chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 12.0
Sex: F
Vaccine: HEPA, MNQ, TDAP, UNK
Symptoms: Cough, Dyspnoea, Pharyngeal swelling
Clinical narrative: Patient received these 4 vaccines in a combo. She developed a swelling in her throat and had a hard time breathing.  She developed a persistent cough. We have been treating with homeopathic medication which has decreased the swelling in her throat.  Cough is still there.
Age: 73.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Contusion, Injection site pain
Clinical narrative: The same evening the patient got the shot she had pain on the distal lateral site of the same arm. She said she had a golf size bruise that settled down with ice and ibuprofen. She said she had pain on a 8 from 0-10. By Tuesday she said it wasn't as bad anymore.
Age: 73.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Contusion, Herpes zoster, Limb mass, Pain in extremity, Peripheral swelling
Clinical narrative: The same evening the patient got the shot she had pain on the distal lateral site of the same arm. She said she had a golf size bruise that settled down with ice and ibuprofen. She said she had pain on a 8 from 0-10. By Tuesday she said it wasn't as bad anymore.
Age: 0.08
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Crying, Ear infection, Hypersomnia, Pyrexia, Rash papular
Clinical narrative: Extremely high fever, uncontrollable crying, had an ear infection within 1 week of vaccine. Never had an ear infection prior to shot. Within 2 weeks small bumps developed all over his back, back of his arms, on his shoulders, and a few places on his legs. Called the Dr. and told him about the fever and the uncontrollable crying and I was told that it was normal and to give him tylenol. I started him on tylenol but his fever wouldn't break so I switched to ibuprofen, it helped for about 2 hours but fever returned. I rotated ibuprofen and tylenol every 4-6 hrs for the following week. The fever was slightly controlled by the ibuprofen but it was a temporary fix. I started using an old trick my grandma taught me, I put a little rubbing alcohol on a rag and rubbed it on his back and legs, it worked the best at lowering the fever. This lasted for 5 days high unexplained fever and he was also sleeping 8 hours at a time, I had to wake him up to get him to eat.
Age: 20.0
Sex: F
Vaccine: HPV9
Symptoms: Asthenia, Blood pressure abnormal, Dizziness, Fatigue, Immediate post-injection reaction
Clinical narrative: Immediately after injection patient became lightheaded and weak.  States her vision became white and she felt very tired.  Patient was sitting, no fall. Patient does not believe she lost consciousness.  Initial BP was 77/57, HR 64, O2 sat 98%, resp 14.  Patient was given water and apple juice to drink over the course of approx. 1/2 hour. BP slowly improved during that time and final BP was 101/69, HR 76, O2 sat 99%, resp 14.  Patient states sxs resolved and was able to ambulate across the hall to restroom on own.  Patient continued denying sxs and ambulated out of clinic on own.
Age: 20.0
Sex: F
Vaccine: HPV9
Symptoms: Visual impairment
Clinical narrative: Immediately after injection patient became lightheaded and weak.  States her vision became white and she felt very tired.  Patient was sitting, no fall. Patient does not believe she lost consciousness.  Initial BP was 77/57, HR 64, O2 sat 98%, resp 14.  Patient was given water and apple juice to drink over the course of approx. 1/2 hour. BP slowly improved during that time and final BP was 101/69, HR 76, O2 sat 99%, resp 14.  Patient states sxs resolved and was able to ambulate across the hall to restroom on own.  Patient continued denying sxs and ambulated out of clinic on own.
Age: 25.0
Sex: F
Vaccine: FLU4
Symptoms: Full blood count, Immune thrombocytopenic purpura, Immunoglobulin therapy, Platelet count decreased, Thrombocytopenia
Clinical narrative: I was sick for ten days before getting the flu shot at the drs office. I was seeing the dr for a viral infection that wouldn?t clear and was given the flu shot that day which they said was safe while I was ill as long as I didn?t have a fever which I did not currently.   I was admitted to the hospital 8 days later and diagnosed with thrombocytopenia with platelets less than 5k and to this day after many treatments I still have a low platelet count. They now are staying between 80-100k but that?s after taking steroids, doing IVIG twice and 4 rounds of rituxan.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Burning sensation, Hyperaesthesia, Hypoaesthesia, Injection site pain, Pain
Clinical narrative: Two months AFTER receiving the vaccination I developed pain in my right arm at the site of the vaccination. The skin around the vaccination site became numb. A self administered pin prick was not felt. Internal to the vaccination site I began experiencing random, what I can best describe as "lightning flashes" of extreme pain that felt, to me, as if I was being burned with a torch. The duration was very short, probably under 2 seconds. Had the duration been longer, it would have been unbearable.  The "flashes" were not correlated with any particular arm movement and would often present with no movement at all. Over the course of the last week or so, the "flashes" have ceased. The skin numbness is now replaced with a skin sensitivity. A light touch is mildly painful. I am due for my second shot but am having thoughts about not getting it. This experience is minor in the scheme of things but decidedly unpleasant.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Anxiety, Constipation, Crying, Ear infection, Insomnia
