chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: HPV4
Symptoms: Activities of daily living impaired, Postural orthostatic tachycardia syndrome
Clinical narrative: This spontaneous report as received from a consumer refers to a currently 17-year-old female, who was the reporter's cousin in law's daughter. The patient's medical history and concurrent conditions were not reported. On an unknown dates, the patient was vaccinated with 3 doses of GARDASIL (doses, routes of administration, anatomical locations, lot# and exp. dates were not reported). Concomitant therapies were not reported. On an unknown date, reported as "several years ago", the patient was diagnosed with Postural Orthostatic Tachycardia Syndrome (POTS). History and details of the diagnosis were not specified. It was reported that the patient was athletic and was playing sports at the time her symptoms started. Since diagnosis the patient was unable to play sports and her activities were limited. The patient was visiting acupuncturist to help her with the symptoms. The outcome of the events was unknown. The relatedness between vaccination with GARDASIL and the events was unknown. Upon internal review, the event of being unable to play sports and limited activities was considered to be disabling. Additional information has been requested.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Acarodermatitis, Allergy test positive, Biopsy skin abnormal, Burning sensation, Central nervous system inflammation
Clinical narrative: Information has been received from a consumer referring to her 61 year old husband with none pertinent medical history or drug reactions/allergies. On 02-APR-2014 the patient was vaccinated with ZOSTAVAX, (dose, lot#, and route not reported). Concomitant therapies included lisinopril (manufacturer unknown) and CRESTOR. The consumer reported that her husband experienced some reactions after being vaccinated with ZOSTAVAX. The consumer said the patient experienced a burning and itching sensation in the back of his head since 03-APR-2014. The sensation traveled down to the crease of his elbows, the small of his back, his upper legs, hands and fingers. The consumer reported the patient would find welts that would show up occasionally, which was the result of the patient scratching due to the "itching sensation". The consumer reported that the patient's nerves were inflamed. The consumer said the first doctor (physician unspecified), thought the patient had scabies and treated him for 2 months with ELIMITE CREAM and cortisone creams. The consumer explained that when he had a biopsy of his skin it came back that he was scratching himself to make the skin scab. The burning and itching sensation that the patient had, became unbearable due to the heat over the summer of 2014. The patient was given a steroid shot (steroid unspecified) on 01-AUG-2014 and it cleared up the symptoms until about 4 weeks later. The patient's burning symptom had came back worse. In September of 2014, the patient was due for a colonoscopy and the doctor thought he might have had celiac disease. The results of the tests determined the patient did not have celiac disease. In November of 2014 the patient tested positive with allergic reactions to different foods such as celery, vanilla, squash, and rice. The consumer believed the new allergic reactions were due to the vaccination. On 03-DEC-2014 the patient received another steroid dose (steroid unspecified) and it wore off by 04-JAN-2015. The patient was experiencing the burning and itching sensations again at reporting time. The symptoms had not cleared up. After 10 months later (of vaccination), the patient was still experiencing problems. The outcome of "nerves were inflamed" and "welts" were unknown. The outcome of allergic reactions to different foods was recovered on 04-JAN-2015. The outcome of burning and itching sensations were not recovered. Upon internal review, the events of allergic reactions to different foods, burning and itching sensation were considered to be medically significant. Additional information has been requested.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Colonoscopy normal, Food allergy, Hypersensitivity, Inflammation, Pruritus generalised
Clinical narrative: Information has been received from a consumer referring to her 61 year old husband with none pertinent medical history or drug reactions/allergies. On 02-APR-2014 the patient was vaccinated with ZOSTAVAX, (dose, lot#, and route not reported). Concomitant therapies included lisinopril (manufacturer unknown) and CRESTOR. The consumer reported that her husband experienced some reactions after being vaccinated with ZOSTAVAX. The consumer said the patient experienced a burning and itching sensation in the back of his head since 03-APR-2014. The sensation traveled down to the crease of his elbows, the small of his back, his upper legs, hands and fingers. The consumer reported the patient would find welts that would show up occasionally, which was the result of the patient scratching due to the "itching sensation". The consumer reported that the patient's nerves were inflamed. The consumer said the first doctor (physician unspecified), thought the patient had scabies and treated him for 2 months with ELIMITE CREAM and cortisone creams. The consumer explained that when he had a biopsy of his skin it came back that he was scratching himself to make the skin scab. The burning and itching sensation that the patient had, became unbearable due to the heat over the summer of 2014. The patient was given a steroid shot (steroid unspecified) on 01-AUG-2014 and it cleared up the symptoms until about 4 weeks later. The patient's burning symptom had came back worse. In September of 2014, the patient was due for a colonoscopy and the doctor thought he might have had celiac disease. The results of the tests determined the patient did not have celiac disease. In November of 2014 the patient tested positive with allergic reactions to different foods such as celery, vanilla, squash, and rice. The consumer believed the new allergic reactions were due to the vaccination. On 03-DEC-2014 the patient received another steroid dose (steroid unspecified) and it wore off by 04-JAN-2015. The patient was experiencing the burning and itching sensations again at reporting time. The symptoms had not cleared up. After 10 months later (of vaccination), the patient was still experiencing problems. The outcome of "nerves were inflamed" and "welts" were unknown. The outcome of allergic reactions to different foods was recovered on 04-JAN-2015. The outcome of burning and itching sensations were not recovered. Upon internal review, the events of allergic reactions to different foods, burning and itching sensation were considered to be medically significant. Additional information has been requested.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Scab, Urticaria
