chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: Patient developed rash at the injection site. The rash grow in size  every day and now its about 6 in by 4 in size. She applied aloe Vera cream and hydro-cortisone cream.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Blood test, Concussion, Feeling abnormal, Headache
Clinical narrative: The patient received dose #2 of shingrix vaccine on Wednesday June 12th. She woke the next morning not feeling herself and having bad headaches and weakness. Upon getting up, she passed out and lost consciousness. She was taken to the emergency room where she was admitted to the hospital and kept overnight for observation. She was discharged on Friday and returned home.   On Monday, she was still not feeling herself, having weakness and headaches. She went back to the emergency room where she was re-admitted on Monday and an MRI was performed. She stayed hospitalized overnight and was discharged on either Tuesday or Wednesday with a final diagnosis of a concussion likely due to side effects from dose # 2 of Shingrix. She is still experiencing symptoms of headaches without other explanation and is taking 2 Tylenol every 4 hours to help the pain.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Loss of consciousness, Nuclear magnetic resonance imaging
Clinical narrative: The patient received dose #2 of shingrix vaccine on Wednesday June 12th. She woke the next morning not feeling herself and having bad headaches and weakness. Upon getting up, she passed out and lost consciousness. She was taken to the emergency room where she was admitted to the hospital and kept overnight for observation. She was discharged on Friday and returned home.   On Monday, she was still not feeling herself, having weakness and headaches. She went back to the emergency room where she was re-admitted on Monday and an MRI was performed. She stayed hospitalized overnight and was discharged on either Tuesday or Wednesday with a final diagnosis of a concussion likely due to side effects from dose # 2 of Shingrix. She is still experiencing symptoms of headaches without other explanation and is taking 2 Tylenol every 4 hours to help the pain.
Age: 74.0
Sex: F
Vaccine: PNC13
Symptoms: Body temperature increased, Injection site erythema, Injection site swelling
Clinical narrative: Patient complaining of a temperature (102 degrees) and redness/swelling around the area the vaccine was given
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Hypotension, Syncope
Clinical narrative: Pt. reported "bottoming out" of blood pressure over the weekend.  Lowest recorded reading at home was 68/50mmHg.  Her medications for A. Fib were withheld during this time.  Pt reported dizziness, fainting and a fear to do anything but lay down during her low blood pressure event.
Age: 70.0
Sex: F
Vaccine: HEPA
Symptoms: Erythema, Inflammation
Clinical narrative: Patient presented with left arm inflammed and red
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Rash generalised
Clinical narrative: Spreading rash  starting from left leg that progressed up the entire body and face.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Joint range of motion decreased, Mobility decreased, Myalgia, Pain
Clinical narrative: Patient contacted the pharmacy on 6/23/19 to report she was still having muscle pain/limited mobility/limited range of motion.  She stated the shot hurt like a normal shot for "a few days" after the vaccination, but that the pain went away for a few weeks. She then said in mid-May, then pain came back after she was pulling weeds.  She said the pain is worse when she uses her arm and better with rest, OTC pain relievers, and hot pads.  She said the pain extends a little above and below where she got the shot, but is the worst at the site of injection which she estimates to be "about 3-4 inches below her shoulder."  She said there is no swelling or redness, but is concerned about lingering pain.  She was referred to her PCP which she said she has an upcoming appointment with on 6/27/2019.
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Pyrexia, Rash generalised, Rash morbilliform
Clinical narrative: Had a fever over 103 up to 3 days after shots then he developed a rash all over his body and rash went away after 3 days then the rash came back again. Rash looked just like the measles
Age: 1.25
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Aphasia, Blood test, Cerebellar ataxia, Computerised tomogram, Gait inability
Clinical narrative: On 6/17/14 I observed my daughter not being able to no longer walk and stopped speaking. I took her to the ER on 6/18/14 and she was diagnosed with cerebellar ataxia. She then developed a speech delay and still requires speech and language services.
Age: 1.25
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Speech disorder developmental, Urine analysis
Clinical narrative: On 6/17/14 I observed my daughter not being able to no longer walk and stopped speaking. I took her to the ER on 6/18/14 and she was diagnosed with cerebellar ataxia. She then developed a speech delay and still requires speech and language services.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Back pain, Chills, Myalgia, Nausea
Clinical narrative: Muscle  and joint pain, especially in the back, chills and nausea
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Headache, Injection site pain, Myalgia, Nausea
Clinical narrative: nausea, shivers, fever, headache, muscle soreness, soreness at injection site. treatment was stay home, extra rest, ibuprofen.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: nausea, shivers, fever, headache, muscle soreness, soreness at injection site. treatment was stay home, extra rest, ibuprofen.
Age: 24.0
Sex: F
Vaccine: HEP, HPV9
Symptoms: Hyperhidrosis, Immediate post-injection reaction, Nausea
Clinical narrative: Immediately after administering HepB vaccine (HPV was already given to pt before HepB) pt began feeling nauseated and diaphoretic. Pt then wished to use the restroom and returned to the exam room and felt well again. Pt declined further eval and wished to be discharged.