Clinical narrative: Inconsolable crying, high fever up to 105, developed an intolerance to milk, got an ear infection. Fever was treated by rotating tylenol and ibuprofen every 4-6 hrs but the tylenol didn't help the fever, ibuprofen helped for short periods of time, alcohol baths with a rag helped a little. Called the dr and she stated that if her fever didn't drop to bring her in in the morning, we went to ER that night because her fever was entirely too high, she received an iv for fluids and tylenol. Her fever dropped after about 2 hours and we were sent home. Within 3 or 4 days the fever subsided and we then notice a milk intolerance. She started to get really constipated to the point where we had to give her laxatives. For the next 3-4 months she wouldn't sleep at night, she developed what we thought was colic, she wouldn't sleep in her bed anymore and had severe anxiety if I put her down for any amount of time, she also developed an ear infection within the first week after having the vaccines. Now she is 6 yrs old and showing signs of ADHD.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Milk allergy, Pyrexia
Clinical narrative: Inconsolable crying, high fever up to 105, developed an intolerance to milk, got an ear infection. Fever was treated by rotating tylenol and ibuprofen every 4-6 hrs but the tylenol didn't help the fever, ibuprofen helped for short periods of time, alcohol baths with a rag helped a little. Called the dr and she stated that if her fever didn't drop to bring her in in the morning, we went to ER that night because her fever was entirely too high, she received an iv for fluids and tylenol. Her fever dropped after about 2 hours and we were sent home. Within 3 or 4 days the fever subsided and we then notice a milk intolerance. She started to get really constipated to the point where we had to give her laxatives. For the next 3-4 months she wouldn't sleep at night, she developed what we thought was colic, she wouldn't sleep in her bed anymore and had severe anxiety if I put her down for any amount of time, she also developed an ear infection within the first week after having the vaccines. Now she is 6 yrs old and showing signs of ADHD.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Headache, Injection site erythema, Malaise, Vaccination site pain
Clinical narrative: on sunday night after receiving the vaccination pt reported feeling very ill and weak. She had a severe headache. Today on 6/18 at 318p, when patient came into pharmacy, pt had a red, swollen, tender spot on her arm that was several inches long and a couple inches wide where the vaccination was given.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Vaccination site swelling
Clinical narrative: on sunday night after receiving the vaccination pt reported feeling very ill and weak. She had a severe headache. Today on 6/18 at 318p, when patient came into pharmacy, pt had a red, swollen, tender spot on her arm that was several inches long and a couple inches wide where the vaccination was given.
Age: 78.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Fatigue, Pain
Clinical narrative: Patient experienced extreme soreness, localized redness, and fatigue.
Age: 78.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Fatigue, Pain in extremity
Clinical narrative: Patient experienced extreme soreness, localized redness, and fatigue.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Injection site induration, Injection site mass
Clinical narrative: Hard lump under skin at injection site, 10 day course of antibiotics.  May need to drain if antibiotics does not resolve issue.  Possible ultrasound
Age: 3.0
Sex: M
Vaccine: MMR
Symptoms: Pruritus, Urticaria
Clinical narrative: Pt developed significant hives throughout his body, most concentrated on his back and abdomen. The child was very itchy and expressed how uncomfortable he felt.  The hives lasted approximately 3-4 days and improved gradually after baths in oatmeal and berries.
Age: 63.0
Sex: F
Vaccine: PPV
Symptoms: Peripheral swelling, Pruritus
Clinical narrative: Patient called pharmacy at 6:50 complaining of her arm swelling and itching.  She mentioned the size between a golf ball and tennis ball.    The pharmacist recommended she see a physician.   This was the only sympton mentioned no swelling of face hands or tongue.   The pharmacist called back to her house with number on file to check and she has not answered the phone.  called at 7  and 8 pm on 6/17/2019 and call at 9 AM on 6/18/2019.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Body temperature fluctuation, Pain, Rash generalised, Urticaria
Clinical narrative: patient has experience a progressive worsen rash all over the body, with non-itchy, but painful welts.  Patient has also been experiencing body temperature fluctuations since getting vaccination.  Primary care doctor has instructed patient to come see him if condition does not improve in 2 days
Sex: M
Vaccine: HPV9
Symptoms: Rash, Rash erythematous
Clinical narrative: Patient experienced a diffuse, flat, red rash on his face, chest, abdomen and legs; This spontaneous report was received from an osteopathic physician, via company representative, and refers to a male patient of unknown age. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications.  On an unknown date, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) for prophylaxis (administration route, anatomical location, lot number and expiration date were not reported).   On an unknown date, the patient experienced a diffuse, flat, red rash on his face, chest, abdomen and legs. It was unknown if the patient sought medical attention, if he received treatment for the event or if laboratory tests were conducted.  By the time of the report it was unknown if the event had resolved.  The reporting physician did not assess the causal relationship between the event and vaccination with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9).
