chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 2.0
Sex: M
Vaccine: DTAP
Symptoms: Abnormal behaviour, Adenovirus infection, Asthenia, Cough, Depressed mood
Clinical narrative: Seemed sad/tired and no energy.  104+ fever. About 9PM had a partial seizure so we took him to the instacare.  Dr said white stuff on his throat and did a strep test. Came back negative.  She said it must be Adenovirus and sent us home and said to just keep the fever down. He woke at 12AM having another partial seizure, fever was 103. Developed a cough several days later. Took 4 days for the fevers to subside.  Returned to primary care physican on 03/14/14 because he still didn't seem like himself, but no fevers. Oxygen kept showing at 86.  They kept checking until it read 96 consistently on his foot.  Gave a prescription for Amoxicilin for ear infection and sent home.
Age: 2.0
Sex: M
Vaccine: DTAP
Symptoms: Ear infection, Fatigue, Partial seizures, Pharyngeal disorder, Pyrexia
Clinical narrative: Seemed sad/tired and no energy.  104+ fever. About 9PM had a partial seizure so we took him to the instacare.  Dr said white stuff on his throat and did a strep test. Came back negative.  She said it must be Adenovirus and sent us home and said to just keep the fever down. He woke at 12AM having another partial seizure, fever was 103. Developed a cough several days later. Took 4 days for the fevers to subside.  Returned to primary care physican on 03/14/14 because he still didn't seem like himself, but no fevers. Oxygen kept showing at 86.  They kept checking until it read 96 consistently on his foot.  Gave a prescription for Amoxicilin for ear infection and sent home.
Age: 2.0
Sex: M
Vaccine: DTAP
Symptoms: Streptococcus test negative
Clinical narrative: Seemed sad/tired and no energy.  104+ fever. About 9PM had a partial seizure so we took him to the instacare.  Dr said white stuff on his throat and did a strep test. Came back negative.  She said it must be Adenovirus and sent us home and said to just keep the fever down. He woke at 12AM having another partial seizure, fever was 103. Developed a cough several days later. Took 4 days for the fevers to subside.  Returned to primary care physican on 03/14/14 because he still didn't seem like himself, but no fevers. Oxygen kept showing at 86.  They kept checking until it read 96 consistently on his foot.  Gave a prescription for Amoxicilin for ear infection and sent home.
Age: 42.0
Sex: M
Vaccine: TYP
Symptoms: Arthralgia, Asthenia, Bone pain, Cold sweat, Discomfort
Clinical narrative: Description taken from patient's email. We were actually airborne I believe around 1500 or so.  A little bit after taking off I began to feel a little bit lethargic, and a short time after that a little bit weak.  As time went on my body started to hurt slightly, as if I were getting the flu.  A few hours into our flight we began refueling.  Shortly after starting our refueling activities I felt a sense of having the flu.  My bones or muscles were extremely achy, though I felt a greater amount of pain in all of my joints.  Fortunately we only did drogue refueling, which required no technical inputs from me that would affect any flight characteristics of either the aircraft I was in, or any of the receivers.  At the time the pain and discomfort was mild.  Shortly after our scheduled refueling had reached its conclusion, and I sat down again and rested.  I felt nauseous and extreme pain throughout my muscles and joints, as well as having a headache.  It became difficult to concentrate and focus on conversations. When the beginning symptoms set on I thought I was reacting to food poisoning.  I have experiences food poisoning which had led to similar symptoms of nausea and joint aching, but then I had realized it had been over 6 hours since I had eaten, and I have never had such a delayed reaction.  Once I had been experiencing the body aching along with cold sweats I recalled that during my first Typhoid immunization injection in 1992 I had an identical reaction, albeit far more severe during the 1st immunization.  During the 1st immunization the body aching was so severe it hurt to move anything.  Everything hurt except to lay still in my bed, and then the pain was limited to throbbing joints.  Though the pain this time was very similar in nature and location on my body, the level of intensity at it's peak was slightly below the previous experience.
Age: 42.0
Sex: M
Vaccine: TYP
Symptoms: Disturbance in attention, Headache, Influenza like illness, Lethargy, Myalgia
Clinical narrative: Description taken from patient's email. We were actually airborne I believe around 1500 or so.  A little bit after taking off I began to feel a little bit lethargic, and a short time after that a little bit weak.  As time went on my body started to hurt slightly, as if I were getting the flu.  A few hours into our flight we began refueling.  Shortly after starting our refueling activities I felt a sense of having the flu.  My bones or muscles were extremely achy, though I felt a greater amount of pain in all of my joints.  Fortunately we only did drogue refueling, which required no technical inputs from me that would affect any flight characteristics of either the aircraft I was in, or any of the receivers.  At the time the pain and discomfort was mild.  Shortly after our scheduled refueling had reached its conclusion, and I sat down again and rested.  I felt nauseous and extreme pain throughout my muscles and joints, as well as having a headache.  It became difficult to concentrate and focus on conversations. When the beginning symptoms set on I thought I was reacting to food poisoning.  I have experiences food poisoning which had led to similar symptoms of nausea and joint aching, but then I had realized it had been over 6 hours since I had eaten, and I have never had such a delayed reaction.  Once I had been experiencing the body aching along with cold sweats I recalled that during my first Typhoid immunization injection in 1992 I had an identical reaction, albeit far more severe during the 1st immunization.  During the 1st immunization the body aching was so severe it hurt to move anything.  Everything hurt except to lay still in my bed, and then the pain was limited to throbbing joints.  Though the pain this time was very similar in nature and location on my body, the level of intensity at it's peak was slightly below the previous experience.
