chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: 6/11/15 Pt given PREVNAR 13 at 12:07. pt called triage line at 16:20 with c/o of (R) arm soreness at injection site. Sore to point pt unable to lift arm without experience extreme soreness. pt given instructions per MD recommendation (TYLENOL and alternate with ibuprofen). EMS was called by pt at 17:00. EMS left home. Pt went to ED later in night with no relief of soreness (R) Deltoid. D/C same day. Pt seen by her provider at 6/17 (R) site pain. SKELAXIN ordered, Ultrasound ordered, Ice therapy, lift restrictions.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Balance disorder, Gait disturbance
Clinical narrative: Mom states the evening after receiving immunizations that child was walking different and off balance. She denies pain in either leg. No redness or induration either.
Age: 72.0
Sex: M
Vaccine: HEP, HIBV, HPV9, IPV, PNC13
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: None.
Age: 22.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Patient states redness happen later on during the same day. Started having swelling, soreness, pain and the redness.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant (C.M.A.) refers to multiple unspecified patients of an unknown age and gender. Medical history and concurrent conditions were not reported. On multiple unknown dates (ranging from December 2014, January 2015, and February 2015), the patients were vaccinated with doses of improperly stored GARDASIL (lot# J009788, with expiration date 17-MAR-2016 and lot# K004205, which expiration date 12-JAN-2017, dose and route of administration were not reported). Concomitant medication was not reported. No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 0.34
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Urticaria
Clinical narrative: 5 minutes after given vaccines, mom noted 2 3mm urticarial rash on his inner forehead with no respirating distress. pt given 6.2 mg = 2.5 ml BENADRYL po and rash improved.
Age: 1.02
Sex: F
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Pyrexia, Rash, Rash macular
Clinical narrative: Fever and rash 10 days after vaccine. Temp up to 100.7. Macular rash on chest only. No treatment.
Age: 73.0
Sex: F
Vaccine: PNC13
Symptoms: Condition aggravated, Neuropathy peripheral
Clinical narrative: Pt has vascular neuropathy controlled by medications. 12 hours post vaccine pt states her neuropathy flared in legs and arms. It diminished every morning and increased every evening over last 4 days. Decreased severity every day.
Age: 73.0
Sex: F
Vaccine: PNC13
Symptoms: Pruritus
Clinical narrative: Patient called 6/23/15 1015am reporting after she received her PREVNAR 13 she experienced moderate itching of her chest that night.
Age: 81.0
Sex: F
Vaccine: PNC13
Symptoms: Chills, Dyspnoea, Erythema, Injection site erythema, Injection site pain
Clinical narrative: (L) arm pain, redness, chills tender, SOB located from (L) deltoid to (L) forearm. Started 6/27/15 to current. Advised antihistamines and OTC PEPCID x 2 days.
Age: 81.0
Sex: F
Vaccine: PNC13
Symptoms: Pain in extremity, Tenderness
Clinical narrative: (L) arm pain, redness, chills tender, SOB located from (L) deltoid to (L) forearm. Started 6/27/15 to current. Advised antihistamines and OTC PEPCID x 2 days.
Age: 2.0
Sex: F
Vaccine: DTAP, HEP, MMRV
Symptoms: Dyskinesia, Seizure like phenomena
Clinical narrative: Parent called and reported child was having strange head movements, jerking head around and around for about 15-20 min. Took to ER - no temperature, no labs or images taken. Pt had since stopped seizure like movements when got to ER.
Age: 55.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site rash, Injection site swelling, Paraesthesia
Clinical narrative: On 6/26/15 at injection site-redness, swelling, tenderness, pain, rash. Started on 6/25/15 with dime sized redness c/o tiredness, nausea, vomiting, fever, tingling in fingers both hands on 6/26/15.
Age: 55.0
Sex: F
Vaccine: TDAP
Symptoms: Pyrexia, Vomiting
Clinical narrative: On 6/26/15 at injection site-redness, swelling, tenderness, pain, rash. Started on 6/25/15 with dime sized redness c/o tiredness, nausea, vomiting, fever, tingling in fingers both hands on 6/26/15.
Age: 27.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, Injection site erythema, Injection site induration, Injection site nodule, Pyrexia
Clinical narrative: This prospective pregnancy case was reported by a nurse via call center representative and described the occurrence of vaccine exposure during pregnancy in a 27-year-old female patient who received BOOSTRIX (batch number 5MG55, expiry date 10th October 2016. On 15th June 2015, the patient received BOOSTRIX (intramuscular) .5 ml. The subject's estimated date of delivery was 19th July 2015. The subject received BOOSTRIX during the third trimester of pregnancy. On 15th June 2015, an unknown time after receiving BOOSTRIX, the patient experienced vaccine exposure during pregnancy and fever. In June 2015, the patient experienced injection site erythema and injection site induration. On an unknown date, the outcome of the vaccine exposure during pregnancy was unknown and the outcome of the fever and injection site erythema were recovered/resolved and the outcome of the injection site induration was not recovered/not resolved. The pregnancy was ongoing. It was unknown if the reporter considered the fever, injection site erythema and injection site induration to be related to BOOSTRIX. Additional information provided: the nurse reported that the patient received a dose of BOOSTRIX and experienced fever on the same day. Then the subject experienced redness at the injection site and a hard know at injection site (1 1/2 inch from the injection site). Patient went to the doctors office and was recovering. The AEs subsided except the hard knot that was not recovered.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: Left arm was red, swollen, and painful.