Age: 45.0
Sex: F
Vaccine: RAB
Symptoms: Injection site bruising, Injection site haemorrhage, Injection site swelling, Nausea, Pain
Clinical narrative: I received the 3rd shot of my rabies vaccine in the Er at approximately 5:30pm. There was significant bleeding from the insertion point in my upper left arm. I almost instantly felt soreness and pain that typically came on slightly later. At around 12:30am, I awoke extremely nauseous. This continued for about three hours, but never led to vomiting. I had no fever. At various points the following day, I felt the waves of nausea return. By the third day after the shot, the nausea subsided. I have a large bruise at the insertion point and slight swelling.  For the first two doses, I believe I received the same vaccine (RabAvert) - the nurse injecting the vaccine said they ran out one and that they used Imovax instead. Or perhaps it was the reverse...I am not sure.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Headache, Musculoskeletal pain, Pain
Clinical narrative: headache, body aches, chills, sore shoulder
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Feeling cold, Feeling hot, Impaired work ability, Middle insomnia
Clinical narrative: Initially felt body aches which resolved with motrin.  Went to bed and woke up at 3am curled into a ball unable to get warm.  Was shaking and had bad body aches.  Got up and took motrin and was able to go back to sleep after an hour or so.  Woke up around 5:30, had 100.9 temp, body aches and felt hot.  Took more motrin, called off of work and went back to bed.  Took motrin all day as indicated on directions.  Started feeling better around 4pm and by 8pm felt completely fine, just tired.  By next day back to normal.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Tremor
Clinical narrative: Initially felt body aches which resolved with motrin.  Went to bed and woke up at 3am curled into a ball unable to get warm.  Was shaking and had bad body aches.  Got up and took motrin and was able to go back to sleep after an hour or so.  Woke up around 5:30, had 100.9 temp, body aches and felt hot.  Took more motrin, called off of work and went back to bed.  Took motrin all day as indicated on directions.  Started feeling better around 4pm and by 8pm felt completely fine, just tired.  By next day back to normal.
Age: 67.0
Sex: F
Vaccine: PPV, TDAP, VARZOS
Symptoms: Dizziness, Fatigue, Feeling abnormal, Injected limb mobility decreased, Injection site erythema
Clinical narrative: By 7-8pm started to feel funny, and left arm started to itch, swelling towards elbow area, nausea, dizziness. Used rubbing alcohol to help with itching.   Next day, left arm was still very swollen and could hardly lift it for 3 days.   Patient took hot shower and used ice compresses to help with arm issues.  Patient called pharmacist, doctor, and ER but did not go in.  On  6/15 patient told to take  Benadryl to help with symptoms.   Patient feels like body has been through a transition; can't turn fast because gets dizzy and very tired. Today patient feels well, still has lump and area is red and itchy.
Age: 67.0
Sex: F
Vaccine: PPV, TDAP, VARZOS
Symptoms: Injection site pruritus, Nausea, Peripheral swelling, Pruritus
Clinical narrative: By 7-8pm started to feel funny, and left arm started to itch, swelling towards elbow area, nausea, dizziness. Used rubbing alcohol to help with itching.   Next day, left arm was still very swollen and could hardly lift it for 3 days.   Patient took hot shower and used ice compresses to help with arm issues.  Patient called pharmacist, doctor, and ER but did not go in.  On  6/15 patient told to take  Benadryl to help with symptoms.   Patient feels like body has been through a transition; can't turn fast because gets dizzy and very tired. Today patient feels well, still has lump and area is red and itchy.
Age: 4.0
Sex: M
Vaccine: MMR
Symptoms: Injection site erythema, Injection site reaction, Urticaria
Clinical narrative: A NICKEL SIZE WELT AT INJECTION SITE WITH HALF DOLLAR SIZE REDNESS IN SURROUNDING AREA, PATIENT STAYED IN OFFICE FOR AROUND 30 MINUTES AFTER INJECTION, OUTCOME GOOD.
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site warmth
Clinical narrative: Left arm localized erythema with induration, warm to touch and itchy on site of injection. Patient was told not itch and to do cold compresses to reduce itching and warmness.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Nausea, Pyrexia
Clinical narrative: Pt complained of Nausea for 5 days following vaccine and fever for 8 days (including today)
Age: 1.33
Sex: M
Vaccine: MMR
Symptoms: Decreased appetite, Irritability, Rash generalised, Rash papular, Rash pruritic
Clinical narrative: full body rash from head to toe developed 10 days after vaccination. Small pink bumps all over. Raised and itchy.  I am filling this out on day 3 of the rash appearing,, the bumps are now smaller but still covering his whole body and on his face as well.  Very irritable and sleep is disturbed from itching, appetite is lower.