Age: 42.0
Sex: M
Vaccine: TYP
Symptoms: Nausea, Pain
Clinical narrative: Description taken from patient's email. We were actually airborne I believe around 1500 or so.  A little bit after taking off I began to feel a little bit lethargic, and a short time after that a little bit weak.  As time went on my body started to hurt slightly, as if I were getting the flu.  A few hours into our flight we began refueling.  Shortly after starting our refueling activities I felt a sense of having the flu.  My bones or muscles were extremely achy, though I felt a greater amount of pain in all of my joints.  Fortunately we only did drogue refueling, which required no technical inputs from me that would affect any flight characteristics of either the aircraft I was in, or any of the receivers.  At the time the pain and discomfort was mild.  Shortly after our scheduled refueling had reached its conclusion, and I sat down again and rested.  I felt nauseous and extreme pain throughout my muscles and joints, as well as having a headache.  It became difficult to concentrate and focus on conversations. When the beginning symptoms set on I thought I was reacting to food poisoning.  I have experiences food poisoning which had led to similar symptoms of nausea and joint aching, but then I had realized it had been over 6 hours since I had eaten, and I have never had such a delayed reaction.  Once I had been experiencing the body aching along with cold sweats I recalled that during my first Typhoid immunization injection in 1992 I had an identical reaction, albeit far more severe during the 1st immunization.  During the 1st immunization the body aching was so severe it hurt to move anything.  Everything hurt except to lay still in my bed, and then the pain was limited to throbbing joints.  Though the pain this time was very similar in nature and location on my body, the level of intensity at it's peak was slightly below the previous experience.
Age: 1.25
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Decreased appetite, Diarrhoea, Faeces discoloured, Injection site erythema, Injection site rash
Clinical narrative: Red Bumps on Right thigh vaccine associated rash, noticed 2 days ago, fussy, decreased appetite, loose light green stools-1x.
Age: 1.25
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Irritability
Clinical narrative: Red Bumps on Right thigh vaccine associated rash, noticed 2 days ago, fussy, decreased appetite, loose light green stools-1x.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Burning sensation, Chromaturia, Constipation, Dysuria
Clinical narrative: Patient was seen in office 03/16/2014.  One week after receiving Zostavax vaccine at local pharmacy, patient began to complain of right hip pain, described as an ache and burn, radiating down right leg.  Also with pins and needles in right foot and toes. Pain is a 9 out of 10.  Difficulty urinating, pink tinged at times, with some noted constipation and nausea. On physical exam there was a nonblanching reticular rash right buttock, right posterior upper leg and right upper calf.  Patient was unaware of rash, but was located at site of pain.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Nausea, Pain, Pain in extremity, Paraesthesia
Clinical narrative: Patient was seen in office 03/16/2014.  One week after receiving Zostavax vaccine at local pharmacy, patient began to complain of right hip pain, described as an ache and burn, radiating down right leg.  Also with pins and needles in right foot and toes. Pain is a 9 out of 10.  Difficulty urinating, pink tinged at times, with some noted constipation and nausea. On physical exam there was a nonblanching reticular rash right buttock, right posterior upper leg and right upper calf.  Patient was unaware of rash, but was located at site of pain.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Patient was seen in office 03/16/2014.  One week after receiving Zostavax vaccine at local pharmacy, patient began to complain of right hip pain, described as an ache and burn, radiating down right leg.  Also with pins and needles in right foot and toes. Pain is a 9 out of 10.  Difficulty urinating, pink tinged at times, with some noted constipation and nausea. On physical exam there was a nonblanching reticular rash right buttock, right posterior upper leg and right upper calf.  Patient was unaware of rash, but was located at site of pain.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Rash generalised
Clinical narrative: Patient stated that she had an all-over-body rash after receiving a booster dose of MCV4, but denies other symptoms. Patient called triage nurse at the medical clinic and was sent to ER for evaluation. Note: this was a booster dose of MCV4, but patient previously received Menactra. Patient received Menveo at this visit.
Sex: F
Vaccine: HEP, HEPA
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a physician refers to a female patient of unknown age. On 03-MAR-2014 the patient was vaccinated with VAQTA (lot # J005081, 0.5 ml, intramuscular). On 03-MAR-2014 the patient received VAQTA instead of an unspecified Hepatitis B vaccine. No adverse event was reported. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Dizziness
Clinical narrative: Dizziness began 3-8-14.
Age: 1.03
Sex: M
Vaccine: HEP, IPV, PNC13, VARCEL
Symptoms: Flushing, Injection site erythema, Injection site warmth
Clinical narrative: Site of injection was red and hot to the touch. Cheeks were also flush. Reaction happened 10 min. after admin. of vaccine. Gave pt 1 tsp of BENADRYL. Check on pt after 20 min. of medication. Pt was looking better site was still red but better. Cheeks were better as well. Adverse reaction was on left thigh.
