chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 12.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Vomiting projectile
Clinical narrative: 5/13/14 father in to clinic stating his son had "shots yesterday". Father stated his son felt fine yesterday and upon arising the next day his son ate a bowl of tomato soup at around 640am.  He stated his son c/o not feeling well.  But wanted to go to school. Father stated he was called from the school around 750am.  That his son had projectile vomiting. After he got home father stated his son had "loose stools with abdominal cramping.  Stated he "looked funny". He noticed a rash to his face, neck, and back, as well as both arms on inside.  He stated it went away quickly and he did c/o itching the the right arm.  The father stated he checked the date on the can of soup and it had expired on June 2012.  The father stated his son is home resting and after a nap stated felt better.  Father requested info if this could be related to vaccines the child received or from the 2 year old expired soup the child consumed. Frequent adverse reactions were discussed with the father and informed the father to follow up with child's PCP if vomiting persists or for further evaluation. Father verbalized understanding.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Activities of daily living impaired, Discomfort, Injection site erythema, Injection site induration, Injection site rash
Clinical narrative: This spontaneous report as received from a practice manager (healthcare worker/nurse) refers to a 70 year old female patient with chronic obstructive pulmonary disease (COPD) and coronary artery disease. The patient had no drug reactions or allergies. On 11-MAY-2014, the patient was vaccinated with a dose of ZOSTAVAX 0.65 ml, once, subcutaneous, lot number J014810, expiration date 21-FEB-2015. Concomitant therapies included SENOKOT, CRESTOR, PRILOSEC, AMITIZA, SYNTHROID, isosorbide dinitrate, ADVAIR, SYMBICORT and DULCOLAX. On 12-MAY-2014, the patient developed a rash at the injection site that was red, hard and "blistering in the center". The reporter didn't know if this reaction caused significant disability. The patient had discomfort and had missed work because of this. The patient sought medical attention: the patient was seen by a physician on 14-MAY-2014. The physician prescribed CLARITIN and MEDROL dosepack for treatment and instructed the patient to call back if the reaction spreads or she develops a fever. The practice manager called the patient on 15-MAY-2014 and the patient's arm was still swollen and sore. The outcome of patient has discomfort and has missed work because of this and rash at the injection site that was red, hard and "blistering in the center" was unknown. The outcome of her arm is still swollen and sore was reported as not recovered/not resolved. The relatedness between the events and ZOSTAVAX was not reported. Upon internal review, the event of discomfort and missed work because of this was considered to be disabling. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site vesicles, Local swelling, Pain in extremity, Pyrexia
Clinical narrative: This spontaneous report as received from a practice manager (healthcare worker/nurse) refers to a 70 year old female patient with chronic obstructive pulmonary disease (COPD) and coronary artery disease. The patient had no drug reactions or allergies. On 11-MAY-2014, the patient was vaccinated with a dose of ZOSTAVAX 0.65 ml, once, subcutaneous, lot number J014810, expiration date 21-FEB-2015. Concomitant therapies included SENOKOT, CRESTOR, PRILOSEC, AMITIZA, SYNTHROID, isosorbide dinitrate, ADVAIR, SYMBICORT and DULCOLAX. On 12-MAY-2014, the patient developed a rash at the injection site that was red, hard and "blistering in the center". The reporter didn't know if this reaction caused significant disability. The patient had discomfort and had missed work because of this. The patient sought medical attention: the patient was seen by a physician on 14-MAY-2014. The physician prescribed CLARITIN and MEDROL dosepack for treatment and instructed the patient to call back if the reaction spreads or she develops a fever. The practice manager called the patient on 15-MAY-2014 and the patient's arm was still swollen and sore. The outcome of patient has discomfort and has missed work because of this and rash at the injection site that was red, hard and "blistering in the center" was unknown. The outcome of her arm is still swollen and sore was reported as not recovered/not resolved. The relatedness between the events and ZOSTAVAX was not reported. Upon internal review, the event of discomfort and missed work because of this was considered to be disabling. 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 registered nurse refers to multiple unspecified patients who were administered vaccines which were stored improperly. This report refers to the patients who on unknown dates were vaccinated with PNEUMOVAX 23 that were stored improperly. No adverse effects reported. This is one of several reports from the same reporter. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report as received from a nurse refers to a 13 year old female patient with no medical history and no drug reactions/allergies. On 05-MAR-2014 the patient was vaccinated subcutaneously with a dose of 0.5ml VARIVAX (Merck) (lot #J009165, expiration date 24-JUL-2015, dose number unknown). There was no concomitant medication. On 06-MAR-2014 the patient experienced redness and swelling at the injection site (which measured 6 inches by 8 inches) and was also hot to the touch. The patient sought for medical attention by contacting physician. Lab diagnostics studies performed were reported as none. Lot check requested by the nurse. The outcome of the adverse events was reported as recovered on 11-MAR-2014. This is one of the several patients reported by the same reporter. Additional information has been requested.