Age: 1.33
Sex: M
Vaccine: MMR
Symptoms: Sleep disorder, Vaccination complication
Clinical narrative: full body rash from head to toe developed 10 days after vaccination. Small pink bumps all over. Raised and itchy.  I am filling this out on day 3 of the rash appearing,, the bumps are now smaller but still covering his whole body and on his face as well.  Very irritable and sleep is disturbed from itching, appetite is lower.
Age: 79.0
Sex: M
Vaccine: VARZOS
Symptoms: Joint swelling, Peripheral swelling
Clinical narrative: Patient experienced swelling of both hands and wrists within hours after getting vaccine.  Noticed slightly more swelling on immunized arm. Swelling still maintaining same level 4 days after injection.  Patient is on dialysis. Patient advised to contact his physician for any additional advise or treatment.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Pt presents for evaluation of area of erythema, swelling, warmth and puritis R upper arm at site of Shingrix vaccine which given 5/10.   Initially area firm. Approximately 48 hours after shot, developed small area of redness which then progressively grew to include almost the entire upper arm.   Describes intense itching.
Age: 69.0
Sex: F
Vaccine: PNC13, TDAP
Symptoms: Injection site erythema, Injection site warmth, Pain in extremity, Pyrexia
Clinical narrative: pt received Prevnar in right arm. 1st day: no symptoms. 2nd day: pt's right arm started to hurt, pt got a fever and a red spot. Over the course of time, red spot became larger, redder and hotter at/around the injection site. Pharmacy advised pt that injection site reactions are common, but due to extent of reaction, we referred pt to follow up with PCP
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Injection site pain, Injection site reaction, Injection site swelling, Pyrexia
Clinical narrative: approximately 10:00pm CDT on 6.1.19 pt was undressing for bed and discovered a red rash in the shape of a long oval on her left arm approximately 2 inches below the injection site.  There was pain and swelling at the injection site. She also had low grade fever and pain in her back from the neck to torso.  Pt did not manage symptoms with any medication and they resolved within 3 days.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash erythematous
Clinical narrative: approximately 10:00pm CDT on 6.1.19 pt was undressing for bed and discovered a red rash in the shape of a long oval on her left arm approximately 2 inches below the injection site.  There was pain and swelling at the injection site. She also had low grade fever and pain in her back from the neck to torso.  Pt did not manage symptoms with any medication and they resolved within 3 days.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Balance disorder, Blood pressure decreased, Body temperature increased, Fatigue, Heart rate increased
Clinical narrative: Awoke feeling unsteady but not lightheaded, and very fatigued.  Took my blood pressure and it was 71 over 53.  My pulse was 110.  My normal blood pressure first thing in the morning is mid 90s over high 60s .  My normal pulse in the morning ranges between 58 and 70.  I also had a temperature of 101.  My normal body temp is just below 97.  The fever remained most of the day except for brief periods where ibuprofen seemed to control it.  My systolic blood pressure eventually climbed into the 90s and the diastolic moved into the 70s.  The rapid heart rate continued all day as did the extreme fatigue.  While I am 68 years old, I probably haven?t taken a nap in more than 20 years.  I took three naps that day.  I felt normal when I woke up the following morning.  I am reporting this due to the extremely low blood pressure and the rapid heart rate.  Material I was given warned of a possible rapid heart rate but made no mention of such a concerningly low bp.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Somnolence
Clinical narrative: Awoke feeling unsteady but not lightheaded, and very fatigued.  Took my blood pressure and it was 71 over 53.  My pulse was 110.  My normal blood pressure first thing in the morning is mid 90s over high 60s .  My normal pulse in the morning ranges between 58 and 70.  I also had a temperature of 101.  My normal body temp is just below 97.  The fever remained most of the day except for brief periods where ibuprofen seemed to control it.  My systolic blood pressure eventually climbed into the 90s and the diastolic moved into the 70s.  The rapid heart rate continued all day as did the extreme fatigue.  While I am 68 years old, I probably haven?t taken a nap in more than 20 years.  I took three naps that day.  I felt normal when I woke up the following morning.  I am reporting this due to the extremely low blood pressure and the rapid heart rate.  Material I was given warned of a possible rapid heart rate but made no mention of such a concerningly low bp.