Clinical narrative: Information has been received from a consumer referring to her 61 year old husband with none pertinent medical history or drug reactions/allergies. On 02-APR-2014 the patient was vaccinated with ZOSTAVAX, (dose, lot#, and route not reported). Concomitant therapies included lisinopril (manufacturer unknown) and CRESTOR. The consumer reported that her husband experienced some reactions after being vaccinated with ZOSTAVAX. The consumer said the patient experienced a burning and itching sensation in the back of his head since 03-APR-2014. The sensation traveled down to the crease of his elbows, the small of his back, his upper legs, hands and fingers. The consumer reported the patient would find welts that would show up occasionally, which was the result of the patient scratching due to the "itching sensation". The consumer reported that the patient's nerves were inflamed. The consumer said the first doctor (physician unspecified), thought the patient had scabies and treated him for 2 months with ELIMITE CREAM and cortisone creams. The consumer explained that when he had a biopsy of his skin it came back that he was scratching himself to make the skin scab. The burning and itching sensation that the patient had, became unbearable due to the heat over the summer of 2014. The patient was given a steroid shot (steroid unspecified) on 01-AUG-2014 and it cleared up the symptoms until about 4 weeks later. The patient's burning symptom had came back worse. In September of 2014, the patient was due for a colonoscopy and the doctor thought he might have had celiac disease. The results of the tests determined the patient did not have celiac disease. In November of 2014 the patient tested positive with allergic reactions to different foods such as celery, vanilla, squash, and rice. The consumer believed the new allergic reactions were due to the vaccination. On 03-DEC-2014 the patient received another steroid dose (steroid unspecified) and it wore off by 04-JAN-2015. The patient was experiencing the burning and itching sensations again at reporting time. The symptoms had not cleared up. After 10 months later (of vaccination), the patient was still experiencing problems. The outcome of "nerves were inflamed" and "welts" were unknown. The outcome of allergic reactions to different foods was recovered on 04-JAN-2015. The outcome of burning and itching sensations were not recovered. Upon internal review, the events of allergic reactions to different foods, burning and itching sensation were considered to be medically significant. Additional information has been requested.
Age: 3.0
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Blood test normal, Hallucination, Pyrexia
Clinical narrative: 01/31/15 high fever of 107 and hallucination mom took child to doctor on 02/02/15.
Age: 41.0
Sex: F
Vaccine: HEP
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: Client states a lymph node in her left armpit became increasingly swollen and painful, peaking on Saturday, July 19th, 2014.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous reprot as received from a healthcare worker refers to a patient of unspecified age and gender. No current or historical conditions were reported. On 08-DEC-2014 the patient was vaccinated with the first dose of ROTATEQ (lot # K005394; expiration date: 23-FEB-2016, dosage information was not provided) orally, which was improperly stored (incorrect product storage). There were no concomitant medications reported. No adverse effect reported. There was no product quality complaint (PQC) involved. The outcome was unknown. This is one of several reports received from the same reporter. Additional information is not expected because the reporter had no further information available.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unspecified age and gender. No current or historical conditions were reported. On 23-DEC-2014 the patient was vaccinated with the third dose of ROTATEQ (lot # K005394; expiration date: 23-FEB-2016, dosage information was not provided) orally, which was improperly stored (incorrect product storage). There were no concomitant medications reported. No adverse effect reported. There was no product quality complaint (PQC) involved. The outcome was unknown. This is one of several reports received from the same reporter. Additional information is not expected because the reporter had no further information available.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unspecified age and gender. No current or historical conditions were reported. On 08-DEC-2014 the patient was vaccinated with the first dose of ROTATEQ (lot # K005394; expiration date: 23-FEB-2016, dosage information was not provided) orally, which was improperly stored. There were no concomitant medications reported. No adverse effect reported. There was no product quality complaint (PQC) involved. The outcome was unknown. This is one of several reports received from the same reporter. Additional information is not expected because the reporter had no further information available.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unspecified age and gender. No current or historical conditions were reported. On 16-DEC-2014 the patient was vaccinated with the first dose of ROTATEQ (lot # K005394; expiration date: 23-FEB-2016, dosage information was not provided) orally, which was improperly stored (incorrect product storage). There were no concomitant medications reported. No adverse effect reported. There was no product quality complaint (PQC) involved. The outcome was unknown. This is one of several reports received from the same reporter. Additional information is not expected because the reporter had no further information available.