Sex: F
Vaccine: HEP
Symptoms: No therapeutic response
Clinical narrative: This case was reported by a consumer and described the occurrence of therapy non-responder in a adult female patient who received Hepatitis B vaccine. Co-suspect products included Hepatitis B vaccine. On an unknown date, the patient received the 1st dose of Hepatitis B vaccine (intramuscular), the 2nd dose of Hepatitis B vaccine (intramuscular), the 3rd dose of Hepatitis B vaccine (intramuscular), the 4th dose of Hepatitis B vaccine (intramuscular), the 5th dose of Hepatitis B vaccine (intramuscular) and the 6th dose of Hepatitis B vaccine (intramuscular). On an unknown date, an unknown time after receiving Hepatitis B vaccine, the patient experienced therapy non-responder. On an unknown date, the outcome of the therapy non-responder was unknown.
Age: 37.0
Sex: F
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a Pharmacist refers to a 37 year old female patient. The patient's concurrent conditions or medical history were not reported. On 23-JUN-2015, the patient was vaccinated with an expired dose of ZOSTAVAX vial, lot # reported as J006107 with expiration date 17-MAY-2015 (dose, route and anatomical location not reported). No adverse effect was reported. Additional information has been requested.
Age: 0.34
Sex: F
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Dyspnoea
Clinical narrative: Dyspnea per grandparent. Evalued by paramedics.
Age: 91.0
Sex: M
Vaccine: PNC13
Symptoms: Erythema, Pain, Rash, Skin warm
Clinical narrative: Pt had a 27cm x 7 cm rash and had been complaining of pain. Rash was noted 6 days after administration when pt was seen back in clinic. Skin rash, rash and erythema, pain, warm to touch.
Age: 12.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Eye swelling, Visual acuity tests normal
Clinical narrative: Pt received MCV4, Tdap and HPV yesterday within 24 hour period, pt experienced bilateral eye swelling treated at home with OTC ibuprofen and BENADRYL. Pt at pt clinic, pt received prednisone.
Age: 74.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site oedema, Injection site pain
Clinical narrative: Patient developed excrutiating pain, edema and erythema at vaccine injection site (R) deltoid.
Age: 76.0
Sex: F
Vaccine: PNC13, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site rash, Injection site warmth
Clinical narrative: Pt. called stating her arm was in severe pain with hot red arm at site of Prevnar.  "Rash" going to elbow. Called pt. today 6/29 pain still present but improving.
Age: 0.18
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Crying, Pyrexia, Tenderness
Clinical narrative: Nonstop crying, 100.3 degree fever, tender all over.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Redness, swelling, pain at injection site.
Age: 60.0
Sex: F
Vaccine: HEPA
Symptoms: Blood glucose normal, Confusional state, Dizziness, Heart rate decreased, Hyperhidrosis
Clinical narrative: 60 year old diabetic female patient started feeling dizzy and fainted while seated approximately 5 minutes after receiving a HEP A vaccine. Patient was seated in immunizations waiting area at the time. Patient was roused with an ammonia inhalant and asked if she was having difficulty breathing to which she shook her head no. Patient was extremely diaphoretic and had a very weak and slow pulse. Code Blue was called. Patient was asked if she knew her name but fainted again before replying. Patient was roused again by shaking/tapping her shoulder. Patient was asked if she knew where she was to which she replied "I don't remember how I got here". Approximately 1-2 minutes after code was called the response team arrived. Husband of patient checked patient's glucose with her personal glucometer and reported it to be normal. Pulse Oximeter was placed on patient and read 85% oxygen level with a heart rate of 31. Patient at this time was able to verbalize her name and where she was. Patient was placed on a gurney and transported to ER.
Age: 60.0
Sex: F
Vaccine: HEPA
Symptoms: Oxygen saturation decreased, Pulse abnormal, Syncope
Clinical narrative: 60 year old diabetic female patient started feeling dizzy and fainted while seated approximately 5 minutes after receiving a HEP A vaccine. Patient was seated in immunizations waiting area at the time. Patient was roused with an ammonia inhalant and asked if she was having difficulty breathing to which she shook her head no. Patient was extremely diaphoretic and had a very weak and slow pulse. Code Blue was called. Patient was asked if she knew her name but fainted again before replying. Patient was roused again by shaking/tapping her shoulder. Patient was asked if she knew where she was to which she replied "I don't remember how I got here". Approximately 1-2 minutes after code was called the response team arrived. Husband of patient checked patient's glucose with her personal glucometer and reported it to be normal. Pulse Oximeter was placed on patient and read 85% oxygen level with a heart rate of 31. Patient at this time was able to verbalize her name and where she was. Patient was placed on a gurney and transported to ER.
Age: 16.0
Sex: M
Vaccine: HEPA, HPV4, MEN
Symptoms: Dizziness, Motion sickness
Clinical narrative: Car sick driving home and lightheaded, dizzy that continued for several weeks including date of this report.
Age: 24.0
Sex: F
Vaccine: TD
Symptoms: Dysphagia, Fatigue, Flushing, Headache, Myalgia
Clinical narrative: Donor stated she started having a hard time swallowing and talking after shot, and it has persisted for 2 days. Donor also reported headache, muscle aches, feeling flushed, and a hard time staying awake. Donor stated she spent the whole day in bed due to fatigue.
Age: 24.0
Sex: F
Vaccine: TD
Symptoms: Somnolence, Speech disorder
Clinical narrative: Donor stated she started having a hard time swallowing and talking after shot, and it has persisted for 2 days. Donor also reported headache, muscle aches, feeling flushed, and a hard time staying awake. Donor stated she spent the whole day in bed due to fatigue.