Age: 6.0
Sex: F
Vaccine: DTAP, DTAP
Symptoms: Erythema, Induration, Pyrexia, Swelling, Tenderness
Clinical narrative: REDNESS, SWELLING, TENDERNESS, LOW-GRADE FEVER, and 9x13cm area of induration
Age: 6.0
Sex: F
Vaccine: DTAP, DTAP
Symptoms: Abdominal pain upper, Discomfort, Headache, Injection site erythema, Injection site pain
Clinical narrative: REDNESS, SWELLING, TENDERNESS, LOW-GRADE FEVER, and 9x13cm area of induration
Age: 6.0
Sex: F
Vaccine: DTAP, DTAP
Symptoms: Injection site swelling, Pain, Pyrexia
Clinical narrative: REDNESS, SWELLING, TENDERNESS, LOW-GRADE FEVER, and 9x13cm area of induration
Age: 4.0
Sex: F
Vaccine: MMR
Symptoms: Local reaction
Clinical narrative: PATIENT WITH SEVERE LOCAL REACTION ON LEFT GLUTEUS  POST MMR VACCINE, DURATION 1 MONTH.
Age: 11.0
Sex: M
Vaccine: DTAP
Symptoms: Abdominal pain, Chills, Cold sweat, Dizziness, Hallucination
Clinical narrative: Hallucinations, severe nausea, abdominal pain, dizziness, headache, body aches, cold sweats, uncontrollable shivering.
Age: 11.0
Sex: M
Vaccine: DTAP
Symptoms: Headache, Nausea, Pain
Clinical narrative: Hallucinations, severe nausea, abdominal pain, dizziness, headache, body aches, cold sweats, uncontrollable shivering.
Age: 38.0
Sex: F
Vaccine: RAB
Symptoms: Anxiety, Body temperature fluctuation, Chest discomfort, Dyspnoea, Eating disorder
Clinical narrative: Day following first injection, I had unbearable anxiety which induced suicidal ideology. so severe I couldn't see how i was going to make it to the next moment.  I would walk in circles and then sit on the ground and rock back and forth.  symptoms include restlessness, anxious with tight chest, tense muscles, labored breathing, increased heart rate (111bpm, 79 bpm resting), flushed, body temperature fluctuations (hot then cold etc),  Food tasted offal and i could barely eat, even if i was hungry.
Age: 38.0
Sex: F
Vaccine: RAB
Symptoms: Feeling of body temperature change, Flushing, Heart rate increased, Muscle tightness, Restlessness
Clinical narrative: Day following first injection, I had unbearable anxiety which induced suicidal ideology. so severe I couldn't see how i was going to make it to the next moment.  I would walk in circles and then sit on the ground and rock back and forth.  symptoms include restlessness, anxious with tight chest, tense muscles, labored breathing, increased heart rate (111bpm, 79 bpm resting), flushed, body temperature fluctuations (hot then cold etc),  Food tasted offal and i could barely eat, even if i was hungry.
Age: 38.0
Sex: F
Vaccine: RAB
Symptoms: Suicidal ideation, Taste disorder
Clinical narrative: Day following first injection, I had unbearable anxiety which induced suicidal ideology. so severe I couldn't see how i was going to make it to the next moment.  I would walk in circles and then sit on the ground and rock back and forth.  symptoms include restlessness, anxious with tight chest, tense muscles, labored breathing, increased heart rate (111bpm, 79 bpm resting), flushed, body temperature fluctuations (hot then cold etc),  Food tasted offal and i could barely eat, even if i was hungry.
Age: 22.0
Sex: F
Vaccine: HPV9
Symptoms: Computerised tomogram, Concussion, Head injury, Syncope
Clinical narrative: Patient received vaccine and was told to stay seated. Patient stood up and experienced syncope.  Patient hit head on floor of exam remove and was take to area hospital ED for evaluation. Patient sustained mild concussion.
