chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 20.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Headache, Migraine, Pyrexia, Tremor
Clinical narrative: Fever (102.9), uncontrollable convulsive-like shakes, chills, headache that progressed into migraine - all lasted 18 hours.
Age: 32.0
Sex: F
Vaccine: TDAP
Symptoms: Rash, Rash erythematous, Rash pruritic, Throat irritation
Clinical narrative: Reported to Employee Health on 11.16.18 that she has fine red itchy rash on right forearm that began on morning of 11.15.18. Also reported rash on nape of neck. She had applied BENADRYL cream, stated it stopped the itching and rash was subsiding. 11.16.18 1030, fine, red rash observed on right forearm and none on nape of neck. 1510 she called Employee Health stating she felt like the rash was worsening and felt something "funny" in her throat. Advised her to contact Healthcare Professional (personal doctor) and to follow-up with Employee Health 11.19.18.
Age: 25.0
Sex: F
Vaccine: TDAP
Symptoms: Headache, Injection site pain, Rash, Rash erythematous, Rash pruritic
Clinical narrative: Reported rash on her back, abdomen, arms, face and in between her thighs. Describes them as itchy, little red bumps. Received Influenza vaccine 11.12.18 and Tdap vaccine 11.14.18. She also reports having a HA since yesterday, denies fever. Soreness at Tdap site but no other symptoms at injection site. Has taken BENADRYL and reports some relief from itching. Few hours later, reported that itching has decreased and rash appears to be clearing up. 11.19.18 Reported she continued BENADRYL every 6 hours through 11.17.18 and rash and itching were gone. No relapse through today.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: No adverse event, Product preparation issue
Clinical narrative: I failed to reconstitute the vaccine with the adjuvant suspension component. Patient only received the adjuvant suspension component.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Fatigue, Pain, Pyrexia
Clinical narrative: Fever, major aches and pains, tiredness. Had to take multiple naps and aspirin to get through the first day after I received the vaccine. Couldn't go to work. The second day: fever lower, minor aches and pain, had to take one long, deep nap in the afternoon, plus aspirin to get through the rest of the day. Not strong enough to work today either. Third day: symptoms dissipating by end of day. Really not sure I want to go through this again with the second dosage in a couple of months. I felt awful.
Age: 13.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness
Clinical narrative: Patient felt dizzy after receiving flu shot; patient was guided to the floor and was put in supine position. Patient did not lose consciousness and was not hurt in the process. Patient returned to baseline after 30 minutes of observation.
Age: 71.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Body temperature increased, Fatigue, Headache, Joint swelling, Malaise
Clinical narrative: Vaccination date: 11/13/18. I am still experiencing side effects at the time of this reporting. About 11/14/18 I started feeling tired and I had joint discomfort but now swelling. I also was experiencing headaches. I had a general sense of malaise and by 11/17/18 I was spiking a temperature up to 102.3. Today my temp so far is 99.6. I typically have been feeling worse in the evening. I have been taking acetaminophen. I am somewhat better than I was 2 days ago but not dramatically so.
Age: 71.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Pyrexia
Clinical narrative: Vaccination date: 11/13/18. I am still experiencing side effects at the time of this reporting. About 11/14/18 I started feeling tired and I had joint discomfort but now swelling. I also was experiencing headaches. I had a general sense of malaise and by 11/17/18 I was spiking a temperature up to 102.3. Today my temp so far is 99.6. I typically have been feeling worse in the evening. I have been taking acetaminophen. I am somewhat better than I was 2 days ago but not dramatically so.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Paraesthesia, Pruritus
Clinical narrative: Itching/tingling on left hip and thigh.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthritis, Back pain, Condition aggravated, Fatigue, Muscle strain
Clinical narrative: Initially (day after the injection) fatigue, could hardly get out of bed then general tiredness, which has continued also shortly after discovered pain in the muscle of the left hip area, back pain suddenly bad (which had been under control), and new pain noted in right middle finger...I feel this injection exasperated the back pain and arthritis, and produced new issues ie weakening of muscles that produced a partial tear.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Muscular weakness, Myalgia, Nuclear magnetic resonance imaging, Pain in extremity
Clinical narrative: Initially (day after the injection) fatigue, could hardly get out of bed then general tiredness, which has continued also shortly after discovered pain in the muscle of the left hip area, back pain suddenly bad (which had been under control), and new pain noted in right middle finger...I feel this injection exasperated the back pain and arthritis, and produced new issues ie weakening of muscles that produced a partial tear.
