chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 47.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: This health authority case was initially received on 22-Feb-2016. The case report was received from a Health Professional and concerns a 47 years old female patient. Weight: not provided, Height: not provided. For concomitant medication and therapy dates refer to the appropriate report sections. The patient received AFLURIA on 08-Jan-2016 - unknown stop date, Batch no: U56907, Route of administration: Intramuscular, Dose: 0.5 ml, site: left arm. PNEUMOVAX, batch number: L033707, site: left arm. Both the vaccines were received in the same arm (medication error not explicitly reported). On 09-Jan-2016, 2 days after starting treatment with AFLURIA the patient experienced 102 F fever which improved with acetaminophen. Fever remained off/on for 48 hours. Following the resolution of fever, the patient developed Injection site became red, Injection site swollen, Injection site warm to touch. The injection site was the size of a playing card. Event treatment: acetaminophen. For relevant test results see appropriate report section. Reporter's assessment: non-serious. VAERS ID: 618563.
Age: 26.0
Sex: F
Vaccine: TDAP
Symptoms: Blood pressure increased, Chills, Dizziness, Exposure during pregnancy, Foetal heart rate increased
Clinical narrative: 36 weeks pregnant and had to get the Tdap shot, the next day after receiving the shot my arm was extremely sore and in a lot of pain/discomfort and could barely get any sleep. Started getting fevers and chills Thursday night into Friday and my blood pressure was slightly raised. Had to go check into labor and delivery so they could monitor the baby's heart rate (baby's heart rate was a little high possibly due to my fever). Still experiencing pain discomfort on arm where I received the shot. My fever went down, but was starting to have contractions with no dilation. I was finally discharged from the hospital Friday night. Around 2:30 am Saturday I had a slight fever, took TYLENOL and hadn't had a fever since. But on Sunday I had a few dizzy spells and felt nauseous for about 2 hours. It is Monday morning and I am still have extreme soreness on my arm to the point I can't even sleep. (4 days after receiving the Tdap shot).
Age: 26.0
Sex: F
Vaccine: TDAP
Symptoms: Insomnia, Limb discomfort, Nausea, Pain in extremity, Pyrexia
Clinical narrative: 36 weeks pregnant and had to get the Tdap shot, the next day after receiving the shot my arm was extremely sore and in a lot of pain/discomfort and could barely get any sleep. Started getting fevers and chills Thursday night into Friday and my blood pressure was slightly raised. Had to go check into labor and delivery so they could monitor the baby's heart rate (baby's heart rate was a little high possibly due to my fever). Still experiencing pain discomfort on arm where I received the shot. My fever went down, but was starting to have contractions with no dilation. I was finally discharged from the hospital Friday night. Around 2:30 am Saturday I had a slight fever, took TYLENOL and hadn't had a fever since. But on Sunday I had a few dizzy spells and felt nauseous for about 2 hours. It is Monday morning and I am still have extreme soreness on my arm to the point I can't even sleep. (4 days after receiving the Tdap shot).
Age: 26.0
Sex: F
Vaccine: TDAP
Symptoms: Uterine contractions during pregnancy
Clinical narrative: 36 weeks pregnant and had to get the Tdap shot, the next day after receiving the shot my arm was extremely sore and in a lot of pain/discomfort and could barely get any sleep. Started getting fevers and chills Thursday night into Friday and my blood pressure was slightly raised. Had to go check into labor and delivery so they could monitor the baby's heart rate (baby's heart rate was a little high possibly due to my fever). Still experiencing pain discomfort on arm where I received the shot. My fever went down, but was starting to have contractions with no dilation. I was finally discharged from the hospital Friday night. Around 2:30 am Saturday I had a slight fever, took TYLENOL and hadn't had a fever since. But on Sunday I had a few dizzy spells and felt nauseous for about 2 hours. It is Monday morning and I am still have extreme soreness on my arm to the point I can't even sleep. (4 days after receiving the Tdap shot).
Age: 0.82
Sex: F
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Rash generalised
Clinical narrative: Generalize rash with big spots.
Age: 24.0
Sex: F
Vaccine: MMR, TDAP, VARCEL
Symptoms: Pain, Rash erythematous, Rash maculo-papular, Rash pruritic, Skin warm
Clinical narrative: Started feeling achy all over especially in hips and noticed a rash on her hands 6/1. Now she is covered head to toe in a red, maculopapular rash. The rash is warm to touch but patient is afebrile. The rash is itchy.
Sex: F
Vaccine: VARZOS
Symptoms: Acne, Arthralgia, Diabetic ulcer, Rash pruritic
Clinical narrative: Information has been received from a female retired nurse concerning herself with diabetes. In approximately 2015 (reported as about a year ago), the nurse was vaccinated with a dose of ZOSTAVAX (dose, route and lot# not reported). On 31-MAY-2016 (reported as last evening), the nurse found a rash under her breast which looked like a pimple and was itchy. The nurse said she had some hip pain. She also stated she had a hip replacement at an unspecified time in the past. The nurse stated she was diabetic, had ulcers and took quite a few unspecified medications. The patient stated she had not sought any medical treatment as yet and would contact her primary care physician on the same reporting day. The causality assessment of the event to the therapy was not reported. The patient's status was reported as not recovered. Upon internal view, hip replacement was considered to be medically significant. Additional information has been requested.
