chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 24.0
Sex: F
Vaccine: RAB
Symptoms: Rash, Urticaria
Clinical narrative: Case previously recorded as EM2000-0003. Hives, swollen mouth: A female patient (age and past history unknown) was exposed to rabies by picking up a rabid animal. She was treated with three doses of RABAVERT, but developed systemic reactions (swollen mouth, hives) to RABAVERT 2 days after the third injection. The patient went to the emergency room to receive treatment. The company physician assessed that the event was possibly related to RABAVERT, and that the case was medically significant. Additional information received 07 Feb 00: On 14 Dec 99, the patient, a 25-year-old female, presented for rabies immunoglobulin (RIG) vaccine and RABAVERT for a cat bite to the middle finger of the left hand on 23 Nov 99. the animal had not been captured and status of animal is unknown. The patient was administered 14.7 ml of RIG in divided doses to the left and right of the gluteal muscle intramuscularly and 1 ml RABAVERT to the left deltoid on 14 Dec 99. The patient missed her fourth RABAVERT vaccine on 04 Jan 00 due to "not feeling well" and said she broke out in hives on 23 Dec 99, two days after the third RABAVERT dose. On 26 Dec 99, she was treated in a private clinic for urticarial rash on the arms, back of the neck, itching and redness to the hands, feet, and lips. The physician at the private clinic stated the hives were caused by something internal, not external. She was discharged in stable condition and advised to follow-up with her personal physician in two days. The patient had not informed the physician at the time that she was receiving post exposure rabies vaccination. On 13 Jan 00 and 27 Jan 00, she received her fourth and fifth vaccination.
Age: 1.0
Sex: F
Vaccine: IPV, MMR, MMRV, MMR, MMRV
Symptoms: Extra dose administered, Irritability
Clinical narrative: This spontaneous report as received from the patient's grandmother refers to her 12 month old female granddaughter. The patient's medical history and concurrent conditions were not reported. On 17-MAR-2015 the patient was vaccinated with a dose of (Oka/Merck) PROQUAD and a dose of MMR II (administration routes, lot numbers and expiration dates were not provided). Concomitant therapies included an unspecified poliovirus vaccine inactivated. Following the vaccination the patient became cranky and irritable. The outcome irritability was unknown. Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: IPV, MMR, MMRV, MMR, MMRV
Symptoms: Irritability
Clinical narrative: This spontaneous report as received from the patient's grandmother refers to her 12 month old female granddaughter. The patient's medical history and concurrent conditions were not reported. On 17-MAR-2015 the patient was vaccinated with a dose of (Oka/Merck) PROQUAD and a dose of MMR II (administration routes, lot numbers and expiration dates were not provided). Concomitant therapies included an unspecified poliovirus vaccine inactivated. Following the vaccination the patient became cranky and irritable. The outcome irritability was unknown. Additional information has been requested.
Age: 6.0
Sex: F
Vaccine: IPV, MMRV, IPV, MMRV
Symptoms: Cough, Morbillivirus test positive, Photophobia, Pyrexia, Rash
Clinical narrative: Mother reports high fever and rash 1 week after vaccine seen in ER and urgent care.
Age: 6.0
Sex: F
Vaccine: IPV, MMRV, IPV, MMRV
Symptoms: Pyrexia, Rash
Clinical narrative: Mother reports high fever and rash 1 week after vaccine seen in ER and urgent care.
Age: 6.0
Sex: F
Vaccine: IPV, MMRV, IPV, MMRV
Symptoms: Cough, Morbillivirus test positive, Photophobia, Pyrexia, Rash
Clinical narrative: Mother reports of developed high fever and rash 1 wk after vaccine. No treatment.
Age: 6.0
Sex: F
Vaccine: IPV, MMRV, IPV, MMRV
Symptoms: Pyrexia, Rash
Clinical narrative: Mother reports of developed high fever and rash 1 wk after vaccine. No treatment.
Sex: U
Vaccine: MMR, MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 27-JAN-2015, the patient was vaccinated with a dose of M-M-R II (administration route, lot number and expiration date were not provided). No concomitant therapies were reported. The reporting nurse stated that the vaccine was reconstituted using an expired diluent (lot number: H015687 and expiration date: October 2014). The nurse also confirmed that the vaccine itself was not expired. No adverse effects were reported. This is one of two reports from the same reporter. Additional information has been requested.
Age: 1.02
Sex: M
Vaccine: MMRV
Symptoms: Activities of daily living impaired, Aphasia, Autism spectrum disorder, Developmental delay
Clinical narrative: Stopped progressing. Stopped talking and needed help with holding a bottle.
Age: 3.0
Sex: F
Vaccine: DTAPIPVHIB, PPV
Symptoms: Aggression, Irritability, Lethargy, Pyrexia, Sensory integrative dysfunction
Clinical narrative: Patient became lethargic, feverish and was vomiting uncontrollably- this lasted for two days when she returned to doctor's office. Tantrums/aggression/irritability followed, eventually diagnosed with Sensory Integration Disorder.