Age: 0.39
Sex: F
Vaccine: DTAPIPVHIB, PPV, RVX
Symptoms: Confusional state, Crying, Faeces discoloured, Hypersomnia
Clinical narrative: Green diarrhea every 1-2 hours, normally she goes every 3-4 days asleep for 16 hours, confusion, loud crying.
Age: 52.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Dizziness, Hyperhidrosis, Malaise, Nausea
Clinical narrative: Hives lasting 3 days, sweating, nauseous, light headed, ill feeling, pain in injection arm. Pain in joints after a couple days.
Age: 52.0
Sex: F
Vaccine: TDAP
Symptoms: Pain in extremity, Urticaria
Clinical narrative: Hives lasting 3 days, sweating, nauseous, light headed, ill feeling, pain in injection arm. Pain in joints after a couple days.
Age: 75.0
Sex: M
Vaccine: PNC13
Symptoms: Arthralgia, Balance disorder, Blood glucose normal, Blood test normal, Bursitis
Clinical narrative: Back & left shoulder muscle pain and immobility, left arm numbness, left hand fingers tingling; increase neck pains; increase arthritis pain throughout body; increased lower body weakness; increased loss of balance; difficulty sleeping; visited doctor MD (DO) 1/7/15 (diagnosed as "Inflamed Tendon, Bursa and Cartilage"; Blood test 4/28/15 relatively normal Vitamin B-12 low; DO 5/19/15 Regional Musculoskeletal Dyfunction; Skeletion Evaluation 5/11/15; pain medicines, exercise and referral to professional physical therapy.
Age: 75.0
Sex: M
Vaccine: PNC13
Symptoms: Chondropathy, Hypoaesthesia, Insomnia, Mobility decreased, Muscular weakness
Clinical narrative: Back & left shoulder muscle pain and immobility, left arm numbness, left hand fingers tingling; increase neck pains; increase arthritis pain throughout body; increased lower body weakness; increased loss of balance; difficulty sleeping; visited doctor MD (DO) 1/7/15 (diagnosed as "Inflamed Tendon, Bursa and Cartilage"; Blood test 4/28/15 relatively normal Vitamin B-12 low; DO 5/19/15 Regional Musculoskeletal Dyfunction; Skeletion Evaluation 5/11/15; pain medicines, exercise and referral to professional physical therapy.
Age: 75.0
Sex: M
Vaccine: PNC13
Symptoms: Myalgia, Neck pain, Paraesthesia, Tendonitis, Vitamin B12 decreased
Clinical narrative: Back & left shoulder muscle pain and immobility, left arm numbness, left hand fingers tingling; increase neck pains; increase arthritis pain throughout body; increased lower body weakness; increased loss of balance; difficulty sleeping; visited doctor MD (DO) 1/7/15 (diagnosed as "Inflamed Tendon, Bursa and Cartilage"; Blood test 4/28/15 relatively normal Vitamin B-12 low; DO 5/19/15 Regional Musculoskeletal Dyfunction; Skeletion Evaluation 5/11/15; pain medicines, exercise and referral to professional physical therapy.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site discolouration, Injection site erythema, Injection site swelling, Peripheral swelling
Clinical narrative: The patient stated that the injection site turned purple and that she had a red swollen area that extended all the way around the front of her arm and below her elbow.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Haematocrit normal, Haemoglobin normal, Lymphocyte percentage increased, Monocyte percentage increased, Neutrophil percentage decreased
Clinical narrative: Fever tmax 101.8 from 6/26/15-6/29/15 (present). Treated with Tylenol. Vomited twice on 6/28/15-6/29/15.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Platelet count normal, Pyrexia, Vomiting, White blood cell count normal
Clinical narrative: Fever tmax 101.8 from 6/26/15-6/29/15 (present). Treated with Tylenol. Vomited twice on 6/28/15-6/29/15.
Age: 0.18
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV1
Symptoms: Chest X-ray, Cyanosis, Dyspnoea, Eye movement disorder, Full blood count
Clinical narrative: Patient began screaming in an unusual and high-pitched manner shortly after getting home after receiving her 2 month immunizations. Patient then stopped breathing, turned pale and difficulty catching her breath with some blueness around her lips. Patient felt hot but not feverish and her eyes did roll back at times but no seizure.
Age: 0.18
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV1
Symptoms: Pallor, Respiratory arrest, Screaming, Skin warm
Clinical narrative: Patient began screaming in an unusual and high-pitched manner shortly after getting home after receiving her 2 month immunizations. Patient then stopped breathing, turned pale and difficulty catching her breath with some blueness around her lips. Patient felt hot but not feverish and her eyes did roll back at times but no seizure.
Age: 61.0
Sex: F
Vaccine: PNC13, VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient developed a local area of redness and swelling, warm to the touch surrounding the Zostavax injection site on the posterior of her left arm about 2-3 inches in diameter.
Age: 89.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Redness, swelling, and warmth at injection site.
Age: 74.0
Sex: M
Vaccine: PPV
Symptoms: Injection site pain
Clinical narrative: At injection site, patient experiences an "awareness of site of injection". There is a stinging sensation localized at the injection site, which occurs periodically throughout the day. There is no redness or bump visible at the site.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Rash started 10 hours after vaccine administered.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Local swelling, Pruritus
Clinical narrative: Localized swelling, redness and itching.  Counseled patient to apply cold compress, apply topical hydrocortisone or Benadryl and if situation worsened take oral Benadryl.
