chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 52.0
Sex: F
Vaccine: PPV
Symptoms: Vaccination complication
Clinical narrative: Ssoreness at site, labored breathing, 101.5 temp, cough. Went back to doc today with same. They checked for flu(negative) Said it was reaction to shot. Watch over weekend.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Erythema
Clinical narrative: Local redness and large blister.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Chills, Decreased appetite, Erythema, Headache, Insomnia
Clinical narrative: Fever 102, Chills, Swelling and redness in left arm, pain in left arm, loss of appetite, headache, muscle pain...irritated, could not sleep.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Irritability, Myalgia, Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: Fever 102, Chills, Swelling and redness in left arm, pain in left arm, loss of appetite, headache, muscle pain...irritated, could not sleep.
Age: 15.0
Sex: F
Vaccine: VARCEL
Symptoms: Activities of daily living impaired, Anxiety, Suicidal ideation
Clinical narrative: Started feeling anxious without previous history of anxiety. This increased over 2 weeks time to the point that she was not able to go to school. Started seeing a therapist, but eventually became so bad that she was hospitalized in a psychiatric hospital due to feeing unsafe and having suicidal thoughts.
Age: 65.0
Sex: F
Vaccine: PNC13, VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site pruritus
Clinical narrative: Redness at the injection site, itchy, very hard lump.  It lasted over the next 3 days or so, then began to resolve.  She has improved significantly at this point.
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Abnormal dreams, Seizure, Syncope
Clinical narrative: Patient fainted but also seem to be having a seizure.  After she fainted she was talking about a dream that she had. Patient lay on the bed for 10 minutes. A juice was given. Patient stated that she had not eaten since 6:00 AM.
Age: 1.17
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Pyrexia, Rash erythematous, Rash generalised
Clinical narrative: Large red rash with white raised bumps, covering entire body. Fever of 101 degrees.
Age: 6.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Peripheral swelling, Pruritus, Skin warm
Clinical narrative: Foster mother brought child in today to report reaction to her influenza vaccination that was given on 2/16/17. She says that on 2/17/17, the school called her, because the child's upper arm was quite swollen (4" in diameter per foster mother) and was red, itchy, and warm to the touch. This lasted 2 days. Foster mother asked if this precludes her from influenza vaccine in the future, and I said a local site reaction did not, per CDC guidelines, preclude from future immunizations.
Age: 20.0
Sex: F
Vaccine: HPV9
Symptoms: Erythema, Pallor, Syncope
Clinical narrative: Several minutes after the patientgot the vaccine, she fainted. Then her face and arms were red. After she regained consciousness I gave her 2 teaspoonsful of  diphenhydramine liquid then her redness slowly went away. She was breathing fine but was very pale. EMT then came and checked up on her.
Age: 49.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity
Clinical narrative: Patient called to the pharmacy to say that she developed pain in her arm that spread down to her arm.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, FLU4, HIBV, PNC13, RV5
Symptoms: Haematochezia
Clinical narrative: Pt was here for 6 Month well check. Baby was fine nothing abnormal. Got her PEDIARIX, Hib, Rota, PCV13, and flu vaccines. Pt called this afternoon stating pt had blood on the stool.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site discolouration, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Left upper arm diffusely pink-red discolored. Obvious swelling to about 1.5x normal as compared to right arm. Skin is warm, intact, non-indurated. No palpable raised rash or suspicious lesions. Non-tender to palpation.
Sex: M
Vaccine: HEP
Symptoms: Agitation, Decreased appetite, Dyspnoea, Fear of injection, Gross motor delay
Clinical narrative: My son was born at 12:45AM, at 2:00AM, a doctor/nurse took the baby to do tests. His clothes did not fit (nb size). Two hours later, a nurse returned my son, which he was bare skinned, no blanket and extremely agitated. He did not gain any weight, and suffered projectile vomiting. He had to take iron drops, which caused worse symptoms. He had a difficult time sleeping alone, and still does. At 4 months, he was in the 3% for weight/height. I believe he has allergies or illness, and that's why he was always sick. I have not seen the complete birth report, and cannot say what he was diagnosed at time of birth, only what was studied through ultrasound imaging. He was smaller than expected at time of birth. Labor was caused by medical malpractice.
Sex: M
Vaccine: HEP
Symptoms: Growth retardation, Haematocrit decreased, Hypoacusis, Insomnia, Malaise
Clinical narrative: My son was born at 12:45AM, at 2:00AM, a doctor/nurse took the baby to do tests. His clothes did not fit (nb size). Two hours later, a nurse returned my son, which he was bare skinned, no blanket and extremely agitated. He did not gain any weight, and suffered projectile vomiting. He had to take iron drops, which caused worse symptoms. He had a difficult time sleeping alone, and still does. At 4 months, he was in the 3% for weight/height. I believe he has allergies or illness, and that's why he was always sick. I have not seen the complete birth report, and cannot say what he was diagnosed at time of birth, only what was studied through ultrasound imaging. He was smaller than expected at time of birth. Labor was caused by medical malpractice.
