chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 64.0
Sex: F
Vaccine: UNK
Symptoms: Urticaria, Vomiting, X-ray
Clinical narrative: Extreme tiredness Headache Chilly then extreme chills By 6:00pm Fever spiked to 102.1 Vomiting  & Diarrhea Convulsions Trouble breathing Called ambulance and taken to ER Sent home 4 hours later after being on IV. Next morning, huge welts were coming and going across my back, arms, legs. Went to see my regular doctor, who prescribed steriods for 4 days.  Only took steroids for2 days.  Felt extremely tired for the following week.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Rash, Rash erythematous
Clinical narrative: Mother claims developed some reddish raised rashes on her face and body at night while at home. She had just received MMR,VZV and Hep A shots earlier in the day. Otherwise she was acting well, continued to eat well and was playful. Denies any fever, no diarrhea, no coughing.
Age: 35.0
Sex: F
Vaccine: UNK
Symptoms: Blindness, Diplopia, Eye pain, Migraine, Nuclear magnetic resonance imaging brain
Clinical narrative: Eye pain on movements, migraine, double vision, partial blindness,
Age: 35.0
Sex: F
Vaccine: UNK
Symptoms: Ophthalmological examination
Clinical narrative: Eye pain on movements, migraine, double vision, partial blindness,
Age: 76.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injected limb mobility decreased, Pain in extremity, Peripheral swelling
Clinical narrative: PATIENT GOT VACCINE ON 5/16/2019 AND CAME ON 5/29/2019,REPORTING AFTER HAVING IMMUNIZATION NEXT DAY HAVE REDNESS ON LEFT ARM,SWELLING AND PAIN, CAN'T LIFT ARM FOR 5 DAYS,ASKED DID YOU CONTACT DOCTOR AS PER HER NO AND AFTER 5 DAYS SWELLING GO AWAY
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Pain, Pain in extremity, Pyrexia
Clinical narrative: Sore Arm, Body Aches, Fatigue, Fever (101.6)
Age: 58.0
Sex: F
Vaccine: CHOL, HEPA, IPV, MNQ, TDAP, TYP
Symptoms: Culture stool negative, Diarrhoea, Nausea
Clinical narrative: Came into Public health travel clinic and received travel vaccines in preparation of going in April x 2 weeks on a humanitarian mission to build wells and help with local school children.  Got IM vaccines and Cholera during appt 3/18/19 and then took Vivotif home and started them at home that evening.  Experienced severe nausea for a couple days after starting vivotif and that resolved. Then developed Diarrhea about 2 days after completion of Vivotif.  No fever; felt fine; no cramping; occasional "queasiness"; Diarrheal episodes occurred 1-2/day average. She took Imodium daily to control it. Has experienced Diarrhea since. Started 2 days after completing Vivotif, continued on through trip and continued on. On 5/7/19 we received the report from her provider. They did a stool culture which didn't show growth so she states they will continue to do some tests to help determine cause of diarrhea.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Muscle spasms
Clinical narrative: Patient experienced extreme cramps and diarrhea < 24 hours after receiving vaccination.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Condition aggravated, Injection site pain, Joint swelling, Mobility decreased
Clinical narrative: Patient came in the day after receiving a shingles vaccine and his right wrist and hand was very swollen, was very painful , and he could barely move it.  He asked me if by chance I thought i was related to the vaccine since it was the same arm he received the vaccine in.  There was no pain or redness at the injection site and was just a little painful at the actual site.  After talking to the patient more he said that hand started hurting earlier in the day (before he received the vaccine) but shortly after receiving the vaccine he got these severe symptoms.  He had went camping a week or so prior to and had an issue with his eye getting red and swollen so he didn't know if it was related to that at all.  He also said he put some rub on some ribs that he was grilling and may have used some muscles in his hand that he was not used to when applying the rub and that could be why his hand hurt earlier in the day but he didn't know what caused the symptoms to be so severe.  I followed up with the patient today and he ended up seeing a doctor because it pain and swelling was still bad after the weekend.  He was prescribed prednisone and after the second dose of it things seemed to get better.  The dr is not sure what caused this.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: Patient came in the day after receiving a shingles vaccine and his right wrist and hand was very swollen, was very painful , and he could barely move it.  He asked me if by chance I thought i was related to the vaccine since it was the same arm he received the vaccine in.  There was no pain or redness at the injection site and was just a little painful at the actual site.  After talking to the patient more he said that hand started hurting earlier in the day (before he received the vaccine) but shortly after receiving the vaccine he got these severe symptoms.  He had went camping a week or so prior to and had an issue with his eye getting red and swollen so he didn't know if it was related to that at all.  He also said he put some rub on some ribs that he was grilling and may have used some muscles in his hand that he was not used to when applying the rub and that could be why his hand hurt earlier in the day but he didn't know what caused the symptoms to be so severe.  I followed up with the patient today and he ended up seeing a doctor because it pain and swelling was still bad after the weekend.  He was prescribed prednisone and after the second dose of it things seemed to get better.  The dr is not sure what caused this.
