chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.19
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a 3 months old patient of unknown gender. No information on patient's medical history or concurrent conditions was provided. On 29-DEC-2014, the patient was vaccinated with the dose of LIQUID PEDVAXHIB lot # K008680 (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: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a health care professional and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medications and drug reactions or allergies was reported. On an unknown date, approximately in 2015, the patient was vaccinated with improperly stored RECOMBIVAX HB INJ 2.5/0.5, lot # K010535; expiration date 27-AUG-2016, 0.5 ml/once, intramuscular. No adverse effects were reported. There was no additional information to report. Follow up information was received from healthcare worker on 18-JUN-2015 who reported that the patient received subsequent dose of RECOMBIVAX HB on an unknown date. The reporter stated that they received letter but had no further information to provide. Additional information is not expected as the reporter requested no further contact regarding the case. General, Products and Narrative were updated.
Age: 1.0
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a 12 months old patient of unknown gender. No information on patient's medical history or concurrent conditions was provided. On 23-DEC-2014, the patient was vaccinated with the dose of PEDVAXHIB lot # K008680 (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: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to 4 patients of unknown age and gender. No information regarding the patient's current conditions and medical history was provided. On unspecified dates, the patients were vaccinated with improperly stored, ROTATEQ oral lot # K001198 and expiry date of 25-OCT-2015 (unknown dose). Concomitant medications were not reported. No adverse effects were reported. The outcome of the event was unknown. Additional information has been requested.
Age: 57.0
Sex: U
Vaccine: IPV, MMRV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 57 year old patient of unknown gender, who was also a nurse. Concurrent or medical conditions were not reported. The nurse reported that on 18-JUN-2015, the adult patient (not a child or adolescent) was vaccinated with the first dose of (Oka-Merck) PROQUAD subcutaneous (dose, strength and lot number were not reported). The patient was also administered a dose of (Oka-Merck) PROQUAD. No adverse effects reported. Additional information has been requested.
Age: 1.09
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a 9 weeks old patient of unknown gender. No information on patient's medical history or concurrent conditions was provided. On 05-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: 1.03
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a 12 months old patient of unknown gender. No information on patient's medical history or concurrent conditions was provided. On 07-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.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' medical history, concomitant medications and drug reactions or allergies was reported. On an unknown date in 2015, an unspecified number of patients might have been vaccinated with doses of improperly stored LIQUID PEDVAXHIB, lot # K007258, expiration date 04-MAR-2017 (route of administration, doses, dose numbers not provided). LIQUID PEDVAXHIB was improperly stored exposed to temperature of 90F for 24 hours on 28-MAY-2015 and 91F for 24 hours on 29-MAY-2015. No adverse events were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a 12 months old patient of unknown gender. No information on patient's medical history or concurrent conditions was provided. On 19-AUG-2014, 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 medications was provided. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from healthcare worker refers to a patient of unknown age and gender. No concurrent condition or medical history reported. On 29-MAY-2015, the patient was inadvertently vaccinated with expired dose of ROTATEQ (lot # J011336, expiry date: 14-MAY-2015), oral. No adverse effects reported. No product quality complaint involved. No further information provided. Additional information has been requested.
Age: 0.62
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report 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 22-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: 0.04
Sex: U
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker referring to a 2 week old baby patient. Concurrent conditions or pertinent medical history were not reported. On 15-JUN-2015, the patient was vaccinated with a first dose of VAQTA 25/0.5 (lot #, expiration date, dose, route of administration and frequency were not reported) (inappropriate schedule of drug administration). No adverse events were reported. Concomitant medications were not specified. Additional information has been requested.
Age: 0.18
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a 9 weeks old patient of unknown gender. No information on patient's medical history or concurrent conditions was provided. On 05-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.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Certified Medical Assistant (C.M.A.) concerning a patient of unknown age and gender. No concurrent conditions or medical history were reported. On 10-JUN-2015, the patient was vaccinated with an improperly stored dose of VARIVAX (Merck), 0.5 ml, subcutaneous (Lot No., expiration date and anatomical administered location were not reported). The patient did not experience any adverse effects. It was unknown if the patient sought medical attention. Additional information has been requested.