Age: 3.0
Sex: F
Vaccine: DTAPIPVHIB, PPV
Symptoms: Vomiting
Clinical narrative: Patient became lethargic, feverish and was vomiting uncontrollably- this lasted for two days when she returned to doctor's office. Tantrums/aggression/irritability followed, eventually diagnosed with Sensory Integration Disorder.
Age: 1.25
Sex: F
Vaccine: DTAP, HIBV, PPV
Symptoms: Abasia, Activities of daily living impaired, Dysstasia, Dysuria, Functional gastrointestinal disorder
Clinical narrative: Unable to walk, stand without assistance. Unable to move feet or toes, unable to void or defecate without assistance. No feelings on toes or feet.
Age: 1.25
Sex: F
Vaccine: DTAP, HIBV, PPV
Symptoms: Hypoaesthesia, Mobility decreased, Myelitis transverse
Clinical narrative: Unable to walk, stand without assistance. Unable to move feet or toes, unable to void or defecate without assistance. No feelings on toes or feet.
Age: 14.0
Sex: F
Vaccine: HPV4, TDAP
Symptoms: Allergy test negative, Arthralgia, Chest pain, Dyspnoea, Dyspnoea exertional
Clinical narrative: My daughter has been to many specialists over the past few years trying to troubleshooting her illness. She has always been very active in sports and a very outgoing child. We noticed some "differences" around age 15, always tired, body aches etc but thought it was her growing. The summer of 2013 she seemed have a hard time breathing after running and physical activity. In Oct.2013 she couldn't keep running during basketball would have what some assumed was sports asthma, we had her tested and test came back she did not have sports asthma, body and joint aches came with this. Step followed and we had her tonsils removed thinking they were too big and possibly restricting her breathing. This occurred in Dec. 2013. She complained of severe chest pains on multiple occasions and had a hard time breathing during the day at normal rest. In Feb/March 2014 we had an EKG done at hospital, test came back everything was ok. We have had her check for allergies those test came back ok also. We have been seeing specialist at a specialist hospital and they have diagnosed her with P.O.T.S. syndrome.  Postural Orthostatic Tachycardia Syndrome. Patient has had severe migraines, trouble waking, body aches daily, a hard time focusing, stomach and digestive issues just to name a few of her everyday symptoms.
Age: 14.0
Sex: F
Vaccine: HPV4, TDAP
Symptoms: Fatigue, Gait disturbance, Gastrointestinal disorder, Injection site pain, Laboratory test normal
Clinical narrative: My daughter has been to many specialists over the past few years trying to troubleshooting her illness. She has always been very active in sports and a very outgoing child. We noticed some "differences" around age 15, always tired, body aches etc but thought it was her growing. The summer of 2013 she seemed have a hard time breathing after running and physical activity. In Oct.2013 she couldn't keep running during basketball would have what some assumed was sports asthma, we had her tested and test came back she did not have sports asthma, body and joint aches came with this. Step followed and we had her tonsils removed thinking they were too big and possibly restricting her breathing. This occurred in Dec. 2013. She complained of severe chest pains on multiple occasions and had a hard time breathing during the day at normal rest. In Feb/March 2014 we had an EKG done at hospital, test came back everything was ok. We have had her check for allergies those test came back ok also. We have been seeing specialist at a specialist hospital and they have diagnosed her with P.O.T.S. syndrome.  Postural Orthostatic Tachycardia Syndrome. Patient has had severe migraines, trouble waking, body aches daily, a hard time focusing, stomach and digestive issues just to name a few of her everyday symptoms.
Age: 14.0
Sex: F
Vaccine: HPV4, TDAP
Symptoms: Migraine, Pain, Postural orthostatic tachycardia syndrome, Tonsillectomy, Vision blurred
Clinical narrative: My daughter has been to many specialists over the past few years trying to troubleshooting her illness. She has always been very active in sports and a very outgoing child. We noticed some "differences" around age 15, always tired, body aches etc but thought it was her growing. The summer of 2013 she seemed have a hard time breathing after running and physical activity. In Oct.2013 she couldn't keep running during basketball would have what some assumed was sports asthma, we had her tested and test came back she did not have sports asthma, body and joint aches came with this. Step followed and we had her tonsils removed thinking they were too big and possibly restricting her breathing. This occurred in Dec. 2013. She complained of severe chest pains on multiple occasions and had a hard time breathing during the day at normal rest. In Feb/March 2014 we had an EKG done at hospital, test came back everything was ok. We have had her check for allergies those test came back ok also. We have been seeing specialist at a specialist hospital and they have diagnosed her with P.O.T.S. syndrome.  Postural Orthostatic Tachycardia Syndrome. Patient has had severe migraines, trouble waking, body aches daily, a hard time focusing, stomach and digestive issues just to name a few of her everyday symptoms.