Age: 1.0
Sex: M
Vaccine: DTAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine was expired on 5-17-2019. No signs and symptoms of any adverse reactions. No treatment given.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site hypoaesthesia, Injection site pain
Clinical narrative: Patient states he had no problems immediately after injection. About 1 month later he experienced pain and numbness at injection site.  Reports continued numbness around the injection site.
Age: 78.0
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling, Skin reaction, Skin warm
Clinical narrative: Patient stopped in and showed me her left arm which was red and warm to the touch.  It looked swollen form her shoulder to her elbow.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Musculoskeletal pain, Pain, Somnolence
Clinical narrative: Pt experienced drowsiness the night of receiving the shot which lasted for a few days. The next morning 5/25/19, pt woke up with upper right shoulder pain (shot was giving in left arm) which radiated into torso pain. This pain was the worse on Saturday 5/25/19 and has been improving slowly, daily. Pt did take naproxen for the pain on 5/27/19. Pt wasn't sure if naproxen helped the pain. Pt called the pharmacy Wednesday 5/29/19 to report of the adverse reaction. As of today, 5/29/19 the pain has been resolved. The pt did not seek medication attention for the adverse reaction to the shot.
Age: 66.0
Sex: M
Vaccine: PPV, VARZOS
Symptoms: Blood pressure decreased, Decreased appetite, Impaired work ability, Influenza like illness, Lethargy
Clinical narrative: One day after patient received both Shingrix and Pneumovax vaccines, he felt ill with flu-like symptoms and didn't eat much. By Monday, he had to leave work because of feeling ill and went to his doctor. The doctor said his BP was low (96/70) and he was very lethargic. He threw up at work on Monday and the MD sent him to urgent care to get rehydrated. He drank a glass of water at the MD and by the time he went to the urgent care, he felt better and did not require any IV hydration.  His arm was very sore, but it was his left arm which rec'd the Pneumovax vaccine.
Age: 66.0
Sex: M
Vaccine: PPV, VARZOS
Symptoms: Malaise, Pain in extremity, Vomiting
Clinical narrative: One day after patient received both Shingrix and Pneumovax vaccines, he felt ill with flu-like symptoms and didn't eat much. By Monday, he had to leave work because of feeling ill and went to his doctor. The doctor said his BP was low (96/70) and he was very lethargic. He threw up at work on Monday and the MD sent him to urgent care to get rehydrated. He drank a glass of water at the MD and by the time he went to the urgent care, he felt better and did not require any IV hydration.  His arm was very sore, but it was his left arm which rec'd the Pneumovax vaccine.
Age: 42.0
Sex: F
Vaccine: MMR
Symptoms: Cold sweat, Dizziness
Clinical narrative: Patient started having cold sweats and dizziness few minutes after having the vaccine around 1:30 pm. Patient was still seated on the chair and pharmacist was standing by there with her and asked her if she wants to call 911 for her which patient said no as she just wanted to sit down and have some water. Store management helped pharmacist to bring cold water and a fan for the patient. After 20-25 minutes patient was feeling normal and she said she  will be ok to leave for home (time was 2:05 pm). Patient was advised to use cold packs on injection site and take Ibuprofen or Tylenol in case of any pain or fever.  Store manager escorted patient to her car . Pharmacist called patient an hour after she left the store to check if she got home ok which she did and was feeling well, no more dizziness or any other side effects.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Dizziness, Headache, Nausea
Clinical narrative: Nausea, headache, mild dizziness
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Decreased appetite, Fatigue, Feeling cold, Head discomfort, Vomiting
Clinical narrative: Very cold and difficult to warm up starting in early morning  hours through afternoon,  very tired, head felt too heavy to lift, no appetite throughout day. vomited in the morning
Age: 0.25
Sex: M
Vaccine: HIBV
Symptoms: Injection site erythema, Screaming, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Inconsolable screaming for over an hour. Swollen, red, and hot skin at vaccine location. Swollen area was about the size of a baseball.
Age: 17.0
Sex: F
Vaccine: MENB, MNQ, TDAP
Symptoms: Injection site pain, Neck pain, Pain in extremity, Peripheral swelling
Clinical narrative: Within 2 hrs after vaccine - pain in injection site and arm is swollen. No heat. States pain goes up neck on (L) side. Also runs down to (L) arm.
Age: 4.0
Sex: F
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine was expired Exp date was 5/4/19  Patient was fine no adverse event happened was told I had to fill out a VAERS report.
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Rash, Rash erythematous
Clinical narrative: Pt. experienced fever for 48 hrs beginning 5/14/19 within 8 hrs of immunization.  5/26/19: pt. has red, rash on left lower abdomen.
Age: 54.0
Sex: F
Vaccine: MMR
Symptoms: Arthralgia, Feeling of body temperature change, Headache, Nausea, Peripheral swelling
Clinical narrative: hot + cold, achy joints, swollen hands + feet, smashing headache in the back of the head, ringing of the ears, swollen tonsils, nausea.