Sex: U
Vaccine: PPV
Symptoms: Pain, Pain in extremity
Clinical narrative: pain that is slowly getting better over time when moving arm.  Not severe pain
Age: 84.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus generalised
Clinical narrative: Pt  said two or three days after she received the vaccine she began to itch over her entire body.  She said even her fingertips itch.  She has not developed a rash.  The itch is disseminated over her entire body, not localized to one particular area.  She said she has had body wide itching before but not to this extreme.  She has not taken anything for it.  She denied any other symptoms.  The itch continues unabated.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Oral herpes
Clinical narrative: Patient reports cold sores in his mouth several days after receiving 2nd Shingrix vaccination
Age: 1.58
Sex: F
Vaccine: DTAP, HIBV, MMRV, PNC13
Symptoms: Rash erythematous, Rash generalised, Rash pruritic
Clinical narrative: Approximately 10 days after receiving vaccines, patient broke out in red, itchy, rash mostly on trunk. The next morning the rash had significantly worsened and spread to all over her body.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Paraesthesia, Rash
Clinical narrative: Patient  is experiencing rash on chest, abdomen, inside of forearms and tingling feeling on feet, calves, hands, and forearms
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Cellulitis, Erythema, Malaise
Clinical narrative: patient woke up on 6/17/19 not feeling well, then noticed a lot of redness on his injected arm. When he went to the medical facility, the nurse practioner diagnosed him with cellulitis. she gave him a 10 day course of cephalexin.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site induration, Pain, Rash, Skin warm
Clinical narrative: rash, swelling, warmth on arm, headache, painful, area where shot given -- hard
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Swelling
Clinical narrative: rash, swelling, warmth on arm, headache, painful, area where shot given -- hard
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Rash, Rash pruritic
Clinical narrative: BURNING AND ITCHY RASH OVER THE BODY (ARMS AND LEGS).  HEAT ESCALATES THE RASH (PATIENT CANNOT EVEN TAKE WARM/HOT SHOWERS) OVER TIME RASH IS SPREADING INTO THE FACE AND HEAD.  SYMPTOMS STARTED 2 DAYS AFTER SECOND DOSE OF SHINGRIX AND HAS BEEN ONGOING FOR 3 MONTHS AND IS WORNSENING. DERMATOLOGIST ATTRIBUTED DERM ISSUES TO SHINGRIX VACCINATION.  PT IS BEING TREATED WITH TOPICAL STEROIDS.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Confusional state, Delirium, Headache, Mobility decreased
Clinical narrative: Delirium, inability to move/leave bed, intense headache, intense muscle and joint pain, nausea, confusion, varying hot/cold skin. It was worst from 9:30 pm on the day of the vaccination through 11 am the next day, but I'm still feeling some of the symptoms now (28 hours later)
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Nausea, Peripheral coldness, Skin warm
Clinical narrative: Delirium, inability to move/leave bed, intense headache, intense muscle and joint pain, nausea, confusion, varying hot/cold skin. It was worst from 9:30 pm on the day of the vaccination through 11 am the next day, but I'm still feeling some of the symptoms now (28 hours later)
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Back pain, Hypersensitivity, Insomnia, Neck pain, Urticaria
Clinical narrative: I was unable to sleep the night following the injection due to back and neck aches.  Several hives that appeared on my back that night and the following day may have been symptoms of an allergic reaction to the medication.
Age: 0.17
Sex: F
Vaccine: DTAP, DTAPIPVHIB, HEP, HIBV, IPV, PNC13, RV5
Symptoms: Blood test, Cow's milk intolerance, Developmental delay, Eczema, Food allergy
Clinical narrative: Severe and acute eczema for almost 2 years Strabismus Extopia on both eyes needs surgery Food allergies (eggs , dairy, sesame...) Developmental delays Non verbal until 3 yrs of age
Age: 0.17
Sex: F
Vaccine: DTAP, DTAPIPVHIB, HEP, HIBV, IPV, PNC13, RV5
Symptoms: Nuclear magnetic resonance imaging, Scan, Speech disorder developmental, Strabismus
Clinical narrative: Severe and acute eczema for almost 2 years Strabismus Extopia on both eyes needs surgery Food allergies (eggs , dairy, sesame...) Developmental delays Non verbal until 3 yrs of age
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Chills, Fatigue, Flatulence, Gastrointestinal disorder
Clinical narrative: Flu symptoms (chills, fever, body aches, headache, fatigue) began about 12 hours after vaccine received.  This was the second vaccine in the 2-part series.  Flu symptoms were severe enough to miss work for a day and feel unwell for about 48 hours.   After the flu symptoms passed, I had GI issues for about two weeks - upset stomach, nausea (no vomiting), gas.  Symptoms evenually resolved after about 2 and a half weeks.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Impaired work ability, Influenza, Malaise, Nausea
Clinical narrative: Flu symptoms (chills, fever, body aches, headache, fatigue) began about 12 hours after vaccine received.  This was the second vaccine in the 2-part series.  Flu symptoms were severe enough to miss work for a day and feel unwell for about 48 hours.   After the flu symptoms passed, I had GI issues for about two weeks - upset stomach, nausea (no vomiting), gas.  Symptoms evenually resolved after about 2 and a half weeks.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: Flu symptoms (chills, fever, body aches, headache, fatigue) began about 12 hours after vaccine received.  This was the second vaccine in the 2-part series.  Flu symptoms were severe enough to miss work for a day and feel unwell for about 48 hours.   After the flu symptoms passed, I had GI issues for about two weeks - upset stomach, nausea (no vomiting), gas.  Symptoms evenually resolved after about 2 and a half weeks.