Age: 11.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect dose administered
Clinical narrative: This spontaneous report as received from a physician assistant via a field representative refers to an 11 year old patient of unknown gender. Concomitant medication and pertinent medical history is not provided. On an unknown date the patient was vaccinated with an extra dose (fourth dose) of GARDASIL. It is unspecified if the patient had any adverse effects from the extra dose of GARDASIL. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Autism, Lymphadenopathy, Pyrexia, Screaming
Clinical narrative: Swelling of lymph nodes in both sides of neck, high fever, screaming. Tylenol was administered. Called doctor to report.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from health care worker/medical assistant refers to a patient of unknown age and gender. No information provided regarding concurrent conditions and medical history. On 15-MAY-2014 the patient was vaccinated with VAQTA (dose, route, lot# not reported) was improperly stored. No information provided regarding concomitant medication. No adverse effect reported and PQC was not involved. This is one of two reports received from same reporter link (1405USA008846). Additional information has been requested.
Sex: M
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to a male patient of unknown age. On an unknown date in April (date and year not reported) the patient was vaccinated with GARDASIL dose 3 (dosing regimen unspecified). Information regarding concomitant therapies was not reported. On an unknown date in April (date and year not reported) medication error reported that the patient received the third dose of GARDASIL in April which would have been only 3 months after his 1st dose and no adverse effects reported. There was no product quality complaint (PQC) involved. The outcome of medication error-received the third dose of GARDASIL in April which would have been only 3 months after his 1st dose was unknown. Additional information has been requested.
Age: 32.0
Sex: F
Vaccine: TDAP
Symptoms: Chest discomfort, Dyspnoea, Paraesthesia, Pharyngeal oedema
Clinical narrative: Initial report was received on 15 May 2014 from a health care professional. A 32 year-old female patient (age also reported as 33 years-old) with no reported past medical history had received on 15 May 2014 an intramuscular right deltoid injection of ADACEL, lot number C4565BA and an unspecified amount time later the same date, developed throat swelling, chest tightness, difficulty breathing and tingling up and down her right arm. The patient had been observed for 15 minutes after vaccination before she left the office, but came back a short time later with the complaints. The patient was taken to the ER (emergency room) "next door to office". The patient had no illness at the time of vaccination and was being seen for a routine visit. No further information was available at the time of the report. Outcome was unknown. Documents held by sender: none.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Headache, Skin warm, Upper extremity mass
Clinical narrative: Severe headache, raised lump about 3 in diameter, warm redness covering the back of my arm from elbow to armpit.
Age: 12.0
Sex: F
Vaccine: TDAP
Symptoms: Discomfort, Injection site swelling, Injection site warmth
Clinical narrative: Mother noticed swelling, intense heat around injection site in child's left deltoid.  Child complained about severe discomfort.  Child was sent to school on May 16 and Mom called the nurse at school and asked her to please check her childs arm.  School nurse checked arm and stated that left arm was about twice the size as the right arm with warmth and suggested that Mom take child to MD.
Age: 24.0
Sex: F
Vaccine: ANTH, SMALL, TYP
Symptoms: Arthralgia, Musculoskeletal pain, Myalgia
Clinical narrative: Patient reported waking up with pain in elbows and knees. She took 800 mg ibuprofen TID that day and woke up the following day with even worse pain that was diffuse through knees, hips, elbows and shoulders. She also had myalgias in her upper arms and thighs. The symptoms persisted for almost a week before she was seen in clinic. There had been no improvement during that time, so she was prescribed prednisone. Still in treatment.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Cellulitis, Malaise, Pyrexia, Skin warm, Swelling
Clinical narrative: CELLULITIS IN UPPER TRICEP AREA. VISITED ER. AREA WAS INJECTED 3 TIMES DURING IMMUNIZATION PROCESS. FEVER 101.5 COMFIRMED CELLULITIS WITH TENDERNESS, SWELLING, WARMTH, GENERAL MALAISE, TREATED WITH DOXYCYCLINE.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Tenderness
Clinical narrative: CELLULITIS IN UPPER TRICEP AREA. VISITED ER. AREA WAS INJECTED 3 TIMES DURING IMMUNIZATION PROCESS. FEVER 101.5 COMFIRMED CELLULITIS WITH TENDERNESS, SWELLING, WARMTH, GENERAL MALAISE, TREATED WITH DOXYCYCLINE.
Age: 48.0
Sex: M
Vaccine: HEPAB
Symptoms: Asthenia, Nausea, Pyrexia, Vision blurred, Vomiting
Clinical narrative: Pt began with N/V and progressed into fever, gen weakness, blurred vision by that same night.  Sx continued through the next day and fever broke <24hrs after onset. By 5/18, pt reports he felt much better but still had some weakness.  Blurred vision resolved.  Pt visited clinic 5/19 to report reaction and visited PCP later that day.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, VARCEL
Symptoms: Cyanosis, Listless, Pallor, Vomiting
Clinical narrative: Gave varicella and Kinrix vaccines, 1 in L deltoid, 1 in L triceps. Mother started to turn child for MMR when she began to vomit & became pale & listless wwith cyanosis around mouth. Did not lose consciousness but required assistance to stand. Withheld MMR. B/P 72/50. Parents took child to ER for evaluation. No treatment given. Discharged home. PMD asked to see child in 2 weeks.