Sex: U
Vaccine: HPVX
Symptoms: Death
Clinical narrative: This spontaneous report was received from a physician and refers to two patients of unknown demographics. The physician was told about the event by other patient. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with GARDASIL or GARDASIL 9 (lot #, dose and route were not provided). On unknown dates, the patients died. The causes of death were not reported. The relatedness between the event and suspect vaccine was not reported. Upon internal review, the event of death was considered to be medically significant. Additional information has been requested.
Age: 1.02
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Rash, Rash erythematous
Clinical narrative: Extreme red rash all over trunk of body & face.
Age: 17.0
Sex: M
Vaccine: TYP
Symptoms: Abdominal pain, Diarrhoea, Flatulence, Oropharyngeal pain, Rhinorrhoea
Clinical narrative: Patient 4th (last) dose of Vivotif oral typhoid vaccine. Pt had done well with first 3 doses. Several hours after taking last dose pt awoke with intense abdominal cramping. Pt had lots of watery diarrhea. No vomiting, no fever. Pt has sore throat and running nose and continued severe cramping and flatulence. Pt did not have any of these symptoms prior to taking the Vivotif.
Age: 12.0
Sex: F
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Acupuncture, Back pain, Blood test normal, Foot deformity, Gait disturbance
Clinical narrative: Initial unsolicited report received from a Consumer on 24 May 2016. This case involves a 16-years-old female patient who was vaccinated with a intramuscular dose of MENACTRA (batch number, expiration date, dose, site of administration was not reported) on an unspecified date in 2014. Illness at time of vaccination was reported as unknown. Pre-existing physician diagnosed allergies, birth defects, medical conditions was reported as asthma, seasonal allergies. Concomitant medications were not reported. On an unspecified date in 2014, following vaccination, patient developed weakness and pain in her lower legs. Symptoms progressed to the patient walking pigeon toed, her feet were became very cold with decreased circulation. Pain began at her sacral bone and continues down her legs to her toes. Her left foot was turned inwards and she had a hard time walking. She had been to her primary care physician and neurologist, and it was reported that there had not been a definitive diagnosis. It was reported that blood work: within normal limit. It was reported that patient underwent acupuncture for a time, that did help with the pain at first. The patient was not recovered from events. it was also reported that symptoms began slowly over a period of time and there had been no improvement. Case was considered as serious due to seriousness criteria: disability. List of documents held by sender: none. Sender's Comments: In this case, the patient developed Pigeon toe with left foot inwards, due to this she has difficulty in walking. pain over sacral area with radiating to lower leg and decreased circulation with cold feet after receiving MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE. Time to onset is unknown. The final diagnosis was also not identified. Further information on the medical confirmation of the case, patient's medical history, treatment provided, lab data confirming the final diagnosis, etc. will be required for complete assessment. Based on the information available, a role of the vaccine cannot be assessed.
Age: 12.0
Sex: F
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Muscular weakness, Pain in extremity, Peripheral coldness, Poor peripheral circulation, Talipes
Clinical narrative: Initial unsolicited report received from a Consumer on 24 May 2016. This case involves a 16-years-old female patient who was vaccinated with a intramuscular dose of MENACTRA (batch number, expiration date, dose, site of administration was not reported) on an unspecified date in 2014. Illness at time of vaccination was reported as unknown. Pre-existing physician diagnosed allergies, birth defects, medical conditions was reported as asthma, seasonal allergies. Concomitant medications were not reported. On an unspecified date in 2014, following vaccination, patient developed weakness and pain in her lower legs. Symptoms progressed to the patient walking pigeon toed, her feet were became very cold with decreased circulation. Pain began at her sacral bone and continues down her legs to her toes. Her left foot was turned inwards and she had a hard time walking. She had been to her primary care physician and neurologist, and it was reported that there had not been a definitive diagnosis. It was reported that blood work: within normal limit. It was reported that patient underwent acupuncture for a time, that did help with the pain at first. The patient was not recovered from events. it was also reported that symptoms began slowly over a period of time and there had been no improvement. Case was considered as serious due to seriousness criteria: disability. List of documents held by sender: none. Sender's Comments: In this case, the patient developed Pigeon toe with left foot inwards, due to this she has difficulty in walking. pain over sacral area with radiating to lower leg and decreased circulation with cold feet after receiving MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE. Time to onset is unknown. The final diagnosis was also not identified. Further information on the medical confirmation of the case, patient's medical history, treatment provided, lab data confirming the final diagnosis, etc. will be required for complete assessment. Based on the information available, a role of the vaccine cannot be assessed.