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Hypersensitivity, Myalgia, Pyrexia, Urticaria
Clinical narrative: 11 pm Fever to 101. Tylenol Myalgias Hives on Left arm, then hives on Right arm seen in Emergency Room on 6/7/19 Benadryl 50 mg given. Dx: Mild allergic
Age: 18.0
Sex: M
Vaccine: HPV4, MENB
Symptoms: Asthenia, Fall, Gait disturbance, Muscular weakness
Clinical narrative: Entire body weakness next morning, fell to floor, leg weakness, walking upstairs w/ difficulty. Sent to ER
Age: 1.5
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Pyrexia, Rash
Clinical narrative: Rash on trunk w/low grade fever on and off.
Age: 70.0
Sex: F
Vaccine: TDAP
Symptoms: Feeling abnormal, Hypersensitivity, Hypertension
Clinical narrative: Patient received a boostrix shot & said she did not feel not herself afterward. She went to see our nurse practitioner on site, her blood pressure was high. Her son took her to the local ER. Followup call I spoke to patient & she said she is ok now. She got IV medication for the allergic reaction.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Eye swelling, Ocular hyperaemia
Clinical narrative: Right eye redness + swelling occuring next day after shot. Pt did say she was pulling weeds the previous day.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site swelling
Clinical narrative: Erythema & swelling 24 hours after injection site - (R) leg. Itching, red & indurated, irregular borders. Antihistamine (Zyrtec) & ice to site, Tylenol prn. Cephalexin 250/5 if progressive inflammation & fever & tenderness develop.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Fatigue, Headache, Injection site erythema, Injection site pain
Clinical narrative: fever; chills; headache; aches; This case was reported by a consumer via call center representative and described the occurrence of fever in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced fever, chills, headache and pain. On an unknown date, the outcome of the fever, chills, headache and pain were unknown.   It was unknown if the reporter considered the fever, chills, headache and pain to be related to Shingrix.  Additional information was provided as follows: The age group was not reported but was selected as adult as per vaccine indication. The patient experienced side effects after receiving Shingrix. The patient was inquiring about what should they expect for second dose. The patient had reported her negative side effects to VAERS and Centers for Disease Control and Prevention (CDC) already.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site swelling, Myalgia, Pyrexia
Clinical narrative: fever; chills; headache; aches; This case was reported by a consumer via call center representative and described the occurrence of fever in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced fever, chills, headache and pain. On an unknown date, the outcome of the fever, chills, headache and pain were unknown.   It was unknown if the reporter considered the fever, chills, headache and pain to be related to Shingrix.  Additional information was provided as follows: The age group was not reported but was selected as adult as per vaccine indication. The patient experienced side effects after receiving Shingrix. The patient was inquiring about what should they expect for second dose. The patient had reported her negative side effects to VAERS and Centers for Disease Control and Prevention (CDC) already.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Headache, Pain, Pyrexia
Clinical narrative: fever; chills; headache; aches; This case was reported by a consumer via call center representative and described the occurrence of fever in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced fever, chills, headache and pain. On an unknown date, the outcome of the fever, chills, headache and pain were unknown.   It was unknown if the reporter considered the fever, chills, headache and pain to be related to Shingrix.  Additional information was provided as follows: The age group was not reported but was selected as adult as per vaccine indication. The patient experienced side effects after receiving Shingrix. The patient was inquiring about what should they expect for second dose. The patient had reported her negative side effects to VAERS and Centers for Disease Control and Prevention (CDC) already.
Age: 78.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Fatigue, Pain
Clinical narrative: Patient suffer redness, soreness, and fatigue in vaccinated arm. Patient experience these symptoms approximately the day after the vaccination and contacted the pharmacy on the 4th day asking about the symptoms.
Age: 78.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Fatigue, Pain in extremity
Clinical narrative: Patient suffer redness, soreness, and fatigue in vaccinated arm. Patient experience these symptoms approximately the day after the vaccination and contacted the pharmacy on the 4th day asking about the symptoms.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Feeling cold, Headache, Myalgia
Clinical narrative: Muscle soreness, headache, shivering, feeling really cold towards night time.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pyrexia, Skin warm, Swelling
Clinical narrative: Pain, swelling, hot to touch. Very low grade fever (98.4, normal ~97.3)
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Chills, Fatigue, Injection site erythema, Injection site pain
Clinical narrative: Pain in injection site started after a couple of hours, then I had body aches, muscle pain, chills, stomachs ache and fatigue and general malaise, lasting two days, either redness and bumpiness around the injection site. Then it became very itchy by the second day afterward and then I started getting a bumpy, itchy rash on the opposite arm.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash, Malaise, Myalgia, Pain, Pruritus
Clinical narrative: Pain in injection site started after a couple of hours, then I had body aches, muscle pain, chills, stomachs ache and fatigue and general malaise, lasting two days, either redness and bumpiness around the injection site. Then it became very itchy by the second day afterward and then I started getting a bumpy, itchy rash on the opposite arm.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash pruritic
Clinical narrative: Pain in injection site started after a couple of hours, then I had body aches, muscle pain, chills, stomachs ache and fatigue and general malaise, lasting two days, either redness and bumpiness around the injection site. Then it became very itchy by the second day afterward and then I started getting a bumpy, itchy rash on the opposite arm.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Ear congestion, Fatigue, Headache, Injection site induration, Injection site mass
Clinical narrative: General malaise beginning approximately 8 hours after injection.  Awoke at 3:30am (approximately 14.5 hours after injection) with severe body aches, fever, headache which persisted for 36 hours unabated.  Sore throat and severe fatigue on second day.  Symptoms began to abate two days after injection.  By third day post-injection, very mild symptoms including ear "fullness."  Hard subcatenous lump 3 inches below injection site, which was itchy and persists (although smaller) four days post-injection.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Malaise, Oropharyngeal pain, Pain, Pyrexia
Clinical narrative: General malaise beginning approximately 8 hours after injection.  Awoke at 3:30am (approximately 14.5 hours after injection) with severe body aches, fever, headache which persisted for 36 hours unabated.  Sore throat and severe fatigue on second day.  Symptoms began to abate two days after injection.  By third day post-injection, very mild symptoms including ear "fullness."  Hard subcatenous lump 3 inches below injection site, which was itchy and persists (although smaller) four days post-injection.