Age: 54.0
Sex: F
Vaccine: MMR
Symptoms: Tinnitus, Tonsillar hypertrophy
Clinical narrative: hot + cold, achy joints, swollen hands + feet, smashing headache in the back of the head, ringing of the ears, swollen tonsils, nausea.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Erythema, Injection site erythema, Injection site warmth, Pain
Clinical narrative: redness; burning; soreness; rash appeared on various parts of her body including arms, chest, back, legs from the knees up, stomach, buttocks and; This case was reported by a consumer via call center representative and described the occurrence of erythema of extremities in a 79-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included allergic reaction to drug excipient (allergy to propylene glycol).   On 15th February 2019, the patient received the 1st dose of Shingrix. On 15th February 2019, less than a day after receiving Shingrix, the patient experienced erythema of extremities, extremities burning sensation of, pain and generalized rash. The patient was treated with antihistamine and hydrocortisone (Cortisone Topical Cream). On an unknown date, the outcome of the erythema of extremities, extremities burning sensation of and pain were recovered/resolved and the outcome of the generalized rash was not recovered/not resolved.   It was unknown if the reporter considered the erythema of extremities, extremities burning sensation of, pain and generalized rash to be related to Shingrix.  Additional details were provided as follows: The patient received 1st dose of Shingrix on left deltoid On the same day of vaccination, the patient experienced rash on various parts of her body including arms, chest, back, legs from the knees up, stomach, buttocks and back of hands. The rash had been coming and going ever since that day. The patient experienced injection site erythema, injection site warmth that spread from her shoulder to her elbow on that arm. The patient took antihistamine daily to kept rash under control. The reporter consented to follow up.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash generalised
Clinical narrative: redness; burning; soreness; rash appeared on various parts of her body including arms, chest, back, legs from the knees up, stomach, buttocks and; This case was reported by a consumer via call center representative and described the occurrence of erythema of extremities in a 79-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included allergic reaction to drug excipient (allergy to propylene glycol).   On 15th February 2019, the patient received the 1st dose of Shingrix. On 15th February 2019, less than a day after receiving Shingrix, the patient experienced erythema of extremities, extremities burning sensation of, pain and generalized rash. The patient was treated with antihistamine and hydrocortisone (Cortisone Topical Cream). On an unknown date, the outcome of the erythema of extremities, extremities burning sensation of and pain were recovered/resolved and the outcome of the generalized rash was not recovered/not resolved.   It was unknown if the reporter considered the erythema of extremities, extremities burning sensation of, pain and generalized rash to be related to Shingrix.  Additional details were provided as follows: The patient received 1st dose of Shingrix on left deltoid On the same day of vaccination, the patient experienced rash on various parts of her body including arms, chest, back, legs from the knees up, stomach, buttocks and back of hands. The rash had been coming and going ever since that day. The patient experienced injection site erythema, injection site warmth that spread from her shoulder to her elbow on that arm. The patient took antihistamine daily to kept rash under control. The reporter consented to follow up.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Bacterial test negative, Body temperature, Brain scan abnormal, CSF test normal, Cardiac monitoring
Clinical narrative: Hours after my 4 month old received all of these vaccinations at once, I noticed his fontanel (cranial soft spot) raised like a cone on his head when he woke in the very early morning. I noticed inflammation of his body, incessant crying, and fluid retention. I raced him to hospital where they admitted him after running tests that showed no sign of a bacterial or viral infection. They took scans of his body and head and found that he had hydrocephalus (fluid on the brain). They drained his spinal fluid to check for any other infections or viruses which came up negative. He was hospitalized and further tested for 4 days and his temperature was treated with motrin/tylenol while being hooked up to heart monitors. He was very uncomfortable and in pain. His heart rate would rise often to an uncomfortable level for us as parents and they still never figured out what his diagnosis was. One of our doctors closed the door and conversed with us about the research she had found on thousands of adverse reactions just like patient's, to vaccinations. She strongly suggested that another vaccination could cause permanent brain damage and the risk was ours to take as parents.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Crying, Discomfort, Fluid retention, Fontanelle bulging, Heart rate increased
Clinical narrative: Hours after my 4 month old received all of these vaccinations at once, I noticed his fontanel (cranial soft spot) raised like a cone on his head when he woke in the very early morning. I noticed inflammation of his body, incessant crying, and fluid retention. I raced him to hospital where they admitted him after running tests that showed no sign of a bacterial or viral infection. They took scans of his body and head and found that he had hydrocephalus (fluid on the brain). They drained his spinal fluid to check for any other infections or viruses which came up negative. He was hospitalized and further tested for 4 days and his temperature was treated with motrin/tylenol while being hooked up to heart monitors. He was very uncomfortable and in pain. His heart rate would rise often to an uncomfortable level for us as parents and they still never figured out what his diagnosis was. One of our doctors closed the door and conversed with us about the research she had found on thousands of adverse reactions just like patient's, to vaccinations. She strongly suggested that another vaccination could cause permanent brain damage and the risk was ours to take as parents.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Hydrocephalus, Hypersensitivity, Inflammation, Pain, Viral test negative