Age: 1.5
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Endotracheal intubation, Guillain-Barre syndrome
Clinical narrative: Guillan Barre Syndrome, ascending paralysis, was intubated for 3 1/2 weeks and required significant rehabilitation, still with residual sx
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Dizziness, Fatigue, Headache, Musculoskeletal pain
Clinical narrative: 6-18-2019 to 6-21-2019 I was feverish, had chills, was fatigued, felt pain in the arm, and had a headache. On 6-24-2019 I awoke with dizziness (4 am) that lasted for 9-10 hours and fatigue that lasted for 4 hours after arising at 9 am.  I also felt pain in my shoulders and had a headache.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: 6-18-2019 to 6-21-2019 I was feverish, had chills, was fatigued, felt pain in the arm, and had a headache. On 6-24-2019 I awoke with dizziness (4 am) that lasted for 9-10 hours and fatigue that lasted for 4 hours after arising at 9 am.  I also felt pain in my shoulders and had a headache.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Decreased appetite, Headache, Insomnia, Myalgia
Clinical narrative: 6/19:  Sore arm, achy muscles, difficulty sleeping.  6/20:  Woke up with severe headache, achy muscles, sore arm, upset stomach, very little appetite.   Later in the day, started getting rash on torso.  Listless.  6/21:  Rash was bright red and covered entire torso, still achy muscles, sore arm, still no appetite, listless.  6/22:  Rash still bright red in morning, expanded to both upper arms overnight.  By evening (after using Benedryl), rash subsiding some, appetite returning.  Arm still sore, achy muscles.  6/23:  Rash subsided considerably, still some rash on upper chest and upper arms.  Very itchy back and lower torso.  Pain in arm subsided as did achy muscles.  6/24:  First day without rash, still some itchiness on back, arm & muscles no longer hurt.  First day I've been able to do anything.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Pruritus, Rash, Rash erythematous
Clinical narrative: 6/19:  Sore arm, achy muscles, difficulty sleeping.  6/20:  Woke up with severe headache, achy muscles, sore arm, upset stomach, very little appetite.   Later in the day, started getting rash on torso.  Listless.  6/21:  Rash was bright red and covered entire torso, still achy muscles, sore arm, still no appetite, listless.  6/22:  Rash still bright red in morning, expanded to both upper arms overnight.  By evening (after using Benedryl), rash subsiding some, appetite returning.  Arm still sore, achy muscles.  6/23:  Rash subsided considerably, still some rash on upper chest and upper arms.  Very itchy back and lower torso.  Pain in arm subsided as did achy muscles.  6/24:  First day without rash, still some itchiness on back, arm & muscles no longer hurt.  First day I've been able to do anything.
Age: 5.0
Sex: M
Vaccine: DTAP
Symptoms: Abnormal behaviour, Aggression, Disturbance in attention, Ear infection, Feeling abnormal
Clinical narrative: That evening he developed a rash up his back and neck. The following day he didn?t want to go on a fun outing. He wanted to sleep instead. He never naps. He fell asleep at 3pm the following day and wouldn?t wake up during the night when we tried to take him to the bathroom. He slept until 8am the next day. I had to wake him up. He didn?t feel well. I took him to the dr to have them check his TB bubble which was fine and to let them know about his rash and how he was acting not himself. The dr was not in so the nurse took notes and looked at rash.  Rash went away Thursday and everyday for 16 days he would wake up violently screaming and would be up for hours in a daze and not talk to us. His preschool told us they even noticed a huge change in his behavior for the worse.  My husband took him to the dr to be checked out for his symptoms they said he now has an ear infection and that the vaccine lowered his immune system.  We are now on week 7 of him no longer sleeping through the night, he is constantly cranky/moody and he has been very aggressive which is not like him.  He is having trouble staying focused and we are trying anything to help him.
Age: 5.0
Sex: M
Vaccine: DTAP
Symptoms: Immune system disorder, Insomnia, Irritability, Malaise, Mood altered
Clinical narrative: That evening he developed a rash up his back and neck. The following day he didn?t want to go on a fun outing. He wanted to sleep instead. He never naps. He fell asleep at 3pm the following day and wouldn?t wake up during the night when we tried to take him to the bathroom. He slept until 8am the next day. I had to wake him up. He didn?t feel well. I took him to the dr to have them check his TB bubble which was fine and to let them know about his rash and how he was acting not himself. The dr was not in so the nurse took notes and looked at rash.  Rash went away Thursday and everyday for 16 days he would wake up violently screaming and would be up for hours in a daze and not talk to us. His preschool told us they even noticed a huge change in his behavior for the worse.  My husband took him to the dr to be checked out for his symptoms they said he now has an ear infection and that the vaccine lowered his immune system.  We are now on week 7 of him no longer sleeping through the night, he is constantly cranky/moody and he has been very aggressive which is not like him.  He is having trouble staying focused and we are trying anything to help him.
Age: 5.0
Sex: M
Vaccine: DTAP
Symptoms: Rash, Screaming
Clinical narrative: That evening he developed a rash up his back and neck. The following day he didn?t want to go on a fun outing. He wanted to sleep instead. He never naps. He fell asleep at 3pm the following day and wouldn?t wake up during the night when we tried to take him to the bathroom. He slept until 8am the next day. I had to wake him up. He didn?t feel well. I took him to the dr to have them check his TB bubble which was fine and to let them know about his rash and how he was acting not himself. The dr was not in so the nurse took notes and looked at rash.  Rash went away Thursday and everyday for 16 days he would wake up violently screaming and would be up for hours in a daze and not talk to us. His preschool told us they even noticed a huge change in his behavior for the worse.  My husband took him to the dr to be checked out for his symptoms they said he now has an ear infection and that the vaccine lowered his immune system.  We are now on week 7 of him no longer sleeping through the night, he is constantly cranky/moody and he has been very aggressive which is not like him.  He is having trouble staying focused and we are trying anything to help him.