Age: 6.0
Sex: M
Vaccine: MMR
Symptoms: Inappropriate affect, Parotid gland enlargement, Partial seizures, Petechiae, Pyrexia
Clinical narrative: Developed high fever ~104, lasted 7 days treated using Motrin / Tylenol. Transient upper trunk and facial rash on 3/08/2015. Swollen parotid glands and petechiae noticed on 3/11/2015, brought to Dr's. office who diagnosed strep infection, which was negative.  Started azithromycin evening of 3/11/2015. Partial SEIZURE* (actual adverse event) observed on 3/12/2015, lasting 60-90 seconds:  lip smacking, inappropriate giggling, staring off, not responding appropriately, then immediately and abruptly fell asleep, had no remembrance of the episode. Got second opinion who diagnosed vaccine reaction.
Age: 6.0
Sex: M
Vaccine: MMR
Symptoms: Rash, Staring, Streptococcus test negative, Sudden onset of sleep, Tardive dyskinesia
Clinical narrative: Developed high fever ~104, lasted 7 days treated using Motrin / Tylenol. Transient upper trunk and facial rash on 3/08/2015. Swollen parotid glands and petechiae noticed on 3/11/2015, brought to Dr's. office who diagnosed strep infection, which was negative.  Started azithromycin evening of 3/11/2015. Partial SEIZURE* (actual adverse event) observed on 3/12/2015, lasting 60-90 seconds:  lip smacking, inappropriate giggling, staring off, not responding appropriately, then immediately and abruptly fell asleep, had no remembrance of the episode. Got second opinion who diagnosed vaccine reaction.
Age: 6.0
Sex: M
Vaccine: MMR
Symptoms: Vaccination complication
Clinical narrative: Developed high fever ~104, lasted 7 days treated using Motrin / Tylenol. Transient upper trunk and facial rash on 3/08/2015. Swollen parotid glands and petechiae noticed on 3/11/2015, brought to Dr's. office who diagnosed strep infection, which was negative.  Started azithromycin evening of 3/11/2015. Partial SEIZURE* (actual adverse event) observed on 3/12/2015, lasting 60-90 seconds:  lip smacking, inappropriate giggling, staring off, not responding appropriately, then immediately and abruptly fell asleep, had no remembrance of the episode. Got second opinion who diagnosed vaccine reaction.
Age: 49.0
Sex: F
Vaccine: PPV
Symptoms: Body temperature decreased, Injection site pain, Mobility decreased
Clinical narrative: Pain at site, decrease in limb mobility, low temperature (95.7).
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to an unknown number of patients of unknown age and gender. On an unknown dates, the patients were vaccinated with improperly stored ROTATEQ orally, dose was not reported (lot# K010222, expiration date: 12-MAY-2016; lot # reported as K009753, expiration date: 28-APR-2016; lot# reported as K007247, expiration date: 17-MAR-2016). The temperature excursion was supported with in-house stability data. No adverse symptoms reported. This is one of two reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to multiple unspecified patients of unknown age and gender. On an unknown dates, the patients received improperly stored ROTATEQ orally, dose, lot numbers and expiration dates were not reported. No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 1.5
Sex: M
Vaccine: RV5
Symptoms: Diarrhoea, Giardia test, Nausea, Parasite stool test, Rotavirus test positive
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 15 month old patient with moderate bilateral hearing loss an no drug allergies. On an unknown dates, the patient had received the ROTATEQ series (orally, 2 ml dose, lot # J008383, expiration date 28-NOV-2014, lot # J010970, expiration date 20-MAR-2015 and K001196, expiration date 22-OCT-2015). Concomitant therapies included sodium fluoride. On an unknown date, the patient had tested positive for Rotavirus. It was reported that the child experienced diarrhoea, nausea and vomiting on 14-FEB-2015 and was seen in the physician's office on 16-FEB-2015. Medical assistant stated that a stool sample was collected and did test positive for Rotavirus (date unspecified). It was also reported that stool tests for giardia, parasites and ovum were also performed (results were not reported). The child was treated with oral fluids. The outcomes of the events were unknown. The patient sought medical attention and was seen in the physician's office. The relatedness between the events and ROTATEQ was not reported. This is one of several reports from the same reporter. Additional information has been requested.
Age: 1.5
Sex: M
Vaccine: RV5
Symptoms: Vomiting
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 15 month old patient with moderate bilateral hearing loss an no drug allergies. On an unknown dates, the patient had received the ROTATEQ series (orally, 2 ml dose, lot # J008383, expiration date 28-NOV-2014, lot # J010970, expiration date 20-MAR-2015 and K001196, expiration date 22-OCT-2015). Concomitant therapies included sodium fluoride. On an unknown date, the patient had tested positive for Rotavirus. It was reported that the child experienced diarrhoea, nausea and vomiting on 14-FEB-2015 and was seen in the physician's office on 16-FEB-2015. Medical assistant stated that a stool sample was collected and did test positive for Rotavirus (date unspecified). It was also reported that stool tests for giardia, parasites and ovum were also performed (results were not reported). The child was treated with oral fluids. The outcomes of the events were unknown. The patient sought medical attention and was seen in the physician's office. The relatedness between the events and ROTATEQ was not reported. This is one of several reports from the same reporter. Additional information has been requested.