Age: 18.0
Sex: M
Vaccine: HEP, HPV9, VARCEL
Symptoms: Dizziness, Headache, Posture abnormal
Clinical narrative: Pt. reported having a headache and feeling light-headed after receiving HPV vaccine.  Pt. slid down in chair and fell over to the side, did not lose consciousness.  Nurse assisted pt. to lie down on cot and offered juice to drink.  Pt. was allowed to lie on cot for 20mins and reported feeling better.  Vitals taken, T - 98.8, BP - 110/78.  Pt. able to walk out with his cousin without assistance.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Myalgia, Pain, Vaccination site reaction
Clinical narrative: Soreness in muscle in left arm where vaccinated - especially when I lift my arm above my shoulder.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Injection site erythema, Injection site pain, Injection site reaction, Injection site swelling
Clinical narrative: Welt, redness, swelling, pain at injection site starting morning after injection (normal injection site reaction). Blister showing up by nose 8 days after shot (unsure if shingles). Patient called her doctor and was told to go to the ER where they put her on a 10 day course of antibiotics.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: Welt, redness, swelling, pain at injection site starting morning after injection (normal injection site reaction). Blister showing up by nose 8 days after shot (unsure if shingles). Patient called her doctor and was told to go to the ER where they put her on a 10 day course of antibiotics.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Red, hard hot area at injection site by day two. By day three redness was resolving.
Age: 50.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Fatigue, Myalgia, Nausea, Pruritus
Clinical narrative: Muscle aches, Fever at 10 hours after vaccination to 100.5 F, continued throughout weekend. Itchy vesicular lesions presented 6/5/2016. Pt also c/o Nausea and Fatigue.
Age: 50.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pyrexia, Varicella virus test
Clinical narrative: Muscle aches, Fever at 10 hours after vaccination to 100.5 F, continued throughout weekend. Itchy vesicular lesions presented 6/5/2016. Pt also c/o Nausea and Fatigue.
Age: 50.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Condition aggravated, Dehydration, Malaise, Nausea, Pyrexia
Clinical narrative: Muscle aches, Fever at 10 hours after vaccination to 100.5 F, continued throughout weekend. Itchy vesicular lesions presented 6/5/2016. Pt also c/o Nausea and Fatigue.
Age: 50.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash, Varicella
Clinical narrative: Muscle aches, Fever at 10 hours after vaccination to 100.5 F, continued throughout weekend. Itchy vesicular lesions presented 6/5/2016. Pt also c/o Nausea and Fatigue.
Age: 26.0
Sex: M
Vaccine: RAB
Symptoms: Dizziness, Syncope
Clinical narrative: Member was feeling lightheaded following 4 mile run prior to vaccine. Member has a syncopal episode 30 min after vaccine. Member was able to walk to aid station and was given full neuro exam without any defects. Vital signs were all normal. Member was monitored at aid station for 40 min and had no residual symptoms. Member continued to hydrate at lightheadedness went away. Member was given 24 hrs light duty and instructed to follow up in 24 hrs. Member was also evaluated at 2:00 and had no complaints. This was members 3rd series of Rabies and he has never had adverse reaction before.
Age: 1.0
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Cough, Irritability, Malaise, Morbillivirus test positive, Nasopharyngitis
Clinical narrative: On 07/23, the case-patient developed cold-like symptoms (cough and runny nose), malaise, and poor feedings. Also, the mother noted the patient was fussy and irritable. On 07/25 the patient developed a fever of 103 F. On 07/27 the patient developed a non-itchy maculopapular rash on his face; by 07/28 the rash covered his entire body including the palms of his hands and soles of his feet. On 07/30, the Department of Public Health collected specimens for measles laboratory testing. Additionally, a throat swab was forwarded to CDC for RT-PCR. CDC's PCR was positive for measles -Genotype A (vaccine strain).
Age: 1.0
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Polymerase chain reaction positive, Poor feeding infant, Pyrexia, Rash, Rash generalised
Clinical narrative: On 07/23, the case-patient developed cold-like symptoms (cough and runny nose), malaise, and poor feedings. Also, the mother noted the patient was fussy and irritable. On 07/25 the patient developed a fever of 103 F. On 07/27 the patient developed a non-itchy maculopapular rash on his face; by 07/28 the rash covered his entire body including the palms of his hands and soles of his feet. On 07/30, the Department of Public Health collected specimens for measles laboratory testing. Additionally, a throat swab was forwarded to CDC for RT-PCR. CDC's PCR was positive for measles -Genotype A (vaccine strain).
Age: 1.0
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Rash maculo-papular, Rhinorrhoea
Clinical narrative: On 07/23, the case-patient developed cold-like symptoms (cough and runny nose), malaise, and poor feedings. Also, the mother noted the patient was fussy and irritable. On 07/25 the patient developed a fever of 103 F. On 07/27 the patient developed a non-itchy maculopapular rash on his face; by 07/28 the rash covered his entire body including the palms of his hands and soles of his feet. On 07/30, the Department of Public Health collected specimens for measles laboratory testing. Additionally, a throat swab was forwarded to CDC for RT-PCR. CDC's PCR was positive for measles -Genotype A (vaccine strain).
Age: 13.0
Sex: F
Vaccine: MENB
Symptoms: Activities of daily living impaired, Insomnia, Musculoskeletal disorder, Pain in extremity
Clinical narrative: Patient states her arm was in extreme pain, which kept her from sleeping. She states the pain in her arm was so bad she couldn't use her arm and stayed home from school the next day.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient was given KINRIX on 06/03/2016 but had received PENTACEL on 10/19/2015. He was already 4 years old when he received the PENTACEL so did not need any further doses of DTaP or polio. Spoke with patient's guardian who states he is fine and had no reaction to the vaccines given.