Clinical narrative: Hours after my 4 month old received all of these vaccinations at once, I noticed his fontanel (cranial soft spot) raised like a cone on his head when he woke in the very early morning. I noticed inflammation of his body, incessant crying, and fluid retention. I raced him to hospital where they admitted him after running tests that showed no sign of a bacterial or viral infection. They took scans of his body and head and found that he had hydrocephalus (fluid on the brain). They drained his spinal fluid to check for any other infections or viruses which came up negative. He was hospitalized and further tested for 4 days and his temperature was treated with motrin/tylenol while being hooked up to heart monitors. He was very uncomfortable and in pain. His heart rate would rise often to an uncomfortable level for us as parents and they still never figured out what his diagnosis was. One of our doctors closed the door and conversed with us about the research she had found on thousands of adverse reactions just like patient's, to vaccinations. She strongly suggested that another vaccination could cause permanent brain damage and the risk was ours to take as parents.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Whole body scan
Clinical narrative: Hours after my 4 month old received all of these vaccinations at once, I noticed his fontanel (cranial soft spot) raised like a cone on his head when he woke in the very early morning. I noticed inflammation of his body, incessant crying, and fluid retention. I raced him to hospital where they admitted him after running tests that showed no sign of a bacterial or viral infection. They took scans of his body and head and found that he had hydrocephalus (fluid on the brain). They drained his spinal fluid to check for any other infections or viruses which came up negative. He was hospitalized and further tested for 4 days and his temperature was treated with motrin/tylenol while being hooked up to heart monitors. He was very uncomfortable and in pain. His heart rate would rise often to an uncomfortable level for us as parents and they still never figured out what his diagnosis was. One of our doctors closed the door and conversed with us about the research she had found on thousands of adverse reactions just like patient's, to vaccinations. She strongly suggested that another vaccination could cause permanent brain damage and the risk was ours to take as parents.
Age: 15.0
Sex: M
Vaccine: HPV9
Symptoms: Dizziness, Fatigue, Lip swelling, Somnolence, Swelling face
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (agency# 706375) referring to a 15 year old male patient. Information about current illness, history, prior vaccinations, other medications and lab data were reported as none. On 20-JUL-2017, the patient was vaccinated with the GARDASIL 9 (lot# M017983, strength, dose, frequency and expiration date were unknown) intramuscularly on right arm for prophylaxis. On 20-JUL-2017, after immunization injection, the patient's mother stated that the patient felt light headed and dizzy lasting only a short time. After they arrived home, the patient was tired and went to sleep till 4 PM. The patient woke up with lips and eyelid swelling but no airway compromise. The patient was given a dose of diphenhydramine hydrochloride (BENADRYL) and had dinner a while later, given another dose around 9-10 PM. The patient's mom checked on him several times during the night, no other reactions noted. The patient woke in the morning and still had facial swelling, given another dose of diphenhydramine hydrochloride (BENADRYL). Symptoms slowly improved, still noticed some swelling until the evening of the 24-JUL-2017. The patient recovered from the events. The relationship between the events and the therapy was not reported. Follow up information has been received from a healthcare professional on 15-APR-2019. On 20-JUL-2017 12:49 (previous 20-JUL-2017), the patient received the first dose of GARDASIL 9. On 20-JUL-2017 16:00 (previous 20-JUL-2017), the patient had adverse events. Follow up report received from a health care professional on 28-MAY-2019. The patient details were updated. The patient was a healthy child and had no illness at the time of vaccination. The patient was vaccinated at private doctor's office/hospital and the vaccine was purchased with private funds. No temperature excursion occurred as a result of a reading from a digital data logger.
Age: 15.0
Sex: M
Vaccine: HPV9
Symptoms: Swelling of eyelid
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (agency# 706375) referring to a 15 year old male patient. Information about current illness, history, prior vaccinations, other medications and lab data were reported as none. On 20-JUL-2017, the patient was vaccinated with the GARDASIL 9 (lot# M017983, strength, dose, frequency and expiration date were unknown) intramuscularly on right arm for prophylaxis. On 20-JUL-2017, after immunization injection, the patient's mother stated that the patient felt light headed and dizzy lasting only a short time. After they arrived home, the patient was tired and went to sleep till 4 PM. The patient woke up with lips and eyelid swelling but no airway compromise. The patient was given a dose of diphenhydramine hydrochloride (BENADRYL) and had dinner a while later, given another dose around 9-10 PM. The patient's mom checked on him several times during the night, no other reactions noted. The patient woke in the morning and still had facial swelling, given another dose of diphenhydramine hydrochloride (BENADRYL). Symptoms slowly improved, still noticed some swelling until the evening of the 24-JUL-2017. The patient recovered from the events. The relationship between the events and the therapy was not reported. Follow up information has been received from a healthcare professional on 15-APR-2019. On 20-JUL-2017 12:49 (previous 20-JUL-2017), the patient received the first dose of GARDASIL 9. On 20-JUL-2017 16:00 (previous 20-JUL-2017), the patient had adverse events. Follow up report received from a health care professional on 28-MAY-2019. The patient details were updated. The patient was a healthy child and had no illness at the time of vaccination. The patient was vaccinated at private doctor's office/hospital and the vaccine was purchased with private funds. No temperature excursion occurred as a result of a reading from a digital data logger.