Age: 7.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Rash
Clinical narrative: Mother of child called me 4/7/2015 to inform me that child developed rash on arms and trunk approximately 90 minutes after receiving Tdap vaccine. Rash continued to worsen. Mother took child to urgent care, where child received epinephrine.
Age: 7.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Urticaria
Clinical narrative: Mother of child called me 4/7/2015 to inform me that child developed rash on arms and trunk approximately 90 minutes after receiving Tdap vaccine. Rash continued to worsen. Mother took child to urgent care, where child received epinephrine.
Age: 7.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Rash
Clinical narrative: Trunk of body covered in severe hives and spreading to arms and legs within 1 1/2 hours of getting vaccinated.  Child seen at ER and given Epi-pen type treatment and released after evaluation.  Treatment to continue Benadryl and steroids for up tp three days.  Hives returned around 3:00am on 4/8/15 and Benadryl was started up again.
Age: 7.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Urticaria
Clinical narrative: Trunk of body covered in severe hives and spreading to arms and legs within 1 1/2 hours of getting vaccinated.  Child seen at ER and given Epi-pen type treatment and released after evaluation.  Treatment to continue Benadryl and steroids for up tp three days.  Hives returned around 3:00am on 4/8/15 and Benadryl was started up again.
Age: 83.0
Sex: M
Vaccine: TYP
Symptoms: Diarrhoea, Fatigue, Vomiting
Clinical narrative: Patient describes fatigue when he awoke on 4/7/2015, which then lead to vomiting, and diarrhea in the evening hours. Patient proceeded to ER, received IV fluids & was discharged, ER doctor ruled out food poisoning according to patient's report.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Infection, Peripheral swelling
Clinical narrative: Redness started slowly and progressed red swollen arm from shoulder to elbow went to walk in clinic and md said probably infection from shingles shot...MD gave cephalexin and it is better now.
Age: 73.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Abnormal behaviour, Aphasia, Hallucination, Immediate post-injection reaction, Irritability
Clinical narrative: Almost immediate pains all over; hallucinations and irrational behavior the next couple of days and continuing pains, inability to speak. Went to doctor, but declined MRI. Pain was later confined to right arm, where the 2 vaccines were given. Pain has never gone away.
Age: 73.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pain, Pain in extremity
Clinical narrative: Almost immediate pains all over; hallucinations and irrational behavior the next couple of days and continuing pains, inability to speak. Went to doctor, but declined MRI. Pain was later confined to right arm, where the 2 vaccines were given. Pain has never gone away.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a unspecified patients of unknown age and gender. The patient's medical history and current conditions were not provided. On an unknown dates, the patients were vaccinated with a doses of (Oka/Merck) VARIVAX (dose and route were not reported) lot # K010441 expiration date 22-JUL-2016 that were improperly stored. The temperature excursion for the (Oka/Merck) VARIVAX was found to be supported with in-house stability data. Secondary suspects and concomitant therapies were not reported. No adverse symptoms reported. Additional information has been requested. This is one of several reports received from the same reporter.
Age: 0.12
Sex: M
Vaccine: DTAPIPVHIB, HEP, RV5
Symptoms: Apparent life threatening event, Feeding disorder, Gastrooesophageal reflux disease, Hypotonia, Irritability
Clinical narrative: A presently 19-month-old child experienced a febrile illness, fussiness, and limpness within 4 days after receipt of 2 month vaccines. The child had a negative rule-out sepsis work-up in 2013, and he had a history of GERD, and while he was feeding in the hospital, he had an acute life threatening event (ALTE) [oxygen desaturation to the 50s and limpness]; he was transferred to another hospital for subspecialty evaluations, had another ALTE there associated with feeding, but tests were negative, the child was d/c to home with apnea monitor and GERD precautons, and he has grown well since that time. The now 19- month-old child has not received any subsequent vaccines.  The parents and pediatrician would now like to begin vaccinating this male child, but they are very concerned because an older female sibling of this child died in 2009, within days after receiving routine 4 month vaccines.  Reportedly, the older sister developed upper respiratory congestion, limpness, was taken to the ED, went into respiratory arrest and died.
Age: 0.12
Sex: M
Vaccine: DTAPIPVHIB, HEP, RV5
Symptoms: Laboratory test normal, Oxygen saturation decreased, Pyrexia
Clinical narrative: A presently 19-month-old child experienced a febrile illness, fussiness, and limpness within 4 days after receipt of 2 month vaccines. The child had a negative rule-out sepsis work-up in 2013, and he had a history of GERD, and while he was feeding in the hospital, he had an acute life threatening event (ALTE) [oxygen desaturation to the 50s and limpness]; he was transferred to another hospital for subspecialty evaluations, had another ALTE there associated with feeding, but tests were negative, the child was d/c to home with apnea monitor and GERD precautons, and he has grown well since that time. The now 19- month-old child has not received any subsequent vaccines.  The parents and pediatrician would now like to begin vaccinating this male child, but they are very concerned because an older female sibling of this child died in 2009, within days after receiving routine 4 month vaccines.  Reportedly, the older sister developed upper respiratory congestion, limpness, was taken to the ED, went into respiratory arrest and died.