Age: 0.34
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 06-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 exucrsion (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 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. 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: HPV4
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist refers to a patient of unknown age and gender. On 17-JUN-2015 the patient was inadvertently administered expired GARDASIL injection (lot # H015555; expiry: 13-APR-2015) (dose, route and frequency unspecified). No concomitant medications were reported. No adverse effects reported. No further information provided. There was no Product Quality Complaint (PQC) involved. Outcome of the medication error was unknown. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Medical Assistant refers to a multiple patients of unknown age and gender. There were no concomitant medications, concurrent conditions and medical history reported. On an unknown date, the patient was vaccinated with VARIVAX (Merck) lot # K021935 expiration date 10-NOV-2016 and lot # K005178 expiration date 10-APR-2016 (dose was not reported). The patients received a dose of VARIVAX (Merck) that was stored improperly. There was no adverse effects reported. Additional information has been requested.
Age: 1.0
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a 12 month 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 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: 10.0
Sex: F
Vaccine: TDAP
Symptoms: Cardio-respiratory arrest, Death, Seizure like phenomena
Clinical narrative: Patient expired approximately 24 hours after receiving Tdap vaccine. Patient experienced seizure like activity and cardiopulmonary arrest while on sports field.
Age: 82.0
Sex: F
Vaccine: PNC13
Symptoms: Ecchymosis, Oedema peripheral, Pain in extremity, Skin warm
Clinical narrative: Came into office for (L) arm edema, ecchymosis and warmth to touch. C/O pain in upper (L) arm radiating to forearm.
Age: 29.0
Sex: F
Vaccine: TDAP
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 46.0
Sex: M
Vaccine: TDAP
Symptoms: Hypoaesthesia, Migraine, Nausea, Paraesthesia, Vomiting
Clinical narrative: N/V, fever, migraine, numbness/tingling head shoulders for 5 days.
Age: 1.1
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a 13 months old patient of unknown gender. No information on patient's medical history or concurrent conditions was provided. On 26-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. No adverse events were experienced. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare professional refers to an unspecified number of patients. In approximately 2015 (reported as since 13-MAR-2015), the patients were vaccinated with doses of RECOMBIVAX HB lot # J013394, K010535, K017721, K021444 (expiration dates, dose, route and site of administrations were not reported) that were exposed to temperatures outside of the recommended range. No adverse effects had been observed or reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' medical history, concomitant medications and drug reactions or allergies was reported. On an unknown date in 2015, an unspecified number of patients might have been vaccinated with a dose of improperly stored GARDASIL, lot # K007828, expiration date 02-MAR-2017 (route of administration, doses, dose numbers not reported). GARDASIL was improperly exposed to temperatures of 90F for 24 hours on 28-MAY-2015 and 91F for 24 hours on 29-MAY-2015. No adverse events were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: VARZOS
Symptoms: Wrong drug administered
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 15 year old female patient. On 15-AUG-2003 the patient was vaccinated with the first dose of VARIVAX (Merck) (dose, route and Lot# were not reported). On 29-JUN-2015, the patient was intended to receive her second dose of VARIVAX (Merck) but received a dose of ZOSTAVAX (Lot#K016320, expiration date 24-DEC-2015) in error. Additional information has been requested.
Age: 76.0
Sex: F
Vaccine: PNC13
Symptoms: Myalgia, Nausea
Clinical narrative: Muscle pain note to left arm, nausea reported on 6/30/15. Patient has taken TYLENOL as needed for muscle pain. No signs of infection noted to injection site.
Age: 2.0
Sex: M
Vaccine: DTAPHEPBIP, PNC13
Symptoms: Cough, Pyrexia, Rhinorrhoea
Clinical narrative: Grandparent reports child developed fever, bad cough, runny nose with clear drainage. Reports fever resolved but cough and runny nose remains.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Injection site pain
Clinical narrative: EXTREME pain at area of injection. Symptoms - It hurt like hell and still hurts bad 20 hours later.
Age: 18.0
Sex: M
Vaccine: YF
Symptoms: Dizziness, Immediate post-injection reaction, Loss of consciousness, Syncope, Vision blurred
Clinical narrative: Patient immediately complained of blurry vision and lightheadedness after injection. Patient proceeded to having a syncopal episode after about 3 minutes. Patient returned to consciousness almost immediately. The paramedics arrived within 5 minutes and checked patient vitals. Patient was fine and left pharmacy in good condition.