Sex: M
Vaccine: HEP
Symptoms: Motor dysfunction, Muscular weakness, Pain, Speech disorder, Swollen tongue
Clinical narrative: My son was born at 12:45AM, at 2:00AM, a doctor/nurse took the baby to do tests. His clothes did not fit (nb size). Two hours later, a nurse returned my son, which he was bare skinned, no blanket and extremely agitated. He did not gain any weight, and suffered projectile vomiting. He had to take iron drops, which caused worse symptoms. He had a difficult time sleeping alone, and still does. At 4 months, he was in the 3% for weight/height. I believe he has allergies or illness, and that's why he was always sick. I have not seen the complete birth report, and cannot say what he was diagnosed at time of birth, only what was studied through ultrasound imaging. He was smaller than expected at time of birth. Labor was caused by medical malpractice.
Sex: M
Vaccine: HEP
Symptoms: Syncope, Urinary tract disorder, Visual impairment, Vomiting projectile, Weight gain poor
Clinical narrative: My son was born at 12:45AM, at 2:00AM, a doctor/nurse took the baby to do tests. His clothes did not fit (nb size). Two hours later, a nurse returned my son, which he was bare skinned, no blanket and extremely agitated. He did not gain any weight, and suffered projectile vomiting. He had to take iron drops, which caused worse symptoms. He had a difficult time sleeping alone, and still does. At 4 months, he was in the 3% for weight/height. I believe he has allergies or illness, and that's why he was always sick. I have not seen the complete birth report, and cannot say what he was diagnosed at time of birth, only what was studied through ultrasound imaging. He was smaller than expected at time of birth. Labor was caused by medical malpractice.
Sex: M
Vaccine: HEP
Symptoms: X-ray limb abnormal
Clinical narrative: My son was born at 12:45AM, at 2:00AM, a doctor/nurse took the baby to do tests. His clothes did not fit (nb size). Two hours later, a nurse returned my son, which he was bare skinned, no blanket and extremely agitated. He did not gain any weight, and suffered projectile vomiting. He had to take iron drops, which caused worse symptoms. He had a difficult time sleeping alone, and still does. At 4 months, he was in the 3% for weight/height. I believe he has allergies or illness, and that's why he was always sick. I have not seen the complete birth report, and cannot say what he was diagnosed at time of birth, only what was studied through ultrasound imaging. He was smaller than expected at time of birth. Labor was caused by medical malpractice.
Age: 0.5
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, RVX
Symptoms: Abnormal behaviour, Crying, Injection site erythema, Irritability
Clinical narrative: Crying red where shot was given fussy all day not acting his self.
Age: 70.0
Sex: F
Vaccine: PNC13, TDAP
Symptoms: Erythema, Skin swelling
Clinical narrative: Skin Redness and Swelling...Dr prescribed Cetirizine, Ranitidine and Benadryl Cream.
Age: 76.0
Sex: M
Vaccine: PPV
Symptoms: Rash
Clinical narrative: Patient had a rash. Possibly erythema but reported to have progressed after injection.
Age: 70.0
Sex: M
Vaccine: FLU3, PNC13, VARZOS
Symptoms: Dysstasia, Fall, Gait disturbance, Guillain-Barre syndrome, Hypoaesthesia
Clinical narrative: Approx 2 weeks after vaccination 10/6/16 felt numbness in left hand and fingers, later at night same feeling in right hand, next morning both feet and then up to knees, difficult standing and walking. Fell down on 10/17 went to hospital dia with GBS. In hospital for 5 weeks.
Age: 12.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Pyrexia
Clinical narrative: Erythema 7 cm x 6 cm surrounding the injection site with fevers lasting for 3 days following vaccine administration.
Age: 0.25
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Pyrexia
Clinical narrative: Pt. developed fever of 103 degrees w/in the first 24 hrs. after being vaccinated. Upon her exam, there was no bacterial, or other source/found that would cause this temp.
Age: 46.0
Sex: M
Vaccine: HEPAB
Symptoms: Throat irritation
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of burning throat in a 46-year-old male patient who received TWINRIX Adult (batch number 7C4Z3, expiry date 6th May 2018). Co-suspect products included TWINRIX Adult (batch number 7C4Z3, expiry date 6th May 2018). On 15 September 2016, the patient received the 1st dose of TWINRIX Adult. On 15th February 2017, the patient received the 2nd dose of TWINRIX Adult. On 15th September 2016, less than a day after receiving TWINRIX Adult and not applicable after receiving TWINRIX Adult, the patient experienced burning in throat. On 15th February 2017, the patient experienced burning in throat. On an unknown date, the outcome of the burning in throat and burning in throat were unknown. It was unknown if the reporter considered the burning in throat to be related to TWINRIX Adult. It was unknown if the reporter considered the burning in throat to be related to TWINRIX Adult. Additional details were provided as follows: The nurse reported a patient who reported that he experienced burning sensation in his right throat after receiving his 3rd dose of TWINRIX Adult, on the day of reporting. The patient had not previously reported to the reporter's office, but when this happened after the 3rd dose the patient told them that the same thing also happened after his 2nd dose (less than a day after receiving the vaccine). The patient did not have any breathing difficulty. The patient stayed in the office for at least 1 hour waiting to see the doctor for a routine appointment and did not report any further effects. It was unclear if the reported lot number (7C4Z3) corresponds to the 1st dose of the vaccine or the 2nd dose or both the doses of the vaccine.