Age: 4.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Anxiety, Nausea, Skin test positive, Urticaria
Clinical narrative: Hives, anxious, nausea.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to multiple unspecified patients who were administered vaccines which were stored improperly. This report refers to the patients who on unknown dates were vaccinated with RECOMBIVAX HB that were stored improperly. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to patients (clients) of unknown age. On an unknown date, the patients were vaccinated with improperly stored ROTATEQ (strength, dose, route of administration and indication were unknown). No concomitant medications were reported. No adverse effects reported at the time of report. No product quality complaint was involved. The outcome of events was unknown. No further details provided. This report is linked to 1405USA009522, 1405USA010570, 1405USA010571 by the same reporter link. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to patients (clients) of unknown age. On an unknown date, the patients were vaccinated with improperly stored RECOMBIVAX HB (strength, dose, route of administration and indication were unknown). No concomitant medications were reported. No adverse effects reported at the time of report. No product quality complaint was involved. The outcome of events was unknown. No further details provided. This report is linked to 1405USA009522, 1405USA010571, 1405USA010572 by the same reporter link. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to multiple unspecified patients who were administered vaccines which were stored improperly. This report refers to the patients who on unknown dates were vaccinated with VAQTA that were stored improperly. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 56.0
Sex: M
Vaccine: PPV
Symptoms: Abdominal discomfort, Chills, Hyperhidrosis, Injection site reaction, Injection site warmth
Clinical narrative: This spontaneous report was received from a registered nurse refers to an approximately 56 year old male patient. The patient's medical history included cardiac history. There was no history of allergies. On an unknown date the patient was vaccinated with PNEUMOVAX 23 (lot # J013555; expiry: 02-MAY-2015) intramuscular injection in the right deltoid, dose: 0.5 millilitres. The patient's concomitant medications included: unspecified cholesterol and blood pressure medications. On 13-MAY-2014 the Nurse states that patient was vaccinated with PNEUMOVAX 23 and that evening developed stomach issues and vomiting. No body aches at that time. Patient was informed to begin a bland diet. Yesterday (approximately on 15-MAY-2014), patient sought medical attention and was seen at the doctor office with vomiting, fever, chills, sweats, and injection site of right arm is blotchy and warm to touch. Patient was treated with ZOFRAN, Cortisone Cream and TYLENOL. Patient was being monitored, and was instructed to call the office if any other problems. The outcome of stomach issues, injection site of right arm warmth, injection site of right arm is blotchy, chills, fever, vomiting and sweats was reported as resolving. Causality assessment was not provided. Additional information has been requested.
Age: 56.0
Sex: M
Vaccine: PPV
Symptoms: Pyrexia, Rash macular, Vomiting
Clinical narrative: This spontaneous report was received from a registered nurse refers to an approximately 56 year old male patient. The patient's medical history included cardiac history. There was no history of allergies. On an unknown date the patient was vaccinated with PNEUMOVAX 23 (lot # J013555; expiry: 02-MAY-2015) intramuscular injection in the right deltoid, dose: 0.5 millilitres. The patient's concomitant medications included: unspecified cholesterol and blood pressure medications. On 13-MAY-2014 the Nurse states that patient was vaccinated with PNEUMOVAX 23 and that evening developed stomach issues and vomiting. No body aches at that time. Patient was informed to begin a bland diet. Yesterday (approximately on 15-MAY-2014), patient sought medical attention and was seen at the doctor office with vomiting, fever, chills, sweats, and injection site of right arm is blotchy and warm to touch. Patient was treated with ZOFRAN, Cortisone Cream and TYLENOL. Patient was being monitored, and was instructed to call the office if any other problems. The outcome of stomach issues, injection site of right arm warmth, injection site of right arm is blotchy, chills, fever, vomiting and sweats was reported as resolving. Causality assessment was not provided. 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 health care worker/medical assistant refers to a patient of unknown age and gender. No information provided regarding concurrent conditions and medical history. On 15-MAY-2014 the patient was vaccinated with M-M-R II (dose, route, lot# not reported) was improperly stored. No information provided regarding concomitant medication. No adverse effect reported and PQC was not involved. This is one of two report received from same reporter link (1405USA010435). 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 registered nurse refers to multiple unspecified patients who were administered vaccines which were stored improperly. This report refers to the patients who on unknown dates were vaccinated with GARDASIL that were stored improperly. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to multiple unspecified patients. On an unknown date multiple unspecified patients were vaccinated with ROTATEQ (strength, dose, route unknown) that was stored improperly. No adverse effects reported. The outcome of the event was unknown. Additional information has been requested.
Age: 1.25
Sex: F
Vaccine: DTPHIB
Symptoms: Blister, Injection site induration, Injection site mass, Injection site vesicles, Skin exfoliation
Clinical narrative: Blisters on her arm, and thigh, also a hard lump apx 1 inch above injection site.  Scaly patches appears in subsequent days on her face.
Sex: U
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unknown age. On 30-APR-2014, the patient received an expired dose of PNEUMOVAX 23 injection, 0.5 ml, intramuscular (batch number J006082, lot # 0744AE, expiration date 12-APR-2014). No adverse effect reported. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to patients (clients) of unknown age. On an unknown date, the patients were vaccinated with improperly stored VAQTA (strength, dose, route of administration and indication were unknown). No concomitant medications were reported. No adverse effects reported at the time of report. No product quality complaint was involved. The outcome of events was unknown. No further details provided. This report is linked to 1405USA009522, 1405USA010570, 1405USA010572 by the same reporter link. 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 nurse refers to patients (clients) of unknown age. On an unknown date, the patient were vaccinated with improperly stored GARDASIL (strength, dose, route of administration and indication were unknown). No concomitant medications were reported. No adverse effects reported at the time of report. No product quality complaint was involved. The outcome of events was unkonwn. No further details provided. This report is linked to 1405USA010570, 1405USA010571, 1405USA010572 by the same reporter link. Additional information has been requested.