Age: 53.0
Sex: F
Vaccine: FLUC4
Symptoms: Abdominal pain upper, Diarrhoea, Headache, Injection site pain
Clinical narrative: I received flu shot at 8:30 a.m. 11-16-18 by 2 pm on the same day I had a bad headache which lasted for 2 days. My arm ached around and at the site of injection and throbbed. I did put heat and alternated with ice and the heat seemed to help but this lasted for approx. 18 hours. On Sunday 11-18-18 I experienced stomach cramps and loose stools. Which lasted for approx. 6 hours.  I am a healthy person otherwise and was feeling well before the injection.
Age: 27.0
Sex: M
Vaccine: ANTH, FLU4, SMALL, TYP
Symptoms: Erythema, Malaise, Nausea, Papule, Pruritus
Clinical narrative: On Saturday, 11/17, pt experienced acute onset of erythema extending to the elbow on the left arm, erythematous/pruritic papules across chest, back, neck, and right shoulder, nausea, significant malaise, fever to 101. Did not seek medical care. Upon follow-up on Monday, 11/19, arm erythema was resolved, energy was returning, pt was afebrile, nausea resolved. Papules remain across chest, upper back, neck, and right shoulder in addition to Smallpox inoculation site on the left shoulder.
Age: 27.0
Sex: M
Vaccine: ANTH, FLU4, SMALL, TYP
Symptoms: Pyrexia
Clinical narrative: On Saturday, 11/17, pt experienced acute onset of erythema extending to the elbow on the left arm, erythematous/pruritic papules across chest, back, neck, and right shoulder, nausea, significant malaise, fever to 101. Did not seek medical care. Upon follow-up on Monday, 11/19, arm erythema was resolved, energy was returning, pt was afebrile, nausea resolved. Papules remain across chest, upper back, neck, and right shoulder in addition to Smallpox inoculation site on the left shoulder.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Feeling cold, Myalgia, Pyrexia
Clinical narrative: Patient had severe muscle soreness, very cold, shivering, fever of 100 F. Lasted about 3 days, she did not feel it was severe enough to seek medical attention.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Injection site cellulitis, Injection site pain, Injection site warmth, Skin warm
Clinical narrative: Cellulitis like reaction, hot and tender, spread throughout her injected arm. Pt went to hospital where she was monitored, she was discard sometimes later.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Tenderness
Clinical narrative: Cellulitis like reaction, hot and tender, spread throughout her injected arm. Pt went to hospital where she was monitored, she was discard sometimes later.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Feeling cold, Injection site erythema, Injection site pain, Pyrexia
Clinical narrative: Fever, Chills, Injection site painful and redness, Tiredness.
Age: 49.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Expired product administered
Clinical narrative: Pt was given VARIVAX with an expiration date of 11/18/2018 (yesterday).
Age: 52.0
Sex: M
Vaccine: FLU4
Symptoms: Gait disturbance, Insomnia, Pain, Pain in extremity, Tenderness
Clinical narrative: Sunday, 11-11-2018 @ approx. 2PM I started to notice soreness in my left leg - upper left side between the knee and butt. The pain progressively got worse as time went on causing difficulty sleeping. On 11-12-18 the pain got much worse. The above mentioned area of the leg became very sensitive to even the lightest touch. As the day progressed, I found it increasingly difficult to walk and put any weight on my left leg when traversing steps or curbs. I really didn't understand what caused this pain. I had no injuries, no swelling, no bruising. It was really strange. It was very difficult to sleep Monday night. Any movement at all caused severe pain. Tuesday, 11-13-18, the pain persisted. It was that afternoon that I reached out to Dr. I was worried it may have been GBS related to the flu shot. On Wednesday, 11-14-18, the pain very slowly started to subside. Since it started getting better, I did not go to Urgent care. By Saturday, 11-17-2018 the pain was completely gone and I was back to normal. I was amazed how fast and how painful it got and then how quickly I recovered. As I started to recover, I realized it may have something to do with the flu shot and sent an email to the CDC.
Age: 52.0
Sex: M
Vaccine: FLU4
Symptoms: Weight bearing difficulty
Clinical narrative: Sunday, 11-11-2018 @ approx. 2PM I started to notice soreness in my left leg - upper left side between the knee and butt. The pain progressively got worse as time went on causing difficulty sleeping. On 11-12-18 the pain got much worse. The above mentioned area of the leg became very sensitive to even the lightest touch. As the day progressed, I found it increasingly difficult to walk and put any weight on my left leg when traversing steps or curbs. I really didn't understand what caused this pain. I had no injuries, no swelling, no bruising. It was really strange. It was very difficult to sleep Monday night. Any movement at all caused severe pain. Tuesday, 11-13-18, the pain persisted. It was that afternoon that I reached out to Dr. I was worried it may have been GBS related to the flu shot. On Wednesday, 11-14-18, the pain very slowly started to subside. Since it started getting better, I did not go to Urgent care. By Saturday, 11-17-2018 the pain was completely gone and I was back to normal. I was amazed how fast and how painful it got and then how quickly I recovered. As I started to recover, I realized it may have something to do with the flu shot and sent an email to the CDC.