Age: 11.0
Sex: M
Vaccine: HEPA, TDAP
Symptoms: Cold sweat, Defaecation urgency, Dizziness, Hyperhidrosis, Pallor
Clinical narrative: After administration of vaccination, patient stated to be feeling dizzy, patient skin color was pale, he become diaphoretic and clammy, patient stated he wanted to pass a bowel movement, but instead patient vomited.
Age: 11.0
Sex: M
Vaccine: HEPA, TDAP
Symptoms: Vomiting
Clinical narrative: After administration of vaccination, patient stated to be feeling dizzy, patient skin color was pale, he become diaphoretic and clammy, patient stated he wanted to pass a bowel movement, but instead patient vomited.
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Loss of consciousness
Clinical narrative: the patient "passed out".; Information has been received from a nurse via a company representative referring to a 14-year-old healthy female patient. The patient's historical condition, concomitant medications and drug reactions or allergies were not reported.  On an unknown date (reported as a couple days ago), the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (strength, dose, frequency, route, lot # and expiration date were not reported) for HPV prevention.         On an unknown date, the patient passed out. The patient responded after two "smelling salts" and was okay. The outcome of event was recovered. No lab Diagnostics/Studies was performed. Information about medical attention was not provided. The causality assessment was not provided.  Upon internal review, the patient passed out was determined to be medically significant.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect; Improperly stored PROQUAD; This spontaneous report as received from a medical assistant refers to an 8 year old patient of unknown gender. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant therapy were not reported.  On 12-JUN-2019 the patient was vaccinated with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) injection recombinant human albumin (rha) (lot # R030801, expiry date: 22-APR-2020) (dose, frequency and route were not reported) for prophylaxis. The measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) was stored in temperature of -14 degree Celsius (C) to -10 C (-14.4 C) for 15 minutes. There was previous temperature excursion reported -9 C to 8 C (-3.2 C, -7.6 C) for 4 hours. A digital data logger was not involved. No adverse effects were reported. No product quality complaint was involved.
Sex: F
Vaccine: HPV4, HPV9
Symptoms: Extra dose administered, Interchange of vaccine products, No adverse event
Clinical narrative: patient received one dose of GARDASIL in 2011, followed by three doses of GARDASIL 9 within the past year; No adverse effects were reported; patient received one dose of GARDASIL in 2011, followed by three doses of GARDASIL 9 within the past year; This spontaneous report was received from a registered nurse and refers to a 20 year old female patient. Information regarding the patient's pertinent medical history, concurrent conditions, concomitant and historical drugs, drug reactions and allergies was not provided.  On an unknown date in 2011, the patient was vaccinated with one dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL), 1 dosage form (strength, route, anatomical location, lot # and expiration date were not provided) for prophylaxis. Subsequently, approximately since 2018, reported as "within the past year", the patient started being vaccinated with three doses of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (strength, dose, frequency, route, anatomical location, lot # and expiration date were not provided) for prophylaxis. On 12-JUN-2019, the patient was vaccinated with the third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9). No adverse effects were reported.
Sex: F
Vaccine: HPV9
Symptoms: Urticaria
Clinical narrative: Broke out in hives all over her body; This spontaneous report was received from a currently 29 year old non pregnant female patient via a company representative. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided.  In 2008 (reported as: "a decade ago"), the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) route reported as: "injection" (strength, anatomical location, lot number and expiration date were not provided) for prophylaxis.  In 2008 (reported as: "a decade ago"), the patient broke out in hives all over her body (urticaria). At the tome of the report, the patient recovered from the urticaria on unspecified date.  The reporter did not assess the relatedness between the event and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9).