Age: 52.0
Sex: F
Vaccine: HEP, PNC13
Symptoms: Erythema, Tenderness, Urticaria
Clinical narrative: L arm was red and had hives and painful to the touch.
Age: 61.0
Sex: F
Vaccine: DTAP
Symptoms: Erythema, Headache, Influenza like illness, Pain in extremity, Wrong drug administered
Clinical narrative: Localized redness, headache, severe pain in arm, flu like symptoms. Told them of previous sensitivity to DTP as child. Asked for plain Tetanus, they accidentally gave me D-TaP pediatric dose!
Age: 24.0
Sex: M
Vaccine: ANTH, YF
Symptoms: Burning sensation, Rash pruritic, Rash vesicular, Skin lesion
Clinical narrative: Onset of herpetic type lesion on the right side of the neck/jaw. Pt describe lesions a pruritic/burning sensation.
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: Swollen arm from elbow to shoulder. Arm was hot to the touch and completely red in color. Fever.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site inflammation
Clinical narrative: ROUND RED INFLAMED AREA AT INJECTION SITE.
Age: 0.36
Sex: F
Vaccine: DTAPIPVHIB, PPV, RV5
Symptoms: Death, Sudden infant death syndrome
Clinical narrative: Patient died.  Diagnosis by coroner was SUIDS.
Age: 77.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Area of shot made the area very pink and slightly swollen, its a week and its still red and swollen no other symptoms.
Age: 54.0
Sex: F
Vaccine: DTAP
Symptoms: Asthenia, Blood test, Chest X-ray, Chest discomfort, Diarrhoea
Clinical narrative: FELT WEAK FIRST. VERY TIRED. WENT TO BED & WOKE TO BURNING PAIN ALL OVER BODY. MIGRAINE. ARM PAIN FROM SHOT OVER SHOULDERS TO OTHER ARM -WEAK ARM & PAIN. [NEXT DAY-6/25/15] TIRED ALL DAY. COULDN'T EAT, DIARRHEA ALL DAY. FRIDAY SAME BUT FELT ITCHING, FLU LIKE SYMPTOMS. CALLED DOCTOR OFFICE BEFORE THEY CLOSED ON FRI 6/26/15. STATING I HAD A PAIN LIKE PINCHED RIB. OVER THE NIGHT INTO SATURDAY THIS GOT WORSE. WHEN I WOKE UP SATURDAY 11 A.M. AFTER HARDLY ANY SLEEP I CALLED DOCTORS OFFICE IMMEDIATELY & WAS TOLD TO GO TO ER IMMEDIATELY. I COULDN'T BREATHE ENOUGH WITHOUT SHARP PAIN & PRESSURE IN RT. RIB. FELT SWOLLEN ALL OVER.
Age: 54.0
Sex: F
Vaccine: DTAP
Symptoms: Dyspnoea, Fatigue, Feeding disorder, Influenza like illness, Insomnia
Clinical narrative: FELT WEAK FIRST. VERY TIRED. WENT TO BED & WOKE TO BURNING PAIN ALL OVER BODY. MIGRAINE. ARM PAIN FROM SHOT OVER SHOULDERS TO OTHER ARM -WEAK ARM & PAIN. [NEXT DAY-6/25/15] TIRED ALL DAY. COULDN'T EAT, DIARRHEA ALL DAY. FRIDAY SAME BUT FELT ITCHING, FLU LIKE SYMPTOMS. CALLED DOCTOR OFFICE BEFORE THEY CLOSED ON FRI 6/26/15. STATING I HAD A PAIN LIKE PINCHED RIB. OVER THE NIGHT INTO SATURDAY THIS GOT WORSE. WHEN I WOKE UP SATURDAY 11 A.M. AFTER HARDLY ANY SLEEP I CALLED DOCTORS OFFICE IMMEDIATELY & WAS TOLD TO GO TO ER IMMEDIATELY. I COULDN'T BREATHE ENOUGH WITHOUT SHARP PAIN & PRESSURE IN RT. RIB. FELT SWOLLEN ALL OVER.
Age: 54.0
Sex: F
Vaccine: DTAP
Symptoms: Migraine, Muscular weakness, Musculoskeletal chest pain, Pain, Pain in extremity
Clinical narrative: FELT WEAK FIRST. VERY TIRED. WENT TO BED & WOKE TO BURNING PAIN ALL OVER BODY. MIGRAINE. ARM PAIN FROM SHOT OVER SHOULDERS TO OTHER ARM -WEAK ARM & PAIN. [NEXT DAY-6/25/15] TIRED ALL DAY. COULDN'T EAT, DIARRHEA ALL DAY. FRIDAY SAME BUT FELT ITCHING, FLU LIKE SYMPTOMS. CALLED DOCTOR OFFICE BEFORE THEY CLOSED ON FRI 6/26/15. STATING I HAD A PAIN LIKE PINCHED RIB. OVER THE NIGHT INTO SATURDAY THIS GOT WORSE. WHEN I WOKE UP SATURDAY 11 A.M. AFTER HARDLY ANY SLEEP I CALLED DOCTORS OFFICE IMMEDIATELY & WAS TOLD TO GO TO ER IMMEDIATELY. I COULDN'T BREATHE ENOUGH WITHOUT SHARP PAIN & PRESSURE IN RT. RIB. FELT SWOLLEN ALL OVER.