Age: 11.0
Sex: M
Vaccine: FLU4
Symptoms: Fall, Head injury
Clinical narrative: Within 5 minutes of receiving the vaccine the patient was in a standing position and suddenly fell to the ground hitting the left side of his forehead.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Chills, Headache, Musculoskeletal pain
Clinical narrative: Patient experienced chills headache and shoulder pain starting the evening of the day he received his flu shot. Patient will be starting physical therapy shortly due to his shoulder pain.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Dizziness, Headache, Hyperhidrosis, Injection site erythema
Clinical narrative: PAIN IN UPPER LEFT ARM, RED SWOLLEN UPPER LEFT ARM (SITE OF INJECTION), 101 FEVER, CHILLS, SHAKING, SWEATS, ACHY BODY, DIZZINESS, HEADACHE FOR 2 DAYS.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling, Pain, Pyrexia, Tremor
Clinical narrative: PAIN IN UPPER LEFT ARM, RED SWOLLEN UPPER LEFT ARM (SITE OF INJECTION), 101 FEVER, CHILLS, SHAKING, SWEATS, ACHY BODY, DIZZINESS, HEADACHE FOR 2 DAYS.
Age: 7.0
Sex: M
Vaccine: FLUN4
Symptoms: Fatigue, Nausea, Vomiting
Clinical narrative: Nausea and vomiting for 48 hours, followed by 48 hours of fatigue.
Age: 14.0
Sex: F
Vaccine: FLU4
Symptoms: Loss of consciousness, Syncope
Clinical narrative: Patient received flu shot, was sitting on the bench and fainted. She was out for maybe 10 seconds.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Flu like symptoms for 1-2 days, and extreme swelling, redness, and hot for about a 2 inch radius around injection site. Treated with ice packs. Swelling has reduced but even 5 days later is red and slightly swollen.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Patient stated there was a persistent soreness that made it hard for her to use her arm. She had to follow up with her physician and is current taking steroids for the pain.
Age: 23.0
Sex: F
Vaccine: FLU4
Symptoms: Culture, Cytomegalovirus test, Exposure during pregnancy, Foetal heart rate abnormal, Foetal hypokinesia
Clinical narrative: At time if immunization, patient was 23 yo G2P1 with history of cesarean section. No pregnancy complications such as gestational diabetes or elevated blood pressure, no IUGR. Her EDD was 12/7/18. She had a normal ultrasound on 11/6/18 with normal growth, AFI 24.4cm. On 11/10/18 she presented to the hospital with complaint of decreased fetal movement, and no cardiac activity was seen. Delivered a stillborn, 2.7 kg male, GA at birth 36w1d. Infant appearance normal.
Age: 23.0
Sex: F
Vaccine: FLU4
Symptoms: Parvovirus B19 test, Pathology test, Stillbirth, Toxicologic test, Treponema test
Clinical narrative: At time if immunization, patient was 23 yo G2P1 with history of cesarean section. No pregnancy complications such as gestational diabetes or elevated blood pressure, no IUGR. Her EDD was 12/7/18. She had a normal ultrasound on 11/6/18 with normal growth, AFI 24.4cm. On 11/10/18 she presented to the hospital with complaint of decreased fetal movement, and no cardiac activity was seen. Delivered a stillborn, 2.7 kg male, GA at birth 36w1d. Infant appearance normal.
Age: 23.0
Sex: F
Vaccine: FLU4
Symptoms: Ultrasound antenatal screen normal
Clinical narrative: At time if immunization, patient was 23 yo G2P1 with history of cesarean section. No pregnancy complications such as gestational diabetes or elevated blood pressure, no IUGR. Her EDD was 12/7/18. She had a normal ultrasound on 11/6/18 with normal growth, AFI 24.4cm. On 11/10/18 she presented to the hospital with complaint of decreased fetal movement, and no cardiac activity was seen. Delivered a stillborn, 2.7 kg male, GA at birth 36w1d. Infant appearance normal.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Diarrhoea, Pyrexia, Weight decreased
Clinical narrative: About 2 days after the shot, he suddenly developed fever and chills. This lasted 3 days. As soon as the fever and chills were gone, he had severe diarrhea. This lasted an additional 3 days. He lost 8 pounds.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injection site erythema, Injection site pain, Injection site pruritus, Myalgia
Clinical narrative: Pain at site began 24 hrs later, site red about 6 cm in diameter, progressed to itching over 8 days. 24 hours after injection, chills, fever of 100, nausea, muscle aches which lasted 12 hours with alternating ibuprofen and acetaminophen.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pyrexia
Clinical narrative: Pain at site began 24 hrs later, site red about 6 cm in diameter, progressed to itching over 8 days. 24 hours after injection, chills, fever of 100, nausea, muscle aches which lasted 12 hours with alternating ibuprofen and acetaminophen.