Age: 65.0
Sex: M
Vaccine: PNC13
Symptoms: Erythema, Pain in extremity
Clinical narrative: Patient had severe redness on the arm which got vaccinated. He took tylenol and applied ice packs. He also stated that he had slight pain on his arm for 4 days. He had to go to his doctor and got a prescription for an antibiotic
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Eye movement disorder, Fall
Clinical narrative: Client stood up after receiving vaccines talking with family and then fell to floor.  Mother states she saw his eyes roll but he never lost consciousness.  He was placed on a mat with legs elevated and a cold towel.  He was able to speak clearly and his eyes were equal and clear.  After resting for about 20-30 minutes his brother helped him to the restroom and then to the car.  Client was alert and coherent.
Age: 55.0
Sex: M
Vaccine: PPV, VARZOS
Symptoms: Asthenia, Back pain, Chills, Feeling cold, Hyperhidrosis
Clinical narrative: Patient received vaccinations for Shingrix and Pneumovax on Saturday 6/22/19 around noon. Wife called today and stated that husband came down with the chills Sunday afternoon and was sweating and cold. She said he was also weak, had a back ache, and had a rash surrounding the shot he received on his left arm (Pneumovax). Patient was also prescribed an antibiotic for infection, but patient stated that he was okay to receive vaccination. At the time, patient also appeared without any signs of issues. Wife stated that patient is slowly improving after giving him Tylenol and ibuprofen but was concerned if she should take him to the ER. I informed her that as long as his condition is improving, it will be okay. Wife stated that she called a physician but the doctor stated that he did not need to go to the ER since there was no vomiting, but could take him to visit a doctor's office if she would like.  Informed wife that I will report this to VAERS and follow up with them in a couple of days to ensure he is getting better
Age: 55.0
Sex: M
Vaccine: PPV, VARZOS
Symptoms: Injection site rash
Clinical narrative: Patient received vaccinations for Shingrix and Pneumovax on Saturday 6/22/19 around noon. Wife called today and stated that husband came down with the chills Sunday afternoon and was sweating and cold. She said he was also weak, had a back ache, and had a rash surrounding the shot he received on his left arm (Pneumovax). Patient was also prescribed an antibiotic for infection, but patient stated that he was okay to receive vaccination. At the time, patient also appeared without any signs of issues. Wife stated that patient is slowly improving after giving him Tylenol and ibuprofen but was concerned if she should take him to the ER. I informed her that as long as his condition is improving, it will be okay. Wife stated that she called a physician but the doctor stated that he did not need to go to the ER since there was no vomiting, but could take him to visit a doctor's office if she would like.  Informed wife that I will report this to VAERS and follow up with them in a couple of days to ensure he is getting better
Age: 0.5
Sex: F
Vaccine: DTAPIPV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: none at this time
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site bruising, Injection site erythema, Pain in extremity
Clinical narrative: Patient said she started getting a sore arm the day of shot it got bruised and red to the skin at site of injection. Still bruised on 6-24.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Fatigue, Headache, Vaccination site pain, Vaccination site reaction
Clinical narrative: Patient received vaccine on 6/18/19. On 6/19/19 patient developed headache, tiredness, weakness and arm pain at vaccination site. On 4/22 patient developed some redness at vaccination site after being out in the sun.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Condition aggravated, Fatigue, Joint swelling
Clinical narrative: The same day: chills, fatigue, shivering, joint and muscle pain.  For the next few weeks: intense pain in old injury sites that had healed years ago: rotator cuffs, knee, feet, also pain in sites without injury such as my big toes, my hands, the knee that had never been injured. As of today: my hands still hurt,  my feet still hurt, the joint that connects to my right big toe now looks swollen and really hurts.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia
Clinical narrative: The same day: chills, fatigue, shivering, joint and muscle pain.  For the next few weeks: intense pain in old injury sites that had healed years ago: rotator cuffs, knee, feet, also pain in sites without injury such as my big toes, my hands, the knee that had never been injured. As of today: my hands still hurt,  my feet still hurt, the joint that connects to my right big toe now looks swollen and really hurts.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Vision blurred
Clinical narrative: Patient stated blurry vision and dizziness at 11 am so I had her sit down and I took her blood pressure 173/98 pulse 51 using an automatic upper arm machine.  We gave her a glass of water and just rest for 18 minutes.  She stated she was feeling better so I took her blood pressure again and it read 115/56 pulse 48.