Age: 67.0
Sex: M
Vaccine: TDAP, VARZOS
Symptoms: Injection site pain, X-ray limb
Clinical narrative: No pain after injection. That night, patient developed LEFT shoulder pain.
Age: 22.0
Sex: M
Vaccine: RAB
Symptoms: Diarrhoea haemorrhagic, Muscle spasms
Clinical narrative: Bad cramping, bloody diarrhea.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Injection site erythema and pain.
Age: 67.0
Sex: M
Vaccine: PNC13
Symptoms: Dyspnoea, Pharyngeal oedema, Urticaria
Clinical narrative: Hives, facial and throat swelling, mild difficulty breathing 48 hrs after receiving PCV13 vaccination. Has been using topical BENADRYL. Reported to PCP 5 days later.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site reaction, Injection site swelling
Clinical narrative: Injection site reaction.  Oval, egg-sized, raised, red, itchy area around injection site.
Age: 0.38
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Rash
Clinical narrative: Rash on trunk on body.
Age: 21.0
Sex: F
Vaccine: MNQ
Symptoms: Anxiety, Blindness
Clinical narrative: Shortly after shot, pt mentioned vision loss and began getting anxiety. Breathing was fine. We called 911, I held off on Epipen since there was no breathing difficulty or hives. Rescue cleared her. Vision was ok by the time they arrived. Pt. walked away ok with mother.
Age: 16.0
Sex: M
Vaccine: HPV4
Symptoms: Throat tightness, Urticaria
Clinical narrative: This spontaneous report as received from a physician via a field representative refers to an adolescent male patient who is currently 16 years old. On an unknown date the patient was vaccinated with first dose of GARDASIL (lot number and expiry date unknown) (dosing regimen and frequency unknown). No concomitant medications were reported. It was reported that there was no adverse event experienced after the first dose. On an unknown date the patient was vaccinated with second dose of GARDASIL (lot number and expiry date unknown) (dosing regimen and frequency unknown). On an unknown date (also reported as one day after the second dose was administered) the patient experienced Hives (urticaria) and throat closing (throat tightness). The action taken with the therapy with GARDASIL was unknown. The outcome of urticaria and throat tightness was unknown. The relatedness of the events to the therapy with GARDASIL was unknown. There was no product quality issue reported. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Alopecia, Biopsy skin, Fatigue, Pain, Weight decreased
Clinical narrative: This spontaneous report was received from a patient's mother and refers to a 25 year old non pregnant female patient who had peanut and animal allergy and no other pertinent medical history. On an unknown date, the patient was vaccinated ("within the recommended dosing schedule for GARDASIL") with the second dose of GARDASIL (dose, frequency, route of administration, lot# and expiration date were not reported) or GARDASIL 9 (dose, frequency, route of administration, lot# and expiration date were not reported). The mother was not sure of what vaccine her daughter received. It could not be confirmed if it was GARDASIL or GARDASIL 9. Concomitant therapies included birth control pill. On an unknown date, approximately in April 2015 (reported as "late April or early May"), the patient started losing her hair, having thinning of her hair, having bald spots, losing weight, achiness and major fatigue. On an unknown date, the patient had been to see her regular physician, dermatologist and rheumatologist for her symptoms. She was given steroid shots and clobetasol propionate ointment as a treatment. She also had biopsy for her scalp performed with no results provided (date unspecified). The outcome of events was reported as not recovered. The relatedness between GARDASIL or GARDASIL 9 and events was not reported. Additional information is not expected as no contact details were provided.