Sex: M
Vaccine: MNQ
Symptoms: Skin warm, Swelling
Clinical narrative: Swollen, hot to touch.
Age: 16.0
Sex: M
Vaccine: MMR
Symptoms: Eye pain, Fatigue, Pyrexia
Clinical narrative: Tired, fever, eyes hurt.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Dizziness
Clinical narrative: PATIENT RECEIVED VACCINATIONS AND SAT IN CHAIR FOR 5-10 MINUTES. PATIENT STATED FELT FINE. PATIENT WALKING TO WAITING ROOM FELT DIZZY. LAID PATIENT FLAT ON FLOOR. PATIENT IMMEDIATELY FELT BETTER. BP 94/69. PATIENT LAID ON FLOOR FOR 5 MINUTES AND SAT UP. BP 116/85. PATIENT STOOD UP BP 114/74. WALKED PATIENT TO CAR. NOTIFIED PATIENT IF DIZZINESS COMES BACK TO LAY DOWN AND IF GETS ANY WORSE GO TO ER.
Sex: M
Vaccine: PPV
Symptoms: Contraindication to vaccination
Clinical narrative: Information has been received for a case in litigation for PROSCAR (MARRS# 1309USA006889) from medical records concerning a male patient. It was noted in the patient's medical records that he had a history of allergy to PNEUMOVAX 23. The onset date and outcome of allergy were not provided. Additional information is not expected.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Hypoaesthesia, Injected limb mobility decreased, Injection site pain, Nuclear magnetic resonance imaging normal
Clinical narrative: Left shoulder pain, trouble moving the arm secondary to pain, numbness in (L) fingers.
Age: 18.0
Sex: M
Vaccine: HPV4
Symptoms: Feeling hot, Hyperhidrosis, Syncope
Clinical narrative: Within about 5 minutes of getting the HPV vaccine and PPD placement patient felt hot and started sweating. He was standing at a desk and fainted. He was observed for about 40 minutes and improved.
Age: 0.18
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling, Injection site warmth, Irritability
Clinical narrative: C/O fussy about 6pm, Rt thigh red, swollen and warm to touch, called Dr on call was instructed to give TYLENOL and warm compress. Redness, swollen, warm decreased then red pinpoint red rash on Rt leg on 5/6/14, then 5/6/14 left leg pinpoint red rash.
Age: 0.18
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Rash erythematous
Clinical narrative: C/O fussy about 6pm, Rt thigh red, swollen and warm to touch, called Dr on call was instructed to give TYLENOL and warm compress. Redness, swollen, warm decreased then red pinpoint red rash on Rt leg on 5/6/14, then 5/6/14 left leg pinpoint red rash.
Age: 38.0
Sex: M
Vaccine: TDAP
Symptoms: Asthenia, Joint range of motion decreased, Pain in extremity
Clinical narrative: 2 days after Tdap - arm painful, decreased ROM, decreased strength.
Age: 49.0
Sex: F
Vaccine: DTAP
Symptoms: Drug administered to patient of inappropriate age, Injection site pain
Clinical narrative: This case was reported by a healthcare professional (certified medical assistant) and described the occurrence of injection site soreness in a 49-year-old female subject who was vaccinated with INFANRIX (GlaxoSmithKline). On 22 August 2013 the subject received 1st dose of INFANRIX (.5 ml, unknown route, left arm) and experienced overdose and inappropriate age at vaccine administration. Per the reporter, an "adult female mistakenly vaccinated with INFANRIX instead of BOOSTRIX." The subject received more antigen than indicated by BOOSTRIX. The subject was older than the indicated age for INFANRIX. On 22 August 2013, less than one day after vaccination with INFANRIX, the subject experienced injection site soreness. The reporter stated that the subject "called office to report more soreness than expected" at the injection site. No additional details were provided. At the time of reporting the outcome of the event was unspecified.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect storage of drug
Clinical narrative: Temperature excursions of vaccine(s) listed in item 13.
Age: 4.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site nodule
Clinical narrative: This case was reported by a healthcare professional (medical assistant) via a sales representative and described the occurrence of injection site induration in a 5-year-old subject of unspecified gender who was vaccinated with INFANRIX (GlaxoSmithKline). In 2014 the subject received a dose of INFANRIX (unknown details). In 2014, within weeks of vaccination with INFANRIX, the subject experienced injection site induration (described as "knots at injection site") and injection site redness. The reporter noted that "the timeframe was is the past 2 weeks." The reporter stated that after the subject received INFANRIX, the subject "developed huge red knots at the injection site." No other events were reported. It was unknown if the immunization series was discontinued. At the time of reporting the outcome of the events was unknown. The healthcare professional considered the events were probably related to vaccination with INFANRIX. The medical assistant reported 4 other cases with INFANRIX. See A1060686A, A1060690A and A1060692A for details on the other cases. Follow-up information was received on 10 March 2014 via healthcare professional who reported the 4-year-old female subject started to experience the events on 02 January 2014. The subject had no relevant medical history. The events were not attributed to medical history/ concurrent illness, lack of efficacy, erroneous administration, suspected transmission of an infectious agent via medicinal product. No action was taken with INFANRIX, the series was not discontinued or delayed. The reporting healthcare professional did not consider the events to be serious. The events resolved on an unspecified date.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Feeling hot, Hypersensitivity, Swelling, Tenderness
Clinical narrative: Allergic reaction - red, swollen, hot, tenderness.