Age: 76.0
Sex: M
Vaccine: FLU3
Symptoms: Swelling
Clinical narrative: Patient had vaccine 11/15/2018. No reaction that day and no reaction ever at injection site. On 11/17/2018, patient began to experience swelling on the left side of his neck only. No pain or redness, and no throat swelling. No fever of rash. He said swelling has not resolved as of 11/19/2018. I encouraged him to discuss this with his physician.
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain
Clinical narrative: Patient received the flu vaccine on October 17th and said she still has muscle pain on the deltoid muscle where she received the vaccine over a month later. She reported seeing a physical therapist for the pain.
Age: 63.0
Sex: M
Vaccine: TDAP
Symptoms: Pharyngeal oedema, Swelling face
Clinical narrative: Swelling of throat and jaw area.
Age: 19.0
Sex: F
Vaccine: MNQ
Symptoms: Blood glucose, Blood pressure decreased, Dizziness, Headache, Loss of consciousness
Clinical narrative: Light headache, dizzy, pale, seizure for pass out on the floor approximate for 10 seconds then woke up, her mental status was fine but her face was still pale and feeling headache.
Age: 19.0
Sex: F
Vaccine: MNQ
Symptoms: Pallor, Seizure
Clinical narrative: Light headache, dizzy, pale, seizure for pass out on the floor approximate for 10 seconds then woke up, her mental status was fine but her face was still pale and feeling headache.
Age: 0.33
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC13, RV5
Symptoms: Haematochezia
Clinical narrative: For 2 days following administration of ROTATEQ vaccine, baby had blood in his stool (total of 2 times). Following the first incident at 2 months, child was seen in the office. Issue self-resolved within 2 days.
Age: 81.0
Sex: M
Vaccine: FLU3
Symptoms: Injected limb mobility decreased
Clinical narrative: Patient came to pharmacy on Monday 11/19/18 with complaint of difficulty raising left arm. Said difficulty raising left arm began around 3 days after receiving flu shot, approx 11/4/2018. Following completion of this form...phoned patient. Contacted patient to verify if any other vaccines/treatments in last several months...No. Told him, that after we met today around 4:00 PM 11/19/18, I contacted his physician and left verbal message with his staff, including all details about the event. Patient mentioned that he took dog for a walk, and was out of house when MD office called him back and left him a message. Patient plans on returning MD's call tomorrow 11/20/18 at 9:00 AM. Asked him if the difficulty raising left arm was getting better or worse, he said neither.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Injection site erythema, Injection site warmth, Pyrexia
Clinical narrative: Red area on L upper thigh where varicella vaccine was given. Warm to touch. Fevers off and on all weekend 11/17 and 11/18. No other Sx.
Age: 31.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Axillary pain, Injection site pain, Lymphadenopathy, Musculoskeletal pain
Clinical narrative: The morning after the vaccination, there was swelling in the left axillary lymph nodes and axilla. There was also a pain radiating from the left shoulder and axilla all the way down my side, hip and into the lower left buttock. I was not able to put excessive weight (from standing or sitting) on my left side.
Age: 31.0
Sex: F
Vaccine: FLU4
Symptoms: Oedema peripheral, Pain, Weight bearing difficulty
Clinical narrative: The morning after the vaccination, there was swelling in the left axillary lymph nodes and axilla. There was also a pain radiating from the left shoulder and axilla all the way down my side, hip and into the lower left buttock. I was not able to put excessive weight (from standing or sitting) on my left side.
Age: 74.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Chills, Contusion, Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: Wed: 12 hrs after shot - arm sore. Thurs: 24 hrs after, upper arm was red, swollen, warm about size of baseball. Later that afternoon my entire upper arm (all the way to bend in arm plus 2 1/2" past crazy bone on back side) was very sore, red, swollen, warm and I was running a low grade fever and had chills. Some improvement by Fri. afternoon. Mostly gone by Sat. except my upper arm was yellowish like a fading bruise. Both shots were given in same arm and same area.
Age: 74.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Pyrexia, Skin warm
Clinical narrative: Wed: 12 hrs after shot - arm sore. Thurs: 24 hrs after, upper arm was red, swollen, warm about size of baseball. Later that afternoon my entire upper arm (all the way to bend in arm plus 2 1/2" past crazy bone on back side) was very sore, red, swollen, warm and I was running a low grade fever and had chills. Some improvement by Fri. afternoon. Mostly gone by Sat. except my upper arm was yellowish like a fading bruise. Both shots were given in same arm and same area.
Age: 40.0
Sex: U
Vaccine: FLU4
Symptoms: Skin warm, Swelling, Vaccination complication
Clinical narrative: Reaction from medication 24 hours after flat warm raised area approx. 3 inches in diameter. (last few years reaction has worsened each year).