Age: 63.0
Sex: F
Vaccine: HEPAB, YF
Symptoms: Erythema, Pruritus, Urticaria
Clinical narrative: This morning (2-24-17) noticed red welt about size of silver dollar on back of red arm. Slightly itchy. No fever. No breathing problems. No egg allergies.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Aspiration bursa, Injection site pain
Clinical narrative: Patient complained of pain in arm where vaccine was given, and saw MD on 2/15/17 for left shoulder pan. MD aspirated fluid 2/16/17 and informed pt to make apt f/u as needed.
Age: 2.0
Sex: F
Vaccine: HPV9
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: HPV9 vaccine administered instead of Hepatitis A vaccine. Vaccine error. No side effects noted to date.
Age: 42.0
Sex: M
Vaccine: HEP
Symptoms: Hypoaesthesia, Injection site hypoaesthesia
Clinical narrative: Numbness noted to left arm, radiating from injection site to hand. Ice pack applied to injection site. Symptoms resolved within 15 minutes.
Age: 69.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Started having redness and puffiness around injection site. Area is about 7.5 cm in diameter. Advised her to take BENADRYL as directed.
Sex: F
Vaccine: HEP
Symptoms: Abnormal behaviour, Blister, Blood pressure abnormal, Cellulitis, Constipation
Clinical narrative: My daughter had redness around her eyes, when going into the sun for a short time, she developed red spots and tiny blisters on the face, she stared at things with a sense of fear almost, and developed into an intense fearful reaction, she was non-emotional, and non receptive to strangers. She grunted, and had dreamy eyes, that now I believe is consistent with seizures, which has progressed each year. She had a slow suckle, and feedings are prolonged, or more frequent short feedings.
Sex: F
Vaccine: HEP
Symptoms: Decreased appetite, Dental caries, Dental operation, Dermatitis contact, Drug hypersensitivity
Clinical narrative: My daughter had redness around her eyes, when going into the sun for a short time, she developed red spots and tiny blisters on the face, she stared at things with a sense of fear almost, and developed into an intense fearful reaction, she was non-emotional, and non receptive to strangers. She grunted, and had dreamy eyes, that now I believe is consistent with seizures, which has progressed each year. She had a slow suckle, and feedings are prolonged, or more frequent short feedings.
Sex: F
Vaccine: HEP
Symptoms: Erythema, Erythema of eyelid, Failure to thrive, Fall, Fear
Clinical narrative: My daughter had redness around her eyes, when going into the sun for a short time, she developed red spots and tiny blisters on the face, she stared at things with a sense of fear almost, and developed into an intense fearful reaction, she was non-emotional, and non receptive to strangers. She grunted, and had dreamy eyes, that now I believe is consistent with seizures, which has progressed each year. She had a slow suckle, and feedings are prolonged, or more frequent short feedings.
Sex: F
Vaccine: HEP
Symptoms: Feeding disorder, Foster care, Grunting, Loss of consciousness, Panic attack
Clinical narrative: My daughter had redness around her eyes, when going into the sun for a short time, she developed red spots and tiny blisters on the face, she stared at things with a sense of fear almost, and developed into an intense fearful reaction, she was non-emotional, and non receptive to strangers. She grunted, and had dreamy eyes, that now I believe is consistent with seizures, which has progressed each year. She had a slow suckle, and feedings are prolonged, or more frequent short feedings.
Sex: F
Vaccine: HEP
Symptoms: Poor sucking reflex, Respiratory disorder, Seizure, Staring, Urinary retention
Clinical narrative: My daughter had redness around her eyes, when going into the sun for a short time, she developed red spots and tiny blisters on the face, she stared at things with a sense of fear almost, and developed into an intense fearful reaction, she was non-emotional, and non receptive to strangers. She grunted, and had dreamy eyes, that now I believe is consistent with seizures, which has progressed each year. She had a slow suckle, and feedings are prolonged, or more frequent short feedings.
Sex: F
Vaccine: HEP
Symptoms: Vomiting
Clinical narrative: My daughter had redness around her eyes, when going into the sun for a short time, she developed red spots and tiny blisters on the face, she stared at things with a sense of fear almost, and developed into an intense fearful reaction, she was non-emotional, and non receptive to strangers. She grunted, and had dreamy eyes, that now I believe is consistent with seizures, which has progressed each year. She had a slow suckle, and feedings are prolonged, or more frequent short feedings.
Age: 50.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Sleep disorder
Clinical narrative: Couldn't sleep on left side where shot was given. Problem raising arm above shoulder height. Problems still occuring 10 days later.
Age: 76.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Limb discomfort, Peripheral swelling, Vaccination site erythema, Vaccination site streaking
Clinical narrative: Patient states she noticed redness and swelling and discomfort in the left arm with a possible red streak.Left arm: Faint red streak noted extending from vaccine site and 3 cm x 4 cm area of erythema.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Back pain, Chest discomfort, Dizziness, Flushing, Hyperhidrosis
Clinical narrative: FLUSHING, SWEATING, COLDNESS OF SKIN, DIZZINESS, CHEST DISCOMFORT, LOWER BACK PAIN.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Peripheral coldness
Clinical narrative: FLUSHING, SWEATING, COLDNESS OF SKIN, DIZZINESS, CHEST DISCOMFORT, LOWER BACK PAIN.
Age: 41.0
Sex: F
Vaccine: HPV9, TD
Symptoms: Intervertebral disc degeneration, Muscle spasms, Muscle tightness, Nuclear magnetic resonance imaging spinal abnormal, Paralysis
Clinical narrative: Cramping muscles, tense muscles, muscle spasms 9 days later partial paralysis.
