHINGRIX doses and out of those 20, 2 to 3 patients reported irritation at the injection site. The health care professional wasn't alarmed because this was expected and fully resolved. The health care professional was reporting this as a general adverse event. She did not provided specific information.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of pain in a adult patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional information was received as follows: The age at vaccination was not reported. The health care professional (HCP) reported that the patient experienced arm soreness. This report came from Inside sales. The Inside Sales representative did not have any patient or vaccine information. The representative only had limited information about the adverse event. This is one of the 7 cases reported by the same reporter.