Age: 21.0
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B surface antibody negative
Clinical narrative: Information has been received from a registered nurse referring to a 21 year old female patient. On unspecified dates, the patient was vaccinated with unspecified number of doses of RECOMBIVAX HB (route, lot# and dose were unknown). The patient sought medical attention by an unspecified means. The result of a Hepatitis B titer on an unspecified date was no immunity to Hepatitis B. On 29-JUN-2015, the patient was vaccinated with another RECOMBIVAX HB (route, lot# and dose were unknown) as the treatment. The outcome of the event was unknown. The relationship of the event and RECOMBIVAX HB was not reported. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from a healthcare worker referring to an unspecified number of patients of unknown age and gender. On unknown dates the patients were vacicnated wiht improperly stored VAQTA (strength, lot#, dosage, route and frequency) (incorrect product storage). This is one of several reprots reeceived from the same reporter. Additional information has been reuqested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Antibody test, Antinuclear antibody, Arthralgia, Blood creatine phosphokinase increased, Borrelia test
Clinical narrative: Mom and patient describe feeling very tired since March, (needing naps) which they say corresponds to the Gardasil vaccine. Exam normal and lab work up normal.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: C-reactive protein, Differential white blood cell count, Fatigue, Full blood count, Metabolic function test
Clinical narrative: Mom and patient describe feeling very tired since March, (needing naps) which they say corresponds to the Gardasil vaccine. Exam normal and lab work up normal.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Muscle enzyme, Myalgia, Red blood cell sedimentation rate, Somnolence, Thyroid function test normal
Clinical narrative: Mom and patient describe feeling very tired since March, (needing naps) which they say corresponds to the Gardasil vaccine. Exam normal and lab work up normal.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker and refers to an unspecified amount of patients of unknown age and gender. No medical history, current conditions and concomitant therapies were reported. On an unknown date in June 2015, the patients received GARDASIL 9 (lot #, expiration date, dose and route of administration were not reported) that was improperly stored on unspecified dates between 10-JUN-2015 through 22-JUN-2015. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous reprot as received from a Medical Assistant refers to a multiple patients of unknown age and gender. There were no concomitant medications, concurrent conditions and medical history reported. On an unknown date, the patients was vaccinated with oral, ROTATEQ lot # K010224, expiration date 13-MAY-2016 (dose was not reported). The patients received a dose of oral, ROTATEQ that was stored improperly. There was no adverse effects reported. Additional information has been requested.
Age: 1.08
Sex: M
Vaccine: FLUX
Symptoms: Dehydration
Clinical narrative: This 17-month-old male subject was enrolled in a study. The subject received the 1st dose of Flu Q-QIV vs FLUZONE QUADRIVALENT (intramuscular) on 24th October 2014. On 27th February 2015, 126 days after receiving Flu Q-QIV vs FLUZONE QUADRIVALENT, the subject developed severe - grade 3 dehydration. Serious criteria included hospitalization. The outcome of dehydration was recovered/resolved on 28th February 2015. The investigator considered that there was a reasonable possibility that the dehydration may have been caused by Flu Q-QIV vs FLUZONE QUADRIVALENT. Investigator comments: Dehydration. Hospital Admission 2/27/15. Discharged 2/28/15.
Age: 9.0
Sex: M
Vaccine: HEPA, HPV9
Symptoms: Drooling, Muscle twitching, Seizure
Clinical narrative: This spontaneous report was received from a physician via company representative refers to a 9 year old male patient. Patient's concurrent condition included right temporal lobe discharge with MRI results as normal. On 24-APR-2015, the patient was vaccinated with GARDASIL 9 one shot (dose, route and lot # were unspecified). Concomitant medication included FOCALIN. On 27-APR-2015, 4 days after onset of therapy the patient experienced twitching and drooling, and which was diagnosed as a seizure. It was reported that the patient received GARDASIL 9 as the third dose of the scheduled 3 doses. The patient received first two doses of GARDASIL. The patient also received VAQTA at the same time as the GARDASIL 9. On 07-JUN-2015, the patient experienced second seizure. On an unknown date, the patient sought medical attention and was hospitalized. On an unknown date, the patient received treatment. The outcome of the events was unknown. The reporter did not provide the causality between the event and the suspect therapy. Upon internal review, seizure was determined to be medically significant. Additional information is not expected as the physician does not want to be contacted.
Sex: U
Vaccine: HPV4, RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from the nurse refers to an unspecified number of patients of unspecified age and gender. Medical history and concurrent conditions were not reported. On an unknown date the patient was vaccinated with improperly stored GARDASIL injection (lot number, dose and route of administration not reported). Other co-suspect therapies included oral, ROTATEQ vial (lot number, dose and route of administration not reported). No adverse effects were reported. The outcome of improperly stored product was unknown. The reporter considered improperly stored product and no adverse event to be not related to Oral, ROTATEQ and GARDASIL. No further information was provided. No product quality compliant (PQC) was filed. Additional information has been requested.