Age: 37.0
Sex: F
Vaccine: TDAP
Symptoms: Activities of daily living impaired, Asthenia, Chills, Grip strength decreased, Injection site pain
Clinical narrative: The vaccine received was Tdap. The injection site was becoming increasingly painful, including the muscles of the upper arm and shoulder.  By the late evening, my left arm was paralyzed from the base of the neck down.  I had a hard time gripping anything with my fingertips and could only hold very light objects (paper, pen, etc).  It was difficult to undress and to sleep.  I also felt extremely weak and had intermittent chills and fever.  Last, I had the TB skin test in the same arm on the same day, and had a very big reaction to that as well, except that it took longer to show.
Age: 37.0
Sex: F
Vaccine: TDAP
Symptoms: Insomnia, Monoplegia, Pyrexia, Tuberculin test positive
Clinical narrative: The vaccine received was Tdap. The injection site was becoming increasingly painful, including the muscles of the upper arm and shoulder.  By the late evening, my left arm was paralyzed from the base of the neck down.  I had a hard time gripping anything with my fingertips and could only hold very light objects (paper, pen, etc).  It was difficult to undress and to sleep.  I also felt extremely weak and had intermittent chills and fever.  Last, I had the TB skin test in the same arm on the same day, and had a very big reaction to that as well, except that it took longer to show.
Age: 72.0
Sex: F
Vaccine: HEPA
Symptoms: Cellulitis, Erythema, Injection site erythema, Injection site pruritus, Skin warm
Clinical narrative: Administered Hep A shot on 2/27/2015. On 3/3/2015, patient called with itching and redness at the site. 3/4/2015 called with redness and warmth increasing. On3/25/15, patient treated for cellulitis.
Age: 67.0
Sex: F
Vaccine: FLUX
Symptoms: Immediate post-injection reaction, Injection site pain, Injury, Joint manipulation, Pain in extremity
Clinical narrative: On 10-11-13 I had a routine physical and a flu shot. The shot was extremely painful the moment it was given. My arm continued to hurt for 6 months. I got no relief from physical therapy. In May 2014 I had a shoulder manipulation under sedation, and finally got relief. The ortho. dr. said the trauma from the shot resulted in a frozen shoulder.
Age: 67.0
Sex: F
Vaccine: FLUX
Symptoms: Periarthritis
Clinical narrative: On 10-11-13 I had a routine physical and a flu shot. The shot was extremely painful the moment it was given. My arm continued to hurt for 6 months. I got no relief from physical therapy. In May 2014 I had a shoulder manipulation under sedation, and finally got relief. The ortho. dr. said the trauma from the shot resulted in a frozen shoulder.
Age: 76.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Pruritus, Skin warm
Clinical narrative: Had shot on 03/23/2015. Then on 03/26/15 arm had redness, hot, itching. Until today my arm still red, itching but less.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash, Rash erythematous
Clinical narrative: Rash across right side of chest, under arm pit around rib cage under shoulder blade up right side of spine to just below neck. Got shot on Fri 6th at 9:56 dr gave me acyclovir 800 mg. I still have red rash on right shoulder blade 4/3/2015.
Age: 62.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Activities of daily living impaired, Drug administered at inappropriate site, Injection site discomfort, Insomnia, Nuclear magnetic resonance imaging
Clinical narrative: Received flu shot on 10/28/14 9:30 am, arm hurt around 10:30 am - could not sleep on it, push door open, lift it, get dressed etc. Called after 1 week, 2 weeks, got PT script after 3 weeks. Injection was high in arm. I am a thin female. Its been 5 months, improved but still some discomfort at injection site.
Age: 62.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Pain in extremity, Ultrasound scan
Clinical narrative: Received flu shot on 10/28/14 9:30 am, arm hurt around 10:30 am - could not sleep on it, push door open, lift it, get dressed etc. Called after 1 week, 2 weeks, got PT script after 3 weeks. Injection was high in arm. I am a thin female. Its been 5 months, improved but still some discomfort at injection site.
Age: 62.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Activities of daily living impaired, Injection site discomfort, Nuclear magnetic resonance imaging, Pain in extremity, Sleep disorder
Clinical narrative: Received flu shot on 10/28/14 9:30 am, arm hurt around 10:30 am - could not sleep on it, push door open, lift it, get dressed etc. Called after 1 week, 2 weeks, got PT script after 3 weeks. Injection was high in arm. I am a thin female. Its been 5 months, improved but still some discomfort at injection site.