Age: 58.0
Sex: F
Vaccine: MMR
Symptoms: Injection site pain, Pain, Tenderness
Clinical narrative: Pt describes delayed onset of pain, started about a week after the shot . Describes tenderness/soreness like a bruise deep inside injection site. Patient thinks the injection might have been given IM, however the pharmacist did tell the patient at the time of injection that is was a sub q shot. Pt alleges that is was given in the deltoid , same are on opposite arm as the Shingrix shot she received that day.  Pt say affecting her sleep.
Age: 1.0
Sex: F
Vaccine: MMR
Symptoms: Regressive behaviour, Speech disorder
Clinical narrative: Child slowly regressed and became non-verbal after receiving MMR.
Age: 1.25
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Injection site rash, Rash
Clinical narrative: VACCINES WERE ADMINISTERED ON 4-29-19. ON 5-2-19 PARENT (MOM) CALLED OUR NURSE TRIAGE LINE TO REPORT THAT PT HAD BROKEN OUT IN A RASH ON HIS ARM, FACE, AND BEHIND HIS THIGH. A FOLLOW UP CALL WAS MADE ON 5-3-19. PER DAD THE RASH HAD RESOLVED. NO OTHER PROBLEMS REPORTED
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injection site erythema, Injection site warmth, Pain, Pain in extremity
Clinical narrative: 9 x 5" red, warm area to left gluteal area that started on 6-18-19. Body aches started on 6-18-19 with chills and pain down left leg. Patient instructed to take Tylenol/Ibuprofen + Benadryl. redness almost completely gone on 6-24-19. Body aches, chills, leg pain lasted 3 days.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Product administered at inappropriate site
Clinical narrative: 9 x 5" red, warm area to left gluteal area that started on 6-18-19. Body aches started on 6-18-19 with chills and pain down left leg. Patient instructed to take Tylenol/Ibuprofen + Benadryl. redness almost completely gone on 6-24-19. Body aches, chills, leg pain lasted 3 days.
Age: 61.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain, Pruritus, Swelling
Clinical narrative: Localize swelling, pain, itchiness, redness
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pain, Pain
Clinical narrative: could not move arm; muscle aches; This case was reported by a consumer via call center representative and described the occurrence of injected limb mobility decreased in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   In April 2019, the patient received the 2nd dose of Shingrix. In April 2019, 2 hrs after receiving Shingrix, the patient experienced injected limb mobility decreased and muscle pain. On an unknown date, the outcome of the injected limb mobility decreased was recovered/resolved and the outcome of the muscle pain was not recovered/not resolved.   It was unknown if the reporter considered the injected limb mobility decreased and muscle pain to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. Approximately 8 weeks before the time of reporting, the patient received a dose of Shingrix on the left arm. Approximately 2 hours after vaccination, the patient could not move her left arm and developed muscle aches approximately 4 inches above the left elbow. The outcome of could not move arm was reported as recovered/resolved in the database however in source document, it was mentioned as recovered/resolved with sequel. The outcome of muscle ache was reported as not recovered in the database however in source document, it was mentioned as recovering/resolving. The reporter did not consent to follow-up.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: could not move arm; muscle aches; This case was reported by a consumer via call center representative and described the occurrence of injected limb mobility decreased in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   In April 2019, the patient received the 2nd dose of Shingrix. In April 2019, 2 hrs after receiving Shingrix, the patient experienced injected limb mobility decreased and muscle pain. On an unknown date, the outcome of the injected limb mobility decreased was recovered/resolved and the outcome of the muscle pain was not recovered/not resolved.   It was unknown if the reporter considered the injected limb mobility decreased and muscle pain to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. Approximately 8 weeks before the time of reporting, the patient received a dose of Shingrix on the left arm. Approximately 2 hours after vaccination, the patient could not move her left arm and developed muscle aches approximately 4 inches above the left elbow. The outcome of could not move arm was reported as recovered/resolved in the database however in source document, it was mentioned as recovered/resolved with sequel. The outcome of muscle ache was reported as not recovered in the database however in source document, it was mentioned as recovering/resolving. The reporter did not consent to follow-up.
Age: 6.0
Sex: F
Vaccine: DTAP, DTAP
Symptoms: Erythema, Induration, Pyrexia, Swelling, Tenderness
Clinical narrative: Redness, pain, swelling of thigh at injection site day following injection. Complaints of headache and stomach ache and inability to sit on toilet without assistance due to pain. Monday morning, 6/24, about 4-5" diameter of swelling and red. Afternoon of 6/24, additional swelling, diameter now closer to 5-6" and bright red in addition to fever close to 101°F. Took to ER for evaluation and additional care.  Marker drawn around redness with about a 1/2" gap.  Was told to use cool compresses and Tylenol/Advil for pain, discomfort and fever.  Morning of 6/25 the redness has passed the marker line by 3/8" up the leg and by 1" going down the leg.  Doctor told us this is a typical and normal reaction to the vaccine and should resolve within 7 days.