Age: 54.0
Sex: F
Vaccine: DTAP
Symptoms: Painful respiration, Pruritus, Swelling
Clinical narrative: FELT WEAK FIRST. VERY TIRED. WENT TO BED & WOKE TO BURNING PAIN ALL OVER BODY. MIGRAINE. ARM PAIN FROM SHOT OVER SHOULDERS TO OTHER ARM -WEAK ARM & PAIN. [NEXT DAY-6/25/15] TIRED ALL DAY. COULDN'T EAT, DIARRHEA ALL DAY. FRIDAY SAME BUT FELT ITCHING, FLU LIKE SYMPTOMS. CALLED DOCTOR OFFICE BEFORE THEY CLOSED ON FRI 6/26/15. STATING I HAD A PAIN LIKE PINCHED RIB. OVER THE NIGHT INTO SATURDAY THIS GOT WORSE. WHEN I WOKE UP SATURDAY 11 A.M. AFTER HARDLY ANY SLEEP I CALLED DOCTORS OFFICE IMMEDIATELY & WAS TOLD TO GO TO ER IMMEDIATELY. I COULDN'T BREATHE ENOUGH WITHOUT SHARP PAIN & PRESSURE IN RT. RIB. FELT SWOLLEN ALL OVER.
Age: 63.0
Sex: M
Vaccine: TDAP
Symptoms: Abdominal pain upper, Blood pressure increased, Pain, Peripheral swelling, Swelling
Clinical narrative: Pains initially, arms swelling radiating to shoulder and chest, blood pressure elevated, stomach cramping.
Age: 12.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Paraesthesia, Syncope
Clinical narrative: Pt c/o tingling sensation in hands and feet approx 10 min after vaccination. pt proceeded to faint after sensation occurred.
Age: 1.28
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Abdominal tenderness, Pyrexia, Rash
Clinical narrative: Pt. developed a fever and rash on 6-29-15. Pt. seen in E.R 6-29-15 for fever, rash and tender abdomen. Pt. discharged to home in improved condition. Told to admin frequent, small amounts of fluids. Return to ED if worsening abdom pain, persistent vomiting, inability to tolerate fluids.
Age: 16.0
Sex: M
Vaccine: HPV4
Symptoms: Hypoaesthesia, Vaccine positive rechallenge
Clinical narrative: Patient received his 3rd HPV vaccine today. 90 min later, the patient reports his arm feels numb. He states same thing happened after receiving 2nd vaccine. Numbness lasted 2-3 days.
Age: 12.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site rash
Clinical narrative: On 6/17/15, pt presented at clinic with rash on left deltoid, 1 cm below bandaid impression area.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Cellulitis, Pyrexia, Rash, Rash erythematous, Skin warm
Clinical narrative: Per mom - patient developed fever + rash, which increased every day. Vaccine date 6-28-15. Evaluated on 6/27/2015 - noted to be very hot and well demarcated red patch - started on cefdinir 10 day course. Fever 104 - cellulitis (L) upper arm seen by PCP on 6/29/15 - area on (L) upper arm rash fading.
Age: 1.04
Sex: M
Vaccine: MMR
Symptoms: Lymphadenopathy, Pyrexia, Rash
Clinical narrative: Rash, fever and swollen gland started on 6-27-15.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Injection site reaction, Pain
Clinical narrative: I got a shingle (boost) shot from pharmacy one year ago (June 2014). I had a very bad injection site reaction for a month after I got the shot. Then, since December, I have been having Shingles all over my body. It is very painful.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a Certified Medical Assistant (C.M.A) concerning of unknown number of patients of unknown demographics. There were no medical history or drug reactions/allergies reported. It was reported that since 04-MAY-2014, the patients had been administered improperly stored ROTATEQ (dose, frequency, route, lot number and expiration were unspecified). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 56.0
Sex: F
Vaccine: FLU3, VARZOS, FLU3, VARZOS
Symptoms: Injection site discharge, Injection site erythema, Injection site pustule, Injection site swelling
Clinical narrative: Case number PHHY2015US037711, is an initial spontaneous report from a health care professional via the Vaccine Adverse Event Reporting System (VAERS, reference number: 560588) website on 30 Mar 2015, with a follow up report received from the Quality Assurance department (QA, reference number: 1000357) on 20 May 2015, with a follow up report received from the QA department on 18 Jun 2015. This report refers to a 56-year-old female patient. Medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 14583P, expiry date: 30 Apr 2015) on to her left arm and ZOSTAVAX (other manufacturer, batch number J011333) on to her right arm on 07 Nov 2014. On 08 Nov 2014 after the vaccination, she had swollen reddened injection site that was oozing pus. The final outcome of the events was unknown. The events were reported as non serious. Causality of the events was not reported. Seriousness assessment of oozing pus was upgraded based on available information in the source document. Based on the investigation performed, the QA department stated that, FLUVIRIN (batch number: 14583P) vaccine was manufactured in accordance with the approved internal procedures and it was in compliance with the cGMP requirements. No further details were provided. Non-significant follow-up information received from the Quality Assurance Department (reference number: 1000357) on 20 May 2015: Updated QA reference number only. Follow up report received from the QA department on 16 Jun 2015: Updated vaccine expiry date and batch review report.