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from medical assistant refers to a patient of unknown age. No medical history and concurrent conditions were reported. On 20-MAY-2015, the patient was vaccinated inadvertently with M-M-R II (lot number: K011317 and expiry date 13-AUG-2016) 0.5 ml injection subcutaneously and VARIVAX (Merck) (lot number: L001335 and expiry date: 13-JAN-2017) (dose and route of administration was not reported) concomitantly that had been stored improperly. No concomitant medications were reported. No adverse effects reported. The outcome of improperly stored product was unknown. The reporter considered incorrect product storage to be not related to M-M-R II and VARIVAX (Merck). No product quality complaint (PQC) was filed. No further information provided. This is one of the several reports of the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a Medical Assistant refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On an unknown date in July 2008, the patient was vaccinated with the first dose of GARDASIL, then a second dose was administered on an unspecified date in July 2011 and the third dose on 30-JUN-2015 (administration routes, lot numbers and expiration dates were not provided). No concomitant therapies were reported. No adverse events were reported. Additional information has been requested.
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from medical assistant refers to a patient of unknown age. No medical history and concurrent conditions were reported. On 19-MAY-2015, the patient was vaccinated inadvertently with M-M-R II (lot number: K011317 and expiry date 13-AUG-2016) 0.5 ml injection subcutaneously and VARIVAX (Merck) (lot number: L001335 and expiry date: 13-JAN-2017) (dose and route of administration was not reported) concomitantly that had been stored improperly. No concomitant medications were reported. No adverse effects reported. The outcome of improperly stored product was unknown. The reporter considered incorrect product storage to be not related to M-M-R II and VARIVAX (Merck). No product quality complaint (PQC) was filed. No further information provided. This is one of the several reports of the same reporter. Additional information has been requested.
Age: 16.0
Sex: M
Vaccine: MEN
Symptoms: Injection site vesicles, Local reaction
Clinical narrative: 16-year-old boy with a past medical history significant for chronic rhinitis, keratosis pilaris, and migraine headaches who developed large local reaction associated with vesicles at the site of meningococcal number to vaccination on 9 April 2015. Patient denies any systemic symptoms and symptoms spontaneously resolved after several days. No long-term sequelae.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker regarding a patient of an unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 11-MAY-2015, the patient was vaccinated with VARIVAX (Merck) (lot # K011082, expiry date 08-AUG-2016) which was exposed to temperature excursion of 25F for 41hours. No adverse effects were reported. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker regarding a patient of an unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 04-MAY-2015, the patient was vaccinated with VARIVAX (Merck) (lot # K011082, expiry date 08-AUG-2016) which was exposed to temperature excursion of 25F for 41 hours. No adverse effects were reported. This is one of the several reports from the same reporter. Additional information has been requested.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Nuclear magnetic resonance imaging, Unevaluable event, X-ray
Clinical narrative: None stated.
Age: 13.0
Sex: F
Vaccine: HPVX, HPV4
Symptoms: Chills, Condition aggravated, Decreased appetite, Dizziness, Fatigue
Clinical narrative: Interview obtained by LPN. Patient was seen for a well care on 6/29. Patient received her third HPV shot. During the night she woke up with chills and sweats. Pain, denies numbness in right hand and foot. Mom even described her color being off. She has decreased appetite, but Mom is pushing fluids. Her symptoms were relieved with the MOTRIN, but pain is still present. Shot site has no redness or swelling at this time. Has been hot and cold, with chills. Skin very sensitive to touch. Tired. Seems to get better after MOTRIN. Was very dizzy when she woke up, lightheaded, but now does not feel that way. Back pain for a few months. Forgot to mention it yesterday but pain seems intensified today.
Age: 13.0
Sex: F
Vaccine: HPVX, HPV4
Symptoms: Feeling of body temperature change, Hyperhidrosis, Pain, Skin discolouration, Skin sensitisation
Clinical narrative: Interview obtained by LPN. Patient was seen for a well care on 6/29. Patient received her third HPV shot. During the night she woke up with chills and sweats. Pain, denies numbness in right hand and foot. Mom even described her color being off. She has decreased appetite, but Mom is pushing fluids. Her symptoms were relieved with the MOTRIN, but pain is still present. Shot site has no redness or swelling at this time. Has been hot and cold, with chills. Skin very sensitive to touch. Tired. Seems to get better after MOTRIN. Was very dizzy when she woke up, lightheaded, but now does not feel that way. Back pain for a few months. Forgot to mention it yesterday but pain seems intensified today.