Age: 6.0
Sex: F
Vaccine: DTAP, DTAP
Symptoms: Abdominal pain upper, Discomfort, Headache, Injection site erythema, Injection site pain
Clinical narrative: Redness, pain, swelling of thigh at injection site day following injection. Complaints of headache and stomach ache and inability to sit on toilet without assistance due to pain. Monday morning, 6/24, about 4-5" diameter of swelling and red. Afternoon of 6/24, additional swelling, diameter now closer to 5-6" and bright red in addition to fever close to 101°F. Took to ER for evaluation and additional care.  Marker drawn around redness with about a 1/2" gap.  Was told to use cool compresses and Tylenol/Advil for pain, discomfort and fever.  Morning of 6/25 the redness has passed the marker line by 3/8" up the leg and by 1" going down the leg.  Doctor told us this is a typical and normal reaction to the vaccine and should resolve within 7 days.
Age: 6.0
Sex: F
Vaccine: DTAP, DTAP
Symptoms: Injection site swelling, Pain, Pyrexia
Clinical narrative: Redness, pain, swelling of thigh at injection site day following injection. Complaints of headache and stomach ache and inability to sit on toilet without assistance due to pain. Monday morning, 6/24, about 4-5" diameter of swelling and red. Afternoon of 6/24, additional swelling, diameter now closer to 5-6" and bright red in addition to fever close to 101°F. Took to ER for evaluation and additional care.  Marker drawn around redness with about a 1/2" gap.  Was told to use cool compresses and Tylenol/Advil for pain, discomfort and fever.  Morning of 6/25 the redness has passed the marker line by 3/8" up the leg and by 1" going down the leg.  Doctor told us this is a typical and normal reaction to the vaccine and should resolve within 7 days.
Sex: U
Vaccine: MMR, UNK
Symptoms: Accidental underdose, Incorrect dose administered
Clinical narrative: received less than a full dose of MMR II; administered this dose routinely only withdraws and administers 0.5ml of MMR II instead of all contents as directed in the prescribing information so they believe less than full dose given; Information has been received from a nurse referring to a child patient of unknown gender. Information about concurrent condition, concomitant medication, drug reactions/allergies and medical history was not provided.  On an unknown date, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (subcutaneous; strength, dose, lot# and expiration date were not reported) for prophylaxis. Other suspect therapies included sterile diluent (Merck manufactured) (subcutaneous; strength, dose, lot#, expiration date and indication were not reported).    The nurse confirmed at least one patient received less than a full dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (Accidental underdose). The unspecified child "moved" and some of the dose "might have squirted out". The reporter reported the unspecified nurse in the practice that administered this dose routinely only withdrawn and administered 0.5ml of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) instead of all contents as directed in the prescribing information so they believe less than full dose was given (Incorrect dose administered).  This is one of two reports which have the same reporter.; Sender's Comments:  US-009507513-1906USA009439:
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse effects were reported; the patient was inadvertently administered an expired dose of VAQTA; This spontaneous report was received from a medical assistant referring to a patient of unknown age and unknown gender. Information about concurrent condition, concomitant medication and medical history was not provided.   On 28-MAY-2019, the patient was inadvertently vaccinated with an expired dose of hepatitis a vaccine, inactivated(VAQTA) (lot # R011952 and expiration date 27-MAY-2019; strength and dose were not reported) intramuscularly for prophylaxis (expired product administered). No adverse effects were reported. There was no temperature excursion.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles; This spontaneous report was received from a lawyer regarding a case in litigation referring to a currently 67-year-old female patient. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. On an unspecified date in 2016 the patient was vaccinated with zoster vaccine live(ZOSTAVAX) (lot#, expiration date, dosage and route of administration were not provided) for the long-term prevention of shingles and zoster-related conditions. On an unknown date, the patient was treated for shingles resulting from her use zoster vaccine live(ZOSTAVAX). At the time of the report, the outcome of shingles was unknown. The reporter considered shingles to be related to Zoster Vaccine Live(ZOSTAVAX).
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles; This spontaneous report was received from a lawyer regarding a case in litigation referring to a currently 70-year-old female patient. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. On or about 23-OCT-2012, the patient was vaccinated with zoster vaccine live(ZOSTAVAX) (lot#, expiration date, dosage and route of administration were not provided) for the long-term prevention of shingles and zoster-related conditions. On an unknown date, the patient was treated by a physician for shingles resulting from her use zoster vaccine live(ZOSTAVAX). At the time of the report, the outcome of shingles was unknown. The reporter considered shingles to be related to Zoster Vaccine Live(ZOSTAVAX).
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles; This spontaneous report was received from a lawyer regarding a case in litigation referring to a currently 58-year-old female patient. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. On an unspecified date in 2016 the patient was vaccinated with zoster vaccine live(ZOSTAVAX) (lot#, expiration date, dosage and route of administration were not provided) for the long-term prevention of shingles and zoster-related conditions. On an unknown date, the patient was treated for shingles resulting from her use zoster vaccine live(ZOSTAVAX). At the time of the report, the outcome of shingles was unknown. The reporter considered shingles to be related to Zoster Vaccine Live(ZOSTAVAX).