Age: 0.36
Sex: M
Vaccine: IPV, PNC13
Symptoms: Incorrect storage of drug
Clinical narrative: Temperature excursions of vaccine(s) listed in item 13.
Age: 0.22
Sex: F
Vaccine: PNC13
Symptoms: Incorrect storage of drug
Clinical narrative: Temperature excursions of vaccine(s) listed in item 13.
Age: 12.0
Sex: F
Vaccine: IPV
Symptoms: Incorrect storage of drug
Clinical narrative: Temperature excursions of vaccine(s) listed in item 13.
Age: 10.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect storage of drug
Clinical narrative: Temperature excursions of vaccine(s) listed in item 13.
Age: 0.35
Sex: F
Vaccine: PNC13
Symptoms: Incorrect storage of drug
Clinical narrative: Temperature excursions of vaccine(s) listed in item 13.
Age: 9.0
Sex: M
Vaccine: IPV
Symptoms: Incorrect storage of drug
Clinical narrative: Temperature excursions of vaccine(s) listed in item 13.
Age: 1.3
Sex: U
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: This case was reported by a healthcare professional (medical assistant) via a sales representative and described the occurrence of injection site induration in a 15-month-old subject of unspecified gender who was vaccinated with INFANRIX (GlaxoSmithKline). In 2014 the subject received a dose of INFANRIX (unknown details). In 2014, within weeks of vaccination with INFANRIX, the subject experienced injection site induration (described as "knots at injection site") and injection site redness. The reporter noted that "the timeframe was is the past 2 weeks." The reporter stated that after the subject received INFANRIX, the subject "developed huge red knots at the injection site." No other events were reported. It was unknown if the immunization series was discontinued. At the time of reporting the outcome of the events were unknown. The healthcare professional considered the events were probably related to vaccination with INFANRIX. The medical assistant reported 4 other cases with INFANRIX. See A1060686A, A1060689A, A1060690A and A1060691A for details on the other cases.
Age: 1.5
Sex: U
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: This case was reported by a healthcare professional (medical assistant) via a sales representative and described the occurrence of injection site induration in a 15-month-old subject of unspecified gender who was vaccinated with INFANRIX (GlaxoSmithKline). In 2014 the subject received a dose of INFANRIX (unknown details). In 2014, within weeks of vaccination with INFANRIX, the subject experienced injection site induration (described as "knots at injection site") and injection site redness. The reporter noted that "the timeframe was is the past 2 weeks." The reporter stated that after the subject received INFANRIX, the subject "developed huge red knots at the injection site." No other events were reported. It was unknown if the immunization series was discontinued. At the time of reporting the outcome of the events were unknown. The healthcare professional considered the events were probably related to vaccination with INFANRIX. The medical assistant reported 4 other cases with INFANRIX. See A1060686A, A1060689A, A1060690A and A1060692A.
Age: 0.14
Sex: F
Vaccine: PNC13
Symptoms: Incorrect storage of drug
Clinical narrative: Temperature excursions of vaccine(s) listed in item 13.
Age: 6.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: This case was reported by a healthcare professional (medical assistant) via a sales representative and described the occurrence of injection site induration in a 5-year-old subject of unspecified gender who was vaccinated with INFANRIX (GlaxoSmithKline). In 2014 the subject received a dose of INFANRIX (unknown details). In 2014, within weeks of vaccination with INFANRIX, the subject experienced injection site induration (described as "knots at injection site") and injection site redness. The reporter noted that "the timeframe was is the past 2 weeks." The reporter stated that after the subject received INFANRIX, the subject "developed huge red knots at the injection site." No other events were reported. It was unknown if the immunization series was discontinued. At the time of reporting the outcome of the events were unknown. The healthcare professional considered the events were probably related to vaccination with INFANRIX. The medical assistant reported 4 other cases with INFANRIX. See A1060689A, A1060690A, A1060691A and A1060692A for details on the other cases. Follow-up information was received on 10 March 2014 via healthcare professional who reported the 6-year old male subject started to experience the events on 30 January 2014. The subject had no relevant medical history. The events were not attributed to medical history/concurrent illness, lack of efficacy, erroneous administration, suspected transmission of an infectious agent via medicinal product. No action was taken with INFANRIX, the series was not discontinued or delayed. The reporting healthcare professional did not consider the events to be serious. The events resolved on an unspecified date.