Age: 2.0
Sex: M
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: Woke up covered in hives, no difficulty breathing, no vomiting, no swelling on face.
Age: 2.0
Sex: F
Vaccine: HEP
Symptoms: Diarrhoea, Influenza like illness, Pyrexia, Vomiting
Clinical narrative: Flu-like symptoms: vomiting, fever, diahhrea.
Age: 70.0
Sex: F
Vaccine: PNC13
Symptoms: Chills, Fatigue, Feeling of body temperature change, Lymphadenopathy
Clinical narrative: Swollen gland on right side of neck under jaw and chills, feeling hot then cold and very tired. The PREVNAR 13 shot was administered into my right arm muscle. The hot/cold sensations  and chills continued every few days during the month of January.  I had 2 other swollen gland incidents during January 2017 (same right side under jaw).  Reported these negative side effects to 2 nurses @ Dr office.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Back pain, Guillain-Barre syndrome, Hypoaesthesia, Metabolic function test, Nerve conduction studies
Clinical narrative: Patient's symptoms started around 11/17 with numbness and tingling in the hands. This progressed to back pain and numbness and tingling in the feet two days later. She was admitted to Hospital on 11/20 and underwent multiple tests. She received a diagnosis of Guillain-Barre Syndrome on 11/28/2016. She had no recent illness but a flu shot 2 months ago. The vaccine she received was the FLUZONE High Dose 2016-17 SYR.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Nuclear magnetic resonance imaging, Paraesthesia
Clinical narrative: Patient's symptoms started around 11/17 with numbness and tingling in the hands. This progressed to back pain and numbness and tingling in the feet two days later. She was admitted to Hospital on 11/20 and underwent multiple tests. She received a diagnosis of Guillain-Barre Syndrome on 11/28/2016. She had no recent illness but a flu shot 2 months ago. The vaccine she received was the FLUZONE High Dose 2016-17 SYR.
Age: 0.17
Sex: F
Vaccine: DTAPH, PPV, RVX
Symptoms: Diarrhoea, Milk allergy
Clinical narrative: Develop milk allergy. My baby had diarrea up to 16 times a day. Before vaccinations she was never allergic to milk.Treatment: doctor switch her to Alimentum formula.
Age: 16.0
Sex: M
Vaccine: FLU4, HPV9, MNQ, FLU4, HPV9, MNQ
Symptoms: Blood pressure decreased, Bradycardia, Hyperventilation, Hypotension, Presyncope
Clinical narrative: NEAR SYNCOPE, HYPOTENSION AND BRADYCARDIA. CHILD WAS HYPERVENTILATING. BP DROPPED TO 79/43 WITH PULSE 44. PULSE OX 100%. TREATED WITH REST, MONITORING. PAPER BAG REBREATHING. GIVEN ORANGE AND WATER. GRADUALLY RECOVERED, NORMAL VS AT D/C, OBSERVED FOR 25 MINUTES. PLEASE NOTE THAT SIBLING ALSO HAD SYNCOPE.
Age: 16.0
Sex: M
Vaccine: FLU4, HPV9, MNQ, FLU4, HPV9, MNQ
Symptoms: Blood pressure decreased, Bradycardia, Electrocardiogram, Hyperventilation, Hypotension
Clinical narrative: NEAR SYNCOPE, HYPOTENSION AND BRADYCARDIA. CHILD WAS HYPERVENTILATING. BP DROPPED TO 79/43 WITH PULSE 44. PULSE OX 100%. TREATED WITH REST, MONITORING. PAPER BAG REBREATHING. GIVEN ORANGE AND WATER. GRADUALLY RECOVERED, NORMAL VS AT D/C, OBSERVED FOR 25 MINUTES. PLEASE NOTE THAT SIBLING ALSO HAD SYNCOPE.
Age: 16.0
Sex: M
Vaccine: FLU4, HPV9, MNQ, FLU4, HPV9, MNQ
Symptoms: Presyncope
Clinical narrative: NEAR SYNCOPE, HYPOTENSION AND BRADYCARDIA. CHILD WAS HYPERVENTILATING. BP DROPPED TO 79/43 WITH PULSE 44. PULSE OX 100%. TREATED WITH REST, MONITORING. PAPER BAG REBREATHING. GIVEN ORANGE AND WATER. GRADUALLY RECOVERED, NORMAL VS AT D/C, OBSERVED FOR 25 MINUTES. PLEASE NOTE THAT SIBLING ALSO HAD SYNCOPE.
Age: 47.0
Sex: F
Vaccine: FLUX, PPV, FLUX, PPV
Symptoms: Injection site erythema, Myalgia, Pyrexia, Vaccination site swelling
Clinical narrative: Fever of 102.6 and redness and swelling of local vaccination area, muscle aches.
Age: 11.0
Sex: M
Vaccine: FLU4, HPV9, MNQ, TDAP
Symptoms: Fall, Haemorrhage, Head injury, Loose tooth, Loss of consciousness
Clinical narrative: SYNCOPE AND STRUCK HEAD ON CABINET WHILE FALLING. LOC FOR A TOTAL OF 5 MINUTES THEN COHERENT BUT SLOW RECOVERY.  PULSE 40 AT NADIR. PULSE OX 100% AT ALL TIMES.  BP AFTER ABOUT 4 MINUTES WAS 98/62. SLOW RECOVERY OF PULSE TO 77.  CRANIUM INTACT, MILD BLEEDING OF LOOS TOOTH.  TREATED WITH OBSERVATION, WATER, ORANGE.  VITALS NORMALIZED PRIOR TO D/C.