Age: 62.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Ultrasound scan
Clinical narrative: Received flu shot on 10/28/14 9:30 am, arm hurt around 10:30 am - could not sleep on it, push door open, lift it, get dressed etc. Called after 1 week, 2 weeks, got PT script after 3 weeks. Injection was high in arm. I am a thin female. Its been 5 months, improved but still some discomfort at injection site.
Age: 87.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Pain, Pain in extremity
Clinical narrative: Left upper arm chronic pain many months (3+) prescription: Diclofenac sodium topical gel.
Age: 87.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Pain in extremity
Clinical narrative: Left upper arm chronic pain many months (3+) prescription: Diclofenac sodium topical gel.
Age: 75.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Pain, Pruritus
Clinical narrative: Erythema, pain, itching x 2 days after injection. Redness continuing to extend in size.
Age: 36.0
Sex: F
Vaccine: PNC13
Symptoms: Full blood count, Hypoaesthesia, Injection site pain, Laboratory test, Neck pain
Clinical narrative: Painful (L) arm from injection site to neck and down arm. Has increased pain with mvt and c/o numbness/tingling of (L) forearm. Consistent with local hypersensitivity reaction.
Age: 36.0
Sex: F
Vaccine: PNC13
Symptoms: Pain in extremity, Paraesthesia
Clinical narrative: Painful (L) arm from injection site to neck and down arm. Has increased pain with mvt and c/o numbness/tingling of (L) forearm. Consistent with local hypersensitivity reaction.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia, Urticaria
Clinical narrative: Started arm hives and fever.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site reaction, Injection site swelling, Injection site warmth, Rash erythematous
Clinical narrative: Pt received PREVNAR 13 in left upper arm on the afternoon of 3/27/15. Patient developed 2 1/2-3 inch diameter red-raised rash around injection site. Was warm to touch and swollen.
Age: 0.2
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Pallor, Syncope, Unresponsive to stimuli
Clinical narrative: Patient had 1 minute syncope after 5 minutes from administering vaccines. He was pale, not responsive. Heart rate and respirations normal, woke up after gagging w/tongue blade.
Age: 76.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site swelling, Mobility decreased, Pain
Clinical narrative: Next day swelling, redness, approx. 3" around site. Pt reports pain/loss of movement 1 week after to currently. Pt has not seen a doctor.
Age: 80.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Pain in extremity
Clinical narrative: Pain elbow to shoulder reported by pt starting 1 week after vaccine to currently.
Age: 0.38
Sex: F
Vaccine: PPV
Symptoms: Death, Hypotonia, Respiratory arrest, Upper respiratory tract congestion, Vaccination complication
Clinical narrative: Died 2 days after receiving routine 4 month vaccines. Reportedly, developed upper respiratory congestion, limpness, was taken to the ED, went into respiratory arrest and died. The mom states the death was linked to "pneumococcal vaccine in her lungs and blood".
Age: 1.26
Sex: M
Vaccine: DTAPHEPBIP, MMR
Symptoms: Eye swelling, Nasal congestion, Pyrexia, Rash
Clinical narrative: According to patient's mother on 4/8/15, patient developed a fever the evening of his vaccines. The fever which was as high as 104 degrees, lasted about 2 weeks. He also developed a facial rash and eye swelling the day after the vaccines. The rash lasted approximately 1 1/2 wks. He also had nasal congestion. He previously had a fever following vaccines on 9/2/14. Mother treated him naturally with sponge baths of water and vinegar. He did not see a doctor.
Age: 1.37
Sex: F
Vaccine: DTAP
Symptoms: Injection site cellulitis, Injection site reaction, Injection site warmth, Rash, Rash erythematous
Clinical narrative: Dtap vaccine administered-12-24 hr after administration-red warm cellulitis appearing rash with vesicular papular eruption approximately 3 in x 3 in in size at injection site-new areas to buttocks, back, and chest with similar presenting pattern. Resolved in 3 days with BENADRYL.