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unspecified age and gender. No current or historical conditions were reported. On 11-DEC-2014 the patient was vaccinated with the first dose of ROTATEQ (lot # K005394; expiration date: 23-FEB-2016, dosage information was not provided) orally, which was improperly stored. There were no concomitant medications reported. No adverse effect reported. There was no product quality complaint (PQC) involved. The outcome was unknown. This is one of several reports received from the same reporter. Additional information is not expected because the reporter had no further information available.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unspecified age and gender. No current or historical conditions were reported. On 09-DEC-2014 the patient was vaccinated with the second dose of ROTATEQ (lot # K005394; expiration date: 23-FEB-2016, dosage information was not provided) orally, which was improperly stored (Incorrect product storage). There were no concomitant medications reported. No adverse effect reported. There was no product quality complaint (PQC) involved. The outcome was unknown. This is one of several reports received from the same reporter. Additional information is not expected because the reporter had no further information available.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unspecified age and gender. No current or historical conditions were reported. On 29-DEC-2014 the patient was vaccinated with the second dose of ROTATEQ (lot # K005394; expiration date: 23-FEB-2016, dosage information was not provided) orally, which was improperly stored (incorrect product storage). There were no concomitant medications reported. No adverse effect reported. There was no product quality complaint (PQC) involved. The outcome was unknown. This is one of several reports received from the same reporter. Additional information is not expected because the reporter had no further information available.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unspecified age and gender. No current or historical conditions were reported. On 16-DEC-2014 the patient was vaccinated with the first dose of ROTATEQ (lot # K005394; expiration date: 23-FEB-2016, dosage information was not provided) orally, which was improperly stored. There were no concomitant medications reported. No adverse effect reported. There was no product quality complaint (PQC) involved. The outcome was unknown. This is one of several reports received from the same reporter. Additional information is not expected because the reporter had no further information available.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patent of unspecified age and gender. No current or historical conditions were reported. On 23-DEC-2014 the patient was vaccinated with the first dose of ROTATEQ (lot # K005394; expiration date: 23-FEB-2016, dosage information was not provided) orally, which was improperly stored (incorrect product storage). There were no concomitant medications reported. No adverse effect reported. There was no product quality complaint (PQC) involved. The outcome was unkown. This is one of several reports received from the same reporter. Additional information is not expected because the reproter had no further information available.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous reprot as received from a healthcare worker refers to a patent of unspecified age and gender. No current or historical conditions were reported. On 19-DEC-2014 the patient was vaccinated with the first dose of ROTATEQ (lot # K005394; expiration date: 23-FEB-2016, dosage information was not provided) orally, which was improperly stored (incorrect product storage). There were no concomitant medications reproted. No adverse effect reported. There was no product quality complaint (PQC) involved. The outcome was unkown. This is one of several reports received from the same reproter. Additional information is not expected because the reporter had no further information available.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Immediate post-injection reaction, Injection site pain
Clinical narrative: Left deltoid hurt when injection started. Left deltoid is still very painful when touched or bumped with casual contact. Even with a TdAP injection at the same site, my muscle has not been so sore.
Age: 10.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash, Injection site swelling
Clinical narrative: Redness, rash, swelling, pruritis on right deltoid area where 2 vaccines were administered; tx included icing, Benadryl, ibuprofen, Allegra.
Age: 79.0
Sex: F
Vaccine: PNC13
Symptoms: Headache, Injection site erythema, Injection site swelling, Injection site warmth, Pain
Clinical narrative: Headache, body aches, left deltoid area - red, swollen, hot to touch.
Age: 58.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity
Clinical narrative: Severe left arm pain requiring ER visit. Treated with Diphenhydramine 50mg IM x1, Hydromorphone 2mg IM x1; then sent home.
Age: 55.0
Sex: F
Vaccine: PNC13
Symptoms: Asthenia, Decreased appetite, Dizziness, Erythema, Hypersensitivity
Clinical narrative: Body Pain, Fever, Muscle Stiffness & Pain, Redness, Swelling & Itching, Patterns of Red areas spreading and shifting in different patterns, raised rash, weakness, nausea, dizziness, loss of appetite, lethargy. As the redness reduced in several days the areas of red changed to a dark tan color, eventually the skin started to peel.
Age: 55.0
Sex: F
Vaccine: PNC13
Symptoms: Lethargy, Musculoskeletal stiffness, Myalgia, Nausea, Pain
Clinical narrative: Body Pain, Fever, Muscle Stiffness & Pain, Redness, Swelling & Itching, Patterns of Red areas spreading and shifting in different patterns, raised rash, weakness, nausea, dizziness, loss of appetite, lethargy. As the redness reduced in several days the areas of red changed to a dark tan color, eventually the skin started to peel.