Age: 79.0
Sex: F
Vaccine: PPV
Symptoms: Inflammation, Pain
Clinical narrative: Patient reported pain and inflammation that was severe. Possible cellulitis per RN. Pending MD visit.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Dyspnoea, Erythema, Pruritus, Scratch, Urticaria
Clinical narrative: Dyspnoea; Erythema; Pruritus; Scratch; Urticaria; This report was identified from a line listing obtained on request by the Company from FDA under the Freedom of Information Act (HA # 744056).  This spontaneous report as received from regulatory agency refers to a 12-year-old female patient. No medical history, concurrent condition and concomitant medications were reported. On 26-MAR-2018, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (strength and dose was not reported) (Lot No. N021572, expiration date 01-MAY-2020), intramuscularly in the right arm for prophylaxis. On 30-MAR-2018, she presented to a walk in clinic with trouble breathing and welts on entire body. The patient was given diphenhydramine (BENADRYL) and at the time of reporting still had some red areas from where patient had scratched. On an unknown date, the patient recovered from the events.  The casual relationship between dyspnoea, urticaria, scratch, pruritus, erythema and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not reported.  Follow up information has been identified from a line listing obtained on request by the Company from FDA under the Freedom of Information Act (HA # 744056) on 15-APR-2019. The primary reporter was a registered nurse. The patient was a non-pregnant female. The patient had no adverse events following any previous vaccine.
Age: 77.0
Sex: F
Vaccine: FLUX, VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: left arm rash; pain; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 77-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 21st May 2019, the patient received the 2nd dose of Shingrix (intramuscular). On 21st May 2019, less than a day after receiving Shingrix, the patient experienced injection site pain. On 22nd May 2019, the patient experienced injection site rash. On an unknown date, the outcome of the injection site pain and injection site rash were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain and injection site rash to be related to Shingrix.  Additional details were provided as follows: The age at administration was 77 years. The patient received Shingrix on left arm. The patient developed pain at the injection site on the day of vaccination, next day a 2 inch by 2 inch rash on her left arm below her injection site. The patient did not give consent to follow up. The patient did not have vaccine information for this adverse event. There is a discrepancy between the outcome reported in the structured field (not resolved/not resolved) and the outcome reported in the narrative (recovering/ resolving). The outcome of the reported events was retained as per the structural fields.
Age: 77.0
Sex: F
Vaccine: FLUX, VARZOS, VARZOS
Symptoms: Injection site pain, Injection site rash
Clinical narrative: left arm rash; pain; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 77-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 21st May 2019, the patient received the 2nd dose of Shingrix (intramuscular). On 21st May 2019, less than a day after receiving Shingrix, the patient experienced injection site pain. On 22nd May 2019, the patient experienced injection site rash. On an unknown date, the outcome of the injection site pain and injection site rash were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain and injection site rash to be related to Shingrix.  Additional details were provided as follows: The age at administration was 77 years. The patient received Shingrix on left arm. The patient developed pain at the injection site on the day of vaccination, next day a 2 inch by 2 inch rash on her left arm below her injection site. The patient did not give consent to follow up. The patient did not have vaccine information for this adverse event. There is a discrepancy between the outcome reported in the structured field (not resolved/not resolved) and the outcome reported in the narrative (recovering/ resolving). The outcome of the reported events was retained as per the structural fields.
Age: 77.0
Sex: F
Vaccine: FLUX, VARZOS, VARZOS
Symptoms: Condition aggravated, Eczema, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: left arm rash; pain; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 77-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 21st May 2019, the patient received the 2nd dose of Shingrix (intramuscular). On 21st May 2019, less than a day after receiving Shingrix, the patient experienced injection site pain. On 22nd May 2019, the patient experienced injection site rash. On an unknown date, the outcome of the injection site pain and injection site rash were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain and injection site rash to be related to Shingrix.  Additional details were provided as follows: The age at administration was 77 years. The patient received Shingrix on left arm. The patient developed pain at the injection site on the day of vaccination, next day a 2 inch by 2 inch rash on her left arm below her injection site. The patient did not give consent to follow up. The patient did not have vaccine information for this adverse event. There is a discrepancy between the outcome reported in the structured field (not resolved/not resolved) and the outcome reported in the narrative (recovering/ resolving). The outcome of the reported events was retained as per the structural fields.