Age: 24.0
Sex: M
Vaccine: HPV9
Symptoms: Blood test, Diarrhoea, Dizziness, Dyspnoea, Lethargy
Clinical narrative: Patient reports that approximately 1 1/2 hours after getting first HPV vaccine had severe nausea and vomiting, some diarrhea, headache, felt light headed and had difficulty breathing. Two days later went to ER after driving himself up to the mountains and was given an IV, IV medication for nausea and vomiting and that "knocked him out". When he woke up he felt somewhat better, but still lethargic.
Age: 24.0
Sex: M
Vaccine: HPV9
Symptoms: Nausea, Urine analysis, Vomiting
Clinical narrative: Patient reports that approximately 1 1/2 hours after getting first HPV vaccine had severe nausea and vomiting, some diarrhea, headache, felt light headed and had difficulty breathing. Two days later went to ER after driving himself up to the mountains and was given an IV, IV medication for nausea and vomiting and that "knocked him out". When he woke up he felt somewhat better, but still lethargic.
Age: 0.15
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Diarrhoea
Clinical narrative: Diarrhea starting 9 days after immunization and lasting for almost one month, thought to be due to rotavirus immunization, no daycare or exposure to anyone who was ill.
Age: 17.0
Sex: F
Vaccine: HPVX, MEN
Symptoms: Apnoea, Cyanosis, Dyskinesia, Immediate post-injection reaction, Loss of consciousness
Clinical narrative: Immediately following HPV9 & Meningococcal Vaccine patient loss of consciousness, her entire body stiffened and started making jerking motions, her jaw was clamped tight, and her lips looked blueish in color and she didn't appear to be breathing. The entire episode lasted less than a minute. The doctor was called in to evaluate her and shortly after appeared to be fine.
Age: 17.0
Sex: F
Vaccine: HPVX, MEN
Symptoms: Muscle tightness, Musculoskeletal stiffness, Respiration abnormal
Clinical narrative: Immediately following HPV9 & Meningococcal Vaccine patient loss of consciousness, her entire body stiffened and started making jerking motions, her jaw was clamped tight, and her lips looked blueish in color and she didn't appear to be breathing. The entire episode lasted less than a minute. The doctor was called in to evaluate her and shortly after appeared to be fine.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Abdominal pain upper, Decreased appetite, Erythema, Local reaction, Local swelling
Clinical narrative: Local reaction- redness and swelling over right lateral bicep. Mom gave TYLENOL then gave ibuprofen. Patient had decreased appetite and stomach ache.
Age: 65.0
Sex: F
Vaccine: TDAP
Symptoms: Head banging, Headache, Injection site pain, Injection site swelling, Lymphadenopathy
Clinical narrative: Progressive swelling and pain at injection site, severe muscle soreness in shoulders and neck, persistent headache, swollen glands and soreness swallowing and opening mouth wide.
Age: 65.0
Sex: F
Vaccine: TDAP
Symptoms: Muscle spasms, Myalgia, Odynophagia, Pain
Clinical narrative: Progressive swelling and pain at injection site, severe muscle soreness in shoulders and neck, persistent headache, swollen glands and soreness swallowing and opening mouth wide.
Age: 5.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site swelling, Pruritus
Clinical narrative: Upper thigh swelling on the side of injection (left leg), occurring after 3rd dose of dTap, patient is on a catch-up schedule. No fever, no pain,  + pruritus, seen by physician on 6/6/2016.
Age: 0.15
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Cardiac monitoring normal, Cold sweat, Cyanosis, Full blood count normal, Hypotonia
Clinical narrative: Pt fussy. MOC picked pt up and turned limp and pale, blue lips, clammy skin.
Age: 0.15
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Irritability, Metabolic function test normal, Pallor, Ultrasound skull normal
Clinical narrative: Pt fussy. MOC picked pt up and turned limp and pale, blue lips, clammy skin.
Age: 1.01
Sex: F
Vaccine: HEPA, PNC13, VARCEL
Symptoms: Pyrexia, Rash
Clinical narrative: Rash and fever.
Age: 16.0
Sex: M
Vaccine: HEPA, HPV9, VARCEL, HEPA, HPV9, VARCEL, HEPA, HPV9, VARCEL
Symptoms: Immediate post-injection reaction, Loss of consciousness, Nausea, Syncope
Clinical narrative: Immediately after give shot, patient became nauseated, fainting slumping down and totally lost consciousness for 10 seconds and in and out of consciousness for 5mins. 911 was call, oxygen administered, V/S taken B/P 120/60 Pulse 74 Resp 20. Patient was kept under observation until paramedic arrive.
Age: 16.0
Sex: M
Vaccine: HEPA, HPV9, VARCEL, HEPA, HPV9, VARCEL, HEPA, HPV9, VARCEL
Symptoms: Consciousness fluctuating, Immediate post-injection reaction, Loss of consciousness, Nausea, Posture abnormal
Clinical narrative: Immediately after give shot, patient became nauseated, fainting slumping down and totally lost consciousness for 10 seconds and in and out of consciousness for 5mins. 911 was call, oxygen administered, V/S taken B/P 120/60 Pulse 74 Resp 20. Patient was kept under observation until paramedic arrive.