Age: 55.0
Sex: F
Vaccine: PNC13
Symptoms: Pruritus, Pyrexia, Rash, Skin discolouration, Skin exfoliation
Clinical narrative: Body Pain, Fever, Muscle Stiffness & Pain, Redness, Swelling & Itching, Patterns of Red areas spreading and shifting in different patterns, raised rash, weakness, nausea, dizziness, loss of appetite, lethargy. As the redness reduced in several days the areas of red changed to a dark tan color, eventually the skin started to peel.
Age: 55.0
Sex: F
Vaccine: PNC13
Symptoms: Swelling
Clinical narrative: Body Pain, Fever, Muscle Stiffness & Pain, Redness, Swelling & Itching, Patterns of Red areas spreading and shifting in different patterns, raised rash, weakness, nausea, dizziness, loss of appetite, lethargy. As the redness reduced in several days the areas of red changed to a dark tan color, eventually the skin started to peel.
Age: 44.0
Sex: M
Vaccine: TDAP
Symptoms: CSF glucose increased, CSF protein increased, CSF white blood cell count increased, Encephalitis viral, Herpes simplex serology negative
Clinical narrative: Pt presented to ER on 12/19/2014 for altered mental status. Had LP showing WBC 19, Protein 64, glucose 83. VZV and HSV PCR  negative per report. Pt was discharged under viral encephalitis.
Age: 44.0
Sex: M
Vaccine: TDAP
Symptoms: Mental status changes, Polymerase chain reaction, Varicella virus test negative, Viral test negative
Clinical narrative: Pt presented to ER on 12/19/2014 for altered mental status. Had LP showing WBC 19, Protein 64, glucose 83. VZV and HSV PCR  negative per report. Pt was discharged under viral encephalitis.
Age: 1.0
Sex: F
Vaccine: FLU3, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Injection site pain, Pyrexia, Restlessness
Clinical narrative: Slight fever, restlessness, pain in both legs, right greater than left. No injection site reaction noted. Bilateral strength intact. No PCP. Referred to clinic.
Age: 25.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Generalised tonic-clonic seizure
Clinical narrative: Tonic clonic seizure.
Age: 28.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Full blood count, Headache, Injection site erythema, Injection site swelling
Clinical narrative: Shooting pain and neuropathy down left arm, then redness and swelling down left arm from injection site. 4 inches. Went to ED, was given toradol and tramadol. Having headache, chills, rash to right arm and neck pain on 2/4/15. re-evaluated by MD.
Age: 28.0
Sex: F
Vaccine: PPV
Symptoms: Neck pain, Neuropathy peripheral, Pain, Pain in extremity, Rash
Clinical narrative: Shooting pain and neuropathy down left arm, then redness and swelling down left arm from injection site. 4 inches. Went to ED, was given toradol and tramadol. Having headache, chills, rash to right arm and neck pain on 2/4/15. re-evaluated by MD.
Age: 2.0
Sex: F
Vaccine: HEPA
Symptoms: Rash generalised
Clinical narrative: Rash all over her torso, legs, arms, and back, and spreading on to face.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Chronic inflammatory demyelinating polyradiculoneuropathy, Electromyogram abnormal, Hypoaesthesia, Muscular weakness, Nerve conduction studies abnormal
Clinical narrative: Numbness, tingling, weakness in legs.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Nuclear magnetic resonance imaging abnormal, Paraesthesia
Clinical narrative: Numbness, tingling, weakness in legs.
Age: 11.0
Sex: F
Vaccine: HPVX
Symptoms: Dizziness, Skin discolouration, Visual impairment
Clinical narrative: Shortly after getting the HPV shot (about 5-8 minutes), my daughter said the pictures on the wall looked strange and then she said she felt dizzy.  We walked her into a nearby patient room.  The nurse had her lay down.  My daughter's skin on her face turned a green color.  The nurse put a wash cloth on her forehead and had her lay still for a short while.  They then asked if we had any food to give her and I think I gave her a granola bar or apple to eat.  Within just a few minutes, the green color went away.  The nurse had her sit up and start eating and my daughter said she was feeling better. We then went to the waiting room and sat there for another 15 minutes to ensure my daughter was fine.  The nurse asked when the last time was that my daughter had eaten and it had been about 4-5 hours.  They then told me that with the HPV vaccine it is wise to eat a little bit before coming for the vaccine.  So, for the third dose of the HPV vaccine (on 5/21/11), my daughter ate a banana just before we arrived at the doctor's office and she was just fine and had no reaction.  I just wish that the doctor's office had informed me of this (to eat before the HPV vaccine) prior to my daughter getting the HPV vaccine in the first place. (My daughter has never had any reactions to any other vaccines before or since and she has received every vaccine available and a flu shot every year).