Age: 77.0
Sex: F
Vaccine: FLUX, VARZOS, VARZOS
Symptoms: Tooth disorder
Clinical narrative: left arm rash; pain; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 77-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 21st May 2019, the patient received the 2nd dose of Shingrix (intramuscular). On 21st May 2019, less than a day after receiving Shingrix, the patient experienced injection site pain. On 22nd May 2019, the patient experienced injection site rash. On an unknown date, the outcome of the injection site pain and injection site rash were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain and injection site rash to be related to Shingrix.  Additional details were provided as follows: The age at administration was 77 years. The patient received Shingrix on left arm. The patient developed pain at the injection site on the day of vaccination, next day a 2 inch by 2 inch rash on her left arm below her injection site. The patient did not give consent to follow up. The patient did not have vaccine information for this adverse event. There is a discrepancy between the outcome reported in the structured field (not resolved/not resolved) and the outcome reported in the narrative (recovering/ resolving). The outcome of the reported events was retained as per the structural fields.
Age: 1.0
Sex: F
Vaccine: HEPA, HIBV, MMR, PNC13, HEPA, HIBV, MMR, PNC13, HEPA, HIBV, MMR, PNC13, HEPA, HIBV, MMR, PNC13
Symptoms: Apnoea, Cyanosis, Electrocardiogram, Electroencephalogram, Resuscitation
Clinical narrative: This case was reported by a nurse via other manufacturer and described the occurrence of febrile convulsion in a 12-month-old female patient who received HAVRIX (batch number 9TL92, expiry date 27th May 2021) for prophylaxis. Co-suspect products included PREVNAR 13 for prophylaxis, PEDVAX HIB (batch number R027320, expiry date 8th July 2021) for prophylaxis and MEASLES MUMPS RUBELLA VACCINE (batch number R028004, expiry date 1st October 2020) for prophylaxis. Previously administered products included PREVNAR 13 (1st dose received on 13th August 2018, intramuscularly on left thigh, batch number W11305/ X62324, expiry date 30th April 2020/ 30th November 2020), PREVNAR 13 (2nd dose received on 24th September 2018, intramuscularly on left thigh, batch number W33491, expiry date 30th June 2020) and PREVNAR 13 (3rd dose received on 26th November 2018, intramuscularly on left thigh, batch number X34315, expiry date 30th September 2020). On 15th May 2019 10:20, the patient received HAVRIX (intramuscular), the 4th dose of PREVNAR 13, PEDVAX HIB (intramuscular) and MEASLES MUMPS RUBELLA VACCINE (subcutaneous). On 15th May 2019, less than a day after receiving HAVRIX, the patient experienced respiratory arrest (serious criteria hospitalization and GSK medically significant). On 15th May 2019 02:00, the patient experienced febrile convulsion (serious criteria hospitalization and GSK medically significant). On an unknown date, the outcome of the febrile convulsion was recovering/resolving and the outcome of the respiratory arrest was unknown. It was unknown if the reporter considered the febrile convulsion and respiratory arrest to be related to HAVRIX. Additional details were provided as follows: Reporter unable to provide ethnicity for the patient. No other concomitant products were provided. The nurse reporting a potential adverse event for PREVNAR 13. A patient received PREVNAR 13, Hepatitis A, Measles Mumps Rubella (MMR), and Haemophilus influenza B (Hib) vaccines on yesterday morning (the day before reporting) and had a seizure around 2 or 3 that afternoon. The patient was in the hospital now (at the time of reporting). The parents reported that the patient had respiratory arrest and had to have rescue breaths, but she was doing fine now. The patient had a very high fever at the time of the seizure. Vaccine was not administered at facility. Investigations was unknown. Reporter declined to provide email. Reporter declined to provide physician email. The reporter considered this event to be medically significant. There a product complaint to report, because patient's father asked that the whole batch of PREVNAR 13 be tested, so that this event does not happen to someone else. There was a medical information request. This was not an other report.
Age: 1.0
Sex: F
Vaccine: HEPA, HIBV, MMR, PNC13, HEPA, HIBV, MMR, PNC13, HEPA, HIBV, MMR, PNC13, HEPA, HIBV, MMR, PNC13
Symptoms: Seizure
Clinical narrative: This case was reported by a nurse via other manufacturer and described the occurrence of febrile convulsion in a 12-month-old female patient who received HAVRIX (batch number 9TL92, expiry date 27th May 2021) for prophylaxis. Co-suspect products included PREVNAR 13 for prophylaxis, PEDVAX HIB (batch number R027320, expiry date 8th July 2021) for prophylaxis and MEASLES MUMPS RUBELLA VACCINE (batch number R028004, expiry date 1st October 2020) for prophylaxis. Previously administered products included PREVNAR 13 (1st dose received on 13th August 2018, intramuscularly on left thigh, batch number W11305/ X62324, expiry date 30th April 2020/ 30th November 2020), PREVNAR 13 (2nd dose received on 24th September 2018, intramuscularly on left thigh, batch number W33491, expiry date 30th June 2020) and PREVNAR 13 (3rd dose received on 26th November 2018, intramuscularly on left thigh, batch number X34315, expiry date 30th September 2020). On 15th May 2019 10:20, the patient received HAVRIX (intramuscular), the 4th dose of PREVNAR 13, PEDVAX HIB (intramuscular) and MEASLES MUMPS RUBELLA VACCINE (subcutaneous). On 15th May 2019, less than a day after receiving HAVRIX, the patient experienced respiratory arrest (serious criteria hospitalization and GSK medically significant). On 15th May 2019 02:00, the patient experienced febrile convulsion (serious criteria hospitalization and GSK medically significant). On an unknown date, the outcome of the febrile convulsion was recovering/resolving and the outcome of the respiratory arrest was unknown. It was unknown if the reporter considered the febrile convulsion and respiratory arrest to be related to HAVRIX. Additional details were provided as follows: Reporter unable to provide ethnicity for the patient. No other concomitant products were provided. The nurse reporting a potential adverse event for PREVNAR 13. A patient received PREVNAR 13, Hepatitis A, Measles Mumps Rubella (MMR), and Haemophilus influenza B (Hib) vaccines on yesterday morning (the day before reporting) and had a seizure around 2 or 3 that afternoon. The patient was in the hospital now (at the time of reporting). The parents reported that the patient had respiratory arrest and had to have rescue breaths, but she was doing fine now. The patient had a very high fever at the time of the seizure. Vaccine was not administered at facility. Investigations was unknown. Reporter declined to provide email. Reporter declined to provide physician email. The reporter considered this event to be medically significant. There a product complaint to report, because patient's father asked that the whole batch of PREVNAR 13 be tested, so that this event does not happen to someone else. There was a medical information request. This was not an other report.