Age: 0.54
Sex: M
Vaccine: DTAPHEPBIP, FLU3, HIBV, PNC13, RV5
Symptoms: Abdominal X-ray, Vomiting
Clinical narrative: Pt receive vaccines around 10 AM on 03/06/14 mother then called back around 2 PM 03/06/14 stating pt vomited about 8 times in a row and it was bright green sent to ER.
Age: 0.38
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Irritability, Urticaria
Clinical narrative: Within minutes of injections (R) leg had multiple whelps while (L) leg had one at lower portion of left leg. Infant was extremely fussy but whelps resolved spontaneously with PRELONE administered.
Age: 1.71
Sex: F
Vaccine: DTAP, HIBV, MMR
Symptoms: Pyrexia, Rash
Clinical narrative: Fever started on 3/15/14, 102 degrees F, Rash started on 3/16/14, on back, spread to belly then to face and earlobes. Give BENADRYL, bid, to prevent scratching and TYLENOL every 4 hours if fever over 102 degrees F, call for concerns.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site swelling, Pain, Pain in extremity, Rash
Clinical narrative: Pt is 16 yo female here for rash. Had 16 yo immunizations - that night had some redness and swelling at injection site on (L) arm. Progressively worsened. Now has increased pain, erythema and swelling. Pain when moves left arm,
Age: 0.19
Sex: M
Vaccine: DTAPIPVHIB, HEP, IPV
Symptoms: Medication error
Clinical narrative: No reaction/pt was given Polio inj x 2 on 3/5/14 due to error.
Sex: M
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a Licensed Practitioner Nurse concerning a male patient (age not reported) who on 11-MAR-2014, was vaccinated inadvertently with a dose of PROQUAD (Merck) (Batch J014238, exp. 07-MAY-2015) (dose, route and site of administration were not reported) instead of a dose of M-M-R. Before been administered the PROQUAD (Merck) was exposed to an unsupported temperature excursion. No adverse effect was reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: F
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a Licensed Practitioner Nurse concerning a female patient (age not reported) who on 11-MAR-2014, was vaccinated inadvertently with a dose of PROQUAD (Batch J014238, exp. 07-MAY-2015) (dose, route and site of administration were not reported) instead of a dose of MMR. After been administered the PROQUAD was exposed to an unsupported temperature excursion. No adverse effect was reported. This is one of several reports 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 as received from a Registered Nurse refers to a patient of unknown age and gender. On an unknown date in February 2014, the patient was vaccinated with GARDASIL, dose route not reported. First dose was administered in March 2011. Lot information of all doses were not provided. The reporter stated that a patient received the first two doses of GARDASIL on time. However, the patient received the third dose late on a unknown date in February 2014. No adverse effects was reported. No product quality complaint was reported. Additional information is not expected.
Age: 89.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Local swelling, Pruritus, Skin warm
Clinical narrative: Pt developed swelling, itching, redness, warmth in the left bicep (not at injection site) about an hour after getting PNA vaccine. Pt reported to the pharmacy the next day. She had iced it. Pt was advised to use BENADRYL, ALEVE and monitor. MD was notified.
Age: 18.0
Sex: F
Vaccine: HEP, HEPA, HPV4, MNQ, VARCEL
Symptoms: Exposure during pregnancy
Clinical narrative: Patient is 4 months pregnant and did not make the provider aware prior to getting 5 vaccines.
Age: 51.0
Sex: F
Vaccine: RAB
Symptoms: Eye swelling, Urticaria
Clinical narrative: 3/13 Hives manifested upper legs, upper lip, right wrist, Benadryl 50mg taken. 3/14 Hives manifested stomach, lower lip, 60mg Prednisone prescribed by physician. 3/15 Hives manifested on scalp, neck.  60mg Prednisone AM, Benadryl daytime. 3/16 Severe hives entire back, neck, scalp and forehead, also arms and shoulder, front and back, right eye swollen, 60mg Prednisone, 25 mg Benadryl every 4-6 hours. 3/17  Hives almost gone except stomach and lower arms, continuing Benadryl.
Age: 2.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Erythema, Rash
Clinical narrative: Parent noticed small red spots under patients eyes on the afternoon of 3/11/14. Patient began to break out in rash spread to cheeks on face, legs, and arms on 3/15/14. Patient was treated with Mupirocin and Hydrocortisone Cream. Zyrtec 5mg/5mL in am and Benadryl 12.5mg/5mL at night, Orapred 15mg/5mL, Calomine lotion and  Oatmeal baths at night.
Age: 46.0
Sex: M
Vaccine: FLU3
Symptoms: Angioedema, Food allergy, Lip swelling, Local swelling, Swelling face
Clinical narrative: Hives, swelling of lips, neck, face, large patches of welts/hives all over my body (head to toe).  Researched and doctor states its urticaria and angioedema.  Went to hospital for treatment on several occasions, problems got progressively worst, seeing immunologist and other specialist and doctors.  Symptoms are ongoing on many medications that's affecting my health in other areas.  I get the hives/swelling in my head feels like it interferes with my thought process and brain.  Doctor said it will not hurt me.  I have reactions all the time and when I eat certain foods its worst, especially eggs.  I've never been allergic to any food and there's no clear trigger.  It feels as if something is in my blood stream so the reaction is constant and can occur at anytime.  I've tried to eliminate anything that triggers a reaction to help but it's difficult to identify.  It's very upsetting and exhausting.  Went back to pharmacist to ask if these symptoms can be related to the shot and was informed yes it's possible.