Age: 26.0
Sex: F
Vaccine: FLUN4
Symptoms: Cataplexy, Insomnia, Narcolepsy, Somnolence
Clinical narrative: Developed Insomnia and Excessive Daytime Sleepiness at the end of March 2014. Developed Cataplexy symptoms April 2014. Diagnosed Narcolepsy with Cataplexy June 5th 2014.
Age: 1.25
Sex: F
Vaccine: MMR, PNC13, VARCEL
Symptoms: Ataxia, Blood test, Cytogenetic analysis, Lumbar puncture, Nuclear magnetic resonance imaging brain
Clinical narrative: Patient developed raised red rash, some with white dots in center, all over her body, except face and hands. The rash lasted two weeks. Patient went onto develop ataxia, which has not resolved nor been explained. Although we hope this is not permanent, it has been now been at least 5 months and is on-going.
Age: 1.25
Sex: F
Vaccine: MMR, PNC13, VARCEL
Symptoms: Nuclear magnetic resonance imaging spinal, Nuclear magnetic resonance imaging whole body, Rash erythematous, Rash generalised, Urine analysis
Clinical narrative: Patient developed raised red rash, some with white dots in center, all over her body, except face and hands. The rash lasted two weeks. Patient went onto develop ataxia, which has not resolved nor been explained. Although we hope this is not permanent, it has been now been at least 5 months and is on-going.
Age: 11.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Discomfort, Eye swelling, Lip swelling, Pruritus, Swelling face
Clinical narrative: Discomfort and itching, followed by her face swelling up, especially her eyes and lips.
Age: 1.01
Sex: M
Vaccine: MMRV
Symptoms: Injection site erythema, Pyrexia, Rash generalised, Rash morbilliform
Clinical narrative: It began with a red spot on his leg where the shot was given to him. The red spot grew each day. After a few days he woke up covered from head to toe in a measles like rash. He had a high fever that came the night after. He was covered in these spots for over a week.
Age: 45.0
Sex: F
Vaccine: TDAP
Symptoms: Cyst
Clinical narrative: Marble size cyst under right collar bone, the same arm as the vaccine was administered. Doctor suggested surgery to remove.
Age: 0.36
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Urticaria
Clinical narrative: Urticaria.
Age: 40.0
Sex: F
Vaccine: FLUR3
Symptoms: Dysgeusia, Paraesthesia oral
Clinical narrative: Pt developed strange taste and tingling in her mouth 10 min. after receiving flu vaccine. Was given 25mg of BENADRYL 14:45. Symptoms subsided.
Age: 35.0
Sex: F
Vaccine: FLUC3
Symptoms: Pityriasis rosea, Rash, Rash erythematous
Clinical narrative: Developed flat red rash on trunk, no itching or drainage. Dx with pityriasis rosea at urgent care. Rash expected to last 4-12 wks. No tx given.
Age: 3.0
Sex: M
Vaccine: FLUN4
Symptoms: Rhinorrhoea
Clinical narrative: After getting FLUMIST patient developed increased sniffling in an exaggerated manner. Lasted for several days and was concerning for development of tic.
Age: 0.18
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Crying, Diet refusal
Clinical narrative: Unconsolable crying for more than 3 hours. Temporarily refusing to nurse.
Age: 66.0
Sex: M
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Pain at injection site since vaccination - trouble raising arm.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Immediate post-injection reaction, Nausea, Pruritus
Clinical narrative: Started having nausea and dizziness and some itching around the arm immediately after receiving flu vaccine. Was given ZYRTEC and prednisone orally in the ER.
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Exposure during pregnancy
Clinical narrative: This is a prospective pregnancy case. This 31-year-old female subject was enrolled in a study. The subject received the 1st dose of Flu seasonal TIV .5 ml on 21st October 2014 14:00. Concomitant products included Prenatal Vitamin. The subject's estimated date of delivery was 1st May 2015. On an unknown date, an unknown time after receiving Flu seasonal TIV the subject developed vaccine exposure during pregnancy (Non-serious). The outcome of vaccine exposure during pregnancy was unknown. The pregnancy was ongoing. Additional information received: Patient in week 12 of pregnancy received FLUARIX vaccination. Patient's due date is in May 2015. No chronic diseases, no maternal or paternal genetic issues.
Sex: F
Vaccine: FLU4
Symptoms: Exposure during pregnancy, Extra dose administered
Clinical narrative: This is a pregnancy case. This female subject was enrolled in a study. The subject received the 2nd dose of FLUARIX QIV on 12th November 2014. Previously administered products included FLUARIX (1st dose while pregnant). On an unknown date, an unknown time after receiving FLUARIX QIV the subject developed extra dose administered (Non-serious). Additional event(s) included vaccine exposure during pregnancy. The outcome of extra dose administered was unknown. The outcome(s) of the additional event(s) included vaccine exposure during pregnancy (unknown). The pregnancy outcome was unknown. Additional information received: 2nd dose of FLUARIX QIV given in same season to a pregnant patient (1st dose given 9/2/14).