Age: 1.0
Sex: F
Vaccine: HEPA, HIBV, MMR, PNC13, HEPA, HIBV, MMR, PNC13, HEPA, HIBV, MMR, PNC13, HEPA, HIBV, MMR, PNC13
Symptoms: Respiratory arrest, Resuscitation, Seizure
Clinical narrative: This case was reported by a nurse via other manufacturer and described the occurrence of febrile convulsion in a 12-month-old female patient who received HAVRIX (batch number 9TL92, expiry date 27th May 2021) for prophylaxis. Co-suspect products included PREVNAR 13 for prophylaxis, PEDVAX HIB (batch number R027320, expiry date 8th July 2021) for prophylaxis and MEASLES MUMPS RUBELLA VACCINE (batch number R028004, expiry date 1st October 2020) for prophylaxis. Previously administered products included PREVNAR 13 (1st dose received on 13th August 2018, intramuscularly on left thigh, batch number W11305/ X62324, expiry date 30th April 2020/ 30th November 2020), PREVNAR 13 (2nd dose received on 24th September 2018, intramuscularly on left thigh, batch number W33491, expiry date 30th June 2020) and PREVNAR 13 (3rd dose received on 26th November 2018, intramuscularly on left thigh, batch number X34315, expiry date 30th September 2020). On 15th May 2019 10:20, the patient received HAVRIX (intramuscular), the 4th dose of PREVNAR 13, PEDVAX HIB (intramuscular) and MEASLES MUMPS RUBELLA VACCINE (subcutaneous). On 15th May 2019, less than a day after receiving HAVRIX, the patient experienced respiratory arrest (serious criteria hospitalization and GSK medically significant). On 15th May 2019 02:00, the patient experienced febrile convulsion (serious criteria hospitalization and GSK medically significant). On an unknown date, the outcome of the febrile convulsion was recovering/resolving and the outcome of the respiratory arrest was unknown. It was unknown if the reporter considered the febrile convulsion and respiratory arrest to be related to HAVRIX. Additional details were provided as follows: Reporter unable to provide ethnicity for the patient. No other concomitant products were provided. The nurse reporting a potential adverse event for PREVNAR 13. A patient received PREVNAR 13, Hepatitis A, Measles Mumps Rubella (MMR), and Haemophilus influenza B (Hib) vaccines on yesterday morning (the day before reporting) and had a seizure around 2 or 3 that afternoon. The patient was in the hospital now (at the time of reporting). The parents reported that the patient had respiratory arrest and had to have rescue breaths, but she was doing fine now. The patient had a very high fever at the time of the seizure. Vaccine was not administered at facility. Investigations was unknown. Reporter declined to provide email. Reporter declined to provide physician email. The reporter considered this event to be medically significant. There a product complaint to report, because patient's father asked that the whole batch of PREVNAR 13 be tested, so that this event does not happen to someone else. There was a medical information request. This was not an other report.