Age: 36.0
Sex: F
Vaccine: FLUX, PPV, FLUX, PPV
Symptoms: Erythema, Injection site swelling, Peripheral swelling, Pyrexia, Skin tightness
Clinical narrative: Case number PHHY2015US077450 is an initial spontaneous report received from a physician's assistant via company representative and via Vaccine Adverse Events Reporting System (VAERS ID: 571405) on 15 Jun 2015. This report refers to a 36 year old female patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) and PNEUMOVAX (other manufacturer, batch number: not reported); both vaccines in the same arm on 18 Feb 2015. On 19 Feb 2015, she experienced swelling around the injection site, vomiting and was unable to keep anything down. She also had fever of 102 Fahrenheit and her arm was swollen, tight and red. The physician's assistant recommended her to visit emergency room on 20 Feb 2015. She sought medical attention. On an unknown date, her white blood count was 1900. The events outcome was unknown. The seriousness of the events was not reported, but the event WBC decreased was upgraded as medically significant based on the information available in the source documents. The reporter did not assess the events with pneumococcal vaccine. The causality assessment to seasonal influenza vaccine was not reported.
Age: 36.0
Sex: F
Vaccine: FLUX, PPV, FLUX, PPV
Symptoms: Vomiting, White blood cell count decreased
Clinical narrative: Case number PHHY2015US077450 is an initial spontaneous report received from a physician's assistant via company representative and via Vaccine Adverse Events Reporting System (VAERS ID: 571405) on 15 Jun 2015. This report refers to a 36 year old female patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) and PNEUMOVAX (other manufacturer, batch number: not reported); both vaccines in the same arm on 18 Feb 2015. On 19 Feb 2015, she experienced swelling around the injection site, vomiting and was unable to keep anything down. She also had fever of 102 Fahrenheit and her arm was swollen, tight and red. The physician's assistant recommended her to visit emergency room on 20 Feb 2015. She sought medical attention. On an unknown date, her white blood count was 1900. The events outcome was unknown. The seriousness of the events was not reported, but the event WBC decreased was upgraded as medically significant based on the information available in the source documents. The reporter did not assess the events with pneumococcal vaccine. The causality assessment to seasonal influenza vaccine was not reported.
Age: 18.0
Sex: M
Vaccine: HEPA, HPV4, MNQ, HEPA, HPV4, MNQ
Symptoms: Pallor, Syncope
Clinical narrative: This spontaneous report was received from other health professional refers to an 18 year old male patient. The patient's medical history included attention deficit/hyperactivity disorder and acne. On 29-MAY-2015, the patient was vaccinated with GARDASIL (lot# K026247 and expiration date not reported) dose 1. Other suspect therapies included MENACTRA (also reported as MCV4P meningococcal vaccine) dose 2 and VAQTA (lot #K008333 and expiration date not reported) dose 1. On 29-MAY_2015, after an unspecified period of time, after receiving the three vaccines the patient turned pale and fainted or lost consciousness. The patient was repositioned to a supine position, and when he regained consciousness, he was given water to drink and he urinated or voided. The nurse reported that she measured his heart rate and his blood pressure during this time, but she did not report the values of those tests. The patient fainted a second time, and the patient was again repositioned to a supine position. When he regained consciousness the second time, he was given water to drink again. On 29-MAY-2015 at an unspecified time, the patient was fully recovered. The reporter did not provide the causality between the event and the suspect therapy. Additional information has been requested.
Age: 18.0
Sex: M
Vaccine: HEPA, HPV4, MNQ, HEPA, HPV4, MNQ
Symptoms: Loss of consciousness, Pallor, Syncope
Clinical narrative: This spontaneous report was received from other health professional refers to an 18 year old male patient. The patient's medical history included attention deficit/hyperactivity disorder and acne. On 29-MAY-2015, the patient was vaccinated with GARDASIL (lot# K026247 and expiration date not reported) dose 1. Other suspect therapies included MENACTRA (also reported as MCV4P meningococcal vaccine) dose 2 and VAQTA (lot #K008333 and expiration date not reported) dose 1. On 29-MAY_2015, after an unspecified period of time, after receiving the three vaccines the patient turned pale and fainted or lost consciousness. The patient was repositioned to a supine position, and when he regained consciousness, he was given water to drink and he urinated or voided. The nurse reported that she measured his heart rate and his blood pressure during this time, but she did not report the values of those tests. The patient fainted a second time, and the patient was again repositioned to a supine position. When he regained consciousness the second time, he was given water to drink again. On 29-MAY-2015 at an unspecified time, the patient was fully recovered. The reporter did not provide the causality between the event and the suspect therapy. Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site bruising, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Swelling, warm to the touch, bump in the center, 3 in. diameter circle of redness with some bruising.
Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Contusion, Erythema, Skin warm, Swelling
Clinical narrative: Swelling, warm to the touch, bump in the center, 3 in. diameter circle of redness with some bruising.
Age: 73.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Injection site cellulitis, Injection site pain, Leukocytosis, Tachycardia
Clinical narrative: Pt received pneumococcal vaccine IM on his (L) deltoid yesterday. C/O since late night arm has been sore, numb, swollen, he feels lightheaded and dizzy, unable to lift arm due to pain, feels like he is drunk, he was so cold last night he used 3 blanket to sleep. Vancomycin 1500 mg every day, Piperacillin/Tazobactam 3.375 mg QID.
Age: 73.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Dizziness, Feeling cold, Feeling drunk, Hypoaesthesia, Mobility decreased
Clinical narrative: Pt received pneumococcal vaccine IM on his (L) deltoid yesterday. C/O since late night arm has been sore, numb, swollen, he feels lightheaded and dizzy, unable to lift arm due to pain, feels like he is drunk, he was so cold last night he used 3 blanket to sleep. Vancomycin 1500 mg every day, Piperacillin/Tazobactam 3.375 mg QID.