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU4, MMRV
Symptoms: Erythema, Injection site erythema, Injection site reaction
Clinical narrative: Redness (L) leg. Non tender. No fever. Right leg muscle redness.
Age: 67.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Dizziness
Clinical narrative: Dizziness. Weakness.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Muscular weakness, Pain in extremity
Clinical narrative: Muscle weakness left side, arm and leg. All on left side. Left knee buckles, weakness. Left hip weakness. Left foot pain, weakness.
Age: 86.0
Sex: F
Vaccine: FLU3
Symptoms: Fatigue, Heart rate increased, Nausea
Clinical narrative: Fast heartbeat. Nausea. Tiredness.
Age: 77.0
Sex: F
Vaccine: FLU3, PNC13, VARZOS
Symptoms: Asthenia, Chills, Headache, Immune system disorder, Pain
Clinical narrative: High fever - severe chills (shaking) body aches, headache. Called pharmacy - 10-06 - said normal, visit doctor 10-11 - immune system low - upper respiratory infection - ZITHROMAX 250 - better, but still have no energy. Dr wanted shots 1 at a time - pharmacy assured/insisted all together would be fine.
Age: 77.0
Sex: F
Vaccine: FLU3, PNC13, VARZOS
Symptoms: Pyrexia, Tremor, Upper respiratory tract infection
Clinical narrative: High fever - severe chills (shaking) body aches, headache. Called pharmacy - 10-06 - said normal, visit doctor 10-11 - immune system low - upper respiratory infection - ZITHROMAX 250 - better, but still have no energy. Dr wanted shots 1 at a time - pharmacy assured/insisted all together would be fine.
Age: 17.0
Sex: M
Vaccine: FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No reaction. 18 year old and older vaccine was given to a 17 year old.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU4, MMRV
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: L thigh w/area of erythema about the size of a quarter, no tenderness, small area of induration. R thigh w/tiny area of erythema and induration. No tenderness. No discharge at b/l injection sites. No treatment needed.
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Mass, Pain, Pruritus, Swelling
Clinical narrative: Influenza given IM right deltoid on 11/7/18. On 11/8/18, noticed lump 1 inch or quarter size, sore, pink and itchy. Took po BENADRYL 2 pills x 2. BENADRYL relieved soreness, swelling, itching. 2 pills of BENADRYL on Sat 11/10/18 and 2 on 11/11/18. Noticed difference (improvement with 1 dose). No ill effects, since 11/12/18.
Age: 1.25
Sex: F
Vaccine: FLU4, HIBV, PNC13
Symptoms: Bone scan normal, Drooling, Electroencephalogram abnormal, Grunting, Muscle twitching
Clinical narrative: 11:15pm 11/17/18 grunt like breathing, eyes wide open staring off to right and head turned to (R). She turned head when name called but blank stare and outfit soaked with drool per foster mom. She also developed bilateral upper extremity twitching ? started with (R) hand. EMS called per PCP recommendation. No time frame documented.
Age: 1.25
Sex: F
Vaccine: FLU4, HIBV, PNC13
Symptoms: Nuclear magnetic resonance imaging brain normal, Staring, Urinary tract infection, Urine analysis abnormal
Clinical narrative: 11:15pm 11/17/18 grunt like breathing, eyes wide open staring off to right and head turned to (R). She turned head when name called but blank stare and outfit soaked with drool per foster mom. She also developed bilateral upper extremity twitching ? started with (R) hand. EMS called per PCP recommendation. No time frame documented.
Age: 18.0
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: No reaction. Vaccine was given two days after expiration.
Age: 1.25
Sex: F
Vaccine: FLU4, HIBV, PNC13, FLUX, HEPA, MMR
Symptoms: Autopsy, Drug screen, Resuscitation, Unresponsive to stimuli
Clinical narrative: Patient was found unresponsive in her bed on 11/16/2018 by mom and HH nurse. CPR performed. Patient did not respond. ? possible adverse reaction.
Age: 1.25
Sex: F
Vaccine: FLU4, HIBV, PNC13, FLUX, HEPA, MMR
Symptoms: Death
Clinical narrative: Patient was found unresponsive in her bed on 11/16/2018 by mom and HH nurse. CPR performed. Patient did not respond. ? possible adverse reaction.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Feeling abnormal, Pain in extremity, Skin tightness
Clinical narrative: Patient reports 11/19/2018 that she feels her arm is sore. It felt sore when she received her shot and thought it should have gone away by now. "Sometimes it feels tight or "out of socket".
Age: 21.0
Sex: M
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Pain at injection site, described as "excruciating", hinders movement.