Age: 73.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Injection site erythema, Injection site swelling, Local reaction
Clinical narrative: Patient had localized reaction to (L) deltoid with redness/swelling 3-4 inches below the injection site. Recommended BENADRYL, ice to reaction, go to ER if more serious reaction occurs.
Age: 29.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, Multiple allergies
Clinical narrative: This case was reported by a nurse and described the occurrence of vaccine exposure during pregnancy in a 29-year-old female subject who was vaccinated with FLUARIX QUADRIVALENT (GlaxoSmithKline). On 25 August 2014, the subject received unspecified dose of FLUARIX QUADRIVALENT (.5 ml, intramuscular, unknown injection site). The subject's gestational age at that time was 26 1/2 weeks. Her last menstrual period was on an unspecified date and estimated date of delivery was on 26 November 2014. The subject was exposed to the vaccine during the 2nd trimester. At the time of reporting, the pregnancy was ongoing. Follow-up information received on 08 October 2014 from the nurse (patient). The patient received BOOSTRIX (batch number 3HG7R, expiry date 8th November 2016). Concurrent medical conditions included anemia. Concomitant products included IRON, docusate sodium, Vitamin C, prenatal multivitamin (tablet, oral from 01 January 2014) and fiber. On 3rd September 2014, the patient received BOOSTRIX (intramuscular) .5 ml. The subject's last menstrual period was on 19th February 2014. The subject received BOOSTRIX at week 28 of the pregnancy and during the 3rd trimester of pregnancy. On an unknown date, an unknown time after receiving Flu Seasonal QIV, the patient experienced vaccine exposure during pregnancy and multiple allergies for which she was treated with loratadine. At the time of the follow-up reporting, the outcome of multiple allergies was unknown. It was unknown if the reporter considered the multiple allergies to be related to Flu Seasonal QIV.
Age: 4.0
Sex: F
Vaccine: TDAP
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: This case was reported by a other health professional and described the occurrence of inappropriate age at vaccine administration in a 4-year-old female patient who received BOOSTRIX (batch number EA2GE, expiry date 24th January 2016). On 24th September 2013, the patient received BOOSTRIX .5 ml. On 24th September 2013, an unknown time after receiving BOOSTRIX, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown. It was unknown if the reporter considered the inappropriate age at vaccine administration to be related to BOOSTRIX.
Sex: F
Vaccine: FLU3
Symptoms: Exposure during pregnancy
Clinical narrative: This case was reported via other manufacturer. This is a pregnancy case. This female subject was enrolled in a study. the subject received FLUARIX on an unknown date. On an unknown date, an unknown time after receiving FLUARIX the subject developed vaccine exposure during pregnancy (Non-serious). The outcome of vaccine exposure during pregnancy was unknown. The pregnancy was ongoing. Additional information received: Reporter stated that, she was at a clinic and overheard that prefilled syringes are administered to pregnant women from GSK.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to incorrect product storage due to on unknown dates unknown number of patients of unknown ages and genders were vaccinated with improperly stored doses of ROTATEQ, oral (dose, lot # and expiration dates were not reported). No adverse effects reported. It was unknown if the patients sought medical attention. This one of several reports from the same source. Additional information is not expected because we cannot contact the physician.
Sex: F
Vaccine: FLU3, FLUX
Symptoms: Drug hypersensitivity
Clinical narrative: This case was reported by a nurse via other manufacturer and described the occurrence of drug allergy in a female patient who received Influenza vaccine. Concurrent medical conditions included drug allergy (allergy to : metformin, lithium, flu shot, trazodone, lisinopril, EFFECOR, ABILIFY and TRILEPTAL). On an unknown date, the patient received Influenza vaccine at an unknown dose. On an unknown date, an unknown time after receiving influenza vaccine, the patient experienced drug allergy. On an unknown date, the outcome of the drug allergy was unknown. It was unknown if the reporter considered the drug allergy to be related to influenza vaccine.
Sex: F
Vaccine: FLU3, FLUX
Symptoms: Allergy to vaccine
Clinical narrative: This case was reported by a nurse via other manufacturer and described the occurrence of drug allergy in a female patient who received Influenza vaccine. Concurrent medical conditions included drug allergy (allergy to : metformin, lithium, flu shot, trazodone, lisinopril, EFFECOR, ABILIFY and TRILEPTAL). On an unknown date, the patient received Influenza vaccine at an unknown dose. On an unknown date, an unknown time after receiving influenza vaccine, the patient experienced drug allergy. On an unknown date, the outcome of the drug allergy was unknown. It was unknown if the reporter considered the drug allergy to be related to influenza vaccine.