Age: 46.0
Sex: M
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Hives, swelling of lips, neck, face, large patches of welts/hives all over my body (head to toe).  Researched and doctor states its urticaria and angioedema.  Went to hospital for treatment on several occasions, problems got progressively worst, seeing immunologist and other specialist and doctors.  Symptoms are ongoing on many medications that's affecting my health in other areas.  I get the hives/swelling in my head feels like it interferes with my thought process and brain.  Doctor said it will not hurt me.  I have reactions all the time and when I eat certain foods its worst, especially eggs.  I've never been allergic to any food and there's no clear trigger.  It feels as if something is in my blood stream so the reaction is constant and can occur at anytime.  I've tried to eliminate anything that triggers a reaction to help but it's difficult to identify.  It's very upsetting and exhausting.  Went back to pharmacist to ask if these symptoms can be related to the shot and was informed yes it's possible.
Age: 59.0
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B antibody negative, Vertigo
Clinical narrative: Last week patient had a needlestick injury. Patient is a nurse practitioner.  Per corporate Employee Health protocol her labs were drawn.  Her Hep B titer came back negative.  She was given a Hep B booster on the evening of 3/13/14  (Lot #K94NR Exp 6/8/14 Left deltoid)  The next morning, 3/14/14, patient woke up with vertigo.  Her symptoms got worse all day and continued through Sunday night 3/16/14.  When patient woke up Monday morning she was feeling much better, but still has lingering symptoms.   No underlying medical conditions, her only medication is a hormone cream.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Drug eruption, Injection site swelling, Pruritus, Rash
Clinical narrative: SKIN RASH, ITCH, SWELLING AT SIGHT OF INJECTION - MD DETERMINED AS DRUG RASH, TREATED WITH ATARAX, PREDNISONE, CEPHALEXIN.
Age: 1.11
Sex: F
Vaccine: DTAPHEPBIP, FLU4, HEPA, HIBV, MMR, VARCEL
Symptoms: Crying, Dyskinesia, Dyspnoea, Laboratory test, Pyrexia
Clinical narrative: Child woke up at 5:00 AM and was crying and had a fever. Child threw up then was staring and had jerky movements and difficulty breathing. Ambulance called and was taken to medical center.
Age: 1.11
Sex: F
Vaccine: DTAPHEPBIP, FLU4, HEPA, HIBV, MMR, VARCEL
Symptoms: Staring, Vomiting
Clinical narrative: Child woke up at 5:00 AM and was crying and had a fever. Child threw up then was staring and had jerky movements and difficulty breathing. Ambulance called and was taken to medical center.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Pruritus generalised
Clinical narrative: Patient reported feeling itching all over his body.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Back pain, Balance disorder, Bedridden, Blood test, Diplopia
Clinical narrative: Vomiting, headache, loss of balance, double vision, numbness, Bells palsy, back pain, restless legs, unable to go to the bathroom, all starting in the morning and continuing to get worse. New symptom everyday. Bedridden for days.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Gait disturbance, Headache, Hypoaesthesia, Lumbar puncture, Nuclear magnetic resonance imaging
Clinical narrative: Vomiting, headache, loss of balance, double vision, numbness, Bells palsy, back pain, restless legs, unable to go to the bathroom, all starting in the morning and continuing to get worse. New symptom everyday. Bedridden for days.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Restless legs syndrome, VIIth nerve paralysis, Vomiting
Clinical narrative: Vomiting, headache, loss of balance, double vision, numbness, Bells palsy, back pain, restless legs, unable to go to the bathroom, all starting in the morning and continuing to get worse. New symptom everyday. Bedridden for days.
Age: 56.0
Sex: M
Vaccine: TDAP
Symptoms: Joint range of motion decreased, Musculoskeletal pain
Clinical narrative: Shoulder pain, progressed after three weeks to extreme shoulder pain at night, limitation of range of motion. Pain and limitation of range of motion still present after two months (and continuing).
Age: 0.34
Sex: F
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Convulsion, Electroencephalogram abnormal, Infantile spasms, Laboratory test normal, Lumbar puncture normal
Clinical narrative: Infantile spasm seizures.