Age: 11.0
Sex: M
Vaccine: FLU4, HPV9, MNQ, TDAP
Symptoms: Syncope
Clinical narrative: SYNCOPE AND STRUCK HEAD ON CABINET WHILE FALLING. LOC FOR A TOTAL OF 5 MINUTES THEN COHERENT BUT SLOW RECOVERY.  PULSE 40 AT NADIR. PULSE OX 100% AT ALL TIMES.  BP AFTER ABOUT 4 MINUTES WAS 98/62. SLOW RECOVERY OF PULSE TO 77.  CRANIUM INTACT, MILD BLEEDING OF LOOS TOOTH.  TREATED WITH OBSERVATION, WATER, ORANGE.  VITALS NORMALIZED PRIOR TO D/C.
Age: 11.0
Sex: F
Vaccine: HEP, HEPA, MNQ, TDAP
Symptoms: Abdominal pain upper, Autonomic nervous system imbalance, Coeliac disease, Confusional state, Cyclic vomiting syndrome
Clinical narrative: Stomach pain, Nausea, Dizziness, Confusion, Headaches, Earache, Sore throat.
Age: 11.0
Sex: F
Vaccine: HEP, HEPA, MNQ, TDAP
Symptoms: Dizziness, Ear pain, Headache, Migraine, Nausea
Clinical narrative: Stomach pain, Nausea, Dizziness, Confusion, Headaches, Earache, Sore throat.
Age: 11.0
Sex: F
Vaccine: HEP, HEPA, MNQ, TDAP
Symptoms: Oropharyngeal pain, Pain, Thyroiditis
Clinical narrative: Stomach pain, Nausea, Dizziness, Confusion, Headaches, Earache, Sore throat.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: No irritation noted after injection but the next morning had a red raised hard hot swelling at site 1 1/2" by 2" with orange peal texture with clearly defined margins. The following day lump same but surrounded with bright pink and swelling 5" by 8 1/2", also with clearly defined margins. Following day swelling and pink area extended by about 1/2" all around. Next day swelling and redness much reduced.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Induration, Pain, Productive cough, Skin warm, Sputum discoloured
Clinical narrative: Patient received vaccine on 2/13/17. 2/15/17 patient reports having a firm, golf ball sized round area that is warm/hot/sore. This started at approximately 7:00 pm on 2/15/17. Patient also stated on 2/13/17 in the evening she developed a cough that became productive with green phlegm the following day. Taking ibuprofen. Intends to apply cool compresses and will contact physician following cold compresses - swelling went down. Called physician and physician told not unusual. 2/20/17 - All resolved except small bump. Pt and Dr felt cough due to sinus not vaccine per patient 2/20/17.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Swelling
Clinical narrative: Patient received vaccine on 2/13/17. 2/15/17 patient reports having a firm, golf ball sized round area that is warm/hot/sore. This started at approximately 7:00 pm on 2/15/17. Patient also stated on 2/13/17 in the evening she developed a cough that became productive with green phlegm the following day. Taking ibuprofen. Intends to apply cool compresses and will contact physician following cold compresses - swelling went down. Called physician and physician told not unusual. 2/20/17 - All resolved except small bump. Pt and Dr felt cough due to sinus not vaccine per patient 2/20/17.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Urticaria
Clinical narrative: Itchy "hive-like" bumps on legs and torso, some on arms. No fever or nausea. Have not gone away in over 2 weeks. Patient is going to doctor on 2/27/17.
Age: 4.0
Sex: M
Vaccine: IPV
Symptoms: Cheilitis, Cough, Crying, Dyspnoea, Lip pain
Clinical narrative: At dinner around 6pm, he complained about his upper lip hurting and it looked a little red and swollen. At 12:30am he woke crying because he was having difficulty breathing. He could breathe in ok but breathing out was hard for him and it came out more like a slow, wheezy moan. He also had an occasional deep cough that really hurt him. He fell asleep on my husband so we stayed up with him to monitor his breathing and make sure it didn't get worse. At about 3am his breathing started to improve. The next morning he was doing better but still had an irritated upper lip and some hives on his neck and leg. We took him to urgent care to get him looked at.
Age: 4.0
Sex: M
Vaccine: IPV
Symptoms: Lip swelling, Moaning, Urticaria, Wheezing
Clinical narrative: At dinner around 6pm, he complained about his upper lip hurting and it looked a little red and swollen. At 12:30am he woke crying because he was having difficulty breathing. He could breathe in ok but breathing out was hard for him and it came out more like a slow, wheezy moan. He also had an occasional deep cough that really hurt him. He fell asleep on my husband so we stayed up with him to monitor his breathing and make sure it didn't get worse. At about 3am his breathing started to improve. The next morning he was doing better but still had an irritated upper lip and some hives on his neck and leg. We took him to urgent care to get him looked at.