Age: 0.17
Sex: M
Vaccine: PNC13
Symptoms: Incorrect storage of drug
Clinical narrative: Temperature excursions of vaccine(s) listed in item 13.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Injection site reaction, Rash, Skin lesion
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of skin lesion at injection site in a 5-year-old female subject who was vaccinated with INFANRIX (GlaxoSmithKline). Concurrent vaccination included poliomyelitis vaccine inactivated (non-gsk) (Sanofi Pasteur MSD; unknown) given on 26 August 2013. On 26 August 2013 at 15:00 the subject received 5th dose of INFANRIX (.5 ml, intramuscular, unknown site). On 27 August 2013, 1 day after vaccination with INFANRIX, the subject experienced skin lesions. The healthcare professional reported that the event was a local injection site reaction (skin lesion at injection site). The subject was seen by the health care professional at a physician's office on 30 August 2013 and a physician was consulted to "look at her arm". At the time of reporting the event was unresolved. Follow up was received from the medical assistant on 01 October 2013. The medical assistant reported that the case had been reported to the regulatory authority of the CDC; however, a reference number was not provided. On 27 August 2013, the subject experienced a diagnosis of "rash on arms" (arm rash) and the outcome was unknown. The reporter identified the suspect product as INFANRIX. The medical assistant did not consider this case serious. There was no alcohol or tobacco use per the reporter. The reporter clarified the lot number as AC14B182BA which was previously reported as AC148182BA. Per the medical assistant, the immunization series was not delayed or discontinued. It was unknown if symptoms recurred with subsequent administration. The subject had not experienced any adverse events to previous vaccinations.
Age: 1.29
Sex: F
Vaccine: PNC13
Symptoms: Incorrect storage of drug
Clinical narrative: Temperature excursions of vaccine(s) listed in item 13.
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Pruritus generalised
Clinical narrative: Patient received influenza vaccine at hospital employee health (she is a student nurse). Traveled by car to health services. Once on campus noted severe whole body pruritus and redness to left arm/chest. No other rash or urticaria, no anaphylaxis, no breathing difficulties or mouth/eye edema. Treated with diphenhydramine and monitored. Relieved a great deal. Sent back to vaccine administrator and PCP for follow-up.
Age: 0.2
Sex: F
Vaccine: DTAP
Symptoms: Dyskinesia, Eyelid ptosis
Clinical narrative: This case was reported by a consumer (father of subject) and described the occurrence of droopy eyelid in a 2-month-old female subject who was vaccinated with INFANRIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. On 15 July 2013 the subject received 1st dose of INFANRIX (unknown details). On 27 July 2013, 12 days after vaccination with INFANRIX, the subject experienced droopy eyelid and jerking of head (described as "jerky head movements". The subject had not had any other vaccinations at the time of reporting. The father reported that medical attention was required at the doctor's office. At the time of reporting the events were unresolved.
Sex: F
Vaccine: DTAP
Symptoms: Dyspnoea, Rash
Clinical narrative: This case was reported by a healthcare professional (nurse) and described the occurrence of possible allergic reaction in a female subject of unspecified age who was vaccinated with DTPa (manufacturer unspecified). Concurrent medical conditions included allergy to tetanus vaccine. The subject reported that she had an "allergic reaction to a Tetanus shot as an infant". On an unspecified date the subject received unspecified dose of DTPa (unknown). At an unspecified time after vaccination with DTPa, the subject experienced possible allergic reaction, rash and difficulty breathing. The healthcare professional called to inquire about possible allergic reaction to Dtap if a subject had an allergic reaction as an infant. It was not confirmed that the vaccine that caused the reaction was a Dtap as the subject told the nurse it was a Tdap, but the nurse was questioning it because the Tdap "came out in 2005" and the subject would not have been an infant at that time as she was college student at the time of the report. The nurse thought it may have been Dtap. The subject also reported that she had an allergic reaction to a Tetanus shot as an infant. No further detail was provided. At the time of reporting the outcome of the events was unspecified.
Age: 14.0
Sex: F
Vaccine: IPV
Symptoms: Incorrect storage of drug
Clinical narrative: Temperature excursions of vaccine(s) listed in item 13.
Age: 1.39
Sex: F
Vaccine: PNC13
Symptoms: Incorrect storage of drug
Clinical narrative: Temperature excursions of vaccine(s) listed in item 13.
Age: 0.15
Sex: F
Vaccine: PNC13
Symptoms: Incorrect storage of drug
Clinical narrative: Temperature excursions of vaccine(s) listed in item 13.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect storage of drug
Clinical narrative: Temperature excursions of vaccine(s) listed in item 13.
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect storage of drug
Clinical narrative: Temperature excursions of vaccine(s) listed in item 13.
Age: 1.33
Sex: F
Vaccine: PNC13
Symptoms: Incorrect storage of drug
Clinical narrative: Temperature excursions of vaccine(s) listed in item 13.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect storage of drug
Clinical narrative: Temperature excursions of vaccine(s) listed in item 13.
Age: 7.0
Sex: M
Vaccine: IPV
Symptoms: Incorrect storage of drug
Clinical narrative: Temperature excursions of vaccine(s) listed in item 13.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect storage of drug
Clinical narrative: Temperature excursions of Vaccine(s) listed in item 13.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect storage of drug
Clinical narrative: Temperature excursions of vaccine(s) listed in item 13.
Age: 39.0
Sex: F
Vaccine: MMR, MNQ, VARCEL
Symptoms: Blister, Erythema, Injection site erythema, Papule, Pruritus
Clinical narrative: 5 small red papules appeared on her back with small/slight vesicles on most of them. She complained of itching. Symptoms resolved in 3 days. She also had a large red area at the site of her Varivax injection 10 days after the injection. It resolved in 3-4 days.