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site cellulitis, Injection site pain, Surgery
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age. The patient's pertinent medical history and drug reactions/allergies were unspecified by the reporter. On 24-FEB-2014 the patient was vaccinated with PNEUMOVAX23 injection 25/0.5 Y lot # J009723, expire date: 30-JAN-2015 (dosage, route, frequency not reported). No concomitant medications were reported. It was reported that on 25-FEB-2014, patient developed cellulitis, was hospitalized and had surgery (medically significant) for cellulitis after receiving PNEUMOVAX23 (hospitalization). The pharmacist stated that the patient initially had pain at the injection site and then the patient developed cellulitis at the injection site. The reporter stated the patient was hospitalized in the for an unknown period of time and was treated with an unspecified antibiotic after having surgery. The patient sought medical attention (reported as contacted nurse). The pharmacist stated he has 50 vials of the same lot the patient received and also inquired whether the lot # still safe to administer to patients. He also requested a lot check on this lot#/expire date of PNEUMOVAX23. The outcome of the event had surgery for cellulitis after receiving PNEUMOVAX was unknown. The outcome of pain at the injection site and cellulitis after receiving PNEUMOVAX23 was reported as recovering/resolving. The reporter considered the event as serious due to hospitalization. Upon internal review the event surgery considered as serious due to medically significant. Additional information has been requested.
Sex: F
Vaccine: PPV, PPV
Symptoms: Vaccination site infection
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age. The patient's pertinent medical history and drug reactions/allergies were unspecified by the reporter. On 24-FEB-2014 the patient was vaccinated with PNEUMOVAX23 injection 25/0.5 Y lot # J009723, expire date: 30-JAN-2015 (dosage, route, frequency not reported). No concomitant medications were reported. It was reported that on 25-FEB-2014, patient developed cellulitis, was hospitalized and had surgery (medically significant) for cellulitis after receiving PNEUMOVAX23 (hospitalization). The pharmacist stated that the patient initially had pain at the injection site and then the patient developed cellulitis at the injection site. The reporter stated the patient was hospitalized in the for an unknown period of time and was treated with an unspecified antibiotic after having surgery. The patient sought medical attention (reported as contacted nurse). The pharmacist stated he has 50 vials of the same lot the patient received and also inquired whether the lot # still safe to administer to patients. He also requested a lot check on this lot#/expire date of PNEUMOVAX23. The outcome of the event had surgery for cellulitis after receiving PNEUMOVAX was unknown. The outcome of pain at the injection site and cellulitis after receiving PNEUMOVAX23 was reported as recovering/resolving. The reporter considered the event as serious due to hospitalization. Upon internal review the event surgery considered as serious due to medically significant. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Convulsion
Clinical narrative: This spontaneous report as received from a other health professional refers to a 16 year old female patient. On 09-OCT-2012, the patient was vaccinated with the first dose of GARDASIL (dose, duration and route were not reported). On 14-DEC-2012, the patient was vaccinated with the second dose of GARDASIL (dose, duration and route were not reported) and on 18-OCT-2013 the patient received the third dose of GARDASIL (dose, duration and route were not reported). The patient had her first seizure two days later on 20-OCT-2013. The patient was under the care of pediatric neurologist. The outcome of seizure disorder after her third dose of GARDASIL was unknown. The family believed GARDASIL triggered the seizure disorder. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to an unspecified number of patiens of unkonwn ages and genders. On an unknown date, the patients were vaccinated with M-M-R II (dose, route and lot number were not reported), vaccine had been exposed to multiple excursions with highest temperature reaching 57F for total time of 206 hours and these vaccines' stability could not be supported. No adverse effects reported. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to an unspecified number of patients of unknown ages and genders. On an unknown date, the patients were vaccinated with GARDASIL (dose, route and lot number were not reported), vaccine had been exposed to multiple excursions with highest temperature reaching 57F for total time of 206 hours and these vaccines' stability could not be supported. No adverse effects reported. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to an unspecified number of patients of unknown ages and genders. On an unknown date, the patients were vaccinated with PNEUMOVAX 23, vaccine had been exposed to multiple excursions with highest temperature reaching 57F for total time of 206 hours and these vaccines' stability could not be supported. No adverse effects reported. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: RVX
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to an unspecified number of patients of patients of unknown ages and genders. On an unknown date, the patients were vaccinated with ROTATEQ (dose, route and lot number were not reported), vaccine had been exposed to multiple excursions with highest temperature reaching 57F for total time of 206 hours and these vaccines' stability could not be supported. No adverse effects reported. This is one of several reports from the same source. Additional information has been requested.
Age: 43.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Local swelling, Skin warm
Clinical narrative: Client states in pm 3/12/14 (L) deltoid became red with some swelling then on 3/13/14 (L) deltoid became very swollen, red and warm. Client states she applied alcohol to area. 3/14/14  (L) deltoid lg amt swelling, redness and warmth. Referred to medical doctor.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Cough, Erythema, Local swelling, Urticaria
Clinical narrative: Had adverse reaction to vaccines in office. Hives, redness and swelling on arms and legs. Cough. Tx in office: albuterol nebulizer, 5 mL of BENADRYL in office. Sent to ER.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Hypoaesthesia, Injected limb mobility decreased, Neck pain, Pain in extremity
Clinical narrative: Weakness, numbness, (L) arm pain, neck pain, lower ext on (L) arm pain, limited range of motion.
Age: 43.0
Sex: F
Vaccine: TDAP
Symptoms: Body temperature increased, Cellulitis, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: About 4cm hard, painful swelling to right deltoid several days after Tdap (5 days) vaccine. Pain with arm movement. Treated w/ KEFLEX, Dx cellulitis. T = 99.2.