Age: 0.33
Sex: M
Vaccine: DTAPH, IPV, PER, RVX, TD
Symptoms: Cough, Crying, Gastrooesophageal reflux disease, Increased appetite, Middle insomnia
Clinical narrative: He started to not sleep well. He would wake 30 minutes to an hour in. Started showing worsened symptoms of reflux. Constantly wanting to nurse again. Sounding really throaty, congested and coughing. Terrible time sleeping at night. Wakes up every hour crying and wanting to nurse and sometimes goes to sleep instantly sometimes have to rock him.
Age: 0.33
Sex: M
Vaccine: DTAPH, IPV, PER, RVX, TD
Symptoms: Poor quality sleep, Respiratory tract congestion
Clinical narrative: He started to not sleep well. He would wake 30 minutes to an hour in. Started showing worsened symptoms of reflux. Constantly wanting to nurse again. Sounding really throaty, congested and coughing. Terrible time sleeping at night. Wakes up every hour crying and wanting to nurse and sometimes goes to sleep instantly sometimes have to rock him.
Age: 0.17
Sex: M
Vaccine: DTAPH, PNC13
Symptoms: Body temperature fluctuation, Decreased appetite, Dysphonia, Hypertonia, Injection site erythema
Clinical narrative: Inconsolable irritability; severely diminished appetite/inability to nurse (newborn had nursed every hour prior to vaccines, didn't nurse for 6 hours post-vaccine) and didn't return to normal appetite for 4 weeks; hypertonic/inability/reluctance to bend hips/knees/bring feet up in air for 2 weeks; temperature instability - low @ 97.0 up to 102.0 and back and forth for 5 days; developed upper respiratory symptoms (hoarseness, stuffiness); red swelling at site of injections.
Age: 0.17
Sex: M
Vaccine: DTAPH, PNC13
Symptoms: Injection site swelling, Irritability, Mobility decreased, Nasal congestion, Respiratory symptom
Clinical narrative: Inconsolable irritability; severely diminished appetite/inability to nurse (newborn had nursed every hour prior to vaccines, didn't nurse for 6 hours post-vaccine) and didn't return to normal appetite for 4 weeks; hypertonic/inability/reluctance to bend hips/knees/bring feet up in air for 2 weeks; temperature instability - low @ 97.0 up to 102.0 and back and forth for 5 days; developed upper respiratory symptoms (hoarseness, stuffiness); red swelling at site of injections.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient has redness and sweeling at injection site that caused her to seek care at her doctor's office. Doctor applied warm compresses, gave her oral benadryl and called to report incident to us for reporting a few days later.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, PNC, RV5
Symptoms: Anaemia, Autism, Developmental delay, Failure to thrive, Urinary incontinence
Clinical narrative: Developmental issues, urinary incontinance, growth development,  anemia, autism signs.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Hyperhidrosis, Pain in extremity
Clinical narrative: Chills, Sweats, sore arm.
Age: 20.0
Sex: M
Vaccine: SMALL
Symptoms: Discomfort, Rash macular
Clinical narrative: RED BLOTCHES ALONG THE ABDOMEN AREA. AND PRESSURE UNDER THE ARMPIT AREA.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Injection site erythema, Injection site warmth, Local reaction
Clinical narrative: Increased redness and warmth of left thigh.
Age: 2.0
Sex: F
Vaccine: HEPA
Symptoms: Electroencephalogram normal, Nuclear magnetic resonance imaging normal, Seizure
Clinical narrative: Had Hep A shot at 9:45-had a seizure at 11 am and another at 2:45 pm (on 2/22/2017) was admitted to hospital after 2nd seizure. No further seizures. She was discharged home 2/23 after negative work-up.
Sex: F
Vaccine: PPV
Symptoms: Hypersensitivity
Clinical narrative: This spontaneous report was received from a third party claims administrator concerning a female patient of unknown age.  Medical history and concomitant medications were not provided.  On 12-NOV-2016, the patient received PNEUMOVAX23 (route and lot # not provided).  She received the vaccination at a pharmacy.  on 12-NOV-2016, the patient experienced an allergic reaction to PNEUMOVAX23.  The outcome of the allergic reaction was unknown. Additional information has been requested.
Age: 0.5
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Pyrexia
Clinical narrative: Fever 101.3 for past 2 days since vaccine.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant, referring to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapy were not provided. On an unknown date, the patients were vaccinated with improperly stored doses of PROQUAD injection (lot# M022401 expiration date 01-NOV-2017) for prophylaxis (strength, dose and route were not provided). It was reported that the vaccines were exposed to a temperature excursion between 5 and 14 Fahrenheit degrees for 63 hours. The call was placed because of a Digital data logger. No previous temperature excursion and no adverse symptoms were reported. This is one of several reports from the same source. Additional information has been requested.; Sender's Comments:  US-009507513-1702USA009056:
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed vocational nurse referring to multiple, unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapy were not provided. On an unknown date, the patients were vaccinated with improperly stored doses of VAQTA injection (strength, dose, route, lot# and expiration date were not provided) for prophylaxis. It was reported that the vaccines were exposed to a temperature excursion between 44 Fahrenheit degrees and 77 Fahrenheit degrees for 2 hours and 45 min. The call was placed because of a Digital data logger. No previous temperature excursion and no adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.; Sender's Comments: US-009507513-1702USA009061:
Sex: F
Vaccine: VARZOS
Symptoms: Injection site vesicles
Clinical narrative: This spontaneous report was received from a physician via a company representative and refers to a female patient of unknown age. The patient's pertinent medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not reported. On an unknown date, the patient was vaccinated with ZOSTAVAX, a single injection subcutaneously (anatomical location, lot # and expiration date not reported) for prevention of herpes Zoster (shingles). On an unknown date, the patient developed blistering at the injection site after receiving ZOSTAVAX. It was unknown if the patient received any treatment, sought medical attention or if laboratory diagnostic tests were performed. At the time of the report, the outcome of the event was unknown. The causality between the event and ZOSTAVAX was not reported. Additional information has been requested.