Sex: U
Vaccine: MEN
Symptoms: Expired product administered, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 24 January 2013. A patient (No information was provided regarding the patient) was administered an expired dose of MENOMUNE. No adverse event was reported. List of documents held by sender: none.
Sex: U
Vaccine: MEN
Symptoms: Expired product administered, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 26 February 2013. A Meningococcal vaccine that expired in 10.2012 was administered. No information was provided regarding the patient. No adverse event was reported. List of documents held by sender: none.
Age: 11.0
Sex: F
Vaccine: MEN
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Initial report received from other company (Novartis) on 05 March 2013. This case was initially reported by a healthcare professional. Other company reference number: PUS2013US011876. An 11-year-old female patient whose medical history and concomitant medications were not reported had received second dose of meningococcal vaccine (Mfr Unknown) (batch number, route and site of administration were not reported) on 20 November 2007. The patient had received first dose of MENVEO (Mfr: Novartis) (batch number, route and site of administration were not reported) on 21 June 2007. Thus the patient was administered an extra dose of vaccine. Laboratory details were not reported. At the time of this report, the patient did not experience any adverse reaction. List of documents held by sender: none.
Sex: U
Vaccine: MEN
Symptoms: Expired product administered, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 19 March 2013. A patient (No information was provided regarding the patient) was administered expired dose of MENOMUNE vaccine. No adverse event was reported. List of documents held by sender: none.
Sex: U
Vaccine: MEN
Symptoms: Expired product administered, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 18 March 2013. A patient (no information was provided regarding the patient) had received a dose of MENOMUNE vaccine on 16 March 2013 that expired in September 2012. No adverse event was reported. List of documents held by sender: none.
Sex: U
Vaccine: MEN
Symptoms: Expired product administered, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 15 May 2013. A dose of MENOMUNE vaccine having expiry date of 13 October 2013 was administered to a patient (no information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none.
Sex: U
Vaccine: MEN
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 17 May 2013. MENOMUNE vaccine that out of storage condition, i.e. outside temperature 61-65 degree Fahrenheit for about 30 minute was administered to the patient (no information was provided regarding the patient). No adverse event was reported. Documents held by sender: none.
Age: 42.0
Sex: U
Vaccine: MEN
Symptoms: Incorrect route of drug administration, No adverse event, Wrong drug administered
Clinical narrative: Initial misuse report received from a healthcare professional on 10 July 2013. A 42-year-old patient was administered MENOMUNE instead of MENACTRA. The patient was administered MENOMUNE intramuscularly instead of subcutaneous route. No adverse event was reported. Documents held by sender: None.
Sex: U
Vaccine: MEN
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 04 September 2013. A patient (date of birth and gender was not reproted) had received MENOMUME vaccine) intramuscularly instead of subcutaneous. No adverse event was reported. Documents held by sender: none.
Sex: U
Vaccine: MEN
Symptoms: Incorrect route of drug administration
Clinical narrative: Case of misuse was received from a healthcare professional on 08 October 2013. A patient of unspecified gender and age received a dose of MENOMUNE (manufacturer not reported, lot-no not reported) on an unspecified date. The patient received IM and then saw that it was to given SC. Do they had to call the patient back to repeat. Advised per Q and A: "Response to vaccines recommended by the subcutaneous route probably will not be affected if the vaccines are administered by the intramuscular rather than subcutaneous route. Repeating doses of vaccine administered by the intramuscular route rather than subcutaneous route is not necessary." No information regarding an adverse event was given at the time of this report.
Sex: U
Vaccine: DTAP, DTAPIPVHIB
Symptoms: No adverse event, Overdose
Clinical narrative: Initial misuse report received from a healthcare professional (pharmacist) on 24 June 2014. A patient had received a dose of PENTACEL and Dtap on an unspecified date. It was reported that patients received PENTACEL and Dtap at the same time resulting in over dose. No adverse event was reported. List of documents held by sender: none.
Age: 11.0
Sex: U
Vaccine: DTAP
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 23 June 2014. An 11-year-old patient (gender was not reported) had received a dose of DTAP (manufacturer unknown, lot number, dose in series, route and site of administration was not reported) instead of a TDAP on an unspecified date. No adverse event was reported. List of documents held by sender: none.