Age: 13.0
Sex: F
Vaccine: HPVX, HPV4
Symptoms: Blood glucose, Body temperature increased, Hyperhidrosis, Hypotension, Inappropriate schedule of drug administration
Clinical narrative: Interview obtained by LPN. Patient was seen for a well care on 6/29. Patient received her third HPV shot. During the night she woke up with chills and sweats. Pain, denies numbness in right hand and foot. Mom even described her color being off. She has decreased appetite, but Mom is pushing fluids. Her symptoms were relieved with the MOTRIN, but pain is still present. Shot site has no redness or swelling at this time. Has been hot and cold, with chills. Skin very sensitive to touch. Tired. Seems to get better after MOTRIN. Was very dizzy when she woke up, lightheaded, but now does not feel that way. Back pain for a few months. Forgot to mention it yesterday but pain seems intensified today.
Age: 13.0
Sex: F
Vaccine: HPVX, HPV4
Symptoms: Paraesthesia
Clinical narrative: Interview obtained by LPN. Patient was seen for a well care on 6/29. Patient received her third HPV shot. During the night she woke up with chills and sweats. Pain, denies numbness in right hand and foot. Mom even described her color being off. She has decreased appetite, but Mom is pushing fluids. Her symptoms were relieved with the MOTRIN, but pain is still present. Shot site has no redness or swelling at this time. Has been hot and cold, with chills. Skin very sensitive to touch. Tired. Seems to get better after MOTRIN. Was very dizzy when she woke up, lightheaded, but now does not feel that way. Back pain for a few months. Forgot to mention it yesterday but pain seems intensified today.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a health professional and refers to an unspecified number of patients of unknown age and gender. The patients medical history, concurrent conditions and concomitant medications were not reported. On an unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX (Merck) (dose, route of administration, lot # and expiration date were not reported). No adverse effects reported. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: TTOX, VARZOS
Symptoms: Blood glucose increased, Diarrhoea, Fatigue, Injection site erythema, Injection site pain
Clinical narrative: This spontaneous report as received from a 61 year old female patient (occupational therapist). The patient's pertinent medical history included episode of shingles approximately in 1997 ("about 17-18 years ago") and an episode of shingles approximately in 1980 ("about 35 years ago"). The patient's current conditions included hypothyroidism, type II diabetes (does not take medications for the type II diabetes) and drug allergy to Erythromycin. On 02-JUN-2015, the patient was vaccinated with ZOSTAVAX (unknown strength), intramuscularly right biceps muscle. Concomitant medications included LIPITOR 20 mg and the patient received tetanus in her left arm on the same day she had received ZOSTAVAX. On 02-JUN-2015, the patient developed soreness at the injection site after receiving ZOSTAVAX. The patient stated that she developed overall body aches, nausea, fatigue, and intermittent diarrhea "within 24 hours" of receiving ZOSTAVAX. The patient developed swelling at the injection site where she received ZOSTAVAX on 03-JUN-2015 and then on 04-JUN-2015, she developed redness at the injection site where she received ZOSTAVAX as well as the injection site was "hot to touch". The patient's blood sugar had increased by "20-25 planks" since an unspecified date in June 2015, after receiving the ZOSTAVAX and she thought it was because she had not felt well. No lab diagnostic procedures were performed. The patient sought medical attention and was seen by an unspecified physician on 05-JUN-2015 for her symptoms listed above and she was informed by the unspecified physician to take BENADRYL and ibuprofen (unknown manufacturer). The patient took diphenhydramine hydrochloride "every four to five hours" for four days and she reported on the fourth day, the redness and swelling at the injection site decreased. The outcome of the events swelling at the injection site and redness at the injection site was resolving and the outcome of the events soreness at the injection site, overall body aches, nausea, fatigue, intermittent diarrhea, injection site was hot to touch, blood sugar had increased by "20-25 planks" and not felt well was unknown. There was no product quality complaint involved. Causality assessment was not reported. Additional information is not expected as the reporter did not wish further contact.