Age: 43.0
Sex: F
Vaccine: TDAP
Symptoms: Pain
Clinical narrative: About 4cm hard, painful swelling to right deltoid several days after Tdap (5 days) vaccine. Pain with arm movement. Treated w/ KEFLEX, Dx cellulitis. T = 99.2.
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Diarrhoea, Expired drug administered, Vomiting
Clinical narrative: This spontaneous report as received from medical assistant (patient's mother) refers to a 4 year old female patient. There was no pertinent medical history. The patient had an unknown reaction to Amoxicillin (manufacturer unknown). On 04-MAR-2014 the patient was vaccinated with a dose of PROQUAD (Merck) (lot # H015629, exp date 24-FEB-2014) (0.5 ml, subcutaneous). There was no concomitant therapy. On 04-MAR-2014, the patient experienced diarrhea since administration of expired PROQUAD (Merck). The patient vomited once the night of 04-MAR-2014. The medical assistant stated her daughter had increased her fluid intake as treatment for adverse events and had not required medical attention at the time of the report. Laboratory diagnostic studies were not performed. At the time of the report the patient's outcome was not recovered. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HEP, IPV, MMR, VARCEL
Symptoms: Rash pruritic
Clinical narrative: Itchy rash to bilateral cheeks x 2 weeks. Treated on 3/17/14 with Acyclovir 400mg 2 tabs every 6 hrs. x 7 days.
Age: 6.0
Sex: F
Vaccine: IPV, VARCEL
Symptoms: Erythema, Local swelling, Pain, Urticaria
Clinical narrative: Large urticarial rash, swelling, red and painful 11 x 16 cm. Improved with ice.
Sex: F
Vaccine: HPV4
Symptoms: Smear cervix abnormal
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age. Medical history and drug reactions/allergies were not reported. On an unknown date, the patient was vaccinated with GARDASIL (lot, dose and route not reported), as a young girl. Concomitant medication was not reported. On an unknown date after receiving GARDASIL, the patient had an abnormal PAP smear. Therapy with GARDASIL continued. The outcome of the event was not reported. Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site swelling, Swelling
Clinical narrative: Friday night (L) arm - swelled. Increased swelling on Saturday - Monday decreased swelling in arm - slight swelling (L) upper chest mom gave ibuprofen. On 3-17-14 given rx for BENADRYL.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist (also reported as pharmacy technician) via company representative refers to a female patient of unknown age. Pertinent medical history and drug reactions/allergies were not reported. In March 2014 "early this month", the patient was vaccinated with ZOSTAVAX (dose, lot number and route were not reported). Concomitant therapy was not reported. In March 2014 the next day after the therapy, the patient developed injection site swelled up and became very red and sore. The patient did not seek medical attention. The outcome of the events was reported as recovered in March 2014. Additional information has been requested.
Age: 1.96
Sex: F
Vaccine: DTAP
Symptoms: Induration, Local swelling
Clinical narrative: Swelling, hard tissue 3cm cir. Warm compress to area, TYLENOL for pain/fever (should it develop).
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood test, Lacrimation increased, Musculoskeletal stiffness, Pain, Pruritus
Clinical narrative: This spontaneous report as received from a consumer of 64 year old with penicillin allergy, autoimmune disease unspecified concerning herself. On an unknown date in 1995, patient had shingles and the pain lasted for one month. On an unknown date patient developed allergic reaction to penicillin (unspecified) (dosage/ frequency/ manufacturer unknown. On 21-FEB-2014 the patient was vaccinated with ZOSTAVAX vial injection, (strength, dose unit, route, and lot # and expiry date unknown). Concomitant therapies included prednisone (manufacturer unknown) and diltiazem hydrochloride (manufacturer unknown). On 28-FEB-2014, patient experienced rash, pain and watering of the left eye, stiffness and phantom itching. Patient visited doctor for medical attention and no treatment was provided. On an unknown date, unspecified blood work was performed and result was unknown. The outcome of rash, pain and watering of the left eye, stiffness and phantom itching was reported as not recovered/not resolved. No further AE information was provided. Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: This spontaneous report as received from a consumer of 64 year old with penicillin allergy, autoimmune disease unspecified concerning herself. On an unknown date in 1995, patient had shingles and the pain lasted for one month. On an unknown date patient developed allergic reaction to penicillin (unspecified) (dosage/ frequency/ manufacturer unknown. On 21-FEB-2014 the patient was vaccinated with ZOSTAVAX vial injection, (strength, dose unit, route, and lot # and expiry date unknown). Concomitant therapies included prednisone (manufacturer unknown) and diltiazem hydrochloride (manufacturer unknown). On 28-FEB-2014, patient experienced rash, pain and watering of the left eye, stiffness and phantom itching. Patient visited doctor for medical attention and no treatment was provided. On an unknown date, unspecified blood work was performed and result was unknown. The outcome of rash, pain and watering of the left eye, stiffness and phantom itching was reported as not recovered/not resolved. No further AE information was provided. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site induration, Injection site rash, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 60 year old female patient. There was no pertinent medical history and no drug reactions or allergies. On 07-MAR-2014, the patient was vaccinated with ZOSTAVAX lot # J011549 expiry date 19-DEC-2014, subcutaneous (dose not reported). Concomitant medication was not reported. On 09-MAR-2014, the patient called into the pharmacy stating she developed a rash, a "hard area" and swelling at the injection site. The pharmacist instructed the patient to "put ice on it" (also reported as no treatment given for the events). No lab diagnostics performed. On 12-MAR-2014, the patient came in to the pharmacy and "only the rash was still there". (The outcome of a rash at the injection site was reported as not recovered. The outcome of a "hard area" and swelling at the injection site was reported as recovered). Additional information has been requested.