Age: 1.37
Sex: F
Vaccine: DTAP
Symptoms: Rash papular
Clinical narrative: Dtap vaccine administered-12-24 hr after administration-red warm cellulitis appearing rash with vesicular papular eruption approximately 3 in x 3 in in size at injection site-new areas to buttocks, back, and chest with similar presenting pattern. Resolved in 3 days with BENADRYL.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Headache
Clinical narrative: Information has been received from a nurse via a company representative referring to an 11 year old female patient. The patient was 15 years old at the time of the report. Concurrent conditions, medical history of the patient were not reported. On an unspecified date in 2011, when the patient was 11 year old, she was vaccinated with the first dose of GARDASIL injection (lot#, dose, route unspecified) and patient developed headaches "2-3 hours after" receiving the vaccine. Also when she was 11 years old, on an unspecified date of 2011, the patient received the second dose of GARDASIK injection (lot#, dose, route unspecified), and developed "a bunch of headaches" after receiving the vaccine. The patient did not receive a 3rd dose of GARDASIL. The outcome of headache was recovered at the time of the report (exact date was unspecified). No product quality complaint (PQC) involved. The relatedness between the event and therapy with GARDASIL was not reported. Additional information is not expected as we are not permitted to contact the physician.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. The medical assistant reported that, on an unknown dates, an unspecified number of patients were administered improperly stored doses of VARIVAX (Merck) (lot #, expiration dates, doses and routes of administration were not reported). No adverse events were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a unspecified patients of unknown age and gender. The patient's medical history and concurrent conditions were not provided. On an unknown dates, the patients were vaccinated with a doses of (Oka/Merck) VARIVAX (dose and route were not reported) lot # J007023 expiration date 05-JUN-2015 that were improperly stored. The temperature excursion for the (Oka/Merck) VARIVAX was found to be supported with in-house stability data. Secondary suspects and concomitant therapies were not reported. No adverse symptoms reported. Additional information has been requested. This is one of several reports received from the same reporter.
Age: 70.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Pyrexia, Swelling
Clinical narrative: Fever, arm erythema and swelling of most of dorsal upper arm.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender who on an unknown dates were administered an unspecified number of improperly stored doses of (Oka/Merck) VARIVAX (dose, route, lot # and expiration date were not provided). No adverse events were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Vaccination site induration, Vaccination site pain, Vaccination site warmth
Clinical narrative: 20mm x 20mm hard red ara where vaccination was injected SQ (on 3-19-15) area warm, itchy and sore given TYLENOL 650mg po 3/19/15 PM and 3/20/15 AM. On 3-20-15 AM area still slightly.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site reaction, Injection site warmth
Clinical narrative: A red welt at site of injection causing an itchy stinging sensation-spreading. Very hot to touch. Directed to Dr.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: A red welt at site of injection causing an itchy stinging sensation-spreading. Very hot to touch. Directed to Dr.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Contusion, Erythema, Induration, Mass, Pruritus
Clinical narrative: Information has been received from a 59 year old female patient concerning herself. Information regarding medical history and concurrent condition was not provided. The patient had no drug allergies/reactions. On an unknown date the patient was vaccinated with ZOSTAVAX (dose, strength and lot# were not reported) in the left arm. Concomitant therapies were not reported. On unspecified date in December 2014 (reported as "3 months ago"), the patient noticed that she had a hard lump, bruising, itching and bright red spot which liked as if a baseball had hit it that lasted for several weeks. At the time of reporting, the hard lump had lasted for 3 months and the outcome of bruising and itching were unknown. The reporter wanted to know how long the hard lump would last. No lab diagnostics were performed. The patient had not sought medical attention. The causality between the adverse events and ZOSTAVAX was not reported. Additional information is not expected as the physician's information was not provided and the physician didn't want to be contacted.
Age: 25.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site nodule, Injection site pain, Injection site swelling
Clinical narrative: The next day, 3/26, had a golf ball size hard knot at inj. site with redness and swelling and soreness.
Age: 79.0
Sex: M
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Injection site induration, Injection site nodule
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 79 year old male patient. On 28-MAR-2015 the patient was vaccinated with ZOSTAVAX (0.65 ml, lot # K020802, exp. date: 31-JAN-2016, subcutaneous). Concomitant therapies included lisinopril, oxycodone, gabapentin, metformin and ranitidine. On 28-MAR-2015 the patient experienced knot, forming at the injection site, immediately, after receiving ZOSTAVAX. The knot was described further as a harder nodule, than normal, which lasted a day or two, and resolved in two or three days (in March 2015). The subject was treated with massage and TYLENOL. The relatedness between knot and ZOSTAVAX was not reported. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a unspecified patients of unknown age and gender. The patient's medical history and current conditions were not provided. On an unknown dates, the patients were vaccinated with a doses of VARIVAX (Merck) (dose and route were not reported) lot # J005724 expiration date 08-MAY-2015 that were improperly stored. The temperature excursion for the VARIVAX (Merck) was found to be supported with in-house stability data. Secondary suspects and concomitant therapies were not reported. No adverse symptoms reported. Additional information has been requested. This is one of several reports received from the same reporter.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Circumstance or information capable of leading to medication error, Erythema, Swelling
Clinical narrative: 4/6/15 at approx 10:18A child received his first MENACTRA (L) arm. He held his arm in very tense posture and was moving (anxious about shot). 4/8/15 Erythema, swelling with a well demarcated margin 8.75" longitudinally and 6" transverse. (R) arm unaffected 9.5" at distal deltoid, (L) 11 1/8" distal deltoid.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a unspecified patients of unknown age and gender. The patient's medical history and current conditions were not provided. On an unknown dates, the patients were vaccinated with a doses of PROQUAD (Merck) (dose and route were not reported) lot # reported as K022444 expiration date 13-MAY-2016 that were improperly stored. The temperature excursion for the PROQUAD (Merck) was found to be supported with in-house stability data. Secondary suspects and concomitant therapies were not reported. No adverse symptom reported. Additional information has been requested. This is one of several reports received from the same reporter.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. The medical assistant reported that, on an unknown dates, an unspecified number of patients were administered improperly stored doses of GARDASIL (lot #, expiration dates, doses and routes of administration were not reported). No adverse event were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: PPV
Symptoms: Discomfort, Injection site erythema, Injection site pain, Injection site reaction, Pain in extremity
Clinical narrative: Soreness present in left arm and mild fever. 60 year old female presents with c/o rash she has a painful red rash in the left deltoid area where she got her PNEUMOVAX two days ago, she was fine on the day that she got the injection but yesterday the rash appeared, it was uncomfortable yesterday and she went home from work, she did have a fever of 101.8F last night but she thinks it was because she was wrapped up in her blanket despite the warmth in the house, she does not have a fever this morning and has not taken any OTC medication to reduce her temperature, today the left upper arm is hurting and is red.