Age: 16.0
Sex: M
Vaccine: HEPA, HPV9, VARCEL, HEPA, HPV9, VARCEL, HEPA, HPV9, VARCEL
Symptoms: Syncope
Clinical narrative: Immediately after give shot, patient became nauseated, fainting slumping down and totally lost consciousness for 10 seconds and in and out of consciousness for 5mins. 911 was call, oxygen administered, V/S taken B/P 120/60 Pulse 74 Resp 20. Patient was kept under observation until paramedic arrive.
Age: 16.0
Sex: M
Vaccine: HEPA, HPV9, VARCEL, HEPA, HPV9, VARCEL, HEPA, HPV9, VARCEL
Symptoms: Immediate post-injection reaction, Loss of consciousness, Nausea, Syncope
Clinical narrative: Immediately after given shots to the patient, he became nauseated, fainting, slumping down and totally lost consciousness for 10 seconds and in and out of consciousness for 5mins. 911 was called, oxygen administered, V/S taken, B/P 120/60. Pulse 74, Resp 20, Pulse oximeter 100%. Patient was kept under close observation until the paramedic arrived.
Age: 16.0
Sex: M
Vaccine: HEPA, HPV9, VARCEL, HEPA, HPV9, VARCEL, HEPA, HPV9, VARCEL
Symptoms: Consciousness fluctuating, Immediate post-injection reaction, Loss of consciousness, Nausea, Posture abnormal
Clinical narrative: Immediately after given shots to the patient, he became nauseated, fainting, slumping down and totally lost consciousness for 10 seconds and in and out of consciousness for 5mins. 911 was called, oxygen administered, V/S taken, B/P 120/60. Pulse 74, Resp 20, Pulse oximeter 100%. Patient was kept under close observation until the paramedic arrived.
Age: 16.0
Sex: M
Vaccine: HEPA, HPV9, VARCEL, HEPA, HPV9, VARCEL, HEPA, HPV9, VARCEL
Symptoms: Syncope
Clinical narrative: Immediately after given shots to the patient, he became nauseated, fainting, slumping down and totally lost consciousness for 10 seconds and in and out of consciousness for 5mins. 911 was called, oxygen administered, V/S taken, B/P 120/60. Pulse 74, Resp 20, Pulse oximeter 100%. Patient was kept under close observation until the paramedic arrived.
Age: 0.15
Sex: F
Vaccine: DTAP, RV5
Symptoms: Abdominal distension, Abdominal pain, Allergy test negative, Bacterial test negative, Blood test
Clinical narrative: 2 days after vaccination patient was very lethargic (slept for 8 hours straight), did not want to eat, very fussy, crying and pulling knees to chest and her tummy felt rock solid. She did not have any stools til 3:30pm. When we saw DR. at 4pm she decided to test stool after hearing her symptoms. Her stool tested positive for blood. Was sent to Emergency Room where they performed an ultrasound. They diagnosed her as "Possible intussusception" that had fixed itself. Patient has had bloody stools for over 4 weeks now. She has tested negative for all viruses, infections, bacteria and allergies.
Age: 0.15
Sex: F
Vaccine: DTAP, RV5
Symptoms: Crying, Culture stool, Decreased appetite, Diet refusal, Haematochezia
Clinical narrative: 2 days after vaccination patient was very lethargic (slept for 8 hours straight), did not want to eat, very fussy, crying and pulling knees to chest and her tummy felt rock solid. She did not have any stools til 3:30pm. When we saw DR. at 4pm she decided to test stool after hearing her symptoms. Her stool tested positive for blood. Was sent to Emergency Room where they performed an ultrasound. They diagnosed her as "Possible intussusception" that had fixed itself. Patient has had bloody stools for over 4 weeks now. She has tested negative for all viruses, infections, bacteria and allergies.
Age: 0.15
Sex: F
Vaccine: DTAP, RV5
Symptoms: Hypersomnia, Irritability, Lethargy, Occult blood positive, Ultrasound abdomen
Clinical narrative: 2 days after vaccination patient was very lethargic (slept for 8 hours straight), did not want to eat, very fussy, crying and pulling knees to chest and her tummy felt rock solid. She did not have any stools til 3:30pm. When we saw DR. at 4pm she decided to test stool after hearing her symptoms. Her stool tested positive for blood. Was sent to Emergency Room where they performed an ultrasound. They diagnosed her as "Possible intussusception" that had fixed itself. Patient has had bloody stools for over 4 weeks now. She has tested negative for all viruses, infections, bacteria and allergies.
Age: 0.15
Sex: F
Vaccine: DTAP, RV5
Symptoms: Viral test negative
Clinical narrative: 2 days after vaccination patient was very lethargic (slept for 8 hours straight), did not want to eat, very fussy, crying and pulling knees to chest and her tummy felt rock solid. She did not have any stools til 3:30pm. When we saw DR. at 4pm she decided to test stool after hearing her symptoms. Her stool tested positive for blood. Was sent to Emergency Room where they performed an ultrasound. They diagnosed her as "Possible intussusception" that had fixed itself. Patient has had bloody stools for over 4 weeks now. She has tested negative for all viruses, infections, bacteria and allergies.
Age: 22.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Chills, Fatigue, Muscular weakness, Pain in extremity, Pyrexia
Clinical narrative: 101 F fever, chills, muscle weakness and fatigue after 12 hours. Pain in upper arm and skin was hot to the touch after vaccination, and continued for over 48 hours. Rash (approximately 4 inches in diameter) appeared about 48 hours after vaccination.