Age: 11.0
Sex: M
Vaccine: HPV4
Symptoms: Dizziness
Clinical narrative: PATIENT RECEIVED VACCINE AND 2 MINUTES AFTER VACCINATION PATIENT STATED HE FELT DIZZY. LAID PATIENT ON EXAM TABLE. BP 114/61 AND FELT BETTER. LAID FOR 5 MINUTES. SAT UP BP 125/52. PATIENT STOOD UP 107/91 AND PATIENT STATED FELT BETTER. WALKED PATIENT TO CAR. INFORMED PATIENT IF FEELS DIZZY AGAIN LAY DOWN AND IF WORSENS GO TO ER.
Age: 42.0
Sex: F
Vaccine: TTOX, YF, TTOX, YF
Symptoms: Body temperature increased, Endotracheal intubation, Mechanical ventilation, Mental status changes, Muscle contractions involuntary
Clinical narrative: Patient with altered mental status, unresponsive, temperature of 102, involuntary muscle contractions. Required intubation and remains intubated.
Age: 42.0
Sex: F
Vaccine: TTOX, YF, TTOX, YF
Symptoms: Unresponsive to stimuli
Clinical narrative: Patient with altered mental status, unresponsive, temperature of 102, involuntary muscle contractions. Required intubation and remains intubated.
Age: 42.0
Sex: F
Vaccine: TTOX, YF, TTOX, YF
Symptoms: Cough, Dyskinesia, Dyspnoea, Endotracheal intubation, Headache
Clinical narrative: Patient with altered mental status, unresponsive, temperature of 102, involuntary muscle contractions. Required intubation and remains intubated.
Age: 42.0
Sex: F
Vaccine: TTOX, YF, TTOX, YF
Symptoms: Mental status changes, Muscle contractions involuntary, Myoclonus, Oropharyngeal pain, Pyrexia
Clinical narrative: Patient with altered mental status, unresponsive, temperature of 102, involuntary muscle contractions. Required intubation and remains intubated.
Age: 42.0
Sex: F
Vaccine: TTOX, YF, TTOX, YF
Symptoms: Respiratory failure, Tardive dyskinesia, Urinary tract infection, Urine analysis abnormal, Vaccination complication
Clinical narrative: Patient with altered mental status, unresponsive, temperature of 102, involuntary muscle contractions. Required intubation and remains intubated.
Age: 42.0
Sex: F
Vaccine: TTOX, YF, TTOX, YF
Symptoms: Visual impairment
Clinical narrative: Patient with altered mental status, unresponsive, temperature of 102, involuntary muscle contractions. Required intubation and remains intubated.
Age: 18.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, VARCEL
Symptoms: Dizziness
Clinical narrative: PATIENT RECEIVED VACCINATIONS AND 1 MINUTE AFTER VACCINATIONS PATIENT FELT DIZZINESS. LAID PATIENT ON EXAM TABLE. PATIENT LAID FOR 5 MINUTES BEFORE SHE FELT BETTER. KEPT PATIENT LAYING DOWN FOR 15 MINUTES. BP 115/67. PATIENT STATED FELT GOOD ENOUGH TO SIT UP. GAVE PATIENT WATER. BP 103/63. PATIENT STOOD UP AND BEGAN TO FEEL DIZZY AGAIN. LAID PATIENT BACK DOWN. BP 120/75. GAVE PATIENT SUCKER SINCE HAD NOT EATEN LUNCH. PATIENT LAID FOR 10 MINUTES. PATIENT SAT UP AND FELT BETTER. BP 116/77. PATIENT STOOD UP AND STATED FELT MUCH BETTER. BP 122/77. WALKED PATIENT TO CAR AND INFORMED HER TO LAY DOWN IF FEEL DIZZY AGAIN. IF WORSENS GO TO ER.
Age: 18.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site oedema
Clinical narrative: Patient developed a erythematous, edematous upper arm around the site of the injection.  Patient treated herself with Benadryl (25 mg each dose 3 times over 2 days), hydrocortisome cream, and a cool compress applied to the site.  Mother marked a circle around the area of erythema which was initially 5cm diameter on 5/20 in the morning, by the evening the measurement increased to 10cm.  In the office the afternoon of 5/21/2014 the diameter of erythema measured 12cm.  There was a firm area in the center measuring 5cm in diameter at the time of the examination.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Food allergy, Hypoaesthesia oral, Tongue dry
Clinical narrative: Patient called at 12:45 pm. Patient felt that her tongue was numb and dry. She took 2 Benadryl tabs and was going to repeat every 6 hours. I told patient that if at any point she felt that here throat was closing got straight to the ER or use her Epi-Pen and go straight to the ER. I called patient again at 3:30pm on 5/17/14 and she felt the same and did not feel worse. When I called the patient on Monday 5/19/14 she says she was feeling better in reference to the Zostavax injection but had a food allergy reaction on Sunday 5/18/14.
Age: 50.0
Sex: F
Vaccine: MMR
Symptoms: Eye pain, Pain, Pyrexia
Clinical narrative: Eyes hurt, fever, achy.
Age: 15.0
Sex: F
Vaccine: IPV
Symptoms: Incorrect storage of drug
Clinical narrative: Temperature excursions of vaccine(s) listed in item 13.
Age: 0.12
Sex: F
Vaccine: PNC13
Symptoms: Incorrect storage of drug
Clinical narrative: Temperature excursions of vaccine(s) listed in item 13.