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy
Clinical narrative: Initial pregnancy report received from literature on 07 July 2014. Objective: A recent increase in pertussis cases prompted the Committee to recommend administering the Tdap vaccine during each pregnancy. We sought to describe uptake of Tdap and identify predictors of vaccination in pregnancy. Study Design: We conducted a retrospective study of all women delivering at a hospital between February and June 2013. Demographic, pregnancy, and vaccination data were abstracted from the medical record. The relationship between maternal age, parity, gestational age, race/ethnicity, marital status, prenatal provider/site, insurance, influenza vaccination status, and Tdap vaccine was described by univariate analysis. Independent predictors were identified by multivariable logistic regression. Results: In our cohort of 1467 women, 1194 (81.6%) received a Tdap vaccine. After adjusting for potential confounders, 3 factors were found to be independent predictors of receiving the vaccine. Patients were more likely to receive Tdap if they had been vaccinated against influenza during this pregnancy (adjusted odds ratio [aOR], 1.7; 95% confidence interval [CI], 1.4-2.3). Women of a specific ethnicity were less likely to receive Tdap when compared with other women (aOR, 0.42; 95% CI, 0.27-0.67). Also, women who delivered preterm were less likely to receive the Tdap vaccine (aOR, 0.33; 95% CI, 0.22-0.48). Conclusion: A high overall Tdap vaccination rate was observed following implementation of the Committee guidelines. Women of a specific ethnicity, however, had significantly lower vaccine uptake than other women. Further research is needed to understand and minimize this disparity. Women who delivered prematurely also had a decreased rate of Tdap vaccination; vaccinating earlier should be considered to better capture this population. Documents held by sender: none.
Sex: M
Vaccine: IPV, MMR, TDAP, VARCEL
Symptoms: Adverse event, Allergy test
Clinical narrative: Initial information received from a healthcare professional on 10 April 2014. A male patient (no other information was provided) whose medical history and concomitant medications was not reported had received dose of DTaP, MMR, IPV, Varicella vaccine (batch number, expiration date, route and site of vaccination was not reported) on an unspecified date six years ago. The patient does not have any illness at the of vaccination and preexisting physician diagnosed allergies, birth defect, medical conditions was unknown. It was also reported that the patient was tested for an allergy to pork gelatin. It was reported that patient had an adverse event six years ago on an unspecified date. The detail of laboratory investigation and corrective treatment was not reported. At the time of this report the outcome of the adverse event was unknown. Documents held by sender: none.
Sex: U
Vaccine: DTAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 23-Sep-2013. The case was received on 21-Mar-2014. This case concerns a child patient (unknown gender) who took expired vaccine. A patient had received 2 doses of TRIPEDIA (Lot # unknown and expiration date 2012) on an unknown date. The reporter stated that a child was administered 2 doses of TRIPEDIA that expired in 2012. No adverse event was reported. List of documents held by sender: none.
Age: 39.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema nodosum, Nodule, Peripheral swelling, Pruritus, Skin hyperpigmentation
Clinical narrative: Initial report received from literature on 17 May 2014. A 39-years-old female patient, has not received any concomitant, received TDAP (batch number, route and anatomical site of administration were not reported) of unknown manufacturer on an unspecified date. It was reported that within 24 hours of receiving TDAP vaccine, the patient noted several areas of pruritus and swelling on her distal lower extremities. During the next 24 hours these areas enlarged and developed into tender red nodules. The painful nodules persisted and she sought dermatologic medical attention. Correlation of the patients medical history, clinical symptoms, and lesion morphology were compatible with a diagnosis of Tdap vaccine-related erythema nodosum; however, the differential diagnosis also included an Arthus like phenomenon induced by immunization and erythema nodosum secondary to another etiology with immunization being associated by chance. Several circumstances favored Tdap vaccine-related erythema nodosum. Specifically, the patient had not been receiving any topical or systemic medications. Also, she had no recent streptococcal pharyngitis or systemic conditions such as Crohn's disease, sarcoidosis, or tuberculosis. Therefore, the temporal association between her recent Tdap vaccination and the development of the skin lesion suggested that the development of her erythema nodosum was related to her receiving Tdap vaccine. On cutaneous examination, 7 day after receiving Tdap vaccine, revealed tender erythematous nodules on her legs. There was a large, 12 by 8 cm, erythematous nodule on distal pretibial left leg. Multiple, individual and grouped, nodules were present on her right leg; they were located on the distal lateral thigh (4.0 by 2.5 cm), the proximal lateral calf (6.0 by 3.5 cm), the distal lateral calf (2.0 by 2.0 cm), and the distal lateral leg proximal to the ankle (each of 3 lesions measuring 2.5 by 2.5 cm). Symptomatic treatment was initiated oral ibuprofen 600 mg four times daily. Since a drug induced etiology was suspected, daily oral systemic therapy with an antihistamine and a corticosteroid, 180 mg of fexofenadine and prednisone (60 mg for 4 days, followed by 40 mg for 3 days, and followed by 20 mg for 2 days). Her symptoms began to improve and the nodules started to flatten within 3 days. One of the nodules proximal to her right ankle was smaller, yet palpable with mild erythema of the skin. All other nodules had completely flattened and there was macular hyperpigmentation at the sites. At the time of this report the patient was recovered from the event. Documents held by sender: none.