Age: 22.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Rash, Skin warm
Clinical narrative: 101 F fever, chills, muscle weakness and fatigue after 12 hours. Pain in upper arm and skin was hot to the touch after vaccination, and continued for over 48 hours. Rash (approximately 4 inches in diameter) appeared about 48 hours after vaccination.
Age: 22.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Chills, Fatigue, Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: 101 F fever, chills, muscle weakness and fatigue after 12 hours. Pain in upper arm and skin was hot to the touch after vaccination, and continued for over 48 hours. Rash (approximately 4 inches in diameter) appeared about 48 hours after vaccination.
Age: 22.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Muscular weakness, Pain, Pyrexia, Rash, Skin warm
Clinical narrative: 101 F fever, chills, muscle weakness and fatigue after 12 hours. Pain in upper arm and skin was hot to the touch after vaccination, and continued for over 48 hours. Rash (approximately 4 inches in diameter) appeared about 48 hours after vaccination.
Age: 93.0
Sex: F
Vaccine: PNC13
Symptoms: Body temperature increased, Chest X-ray normal, Chills, Confusional state, Injection site erythema
Clinical narrative: Patient came in with her daughter at the recommendation from a visiting pharmacist from a previous visit as well as a suggestion from her PCP - she was given a prescription for PCV 13 from the PCP.  Neither had received PCV 13, were eligible under Medicare Part B and decided to receive the immunization at this facility. The patient indicated that she had received a pneumonia shot (PPSV 23) previously without issue (PPSV 23 was given but not given within the past calendar year.)  The patient received the vaccination (PCV 13) intramuscularly to the left arm; she appeared lucid and did not report any unusual pain/soreness.  The patient's daughter returned on 6/6/2016 and mentioned that the patient experienced unusual chills and recorded a temperature of approximately 102F later that evening of the vaccination.  Subsequent to this 'reaction' the patient requested transport to the emergency room.  The patient was admitted through the emergency room and treated by a local facility where she remains.  The patient has been observed to have had local redness near/around the site of injection which has since resolved.  The patient has reportedly experienced some confusion.  The patient's daughter was hesitant to report the incident.  She indicated that the VIS given to her and her mother does indicate/acknowledge the possibility of redness at the site of injection as well as the chills/fever as a potential reaction.  The patient's PCP has been notified of the reaction/incident by the patient's daughter.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PPV, RVX
Symptoms: Crying, Emotional distress, Encephalitis, Pain
Clinical narrative: Cry-encephalitis/encephalitic cry. Horrid shrieking, inconsolable, intense symptoms of pain. Motrin Administered.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: I have shingles.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Crying, Headache, Lymphadenopathy, Muscle strain, Musculoskeletal stiffness
Clinical narrative: Approximately 7 days after immunizations a hive-like rash appeared on our sons neck, stomach, and portions of his legs. It cleared up after approximately 4 days. Approximately 14 days after the immunizations, our son had a bump on the back of his head/neck, and developed a stiff neck. He cried frequently and rubbed his face/head as if he had a headache/pain. We took him to the doctor and were told it was likely  a swollen lymph node and a neck muscle strain. Our son's head was tilted to the side for roughly 4 days, after which it slowly regained motion.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Pain, Posture abnormal, Swelling, Urticaria
Clinical narrative: Approximately 7 days after immunizations a hive-like rash appeared on our sons neck, stomach, and portions of his legs. It cleared up after approximately 4 days. Approximately 14 days after the immunizations, our son had a bump on the back of his head/neck, and developed a stiff neck. He cried frequently and rubbed his face/head as if he had a headache/pain. We took him to the doctor and were told it was likely  a swollen lymph node and a neck muscle strain. Our son's head was tilted to the side for roughly 4 days, after which it slowly regained motion.
Age: 0.35
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC13, RV5
Symptoms: Dyskinesia
Clinical narrative: Patient had jerking of entire body for about 5-10 seconds just after patient left office.
Age: 12.0
Sex: F
Vaccine: MENB
Symptoms: Drooling, Facial paralysis, Hypogeusia
Clinical narrative: Pt complained that she trouble tasting food/discerning Flavors. Condition worsen and pt taken to ER on Wednesday due to facial drop/drooling for evaluation where she was diagnosed with Bells palsy.