Age: 27.0
Sex: F
Vaccine: FLU4
Symptoms: Hypoaesthesia oral, Lip swelling, Paraesthesia oral, Swollen tongue, Urticaria
Clinical narrative: 12 hours after flu shot developed hives to upper extremities, neck and face. Had lip and tongue swelling, tingling, and numbness. BENADRYL relieved symptoms. Employee reported a reaction 10/11/2018 but didn't provide details until 11/5/2018 after several phone calls.
Age: 0.58
Sex: F
Vaccine: FLU4
Symptoms: Diarrhoea, Pyrexia, Rash, Streptococcus test negative
Clinical narrative: Started fever along with a non itchy rash the day after the shot, along with diarrhea. The rash worsened.
Age: 7.0
Sex: M
Vaccine: FLU4
Symptoms: Seizure
Clinical narrative: Seizure 2hrs after FLUZONE.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, FLU4, MMR, VARCEL
Symptoms: Injection site cellulitis, Injection site erythema
Clinical narrative: Left arm with cellulitis and erythema.
Age: 75.0
Sex: F
Vaccine: FLUA3, PPV
Symptoms: Injection site hypoaesthesia, Injection site pain, Pain, Pain in extremity
Clinical narrative: Patient reported numbness and pain at injection site that radiated down arm. Patient was advised to take an NSAID per her primary care physician.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: 10 by 12 cm area of swelling and erythema and tenderness at (L) lateral upper arm. Pt has more BENADRYL and ice and symptoms are resolving.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding concurrent conditions, medical history, or concomitant medications. In 2007, a healthcare provider at a medical clinic administered ZOSTAVAX to the patient to obtain permanent prevention and protection against shingles and zoster-related injuries (dose, route, and lot # not provided). In 2007, the patient was treated by a healthcare provider at the medical clinic for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with ZOSTAVAX, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of ZOSTAVAX, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was not recovered.  Causality assessment was related. Additional information has been requested.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Injected limb mobility decreased, Injection site pain, Myalgia, Sleep disorder
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injected limb mobility decreased in a patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, 1 day after receiving SHINGRIX, the patient experienced injected limb mobility decreased, injection site pain, sleep disturbance, muscle soreness and activities of daily living impaired. On an unknown date, the outcome of the injected limb mobility decreased, injection site pain, sleep disturbance, muscle soreness and activities of daily living impaired were recovered/resolved. It was unknown if the reporter considered the injected limb mobility decreased, injection site pain, sleep disturbance, muscle soreness and activities of daily living impaired to be related to SHINGRIX. Additional details were provided as follows: This case was reported to VAERS by the reporter. The patient had many injections over his lifespan, some of them pretty rare. The age at vaccination was not reported. The patient said that the initial SHINGRIX injection was much more painful than any others. Within an hour after vaccination, his muscle became sore. The evening after it interfered with his sleep. The next morning, the patient only had use of about 25 percent of that arm and had to cancel activities that morning. This slowly diminished over 3 weeks time. The patient said hopefully that SHINGRIX would provide some protection because it was doubtful that he would get the 2nd dose. The reporter asked what did GlaxoSmithKline thought the issue was. This case was linked with the case US2018GSK194107, reported by the same reporter.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Injected limb mobility decreased, Injection site pain, Loss of personal independence in daily activities, Myalgia, Sleep disorder
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injected limb mobility decreased in a patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, 1 day after receiving SHINGRIX, the patient experienced injected limb mobility decreased, injection site pain, sleep disturbance, muscle soreness and activities of daily living impaired. On an unknown date, the outcome of the injected limb mobility decreased, injection site pain, sleep disturbance, muscle soreness and activities of daily living impaired were recovered/resolved. It was unknown if the reporter considered the injected limb mobility decreased, injection site pain, sleep disturbance, muscle soreness and activities of daily living impaired to be related to SHINGRIX. Additional details were provided as follows: This case was reported to VAERS by the reporter. The patient had many injections over his lifespan, some of them pretty rare. The age at vaccination was not reported. The patient said that the initial SHINGRIX injection was much more painful than any others. Within an hour after vaccination, his muscle became sore. The evening after it interfered with his sleep. The next morning, the patient only had use of about 25 percent of that arm and had to cancel activities that morning. This slowly diminished over 3 weeks time. The patient said hopefully that SHINGRIX would provide some protection because it was doubtful that he would get the 2nd dose. The reporter asked what did GlaxoSmithKline thought the issue was. This case was linked with the case US2018GSK194107, reported by the same reporter.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Nasopharyngitis, Pain, Pyrexia, Rash