Age: 56.0
Sex: F
Vaccine: DTAPIPV, PPV, VARZOS
Symptoms: Chills, Feeling cold, Pain, Pyrexia
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 56 year old female patient. No information regarding the patient's medical history was provided. With valid lot # J011651, subcutaneously in the left arm, ZOSTAVAX with valid lot # J011338, subcutaneously in the left arm and DTAP-IPV intramuscularly in the left deltoid (lot number T25EG). Dose and dose number were not reported. No concomitant medication was reported. The nurse reported that all patients received PNEUMOVAX 23, but that some of the patients may also have received ZOSTAVAX concomitantly, that day. On 17-DEC-2013 the patient experienced fever (101), achy and freezing/chills. The patient denied illness at time of vaccination and denied pre-existing physician diagnosed allergies, birth defects and medical conditions. The outcome of fever (101), achy and freezing/chills were reported as recovered/resolved (date not reported). Reporter causality assessment was not reported. The linked case are 1312USA010905, 1403USA003215, 1403USA003216, 1403USA003217, 1403USA003218, 1403USA003219, 1403USA003220, 1403USA003221, 1403USA003222, 1403USA003223, 1403USA003224, 1403USA003225, 1403USA003226, 1403USA003227, 1403USA003228, 1403USA003229, 1403USA003231, 1403USA003232, 1403USA003233, 1403USA003234, 1403USA003235, 1403USA003236, 1403USA003237, 1403USA003238, 1403USA003239, 1403USA003240, 1403USA003241, 1403USA003242, 1403USA003243, 1403USA003244, 1403USA003245, 1403USA003246, 1403USA003247, 1403USA003248, 1403USA003249, 1403USA003250, 1403USA003251, 1403USA003252 and 1403USA003253. Additional information has been requested.
Age: 53.0
Sex: F
Vaccine: DTAPIPV, PPV, VARZOS
Symptoms: Chills, Headache, Nausea, Pyrexia, Vomiting
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 53 year old female patient. No information regarding the patient's medical history was provided. With valid lot # J011651, subcutaneously in the left arm, ZOSTAVAX with valid lot # J011338, subcutaneously in the left arm and DTAP-IPV intramuscularly in the lett deltoid (lot number T25EG). Dose and dose number were not reported. No concomitant medication was reported. The nurse reported that all patients received PNEUMOVAX 23, but that some of the patients may also have received ZOSTAVAX concomitantly, that day. On 17-DEC-2013 the patient experieneced headaches, vomiting, nausea, fever and chills. The patient denied illness at time of vaccination and denied pre-existing physician diagnosed allergies, birth defects and medical conditons. The outcome of headaches, vomiting, nausea, fever and chills were reported as recovered/resolved (date not reported). Reporter causality assessment was not reported. The linked case are 1312USA010905, 1403USA003215, 1403USA003216, 1403USA003217, 1403USA003218, 1403USA003219, 1403USA003220, 1403USA003221, 1403USA003222, 1403USA003223, 1403USA003224, 1403USA003225, 1403USA003226, 1403USA003227, 1403USA003228, 1403USA003229, 1403USA003230, 1403USA003232, 1403USA003233, 1403USA003234, 1403USA003235, 1403USA003236, 1403USA003237, 1403USA003238, 1403USA003239, 1403USA003240, 1403USA003241, 1403USA003242, 1403USA003243, 1403USA003244, 1403USA003245, 1403USA003246, 1403USA003247, 1403USA003248, 1403USA003249, 1403USSA03250, 1403USA003251, 1403USA003252 and 1403USA003253. Additional information has been requested.
Age: 52.0
Sex: M
Vaccine: DTAPIPV, PPV, VARZOS
Symptoms: Influenza like illness
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 52 year old male patient. No information regarding the patient's medical history was provided. With valid lot # J011651, subcutaneously in the right arm, ZOSTAVAX with valid lot # J011338, subcutaneously in the right arm and DTAP-IPV intramuscularly in the right deltoid (lot number T25EG). Dose and dose number were not reported. No concomitant medication was reported. The nurse reported that all patients received PNEUMOVAX 23, but that some of the patients may also have received ZOSTAVAX concomitantly, that day. On 17-DEC-2013 the patient experienced flu like symptoms. The patient denied illness at time of vaccination and denied pre-existing physician diagnosed allergies, birth defects and medical conditions. The outcome of flu like symptoms was reported as recovered/resolved (date not reported). Reporter causality assessment was not reported. This case was linked to cases: 1312USA010905, 1403USA003215, 1403USA003216, 1403USA003217, 1403USA003218, 1403USA003219, 1403USA003220, 1403USA003221, 1403USA003222, 1403USA003223, 1403USA003224, 1403USA003225, 1403USA003226, 1403USA003227, 1403USA003228, 1403USA003230, 1403USA003231, 1403USA003232, 1403USA003233, 1403USA003234, 1403USA003235, 1403USA003236, 1403USA003237, 1403USA003238, 1403USA003239, 1403USA003240, 1403USA003241, 1403USA003242, 1403USA003243, 1403USA003244, 1403USA003245, 1403USA003246, 1403USA003247, 1403USA003248, 1403USA003249, 1403USA003250, 1403USA003251, 1403USA003252 and 1403USA003253 (same reporter link). Additional information has been requested.