Age: 1.23
Sex: F
Vaccine: PNC13
Symptoms: Incorrect storage of drug
Clinical narrative: Temperature excursions of vaccine(s) listed in item 13.
Age: 45.0
Sex: M
Vaccine: PPV
Symptoms: Computerised tomogram head, Headache, Injection site erythema, Injection site pain, Lumbar puncture
Clinical narrative: Received PNEUMOVAX Thurs A.M. - Developed redness and pain at injection site. Developed headache and fever. Treated with over counter Ibupro, TYL. No relief in 3 days. Went to E.R. Checked for meningitis. Was treated next day with prednisone by primary (Monday). Redness and fever diminished by Tues.
Age: 45.0
Sex: M
Vaccine: PPV
Symptoms: Pyrexia, Vaccination complication
Clinical narrative: Received PNEUMOVAX Thurs A.M. - Developed redness and pain at injection site. Developed headache and fever. Treated with over counter Ibupro, TYL. No relief in 3 days. Went to E.R. Checked for meningitis. Was treated next day with prednisone by primary (Monday). Redness and fever diminished by Tues.
Age: 0.69
Sex: M
Vaccine: IPV
Symptoms: Incorrect storage of drug
Clinical narrative: Temperature excursions of vaccine(s) listed in item 13.
Age: 0.37
Sex: M
Vaccine: IPV, PNC13
Symptoms: Incorrect storage of drug
Clinical narrative: Temperature excursions of vaccine(s) listed in item 13.
Age: 8.0
Sex: M
Vaccine: IPV
Symptoms: Incorrect storage of drug
Clinical narrative: Temperature excursions of vaccine(s) listed in item 13.
Age: 10.0
Sex: F
Vaccine: IPV
Symptoms: Incorrect storage of drug
Clinical narrative: Temperature excursions of vacccine(s) listed in item 13.
Age: 9.0
Sex: F
Vaccine: IPV
Symptoms: Incorrect storage of drug
Clinical narrative: Temperature excursions of vaccine(s) listed in item 13.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect storage of drug
Clinical narrative: Temperature excursions of vaccine(s) listed in item 13.
Age: 0.15
Sex: M
Vaccine: PNC13
Symptoms: Incorrect storage of drug
Clinical narrative: Temperature excursions of vaccine(s) listed in item 13.
Age: 0.69
Sex: F
Vaccine: PNC13
Symptoms: Incorrect storage of drug
Clinical narrative: Temperature excursions of vaccine(s) listed in item 13.
Age: 1.88
Sex: M
Vaccine: PNC13
Symptoms: Incorrect storage of drug
Clinical narrative: Temperature excursions of vaccine(s) listed in item 13.
Age: 0.32
Sex: M
Vaccine: IPV, PNC13
Symptoms: Incorrect storage of drug
Clinical narrative: Temperature excursions of vaccine(s) listed in item 13.
Age: 0.25
Sex: F
Vaccine: PNC13
Symptoms: Incorrect storage of drug
Clinical narrative: Temperature excursions of vaccine(s) listed in item 13.
Age: 1.01
Sex: F
Vaccine: MMR
Symptoms: Injection site erythema, Rash, Rash erythematous, Skin exfoliation
Clinical narrative: Diffuse red flat rash on head, arms, and trunk. Slight redness right thigh at injection site. No signs of infection. Was well appearing and happy. Was seen by FNP. Rash lasted for 3 days and there was some skin peeling as per mom.
Age: 1.66
Sex: M
Vaccine: DTAP
Symptoms: Injection site swelling
Clinical narrative: Vaccine received and thigh is swollen. No temperature, not painful.
Age: 1.51
Sex: M
Vaccine: MMR
Symptoms: Body temperature, Rash, Urticaria
Clinical narrative: Urticaria, rash and temperature.
Age: 2.0
Sex: M
Vaccine: HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Injection site erythema, Injection site rash, Injection site swelling
Clinical narrative: Small palpable red bump with surrounding rash to right leg.
Age: 3.0
Sex: M
Vaccine: DTAPIPV, HEPA, MMR
Symptoms: Local swelling, Vaccination complication
Clinical narrative: Left Thigh Swelling Localized Swelling, Probably reaction to immunization.
Age: 32.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Local swelling, Skin warm, Tenderness
Clinical narrative: C/o swollen reddened area on right arm. 7cm by 5cm, erythematous patch, warm to touch on right arm, mildly TTP.
Age: 1.42
Sex: F
Vaccine: HEPA
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: 2cm area leg swelling, erythema and warmth.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Headache, Pyrexia, Vomiting
Clinical narrative: Pt developed severe headache on day 0, on day 1 developed fever and vomiting.
Age: 54.0
Sex: F
Vaccine: TDAP
Symptoms: Abdominal pain upper, Chest discomfort, Dyspnoea, Feeling hot, Injection site pain
Clinical narrative: Several minutes after vaccine, I began to feel warmth and swelling in the back of my throat and tongue, and heat down the from of my chest, as well as tenderness. I had a little heart racing, and some minor trouble breathing. I emailed my doctor at 12:30 PM. Some pressure in chest. Took a nap, and woke at 3:30 PM with tingling in hands and fingers. Called doctor. Left a message. Call was returned around 4 PM. Was having tingling in face, stiff neck. Sore arm, left shoulder but not red. She told me my doctor had left and to file this report and that I would probably feel better but would never get this "acella"? dosage again.