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of viral rash in a 60-year-old female patient who received SHINGRIX (batch number 27J4P, expiry date unknown) for prophylaxis. On 5th November 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 5th November 2018, less than a day after receiving SHINGRIX, the patient experienced viral rash, influenza-like symptoms, fever, chills, muscle pain and upper respiratory tract infection. The patient was treated with steroid ointment nos. On an unknown date, the outcome of the viral rash, influenza-like symptoms, fever, chills, muscle pain and upper respiratory tract infection were unknown. It was unknown if the reporter considered the viral rash, influenza-like symptoms, fever, chills, muscle pain and upper respiratory tract infection to be related to SHINGRIX. Additional details were received as follows: The patient received SHINGRIX vaccine in left arm. The pharmacist reported that within hours the patient presented with viral rash, flu like symptoms, fever, chills, muscle ache, and upper respiratory infection. The patient required a visit to her doctor and emergency room as well and had been put on a steroid ointment for the rash. No further details were provided. Emergency room (ER) was required.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Respiratory symptom
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of viral rash in a 60-year-old female patient who received SHINGRIX (batch number 27J4P, expiry date unknown) for prophylaxis. On 5th November 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 5th November 2018, less than a day after receiving SHINGRIX, the patient experienced viral rash, influenza-like symptoms, fever, chills, muscle pain and upper respiratory tract infection. The patient was treated with steroid ointment nos. On an unknown date, the outcome of the viral rash, influenza-like symptoms, fever, chills, muscle pain and upper respiratory tract infection were unknown. It was unknown if the reporter considered the viral rash, influenza-like symptoms, fever, chills, muscle pain and upper respiratory tract infection to be related to SHINGRIX. Additional details were received as follows: The patient received SHINGRIX vaccine in left arm. The pharmacist reported that within hours the patient presented with viral rash, flu like symptoms, fever, chills, muscle ache, and upper respiratory infection. The patient required a visit to her doctor and emergency room as well and had been put on a steroid ointment for the rash. No further details were provided. Emergency room (ER) was required.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Influenza like illness, Myalgia, Pyrexia, Upper respiratory tract infection
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of viral rash in a 60-year-old female patient who received SHINGRIX (batch number 27J4P, expiry date unknown) for prophylaxis. On 5th November 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 5th November 2018, less than a day after receiving SHINGRIX, the patient experienced viral rash, influenza-like symptoms, fever, chills, muscle pain and upper respiratory tract infection. The patient was treated with steroid ointment nos. On an unknown date, the outcome of the viral rash, influenza-like symptoms, fever, chills, muscle pain and upper respiratory tract infection were unknown. It was unknown if the reporter considered the viral rash, influenza-like symptoms, fever, chills, muscle pain and upper respiratory tract infection to be related to SHINGRIX. Additional details were received as follows: The patient received SHINGRIX vaccine in left arm. The pharmacist reported that within hours the patient presented with viral rash, flu like symptoms, fever, chills, muscle ache, and upper respiratory infection. The patient required a visit to her doctor and emergency room as well and had been put on a steroid ointment for the rash. No further details were provided. Emergency room (ER) was required.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Viral rash
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of viral rash in a 60-year-old female patient who received SHINGRIX (batch number 27J4P, expiry date unknown) for prophylaxis. On 5th November 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 5th November 2018, less than a day after receiving SHINGRIX, the patient experienced viral rash, influenza-like symptoms, fever, chills, muscle pain and upper respiratory tract infection. The patient was treated with steroid ointment nos. On an unknown date, the outcome of the viral rash, influenza-like symptoms, fever, chills, muscle pain and upper respiratory tract infection were unknown. It was unknown if the reporter considered the viral rash, influenza-like symptoms, fever, chills, muscle pain and upper respiratory tract infection to be related to SHINGRIX. Additional details were received as follows: The patient received SHINGRIX vaccine in left arm. The pharmacist reported that within hours the patient presented with viral rash, flu like symptoms, fever, chills, muscle ache, and upper respiratory infection. The patient required a visit to her doctor and emergency room as well and had been put on a steroid ointment for the rash. No further details were provided. Emergency room (ER) was required.
Age: 33.0
Sex: M
Vaccine: FLUX, FLU4
Symptoms: Immediate post-injection reaction, Mobility decreased, Musculoskeletal pain, Myalgia, Pain
Clinical narrative: The patient complained about severe pain in his arm where the flu injection was given and he to get physical treatment for it and it last for a very long time.
Age: 33.0
Sex: M
Vaccine: FLUX, FLU4
Symptoms: X-ray limb normal
Clinical narrative: The patient complained about severe pain in his arm where the flu injection was given and he to get physical treatment for it and it last for a very long time.
Age: 33.0
Sex: M
Vaccine: FLUX, FLU4
Symptoms: Injection site pain
Clinical narrative: The patient complained about severe pain in his arm where the flu injection was given and he to get physical treatment for it and it last for a very long time.