Age: 66.0
Sex: M
Vaccine: PNC13
Symptoms: Cellulitis, International normalised ratio increased, Rash generalised, Rash pruritic, Urinary tract infection
Clinical narrative: Patient received PREVNAR 13 on 4/25/16. He called clinic on 4/28/16 and reported rash all over his body. He called clinic again on 5/2/16 and reported he continued to have rash on legs, arms, and chest that is itchy. Patient was advised to go to ER. Patient was admitted to the hospital for multiple problems: UTI, cellulitis of the RLE (unrelated to drug rash), supratherapeutic INR, and nonspecific rash and eruption all over his body. During admission, dermatology was consulted for the rash. He was started on topical steroid cream with improvement. He progressively got better. Itching was controlled with hydroxyzine.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Computerised tomogram, Electrocardiogram, Guillain-Barre syndrome, Nuclear magnetic resonance imaging
Clinical narrative: Information has been received from a physician via a company representative referring to a 63 year old male patient. On 13-MAY-2016 the patient was vaccinated with ZOSTAVAX (dose unknown, lot # L037790, expiry date: 30-DEC-2016, subcutaneous). On 24-MAY-2016, the patient exhibited unspecified symptoms of Guillain-Barre syndrome. The patient was admitted to an unspecified hospital on 24-MAY-2016 for an unspecified length of time. There was also treatment given for the event. Magnetic resonance imaging (MRI), electrocardiogram (EKG) and computerized tomography (CT) scan were performed and the results were not reported. The patient had not recovered from the event. Causality was not provided. Upon internal review, Guillain-Barre syndrome was determined to be medically significant. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Urticaria
Clinical narrative: Developed diffuse urticaria approximately 20-24 hrs post-administration. No associated wheezing, difficulty swallowing, fever, arthralgia. Taken to urgent care received injectable corticosteroid and placed on loratadine and diphenhydramine.
Age: 1.0
Sex: F
Vaccine: MMR
Symptoms: Irritability, Pyrexia
Clinical narrative: Fever-Last week Thurs and again this week 103 last night. No rashes. Went to clinic yesterday. More crabby. Eating and drinking ok T.C. with mom. Fever broke Sat. afternoon medical thinks it's a viral illness.
Age: 1.01
Sex: F
Vaccine: HEPA, HIBV, PNC13, VARCEL
Symptoms: Injection site bruising, Injection site cellulitis, Injection site erythema, Injection site inflammation, Injection site nodule
Clinical narrative: Pt. seen in pediatric clinic for silver dollar size area on right thigh/vastus lat. of redness, warmth, swelling and small pea size nodules x 3 palpated in that location. Father reports became noticeable the day before on 6/2. Pt. was put on BACTRIM for 10 days for diagnosis of cellulitis. Provider called pt's mother today 6/6/16 and mom reports inflammation resolved, area has almost completely "healed" with only a bruise remaining. Pt. been tolerating ABT well.
Age: 1.01
Sex: F
Vaccine: HEPA, HIBV, PNC13, VARCEL
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: Pt. seen in pediatric clinic for silver dollar size area on right thigh/vastus lat. of redness, warmth, swelling and small pea size nodules x 3 palpated in that location. Father reports became noticeable the day before on 6/2. Pt. was put on BACTRIM for 10 days for diagnosis of cellulitis. Provider called pt's mother today 6/6/16 and mom reports inflammation resolved, area has almost completely "healed" with only a bruise remaining. Pt. been tolerating ABT well.
Sex: U
Vaccine: FLU3
Symptoms: Incorrect dose administered, Incorrect product storage, Multiple use of single-use product, Wrong technique in product usage process
Clinical narrative: This medically confirmed health authority report (initial receipt 22-FEB-2016) concerns a patient (gender unknown). On 30-SEP-2015, the nurse had re-used the syringe for multiple patients at a employee influenza vaccination clinic. The nurse brought three multiple dose vials of the vaccine that were intended for another event and were stored in her personal fridge without temperature monitoring. The nurse reported using two syringes she found in her supplies to administer vaccine to 67 patients. She reported wiping the syringes with alcohol and using a new needle for each patient. Only 2 multiple dose vials of vaccine (10 doses/vial) were used for 67 adult patients. The patient (one of the 67 patients) was administered intramuscular AFLURIA injection , batch number:11049221A) in the arm. The patient was offered blood pathogen testing (hep B, hep C, HIV), hepatitis B vaccine and flu vaccine. However, the test results were not received as the patient was not seen at the sponsored clinic and had the results-tested through a private physician. The outcome was unknown. Reporter's comments: The health authority assessed the events as non-serious.
Age: 58.0
Sex: F
Vaccine: PPV
Symptoms: Local reaction, Pain, Pharyngeal oedema, Pyrexia
Clinical narrative: Large local reaction within 2 hrs of admin. of PNEUMOVAX. Fever of 103 degrees, throat fullness, persistent pain for 3 wks.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to multiple unspecified patients of unknown ages and genders. The patients' medical history and concurrent conditions were not reported. On multiple unspecified dates, the patients were vaccinated with PEDVAXHIB (lot #: L030871, expiry date: 10-JUN-2018) (route of administration: intramuscular) that had been improperly stored at a temperature of 47 F for a time frame of 74 hours. No adverse effects reported. The outcome of the events was unknown. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to multiple unspecified patients of unknown ages and genders. The patients' medical history and concurrent conditions were not reported. On unspecified dates, the patients were vaccinated with GARDASIL (lot #: K006960, expiry date: 19-FEB-2017) (route of administration: intramuscular) that had been improperly stored at a temperature of 47 F for a time frame of 74 hours (incorrect product storage). No adverse effects reported. The outcome of the events was unknown. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to an unspecified number of patients of unknown age and gender. Information regarding the patients current condition and medical history was not provided. On an unknown date in March 2016 an unspecified number of patients were vaccinated with improperly stored (temperature excursion-55F) dose of M-M-R II lot # L003856, expiry date-05-FEB-2017. No adverse effects were reported. No laboratory tests were reported. No product quality complaint (PQC) was involved. No further information was provided. Additional information is not expected as the reporter did not wish any further contact.