Age: 73.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: Pt received pneumococcal vaccine IM on his (L) deltoid yesterday. C/O since late night arm has been sore, numb, swollen, he feels lightheaded and dizzy, unable to lift arm due to pain, feels like he is drunk, he was so cold last night he used 3 blanket to sleep. Vancomycin 1500 mg every day, Piperacillin/Tazobactam 3.375 mg QID.
Age: 1.31
Sex: F
Vaccine: DTAP, FLUX, HIBV, PNC13
Symptoms: Condition aggravated, Crying, Decreased eye contact, Dyskinesia, Ear infection
Clinical narrative: She had a fever and withdrew from herself. She stopped eating and drinking. She started screaming with a high pitched scream, arching her back and writhing. She continued to scream and cry without eating or sleeping well for 3 days. She stopped having eye contact. After 3 days the reactions subsided. She came down with an ear infection and continued having severe reflux.
Age: 1.31
Sex: F
Vaccine: DTAP, FLUX, HIBV, PNC13
Symptoms: Fluid intake reduced, Gastrooesophageal reflux disease, Hypophagia, Opisthotonus, Pyrexia
Clinical narrative: She had a fever and withdrew from herself. She stopped eating and drinking. She started screaming with a high pitched scream, arching her back and writhing. She continued to scream and cry without eating or sleeping well for 3 days. She stopped having eye contact. After 3 days the reactions subsided. She came down with an ear infection and continued having severe reflux.
Age: 1.31
Sex: F
Vaccine: DTAP, FLUX, HIBV, PNC13
Symptoms: Screaming
Clinical narrative: She had a fever and withdrew from herself. She stopped eating and drinking. She started screaming with a high pitched scream, arching her back and writhing. She continued to scream and cry without eating or sleeping well for 3 days. She stopped having eye contact. After 3 days the reactions subsided. She came down with an ear infection and continued having severe reflux.
Age: 54.0
Sex: M
Vaccine: JEV1
Symptoms: Chills, Influenza like illness, Nausea, Pain, Pyrexia
Clinical narrative: Pt states he had flu like symptoms; fever, chills, body aches with nausea.
Age: 40.0
Sex: F
Vaccine: FLUX
Symptoms: Grip strength decreased, Muscle spasms, Pain in extremity
Clinical narrative: Left hand cramping, difficulty closing left hand, hard to grasp items with left hand, sporadic pain in left hand-- mistaken for carpal tunnel.
Age: 13.0
Sex: M
Vaccine: HPV4
Symptoms: Immediate post-injection reaction, Seizure
Clinical narrative: This spontaneous report was received from an office manager regarding a 13 year old male patient. Patient's medical history and current condition was not reported. On 25-JUN-2015, in the physician's office, the patient experienced seizures immediately following the administration of the first dose in the series of three of GARDASIL (lot # K008931 and expiry date 04-MAR-2017), 0.5 milliliter (ml) intramuscularly. Concomitant medication were not reported. The outcome of the event seizures was reported as recovered on 25-JUN-2015. Causality assessment was not provided by the reporter. Upon internal review, the event seizure was considered to be medically significant. Additional information has been requested.
Sex: F
Vaccine: HPV9
Symptoms: Biopsy lymph gland, Lymphadenectomy, Lymphadenopathy, Pathology test
Clinical narrative: This spontaneous report was received from a medical assistant via company representative and refers to a female patient of unknown age. The patient's medical history, concurrent conditions, drug reactions and allergies were not reported. On an unknown date, the patient was vaccinated with GARDASIL 9 (dose, route of administration, anatomical location, lot# and expiration date were not reported). Concomitant therapies were not reported. On an unknown date, 1-2 days after administration of GARDASIL 9, the patient developed severe swelling of a lymph node, in the left neck area. The patient's mother took the patient for evaluation at unspecified otolaryngologist on an unspecified date. Otolaryngologist surgically removed the lymph node (on an unknown date) and the specimen was sent for pathology evaluation. At the time of the report the pathology results were pending. The outcome of the event was reported as not recovered. The causality assessment between swelling and removal of the nymph node and GARDASIL 9 was not provided. Upon internal review, the event was considered to be medically significant. Additional information has been requested.
Sex: M
Vaccine: HPV4
Symptoms: Guillain-Barre syndrome, Intensive care, Malaise
Clinical narrative: This spontaneous report as received from a registered nurse (R.N.) via a field representative refers to a male patient of an unknown age. The patient's medical history and drug allergies were not specified by the reporter. On an unknown date, the patient was vaccinated with a dose of GARDASIL (intramuscular, dose, lot# and expiration date were not reported). It was not confirmed if this was the first time the patient was vaccinated with GARDASIL. The patient's concomitant medication was not specified by the reporter. It was reported that in approximately 2015 (reported as a few weeks ago), the patient became "ill" after receiving GARDASIL and was admitted to an unspecified hospital (in the Intensive Care Unit) for about a week. While in the hospital the patient was diagnosed with Guillain-Barre syndrome. It was reported that unspecified diagnostic tests were performed and that an unspecified treatment was given for the adverse event. The outcome of Guillain-Barre syndrome was reported as recovering. Causality assessment between the event of Guillain-Barre syndrome and GARDASIL was not provided. The reporter considered the event of Guillain-Barre syndrome as medically significant, disabling and life threatening (based on the physician's diagnosis). Additional information has been requested.