Age: 46.0
Sex: M
Vaccine: FLU4
Symptoms: Computerised tomogram, Guillain-Barre syndrome, Immunoglobulin therapy, Influenza like illness, Intensive care
Clinical narrative: Gillian Barre syndrome. My husband is on a ventilator in ICU. Flu like symptoms 36 hours after flu shot received. 12 days later paralysis.
Age: 46.0
Sex: M
Vaccine: FLU4
Symptoms: Lumbar puncture, Mechanical ventilation, Nuclear magnetic resonance imaging, Paralysis, Plasmapheresis
Clinical narrative: Gillian Barre syndrome. My husband is on a ventilator in ICU. Flu like symptoms 36 hours after flu shot received. 12 days later paralysis.
Age: 46.0
Sex: M
Vaccine: FLU4
Symptoms: Sedative therapy
Clinical narrative: Gillian Barre syndrome. My husband is on a ventilator in ICU. Flu like symptoms 36 hours after flu shot received. 12 days later paralysis.
Age: 42.0
Sex: M
Vaccine: HEPA, TYP, YF
Symptoms: Myalgia, Rash
Clinical narrative: Muscle aches & rash on arms, chest, torso, back.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Red and swollen at injection site. Low grade fever.
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Exposure during pregnancy, Interchange of vaccine products, Pregnancy test urine positive
Clinical narrative: This spontaneous prospective pregnancy report was received from a nurse prescriber and a nurse, and refers to a 14 year old female patient. The patient had no concomitant or historical therapies, historical conditions neither drug reactions or allergies. Information regarding the patient's concurrent conditions was not provided. The patient's last menstrual period was on 30-SEP-2018. On an unknown dates, the patient was vaccinated with two separate doses of GARDASIL (route, anatomical location, lot # and expiration date were not provided) for prophylaxis. The patient became pregnant on approximately 14-OCT-2018. On 25-OCT-2018, the patient received GARDASIL 9 as the third dose in the vaccination series, 0.5 ml, intramuscular, once, lot # R016970, expiration date 22-MAR-2021, for prophylaxis (interchange of vaccine products) (wrong product administered)(exposure during pregnancy). On the same date, an urine pregnancy test was performed and the result was positive. The gestation period at exposure was 3 weeks. It was reported that on an unknown date, the patient was in a medical office for well child check. The estimated date of delivery (EDD) was on 07-JUL-2019. The pregnancy outcome was outcome pending.
Sex: F
Vaccine: FLUX, PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This is spontaneous report was received from a health care professional referring to a female patient of unknown age. The patient's medical history and concomitant medication were not reported. On 30-OCT-2018 the patient was vaccinated with PNEUMOVAX 23 (Lot number and expiration date unknown) in the arm (unspecified) for prophylaxis and  at the same day the patient was vaccinated with influenza virus vaccine (unspecified) reported as  in the other arm. On an unknown date, the patient experienced redness and swelling from the injection site to the elbow (injection site swelling and injection site erythema)  in the arm where PNEUMOVAX 23 was administered. It was unknown if any treatment was given for the events. At the time of the report, the patient had not recovered from the events.. The causality assessment between PNEUMOVAX 23 and the adverse events was not provided.
Age: 1.5
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Information has been received from a physician concerning an 18 months old patient of unknown gender. Information about concomitant medications, medical history and drug reactions was not provided. On 05-NOV-2018 (reported as three days ago), the patient received one dose of GARDASIL 9 (lot #, expiration date and route were not provided) for prophylaxis instead of PREVNAR 13 (wrong product administered and product administered to patient of inappropriate age). No adverse effects were reported.
Sex: F
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: Information has been received from a pharmacist via a field representative, referring to herself, a female patient of unknown age. Information about medical history, concurrent condition and concomitant therapy was unknown. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 (dose, strength, route, frequency, lot# and expiration date were unknown) for prophylaxis(reported as vaccination). On an unknown date, the patient had a low grade fever for one day. The outcome of the event was reported as recovered. The causality assessment was not provided by the reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. Medical history, concurrent conditions, and concomitant medications were not provided. The patient's healthcare provider (unspecified healthcare professional), recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. In 2015, a healthcare provider (unspecified healthcare professional), at a pharmacy, administered the ZOSTAVAX (lot number, dosage and route of administration not provided) to the patient. In 2016, the patient was treated by an unspecified healthcare professional at a medical center for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death; aggravation of preexisting conditions and activation of latent conditions (unspecified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. Medical history, concurrent conditions, and concomitant medications were not provided. The patient's healthcare provider (unspecified healthcare professional), recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On 29-NOV-2012, a healthcare provider (unspecified healthcare professional) at the medical center, administered the ZOSTAVAX (lot number, dosage and route of administration not provided) to the patient. On 10-DEC-2012, the patient was treated by a healthcare provider (not further specified if physician or other health care professional) at a medical center for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death; aggravation of preexisting conditions and activation of latent conditions (unspecified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.