Age: 1.0
Sex: F
Vaccine: HEPA, HIBV, MMR, PNC13, HEPA, HIBV, MMR, PNC13, HEPA, HIBV, MMR, PNC13, HEPA, HIBV, MMR, PNC13
Symptoms: Pyrexia, Respiratory arrest, Resuscitation, Seizure
Clinical narrative: This case was reported by a nurse via other manufacturer and described the occurrence of febrile convulsion in a 12-month-old female patient who received HAVRIX (batch number 9TL92, expiry date 27th May 2021) for prophylaxis. Co-suspect products included PREVNAR 13 for prophylaxis, PEDVAX HIB (batch number R027320, expiry date 8th July 2021) for prophylaxis and MEASLES MUMPS RUBELLA VACCINE (batch number R028004, expiry date 1st October 2020) for prophylaxis. Previously administered products included PREVNAR 13 (1st dose received on 13th August 2018, intramuscularly on left thigh, batch number W11305/ X62324, expiry date 30th April 2020/ 30th November 2020), PREVNAR 13 (2nd dose received on 24th September 2018, intramuscularly on left thigh, batch number W33491, expiry date 30th June 2020) and PREVNAR 13 (3rd dose received on 26th November 2018, intramuscularly on left thigh, batch number X34315, expiry date 30th September 2020). On 15th May 2019 10:20, the patient received HAVRIX (intramuscular), the 4th dose of PREVNAR 13, PEDVAX HIB (intramuscular) and MEASLES MUMPS RUBELLA VACCINE (subcutaneous). On 15th May 2019, less than a day after receiving HAVRIX, the patient experienced respiratory arrest (serious criteria hospitalization and GSK medically significant). On 15th May 2019 02:00, the patient experienced febrile convulsion (serious criteria hospitalization and GSK medically significant). On an unknown date, the outcome of the febrile convulsion was recovering/resolving and the outcome of the respiratory arrest was unknown. It was unknown if the reporter considered the febrile convulsion and respiratory arrest to be related to HAVRIX. Additional details were provided as follows: Reporter unable to provide ethnicity for the patient. No other concomitant products were provided. The nurse reporting a potential adverse event for PREVNAR 13. A patient received PREVNAR 13, Hepatitis A, Measles Mumps Rubella (MMR), and Haemophilus influenza B (Hib) vaccines on yesterday morning (the day before reporting) and had a seizure around 2 or 3 that afternoon. The patient was in the hospital now (at the time of reporting). The parents reported that the patient had respiratory arrest and had to have rescue breaths, but she was doing fine now. The patient had a very high fever at the time of the seizure. Vaccine was not administered at facility. Investigations was unknown. Reporter declined to provide email. Reporter declined to provide physician email. The reporter considered this event to be medically significant. There a product complaint to report, because patient's father asked that the whole batch of PREVNAR 13 be tested, so that this event does not happen to someone else. There was a medical information request. This was not an other report.
Age: 1.0
Sex: F
Vaccine: HEPA, HIBV, MMR, PNC13, HEPA, HIBV, MMR, PNC13, HEPA, HIBV, MMR, PNC13, HEPA, HIBV, MMR, PNC13
Symptoms: Pyrexia, Respiratory arrest, Resuscitation
Clinical narrative: This case was reported by a nurse via other manufacturer and described the occurrence of febrile convulsion in a 12-month-old female patient who received HAVRIX (batch number 9TL92, expiry date 27th May 2021) for prophylaxis. Co-suspect products included PREVNAR 13 for prophylaxis, PEDVAX HIB (batch number R027320, expiry date 8th July 2021) for prophylaxis and MEASLES MUMPS RUBELLA VACCINE (batch number R028004, expiry date 1st October 2020) for prophylaxis. Previously administered products included PREVNAR 13 (1st dose received on 13th August 2018, intramuscularly on left thigh, batch number W11305/ X62324, expiry date 30th April 2020/ 30th November 2020), PREVNAR 13 (2nd dose received on 24th September 2018, intramuscularly on left thigh, batch number W33491, expiry date 30th June 2020) and PREVNAR 13 (3rd dose received on 26th November 2018, intramuscularly on left thigh, batch number X34315, expiry date 30th September 2020). On 15th May 2019 10:20, the patient received HAVRIX (intramuscular), the 4th dose of PREVNAR 13, PEDVAX HIB (intramuscular) and MEASLES MUMPS RUBELLA VACCINE (subcutaneous). On 15th May 2019, less than a day after receiving HAVRIX, the patient experienced respiratory arrest (serious criteria hospitalization and GSK medically significant). On 15th May 2019 02:00, the patient experienced febrile convulsion (serious criteria hospitalization and GSK medically significant). On an unknown date, the outcome of the febrile convulsion was recovering/resolving and the outcome of the respiratory arrest was unknown. It was unknown if the reporter considered the febrile convulsion and respiratory arrest to be related to HAVRIX. Additional details were provided as follows: Reporter unable to provide ethnicity for the patient. No other concomitant products were provided. The nurse reporting a potential adverse event for PREVNAR 13. A patient received PREVNAR 13, Hepatitis A, Measles Mumps Rubella (MMR), and Haemophilus influenza B (Hib) vaccines on yesterday morning (the day before reporting) and had a seizure around 2 or 3 that afternoon. The patient was in the hospital now (at the time of reporting). The parents reported that the patient had respiratory arrest and had to have rescue breaths, but she was doing fine now. The patient had a very high fever at the time of the seizure. Vaccine was not administered at facility. Investigations was unknown. Reporter declined to provide email. Reporter declined to provide physician email. The reporter considered this event to be medically significant. There a product complaint to report, because patient's father asked that the whole batch of PREVNAR 13 be tested, so that this event does not happen to someone else. There was a medical information request. This was not an other report.