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Herpes zoster; This spontaneous report was received from a lawyer regarding a case in litigation referring to a currently 61-year-old female patient. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. On an unspecified date in 2016 the patient was vaccinated with zoster vaccine live(ZOSTAVAX) (lot#, expiration date, dosage and route of administration were not provided) for the long-term prevention of shingles and zoster-related conditions. On an unknown date, the patient was treated for Herpes Zoster resulting from her use zoster vaccine live(ZOSTAVAX). At the time of the report, the outcome of Herpes Zoster was unknown. The reporter considered Herpes Zoster to be related to Zoster Vaccine Live(ZOSTAVAX).
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: patient was administered an expired VAQTA; no adverse effects; This spontaneous report was received from a nurse and refers to a 52-year-old patient. The patient's gender was not reported. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 18-JUN-2019, the patient was vaccinated with an expired dose of Hepatitis A Vaccine, Inactivated (VAQTA) (lot number R009799, expiration date 02-jun-2019) for prophylaxis (dose and route of administration were not reported). There were no adverse effects.   The outcome of expired product administered was unknown.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: herpes zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 72-year-old female patient. Information on the patient's concurrent conditions, medical history or concomitant therapy was not reported.  In June 2016, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, lot# and expiration date were not reported) for the long-term prevention of shingles and zoster-related conditions. On an unknown date, the patient was treated for the following injuries resulting from zoster vaccine live (ZOSTAVAX) use: Herpes Zoster. The outcome of herpes zoster was unknown. The reporter considered herpes zoster to be related to Zoster Vaccine Live (ZOSTAVAX).     Additional information has been requested.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: herpes zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 72-year-old male patient. Information on the patient's concurrent conditions, medical history or concomitant therapy was not reported.  On or about 28-FEB-2014, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, lot# and expiration date were not reported) for the long-term prevention of shingles and zoster-related conditions. On an unknown date, the patient was treated in emergency department for the following injuries resulting from zoster vaccine live (ZOSTAVAX) use: Herpes Zoster. The outcome of herpes zoster was unknown. The reporter considered herpes zoster to be related to Zoster Vaccine Live(ZOSTAVAX).     Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse effect; Patient used expired VAQTA; This spontaneous report as received from a medical assistant refers to a patient of unknown demographics. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant therapy were not reported.  On 17-JUN-2019, the patient was vaccinated with expired dose of hepatitis a vaccine, inactivated(VAQTA) injection (dose and frequency were not reported) (lot # R009954, expiry date: 12-JUN-2019) intramuscularly for prophylaxis. No adverse effects were reported. No product quality complaint was involved.
Age: 0.5
Sex: M
Vaccine: HIBV
Symptoms: Chills, Extrapyramidal disorder
Clinical narrative: shudders and chills; Information has been received from a consumer (patient's father) and refers to a 6 month old male patient. The patient had no medical history, concurrent conditions, drug reactions or allergies reported. Concomitant medication included diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid.  On an unknown date (reported as a couple of months ago), the patient received Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) (route of administration reported as shot; dose, lot #, expiration date were not mentioned) for prophylaxis.      Since that time he had been getting shudders and chills. No treatment was given for the event. The patient had spoken with pediatric nurse practitioner. At the time of reporting, the patient had not recovered from the event.  Causality assessment was not provided.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: No adverse effects; Inadvertently administered a dose of PROQUAD, rather than MMRII; 44 year old patient was inadverently administered a dose of PROQUAD, rather than MMRII; This spontaneous report was received from a registered nurse and refers to a 44-year-old patient of unknown gender. The patient's medical history, concurrent conditions, past drug reactions or allergies and concomitant medications were not reported. On 20-JUN-2019, the patient was inadvertently administered a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) (therapy type as rHA (recombinant Human albumin)) subcutaneously, lot # R024018, expiration date as 19-FEB-2020 (dose number, dose were not reported) for prophylaxis, rather than measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II)(wrong product administered and product administered to patient of inappropriate age). No adverse effects were reported. The outcome of wrong product administered, product administered to patient of inappropriate age and no adverse event was unknown.
Sex: U
Vaccine: VARZOS
Symptoms: Dizziness, Fatigue
Clinical narrative: tiredness; bit light headed; This case was reported by a consumer via call center representative and described the occurrence of tiredness in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 14th June 2019, the patient received Shingrix. In June 2019, less than a week after receiving Shingrix, the patient experienced tiredness and light headedness. On an unknown date, the outcome of the tiredness was not recovered/not resolved and the outcome of the light headedness was unknown.   It was unknown if the reporter considered the tiredness and light headedness to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported, but as per indication of the vaccine age group was captured as adult. On Friday from the date of reporting, the patient received a dose of Shingrix. The patient was a bit light headed and very tired.  The reporter asked how long did the tiredness last. The patient was tired at the time of reporting.