Age: 61.0
Sex: F
Vaccine: TTOX, VARZOS
Symptoms: Injection site swelling, Injection site warmth, Nausea, Pain
Clinical narrative: This spontaneous report as received from a 61 year old female patient (occupational therapist). The patient's pertinent medical history included episode of shingles approximately in 1997 ("about 17-18 years ago") and an episode of shingles approximately in 1980 ("about 35 years ago"). The patient's current conditions included hypothyroidism, type II diabetes (does not take medications for the type II diabetes) and drug allergy to Erythromycin. On 02-JUN-2015, the patient was vaccinated with ZOSTAVAX (unknown strength), intramuscularly right biceps muscle. Concomitant medications included LIPITOR 20 mg and the patient received tetanus in her left arm on the same day she had received ZOSTAVAX. On 02-JUN-2015, the patient developed soreness at the injection site after receiving ZOSTAVAX. The patient stated that she developed overall body aches, nausea, fatigue, and intermittent diarrhea "within 24 hours" of receiving ZOSTAVAX. The patient developed swelling at the injection site where she received ZOSTAVAX on 03-JUN-2015 and then on 04-JUN-2015, she developed redness at the injection site where she received ZOSTAVAX as well as the injection site was "hot to touch". The patient's blood sugar had increased by "20-25 planks" since an unspecified date in June 2015, after receiving the ZOSTAVAX and she thought it was because she had not felt well. No lab diagnostic procedures were performed. The patient sought medical attention and was seen by an unspecified physician on 05-JUN-2015 for her symptoms listed above and she was informed by the unspecified physician to take BENADRYL and ibuprofen (unknown manufacturer). The patient took diphenhydramine hydrochloride "every four to five hours" for four days and she reported on the fourth day, the redness and swelling at the injection site decreased. The outcome of the events swelling at the injection site and redness at the injection site was resolving and the outcome of the events soreness at the injection site, overall body aches, nausea, fatigue, intermittent diarrhea, injection site was hot to touch, blood sugar had increased by "20-25 planks" and not felt well was unknown. There was no product quality complaint involved. Causality assessment was not reported. Additional information is not expected as the reporter did not wish further contact.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Medical Assistant refers to a multiple patients of unknown age and gender. There were no concomitant medications, concurrent conditions and medical history reported. On an unknown date, the patient was vaccinated with GARDASIL lot#K006960 expiration date 19-FEB-2017 and lot#K005083 expiration date 04-NOV-2016 (dose was not reported). The patients received a dose of GARDASIL that was stored improperly. There was no adverse effects reported. Additional information has been requested.
Age: 23.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Abdominal discomfort, Blood test, Culture, Dysphagia, Headache
Clinical narrative: Arm swollen. Discolored puss. Extreme headache. Uneasy stomach. Tenderness of arm, armpit. Loss of falling in leg. Hard/painful to swallow.
Age: 23.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Odynophagia, Peripheral swelling, Purulent discharge, Sensory loss, Tenderness
Clinical narrative: Arm swollen. Discolored puss. Extreme headache. Uneasy stomach. Tenderness of arm, armpit. Loss of falling in leg. Hard/painful to swallow.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Acoustic stimulation tests abnormal, Balance disorder, Deafness, Ear infection viral, Gait disturbance
Clinical narrative: Vertigo-viral ear infection resulting in hearing loss, vision and eyesight changes, severe imbalance and abnormal gait. General sick feeling. Consulted 16 different doctors prescribed therapy twice. Persistent headache.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Malaise, Nuclear magnetic resonance imaging brain, Scan brain, Vertigo
Clinical narrative: Vertigo-viral ear infection resulting in hearing loss, vision and eyesight changes, severe imbalance and abnormal gait. General sick feeling. Consulted 16 different doctors prescribed therapy twice. Persistent headache.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Visual impairment
Clinical narrative: Vertigo-viral ear infection resulting in hearing loss, vision and eyesight changes, severe imbalance and abnormal gait. General sick feeling. Consulted 16 different doctors prescribed therapy twice. Persistent headache.
Age: 24.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Injection site erythema, Injection site streaking, Miliaria, Nausea
Clinical narrative: Nausea, heat rash, red line from sight to armpit.
Age: 26.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Localised infection, Pain in extremity
Clinical narrative: I received smallpox on 06-13-15. Infected at left arm. Left arm sore.
Age: 71.0
Sex: F
Vaccine: PNC13
Symptoms: Syncope
Clinical narrative: Syncope.