Age: 1.5
Sex: F
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a 18 month old (reported also as 2 year-old), black, female patient who did not have any known drug reactions or allergies. There was no information about the patient's concomitant therapy or medical history provided. The patient did not have any illnesses at the time of vaccination. On 23-OCT-2015 at 14:30 (reported also as 2:30 pm), the patient was vaccinated with improperly stored dose of VARIVAX lot # L013068 in the right thigh for prophylaxis (dose, route of administration, and expiration date were not reported). The vaccination was in privates doctor's office/ hospital and administered VARIVAX was purchase with public funds. No adverse event was reported. Previous temperature excursions, the range and time of temperature excursion the administered VARIVAX experienced were not reported. It was unspecified if a digital data logger was involved. A signed informed consent form was not obtained. This is one of several reports from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1611USA014213: US-009507513-1702USA004104: US-009507513-1702USA004102: US-009507513-1702USA004103: US-009507513-1702USA004110: US-009507513-1702USA004109: US-009507513-1702USA004108: US-009507513-1702USA004107: US-009507513-1611USA008278: US-009507513-1702USA004105:
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a 4 year-old (reported also as 5 year-old), female patient who did not have any known drug reactions or allergies. There was no information about the patient's concomitant therapy or medical history provided. The patient did not have any illnesses at the time of vaccination. On 05-FEB-2016 at 11:15, the patient was vaccinated with an improperly stored dose of VARIVAX lot # L013068 dose 2 in the left thigh for prophylaxis (dose, route of administration and expiration date were not reported). It was the patient's second dose of VARIVAX (the start date of first vaccination, dose, route of administration and expiration date were not reported). The vaccination was in privates doctor's office/ hospital and administered VARIVAX was purchase with public funds. No adverse event was reported. Previous temperature excursions, the range and time of temperature excursion of the administered VARIVAX were not reported. It was unspecified if a digital data logger was involved. A signed informed consent form was not obtained. This is one of several reports from the same reporter. Additional information has been requested. Sender's Comments:  US-009507513-1611USA014213: US-009507513-1702USA004104: US-009507513-1702USA004102: US-009507513-1702USA004103: US-009507513-1702USA004110: US-009507513-1702USA004109: US-009507513-1702USA004108: US-009507513-1702USA004106: US-009507513-1702USA004105.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reaction/allergies or concomitant medication were not reported. On an unknown date, the patient was vaccinated with VARIVAX, intramuscularly (dosage schedule, lot # and expiration date were not reported) for prophylaxis (drug use via unapproved administration route). Furthermore, no adverse effect reported. There was no product quality (PQC) involved. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report has been received from a registered nurse referring to a patient of unknown age and gender. Information regarding medical history, drug reactions, allergies, concurrent conditions and concomitant therapies was not provided. On 07-FEB-2017 the patient was vaccinated with an expired dose of VAQTA, intramuscular, (anatomical location, dose, frequency, and strength were not provided), lot# reported as L003196 and expiration date 06-FEB-2017 for prophylaxis. No adverse effects were reported and not product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Liquid product physical issue, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. It was reported that the VAQTA vials were "cloudy, instead of clear" causing to the patient to miss a dose on 13-FEB-2017 (intramuscular for prophylaxis) lot/batch M040421 expiration date 26-MAY-2017. No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions, allergies and concomitant medications were not reported. On 14-FEB-2017, the patient was vaccinated once with an expired 0.65 ml dose of ZOSTAVAX lot # L039126, expiration date 08-JAN-2017, subcutaneously. No adverse effects were reported. Product quality complaint (PQC) was not involved. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a female patient of unknown age, who was reporting on herself. The patient's pertinent medical history, concurrent conditions, drug reactions, allergies and concomitant medications were not reported. On an unknown date in 2012, the patient was vaccinated with the first dose of ZOSTAVAX subcutaneously (dose, lot# and expiration date were not reported). In 2015 (date unspecified), she was re-vaccinated with the second dose of ZOSTAVAX subcutaneously (dose, lot# and expiration date were not reported). She did not experience any adverse reactions from being re-vaccinated. Product quality complaint (PQC) was not involved. Additional information is not expected, as there was no contact details provided.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema
Clinical narrative: This spontaneous report as received from a pharmacist via a company representative refers to a female patient of unknown age. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions, or allergies was provided. On 13-FEB-2017, the patient was vaccinated with a dose of ZOSTAVAX injection (1 dose/once, subcutaneously; lot# and expiration date were not provided), to prevent shingles. On 14-FEB-2017 (reported as "the next day"), the patient experienced a red streak on her arm. The pharmacist was not able to confirm whether the red streak was rash-like or not. However, he advised the patient to see a physician if something changes. It was reported, that Varicella Zoster Virus (VZV) was alerted as a precaution. At the time of the report, the patient did not recover from the adverse event, and she stated, that the streak did not bother her so she was not going to visit a physician. The relatedness between the adverse event and ZOSTAVAX was not reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant, referring to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapy were not provided. On an unknown date, the patients were vaccinated with improperly stored doses of VARIVAX injection (lot# M034583 expiration date 27-JUL-2018, lot # M035141 expiration date 03-AUG-2018) for prophylaxis (strength, dose and route were not provided). It was reported that the vaccines were exposed to a temperature excursion between 5 and 14 Fahrenheit degrees for 63 hours. The call was placed because of a Digital data logger. No previous temperature excursion and no adverse symptoms were reported. This is one of several reports from the same source. Additional information has been requested.; Sender's Comments: US-009507513-1701USA012339:
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed vocational nurse referring to multiple, unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapy were not provided. On an unknown date, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB injection (strength, dose, route, lot# and expiration date were not provided) for prophylaxis. It was reported that the vaccines were exposed to a temperature excursion between 44 Fahrenheit degrees and 77 Fahrenheit degrees for 2 hours and 45 min. The call was placed because of a Digital data logger. No previous temperature excursion and no adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.; Sender's Comments:  US-009507513-1701USA012349:
Sex: F
Vaccine: PPV
Symptoms: Chills, Erythema, Headache, Influenza like illness, Pain
Clinical narrative: This spontaneous report was received from a nurse practitioner referring to a female patient of unknown age. The patien's concurrent conditions included asthma and cardiomyopathy. The patient had no drug reactions or allergies. On 17-FEB-2017, the patient was vaccinated with PNEUMOVAX23 lot # M041394 with expiration date 23-MAY-2018 (dose, frequency and route of administration were unspecified) for prophylaxis. Concomitant therapies included losartan potassium (manufacturer unknown), pravastatin sodium (PRAVACHOL), metoprolol succinate (TOPROL) and aspirin (manufacturer unknown). At the end of the day on 17-FEB-2017, the patient experienced headache; flu-like symptoms (reported as: aching, congestion, chills) (influenza like illness) and her left arm was sore (pain in extremity). On 18-FEB-2017, she continued with the symptoms and treated herself with acetaminophen (TYLENOL). Then, on 19-FEB-2017, the patient continued with influenza like illness and found that on that same date, her left arm had red blotches and erythema (rash macular and erythema). No product quality complaint was involved. No laboratory diagnostics were performed. At the time of the report, the outcome of pain in extremity, erythema, rash macular, headache and influenza like illness was reported as recovering. The relatedness of pain in extremity, erythema, rash macular, headache and influenza like illness with PNEUMOVAX23 was not reported. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity, Rash macular, Respiratory tract congestion
Clinical narrative: This spontaneous report was received from a nurse practitioner referring to a female patient of unknown age. The patien's concurrent conditions included asthma and cardiomyopathy. The patient had no drug reactions or allergies. On 17-FEB-2017, the patient was vaccinated with PNEUMOVAX23 lot # M041394 with expiration date 23-MAY-2018 (dose, frequency and route of administration were unspecified) for prophylaxis. Concomitant therapies included losartan potassium (manufacturer unknown), pravastatin sodium (PRAVACHOL), metoprolol succinate (TOPROL) and aspirin (manufacturer unknown). At the end of the day on 17-FEB-2017, the patient experienced headache; flu-like symptoms (reported as: aching, congestion, chills) (influenza like illness) and her left arm was sore (pain in extremity). On 18-FEB-2017, she continued with the symptoms and treated herself with acetaminophen (TYLENOL). Then, on 19-FEB-2017, the patient continued with influenza like illness and found that on that same date, her left arm had red blotches and erythema (rash macular and erythema). No product quality complaint was involved. No laboratory diagnostics were performed. At the time of the report, the outcome of pain in extremity, erythema, rash macular, headache and influenza like illness was reported as recovering. The relatedness of pain in extremity, erythema, rash macular, headache and influenza like illness with PNEUMOVAX23 was not reported. Additional information has been requested.
Sex: M
Vaccine: MMR
Symptoms: Autism
Clinical narrative: A entertainment reporter reported referring to a male patient of unknown age. The patient's medical history, concurrent condition and concomitant medication were unknown. On an unknown date, the patient was vaccinated with a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) (dose, route, lot# and expiration date unknown) for prophylaxis. Subsequently on an unknown date, the patient developed autism. The patient's father believed his autistic son "changed overnight" after being administered the vaccine and linked thimerosal to the developed of the condition. The outcome of the event was unknown. Upon internal review, autism was considered as medically significant. Additional information has been requested.
Age: 1.0
Sex: U
Vaccine: HPV9
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to a 12 month old patient of unknown gender. Information about concurrent condition, concomitant medication and medical history was not provided. On 24-FEB-2017, the patient was inadvertently vaccinated with a dose of GARDASIL 9 (strength, dose, frequency, lot# and expiration date were unknown) intramuscularly for prophylaxis (Inappropriate age at vaccine administration). No adverse effect was reported. Additional information is not expected as there is no consent for follow up.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. Information about concomitant medication and medical history was not provided. On an unknown date, the patient was inadvertently vaccinated with an expired dose of PNEUMOVAX23 (injection, lot # L014458, expiration date 11-FEB-2017, 1 dose, frequency unknown) intramuscularly for prophylaxis. No adverse effects reported. Additional information has been requested.