Age: 76.0
Sex: F
Vaccine: PNC13
Symptoms: Rash macular, Rash pruritic
Clinical narrative: Pt developed itchy rash 5 days after PREVNAR vaccine. Red blotches on arm vaccine was given.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site hypoaesthesia, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 61 year old female patient. On 25-JUN-2015 the patient was vaccinated with ZOSTAVAX dose 0.65 ml once (route of administration and lot# were not provided). On 26-JUN-2015, following the administration of ZOSTAVAX, the patient experienced swelling, a red bump "the size of a fifty cent piece" and intermittent numbness at the injection site. No treatment was given for adverse events. The patient sought medical attention by calling the pharmacy. The outcome of swelling, a red bump "the size of a fifty cent piece" and intermittent numbness at the injection site was reported as not recovered/not resolved. Causality assessment was not provided. Additional information has been requested.
Age: 0.64
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous reprot as received from a nurse practitioner refers to a 7 months old patient of unknown gender. No information on patient's medical history or concurrent conditions was provided. On 16-JAN-2015, the patient was vaccinated with the dose of PEDVAXHIB lot # K008874 (dose, strength, route of administration and expiration date were not reported), which had temperature excursion (incorrect product storage). No information on patient's concomitant medication was provided. This is one of several reports from the same reporter. Additional information has been requested.
Age: 0.13
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a 6 weeks old patient of unknown gender. No information on patient's medical history or concurrent conditions was provided. On 28-JAN-2015, the patient was vaccinated with the dose of PEDVAXHIB lot # K008874 (dose, strength, route of administration and expiration date were not reported), which had temperature excursion. No information on patient's concomitant medication was provided. This is one of several reports from the same reporter. Additional information has been requested.
Age: 0.48
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous reprot as received from a nurse practitioner refers to a 5 months old patient of unknown gender. No information on patient's medical history or concurrent conditions was provided. On 14-JAN-2015, the patient was vaccinated with the dose of PEDVAXHIB lot # K008874 (dose, strength, route of administration and expiration date were not reported), which had temperature excursion (incorrect product storage). No information on patient's concomitant medication was provided. This is one of several reports from the same reporter. Additional information has been requested.
Age: 1.53
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a 18 months old patient of unknown gender. No information on patient's medical history or concurrent conditions was provided. On 15-JAN-2015, the patient was vaccinated with the dose of LIQUID PEDVAXHIB lot # K008874 (dose, strength, route of administration and expiration date were not reported) which had temperature excursion. No information on patient's concomitant medication was provided. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PNC13, PPV
Symptoms: Erythema, Local reaction, Swelling
Clinical narrative: Information has been received from a pharmacist via Pfizer Inc. referring to a patient of unknown age and gender. No relevant medical history or concurrent conditions were reported. On an unknown date the patient was vaccinated with PNEUMOVAX 23 (lot#, expiration date, dose and route not reported). Concomitant therapies included PREVNAR 13. On an unknown date in 2011 the patient experienced a local severe reaction with excess swelling and redness. The patient required treatment with MEDROL the following day. The outcome of the events was unknown. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Lyme disease
Clinical narrative: This spontaneous report was received from a health care professional refers to a female teenager patient of unknown age. On an unknown date the patient was vaccinated with GARDASIL (dose, route, frequency, lot # unspecified). Concomitant therapy was not reported. On an unknown date the reporter read a posting on social media that discuseed an unspecified teenage girl developing Lymes disease after receiving GARDASIL. Vaccine on an unspecified date. No further information provided. The outcome of Lymes disease was unknown. Causality assessment was not reported. Additional information was not reported. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: VARCEL
Symptoms: Blister, Rash vesicular
Clinical narrative: This spontaneous report was received from a healthcare student refers to a 23 year old female patient. No concurrent condition or medical history was reported. On 30-MAY-2015, the patient was vaccinated with VARIVAX, dose 1, (lot # K002050, dose and route of administration was not reported). No concomitant therapy was reported. On 02-JUN-2015, the patient developed a varicella like rash. It was also reported that the patient had blisters on her arms and hands that look like chicken pox. The patient sought medical attention and contacted pharmacist. No treatment was given for the events. The outcome of the events was reported as not recovered. The causality assessment was not reported. No product quality issue was involved. Additional information has been requested.
Age: 0.4
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a 4 months old patient of unknown gender. No information on patient's medical history or concurrent conditions was provided. On 22-JAN-2015, the patient was vaccinated with the dose of LIQUID PEDVAXHIB lot # K008874 (dose, strength, route of administration and expiration date were not reported) which had temperature excursion. No information on patient's concomitant medication was provided. This is one of several reports from the same reporter. Additional information has been requested.
Age: 0.44
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a 5 months old patient of unknown gender. No information on patient's medical history or concurrent conditions was provided. On 02-JAN-2015, the patient was vaccinated with the dose of PEDVAX HIB lot # K008874 (dose, strength, route of administration and expiration date were not reported) which had temperature excursion. No information on patient's concomitant medication was provided. This is one of several reports from the same reporter. Additional information has been requested.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: Fever. Ibuprofen 800 mg prn.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refer to an unspecified number of patients of unknown age and gender. No information regarding the patient's medical history or concurrent conditions was provided. On an unknown date, the patients were vaccinated with doses of PNEUMOVAX 23 (dose, frequency, route of administration, injection anatomical location, lot# and expiry date were not reported), which were improperly stored. There were no concomitant or co-suspect therapies reported. No adverse events were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Rash
Clinical narrative: Patient reported to clinic the next day with redness, pain and swelling in injection site. She stated this had worsened overnight.