Age: 27.0
Sex: M
Vaccine: TDAP
Symptoms: Dizziness, Syncope
Clinical narrative: Patient received Tdap vaccine during routine physical exam. At check out, patient felt dizzy and fainted. Assessment was fine after syncopal event.
Age: 16.0
Sex: M
Vaccine: YF
Symptoms: Urticaria
Clinical narrative: Per Mom:  Awoke yesterday with hives, on abdomen and back and arms.  Took Zyrtec and all symptoms resolved.  Patient states may have been bitten by something.  No redness/rash at injection site.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Erythema, Injection site pain, Injection site swelling, Peripheral swelling, Tenderness
Clinical narrative: Swelling of left arm with redness and tenderness and increase by 7/1/15; patient was leaving out-of-town; photos forwarded to mom who showed photos to MD; patient had no fever, only local tenderness and swelling at site of Tdap to left arm; Tx:  ice, Benadryl.
Age: 17.0
Sex: F
Vaccine: HPV9
Symptoms: Erythema, Injection site pain
Clinical narrative: Vaccine administered 06/18/15 on 6/23/15, injection site painful, w/ central erythema approximately 4mm. No treatment other than warm packs.
Age: 33.0
Sex: M
Vaccine: HEP
Symptoms: Hyperhidrosis, Injection site mass, Injection site pain, Paraesthesia, Pyrexia
Clinical narrative: Approximately 15-30 minutes after injection patient reported tingling in his left hand, a strange sensation down his entire left arm, tingling down the left side of his back.  Later on at night he developed a fever of 102 degrees along with profuse sweating.  The fever broke about 4:00 am. Today (7/1) he reports the tingling and strange sensations are gone, his arm is sore near the injection site with a slight lump.
Age: 33.0
Sex: M
Vaccine: HEP
Symptoms: Sensory disturbance
Clinical narrative: Approximately 15-30 minutes after injection patient reported tingling in his left hand, a strange sensation down his entire left arm, tingling down the left side of his back.  Later on at night he developed a fever of 102 degrees along with profuse sweating.  The fever broke about 4:00 am. Today (7/1) he reports the tingling and strange sensations are gone, his arm is sore near the injection site with a slight lump.
Age: 18.0
Sex: M
Vaccine: VARCEL
Symptoms: Eye swelling, Ocular hyperaemia, Pruritus, Rash generalised, Vomiting
Clinical narrative: Mother called 7/1/15 at 1:00 pm stating her son had received the varicella vaccine a week ago (6/22/15), they noticed a few raised bumps on him a few days later that have turned into a rash all over his body.  He awoke at 2am this morning (7/1/15) itching and his eyes started getting red and swollen.  Mom denies any SOB, scratchy throat, itching ears or any respiratory difficulties.  Advised mom to take him to the ER or minor med to be evaluated by a MD, possibly starting steroids for the itching and rash.  Mom then stated her step son got the varicella shot elsewhere yesterday and is now vomiting; I advised her again to seek medical evaluation to ensure that he was not exposed to something else and having a reaction to that and that I would call her to check up on him in a day or two.  Told her we may possibly fill out a VAERS but not to delay treatment waiting for that.   Mom denies any fever or allergies to any thing else but will take him in to the ER or minor med.
Age: 10.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Pallor, Syncope
Clinical narrative: Patient had syncope about an hour after administration, per parent report. Patient was not fully alert and then had another episode of syncope. Event lasted for undetermined amount of time. Mom reports she was pale.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Apnoea, Dyspnoea, Hypopnoea, Irritability, Pallor
Clinical narrative: Episode of pallor associated with irregular breathing in afternoon following vaccine admin. in am. Fussy then fell asleep upon awakening had episode of pallor associated with brief apnea approximately 5 seconds followed by shallow breathing. Occurred 2-3 times. No cyanosis or apnea. No vomiting. Not related to feed. Self resolved. Transported to ED. Observed in ED for 2hrs. Well appearing.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker regarding a patient of an unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 21-MAY-2015, the patient was vaccinated with VARIVAX (Merck) (lot # K021487, expiry date 30-JAN-2016) which was exposed to temperature excursion of 25F for 41hours. No adverse effects were reported. This is one of the several reports from the same reporter Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pruritus, Skin warm, Swelling
Clinical narrative: Skin turned red, minor swelling, warm, itched. Cleared up in a week. Redness was about 5" x 4".