Age: 54.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Injection site induration, Injection site nodule, Injection site rash
Clinical narrative: Initial case received from a pharmacist on 07 March 2014. According to the pharmacist, the case had also been reported to VAERS (reference number 518424). A 54-year-old female patient received an intradermal injection of FLUZONE (lot not reported) on an unspecified date. The patient subsequently experienced a localized injection site reaction and infection at the injection site. According to the reporter, the patient was immunocompromised at the time of vaccination due to treatment with chemotherapy (other medical history and concomitant medications not reported). Outcome was not reported. Additional documents held by sender: None.
Age: 54.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Injection site infection, Injection site reaction
Clinical narrative: Initial case received from a pharmacist on 07 March 2014. According to the pharmacist, the case had also been reported to VAERS (reference number 518424). A 54-year-old female patient received an intradermal injection of FLUZONE (lot not reported) on an unspecified date. The patient subsequently experienced a localized injection site reaction and infection at the injection site. According to the reporter, the patient was immunocompromised at the time of vaccination due to treatment with chemotherapy (other medical history and concomitant medications not reported). Outcome was not reported. Additional documents held by sender: None.
Age: 47.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: 47 y/o male who reports onset of upper left arm pain from vaccination site down arm. Pains have persisted intermittently since NOV and are described as sharp, shooting pains. Movement tends to make pain worse; intensity of pain ranges between 3 and 8/10, using pain scale of 0 (=no pain) to 10 (=worst pain ever experienced). Denies anything unusual regarding vaccine administration. Denies experiencing a large, local reaction. Denies history of LUE pain or similar pain in past. No history of trauma to LUE. Denies numbness and tingling and weakness of LUE. Denies previous AEFIs with past flu vaccines, or any vaccines. Has not sought evaluation of pain.
Age: 47.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Pain in extremity, Vaccination site pain
Clinical narrative: 47 y/o male who reports onset of upper left arm pain from vaccination site down arm. Pains have persisted intermittently since NOV and are described as sharp, shooting pains. Movement tends to make pain worse; intensity of pain ranges between 3 and 8/10, using pain scale of 0 (=no pain) to 10 (=worst pain ever experienced). Denies anything unusual regarding vaccine administration. Denies experiencing a large, local reaction. Denies history of LUE pain or similar pain in past. No history of trauma to LUE. Denies numbness and tingling and weakness of LUE. Denies previous AEFIs with past flu vaccines, or any vaccines. Has not sought evaluation of pain.
Age: 0.18
Sex: M
Vaccine: DTAPHEPBIP, MENHIB, RVX
Symptoms: Crying
Clinical narrative: Constant continuous crying despite comforting and trying all measures to get crying to stop lasted from 6pm-11pm then infant finally went to sleep and was fine through the night and there after.
Sex: M
Vaccine: FLUX, PPV
Symptoms: Blood glucose increased, Cough, Glucose tolerance impaired, Increased upper airway secretion, Poor quality sleep
Clinical narrative: This consumer report (initial receipt 05-Mar-2014) was received via a pharmaceutical company and concerns a male patient who was aged between 60 and 69 years. Medical history included acid reflux, allergy to animals, citrus, dairy, iodine, peanuts, walnuts and shellfish; osteoporosis (diagnosed in Oct-2010). Concomitant medications included metformin hydrochloride, vitamin D, multivitamins and esomeprazole. On an unspecified date, the patient received the influenza virus vaccine (manufacturer and batch number not provided) and pneumococcal virus vaccine (manufacturer and batch number not provided). On an unspecified date, within months of vaccination with the influenza vaccine and pneumonia vaccine, the patient developed serum sickness and lung congestion. On the 15-Nov-2013, the patient commenced fluticasone propionate/salmeterol xinafoate inhaler 500/50mcg to be taken one puff twice daily for the lung congestion which was secondary to the serum sickness. The patient was concerned to take the steroid inhaler therefore reduced the dose on the 24-Nov-2013 to 250/50mcg, one puff before bedtime when he felt a build-up of phlegm on his chest and would start to cough. The fluticasone propionate/salmeterol xinafoate inhaler allowed him to sleep, as he was not sleeping well, and was pleased with the medication. On approximately 23-Dec-2013, the patient received a blood test which showed his blood sugar numbers increased to 5.8 during treatment with fluticasone propionate/salmeterol xinafoate inhaler. Late Dec-2013, the patient was diagnosed with diabetes but his doctor said he was right on the edge of having diabetes. Outcome was reported as not recovered for serum sickness, lung congestion, mucus in chest, cough, diabetes, increased blood sugar. The patient had recovered from the poor quality sleep.