Sex: F
Vaccine: MENB
Symptoms: Pneumonia
Clinical narrative: Pneumonia; This case was reported by a consumer via patient support programs and described the occurrence of pneumonia in a adult female patient who received Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received Bexsero at an unknown dose. On an unknown date, unknown after receiving Bexsero, the patient experienced pneumonia (serious criteria GSK medically significant). On an unknown date, the outcome of the pneumonia was unknown.   It was unknown if the reporter considered the pneumonia to be related to Bexsero.  Additional information was provided as follows: The age at vaccination was not reported. The patient received Bexsero in 2013 or 2014 and had pneumonia.
Sex: U
Vaccine: VARZOS
Symptoms: Fatigue, Myalgia
Clinical narrative: significant myalagias; significant fatigue; This case was reported by a physician via call center representative and described the occurrence of myalgia in an unspecified number of adult patients who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced myalgia and fatigue. On an unknown date, the outcome of the myalgia and fatigue were unknown.   It was unknown if the reporter considered the myalgia and fatigue to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. An unspecified number of patients received 1st dose of Shingrix and experienced significant myalgia and significant fatigue. The reporter was asking that how important was it to patient to receive 2nd dose of Shingrix. This case has been linked with US2019AMR105829, same reporter.
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Malaise, Pyrexia, Vaccine positive rechallenge
Clinical narrative: fever; fatigue; malaise; This case was reported by a consumer via call center representative and described the occurrence of fever in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pyrexia (received 1st dose on an unknown date, refer case US2019109624).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced fever, fatigue and malaise. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the fever, fatigue and malaise were recovered/resolved.   It was unknown if the reporter considered the fever, fatigue and malaise to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient's friend. The age at vaccination was not reported. The patient received Shingrix and, the patient developed fever, fatigue, and malaise that lasted approximately 2 to 3 days. The reporter did not provide any additional information. The reporter stated that the patient is in his 60's.
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B antibody negative
Clinical narrative: lack of effect; This case was reported by a consumer via call center representative and described the occurrence of hepatitis b antibody negative in a 35-year-old female patient who received Hepatitis B vaccine for prophylaxis.   The patient's past medical history included chickenpox (chicken pox outbreak in past). Concurrent medical conditions included ulcerative colitis (chrone's disease), hypothyroidism and immunocompromised (immunosuppressant therapy).   On an unknown date, the patient received Hepatitis B vaccine at an unknown dose. On an unknown date, unknown after receiving Hepatitis B vaccine, the patient experienced hepatitis b antibody negative. The patient was treated with thyroid medication {nos} (Thyroid Medication). On an unknown date, the outcome of the hepatitis b antibody negative was unknown.   The reporter considered the hepatitis b antibody negative to be unrelated to Hepatitis B vaccine.  Additional details were provided as follows: This case was reported by the patient's mother. The age at vaccination was not reported. The patient had a history of having chicken pox breakout in the past.  The patient's medical history of ulcerative colitis which was now Chrone's disease. The patient was on medications such as Humara, thyroid medication and she would be started on (azothiaprine) Imuran soon. Her physician wants to give her the shingrix shot (even though she would be started Imuran soon), along with the MMR, and HPV vaccine but the patient was concerned about getting these when taking immunosuppressants. The reporter mentioned that the patient had the hepatitis B injection series (unknown number of doses) and that because of her immunosuppressant therapy, the hepatits B vaccine had completed washed out.  the patient had to have both Hepatitis B injections again.  This was all the information collected.
Sex: M
Vaccine: VARZOS
Symptoms: Condition aggravated, Eye infection, Ocular discomfort, Visual impairment
Clinical narrative: vision got worse/ almost lost of all vision; Condition aggravated; pressure problems in eye; infected eye; This case was reported by a consumer via call center representative and described the occurrence of vision decreased in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (had in his eye in 2016.). Concurrent medical conditions included ophthalmic herpes zoster and vision decreased.   On an unknown date, the patient received Shingrix (intramuscular). On an unknown date, unknown after receiving Shingrix, the patient experienced vision decreased, condition aggravated, sensation of pressure in eye and eye infection. On an unknown date, the outcome of the vision decreased, condition aggravated and sensation of pressure in eye were not recovered/not resolved and the outcome of the eye infection was unknown.   It was unknown if the reporter considered the vision decreased, condition aggravated, sensation of pressure in eye and eye infection to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that her son in law got shingles in 2016 in his eye. The virus was still active 2 years later. The reporter stated that when the virus went into remission, his physician gave him a Shingrix injection. The patient vision got worse after the Shingrix injection but he had already almost lost all vision in the infected eye anyway. Now the patient was having pressure problems in the same eye and sees a specialist and was having a hard time of it. The reporter did not provide any specific information regarding the patient. This was all the information that was reported. The reporter did not consent to follow-up.