Age: 60.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia, Rash, Rash erythematous
Clinical narrative: Soreness present in left arm and mild fever. 60 year old female presents with c/o rash she has a painful red rash in the left deltoid area where she got her PNEUMOVAX two days ago, she was fine on the day that she got the injection but yesterday the rash appeared, it was uncomfortable yesterday and she went home from work, she did have a fever of 101.8F last night but she thinks it was because she was wrapped up in her blanket despite the warmth in the house, she does not have a fever this morning and has not taken any OTC medication to reduce her temperature, today the left upper arm is hurting and is red.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician concerning unspecified number of unspecified patients. On unspecified dates since 30-JAN-2015, the unspecified number of unspecified patients were administered an unspecified number of improperly stored dose of GARDASIL (dose, strength and lot# were not reported, intramuscular). No adverse effects were reported. This case is one of several cases received from the same reporter. (other two case were 1504USA002464 and 1504USA002465). Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender who on an unknown dates were administered an unspecified number of improperly stored does of PROQUAD (Merck) (dose, route, lot # and expiration date were not provided). No adverse events were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a health professional refers to a patient of unknown demographics. 10 years ago, on an unspecified date in 2005, the patient received first dose of GARDASIL. Then on 01-APR-2015, the patient received second dose of GARDASIL lot # K011492, expiry date: 22-JUN-2016. No adverse effect was reported. Outcome of the event, inappropriate schedule of drug administration was unknown. Reporting health professional considered the adverse event to be not related to GARDASIL. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a unspecified patients of unknown age and gender. The patient's medical history and current conditions were not provided. On an unknown dates, the patients were vaccinated with a doses of (Oka/Merck) VARIVAX (dose and route were not reported) lot # K003408, expiration date 06-MAR-2016 that were improperly stored. The temperature excursion for the (Oka/Merck) VARIVAX was found to be supported with in-house stability data. Secondary suspects and concomitant therapies were not reported. No adverse symptoms reported. Additional information has been requested. This is one of several reports received from the same reporter.
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Urticaria
Clinical narrative: Information has been received from a physician via company representative referring to a patient of unknown age. On an unknown date the patient was vaccinated with M-M-R II (dose, route and frequency were not reported, lot# was unknown) and VARIVAX (Merck) (dose, route and frequency were not reported, lot# was unknown) at the same time. The reporter reported after receiving the vaccines, the patient experienced urticaria. The outcome of urticaria 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 healthcare worker refers to an unknown number of patients of unknown age and gender. On an unknown dates, the patients were vaccinated with improperly stored GARDASIL dose and route were not reported (lot # K008931, expiration date: 04-MAR-2017; lot # K007828, expiration date:03-MAR-2016; lot# H021861, expiration date:09-OCT-2015; lot # J008423; expiration date:21-JAN-2016). The temperature excursion was supported with in-house stability data. No adverse symptoms reported. This is one of two reports received from the same source. Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: MMR
Symptoms: Measles antibody negative
Clinical narrative: This spontaneous report as received from a 22 year old, non-pregnant female patient. Patient's medical history and concurrent conditions were not reported. On 06-FEB-1994, the patient was vaccinated with a first dose of M-M-R II (lot number, expiry date, dose, route were not reported). On 23-JUN-1998, the patient was vaccinated with a second dose of M-M-R II (lot number, expiry date, dose, route were not reported). Concomitant medications were not reported. On 05-FEB-2015, the patient had "titers" test performed, and the results confirmed that she was not immune against the measles. The outcome of the event was not reported. No treatment was given for the event. The relatedness between the event and M-M-R II was not reported. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to multiple unspecified patients of unknown age and gender. On an unknown dates, the patients received improperly stored VAQTA dose, route, lot numbers and expiration dates were not reported. This is one of several reports received from the same source. 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 medical assistant refers to multiple unspecified patients of unknown age and gender. On an unknown dates, the patients received improperly stored GARDASIL dose, route, lot numbers and expiration dates were not reported. No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.