Sex: M
Vaccine: HPV9
Symptoms: Syncope
Clinical narrative: Syncope; This spontaneous report was received from a pharmacist via company representative refers to a 15-year-old male patient. The patient's medical history, drug reactions/allergies and concomitant medications were not reported. On an unknown date, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (dosing details, route, lot # and expiration date were not reported) for prophylaxis. On an unknown date, the patient experienced syncope post administration of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9). The outcome of syncope was unknown. Reporters causality assessment was not reported. There was no product quality complaint associated with this report.     Upon internal review the event syncope was determined to be medically significant.
Age: 0.33
Sex: M
Vaccine: RV5, DTAPIPVHIB, PNC13, RV5
Symptoms: Urticaria
Clinical narrative: Urticaria all over his body except than chest, belly and back; Urticaria all over his body except than chest, belly and back; This spontaneous report was received from the patient's grandmother referring to her grandson, a 4-month old male patient. The patient had none concomitant medication, pertinent medical history or drug reaction/allergies.  On 13-JUN-2019, the patient was vaccinated with the second dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # R034878 (expiration date: 11-SEP-2020), orally, for prophylaxis.       On 14-JUN-2019, the patient experienced urticaria all over his body except than chest, belly and back. The patient was taken to the local emergency room on that same date, where the patient was administered unspecified steroids (no laboratory diagnostics were performed). Then, the urticaria subsided on that same date, but the symptoms reappeared on 15-JUN-2019. The patient was again taken to the local emergency room on that same date. It was mentioned that the patient did not experience any adverse events with the first dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ).  At the time of the report, the vaccination with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) was discontinued on 14-JUN-2019. The outcome of the second urticaria episode was not reported. No causality assessment was provided.
Age: 0.33
Sex: M
Vaccine: RV5, DTAPIPVHIB, PNC13, RV5
Symptoms: Crying, Injection site erythema, Injection site urticaria, Irritability, Urticaria
Clinical narrative: Urticaria all over his body except than chest, belly and back; Urticaria all over his body except than chest, belly and back; This spontaneous report was received from the patient's grandmother referring to her grandson, a 4-month old male patient. The patient had none concomitant medication, pertinent medical history or drug reaction/allergies.  On 13-JUN-2019, the patient was vaccinated with the second dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # R034878 (expiration date: 11-SEP-2020), orally, for prophylaxis.       On 14-JUN-2019, the patient experienced urticaria all over his body except than chest, belly and back. The patient was taken to the local emergency room on that same date, where the patient was administered unspecified steroids (no laboratory diagnostics were performed). Then, the urticaria subsided on that same date, but the symptoms reappeared on 15-JUN-2019. The patient was again taken to the local emergency room on that same date. It was mentioned that the patient did not experience any adverse events with the first dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ).  At the time of the report, the vaccination with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) was discontinued on 14-JUN-2019. The outcome of the second urticaria episode was not reported. No causality assessment was provided.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse event; inadverently administered a dose of vaqta that was expired; This spontaneous report was received from a medical assistant (also reported as nurse) refers to a patient of unknown age. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On 13-JUN-2019, the patient was inadvertently vaccinated with expired dose of hepatitis a vaccine, inactivated(VAQTA) (lot # R013858, expiry date: 12-JUN-2019) for prophylaxis (expired product administered). No adverse effect reported (no adverse event).
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Chills, Erythema, Extensive swelling of vaccinated limb, Fatigue
Clinical narrative: swelling with red area extending to elbow; pain; redness; myalgia; fatigue; headache; shivering; fever; gastrointestinal upset; vomiting; bruising at injection site; This case was reported by a nurse via sales rep and described the occurrence of extensive swelling of vaccinated limb in a female patient who received Herpes zoster (Shingrix) (batch number 47JA3, expiry date 12th May 2020) for prophylaxis.   On 22nd April 2019, the patient received Shingrix (intramuscular) .5 ml. On 22nd April 2019, less than a day after receiving Shingrix, the patient experienced extensive swelling of vaccinated limb, pain in arm, erythema of extremities, myalgia, fatigue, headache, shivering, fever, gastrointestinal upset, vomiting and injection site bruising. On an unknown date, the outcome of the extensive swelling of vaccinated limb, pain in arm, erythema of extremities, myalgia, fatigue, headache, shivering, fever, gastrointestinal upset, vomiting and injection site bruising were recovering/resolving.   The reporter considered the extensive swelling of vaccinated limb, pain in arm, erythema of extremities, myalgia, fatigue, headache, shivering, fever, gastrointestinal upset, vomiting and injection site bruising to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in left deltoid. The nurse used 25gauge needle. Within 12 hours of vaccine administration, the patient had pain, redness and swelling with red area extending to elbow, myalgia, fatigue, headache, shivering, fever of 103 degree F, Gastrointestinal upset with vomiting and bruising at injection site. The patient was still experiencing less severe symptoms at this time of reporting. The patient was recovering after missing day of work. The reporter thought that the event was related to the product and incident was directly related to vaccine. The reporter did not agreed to follow up from GlaxoSmithKline.