Sex: U
Vaccine: MENB
Symptoms: Erythema, Induration
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of redness in an unspecified number of patients who received BEXSERO. On an unknown date, the patients received BEXSERO. On an unknown date, an unknown time after receiving BEXSERO, the patients experienced redness and induration. On an unknown date, the outcome of the redness and induration were unknown. It was unknown if the reporter considered the redness and induration to be related to BEXSERO. Additional details were provided as follows: This case was reported by a office manager. The office manager reported that an unknown number of patients experienced redness and induration with unknown number of BEXSERO vaccinations. The details of vaccinations and patients was not available. A message was left with the office manager to call back GlaxoSmithKline with event details.
Sex: F
Vaccine: PPV
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report has been received from a registered nurse via Pfizer referring to a female patient of unknown age. The patient's current condition and medical history was not reported. Approximately in 2015, last year, the patient was vaccinated the first dose of PNEUMOVAX 23 (lot number, expiration date, dose and route unknown). Concomitant therapy was not reported. On 12-FEB-2016, the patient was vaccinated with the second dose of PNEUMOVAX 23 instead of the ordered PREVNAR 13. The patient would be scheduled to receive PREVNAR 13 at a later date. The patient did not have any adverse effects. It was also reported as that the patient had received PREVNAR last year. The patient was ordered to receive PNEUMOVAX 23 this year, but received PREVNAR on 12-FEB-2016. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant refers to an unspecified patients of unknown age. On an unknown date, the patients were vaccinated with unspecified doses of improperly stored VAQTA. No adverse events were reported. Temperature of 49.3 F for 24 hours and there was no previous temperature excursion. This is one of the 4 reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant refers to an unspecified patients of unknown age. On an unknown date, the patients were vaccinated with unspecified doses of improperly stored PEDVAXHIB, M001813, 14-OCT-2018. No adverse events were reported. Temperature of 49.3 F for 24 hours and there was no previous temperature excursion. This is one of the 4 reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from healthcare worker refers to multiple unspecified patients of unknown age and gender. Information on pertinent medical history and concurrent condition was not provided. On an unspecified dates, the patients were vaccinated with improperly stored doses of M-M-R II lot # L026551, expiry 16-JUL-2017 (dose and route not reported). No adverse effects reported. No additional information was provided. Temperature: 32 F. Time frame: 3 minutes and back in range. No previous temperature excursions reported. Data logger was used. Follow up information has been received from healthcare worker on 27-MAY-2016. It was confirmed that there was no previous temperature excursion. The call was made because of data logger. It was reported that temperature was 0,3C and time frame: 871 minutes. This case is one of the 4 reports from the same source. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to an unspecified number of patients of unknown age and gender. The patients' concurrent conditions, concomitant medication and medical history were not provided. On unspecified dates, the patients were vaccinated with improperly stored doses of M-M-R II (Lot # L024268, 01-JUL-2017, dose, route and dose number were unspecified). No adverse effect was reported. This is one of two reports received from the same source. Additional information is not expected because there was no consent for contact.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to multiple unspecified patients of unknown age and gender. No information regarding the patients' pertinent medical history, concomitant medications and drug reactions or allergies was reported. On an unknown dates, the patients were vaccinated with improperly stored doses of VAQTA injection, lot # L004745, expiry date 28-APR-2017 (dose, route of administration and anatomical location were not specified). On an unknown date, the administered doses of VAQTA underwent temperature excursion at 32.4 Fahrenheit degrees for 1 hour. There was no previous temperature excursion. No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to unspecified number of unspecified patients of unknown age and gender. No information about the patients' pertinent medical history, concomitant medications, drug reactions or allergies was provided. On unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB (dose, route of administration, lot # and expiration date were not reported). The vaccine underwent a temperature excursion of maximum 46.9 degrees Fahrenheit for 15 minutes and minimum 34.9 degrees Fahrenheit for 2 hours (6 cycles). It was reported that Digital Data Logger was involved. There were no previous temperature excursions. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker regarding an unspecified number of patients of unknown demographics. There was no information about concurrent condition and historical medication. On an unknown date the patient was vaccinated with improperly stored GARDASIL 9 lot # L016429/expiration date - 09-AUG-2017 (incorrect product storage). No adverse event. Excursion temperature was 51.22 F and timeframe was 92 hours. There was no previous temperature excursion. Call was because of the data logger. No concomitant medication was reported. The outcome of the event was unknown. This is one of several reports received from the same operator. Additional information has been requested.
Age: 51.0
Sex: F
Vaccine: TDAP
Symptoms: Asthenia, Blood pressure increased, Discomfort, Headache, Paraesthesia
Clinical narrative: Patient's husband called DPH to report his wife has had elevated BP and "tingling in her head" since receiving the Tdap 3 days prior on 5/31/16. She had not eaten lunch but had eaten 5 hrs. prior to vaccination. He reports her normal BP is 116/70 HR in 70s which is taken by home digital automatic cuff but after she went to eat after vaccination and upon returning home her BP was 136/96 HR 90s. Husband reports she is feeling better that BP normal and tingling in head better. She layed down and took nap because felt weak and had headache. She did not take any NSAIDs for discomfort. Symptoms gradually improved. Husband reports she took BP.