chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 71 year old female patient. No medical history, current conditions and concomitant therapies were reported. On 30-MAY-2015, the patient experienced warmth, swelling and redness at the injection site. The outcome of the event was unknown. The patient sought medical attention, she visited the pharmacy. The relatedness between the events and ZOSTAVAX was not reported. 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 Licensed Practical Nurse refers to a multiple unspecified patients, who on an unknown dates were vaccinated for prophylaxis with a dose of ROTATEQ (Lot K009901 exp date: 08-MAY-2016) (dose and route were not reported) that had experienced temperature excursion. No adverse effects were reported. This is one of several reports received from the same source. All telephone attempts to obtain follow-up information have been unsuccessful. Additional information has been requested.
Age: 32.0
Sex: F
Vaccine: HEPA
Symptoms: Hepatic enzyme increased
Clinical narrative: This spontaneous report was received from a nurse and refers to a 32 year old female patient. No medical history and current conditions were reported. The patient did not have any drug reactions or allergies. On 21-MAY-2015, the patient was vaccinated with VAQTA 50 IU/ml, 1 ml intramuscularly (lot # and expiration date were not reported). Concomitant therapy included vitamin d. On 22-MAY-2015, the patient had complete metabolic panel test performed and the patient was determined to have an elevated liver enzyme level. The outcome of the event was reported as not recovered. The patient sought medical attention. The relatedness between the event and VAQTA was not reported. Additional information is not expected, because the reporter declined any further contact.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 26-MAY-2015, the patient was inadvertently vaccinated with an expired dose of PNEUMOVAX 23 (intramuscular; lot # reported as J0155222, expiration date 21-FEB-2015; dose was not reported). It was reported that PNEUMOVAX 23 did not have any previous temperature excursions. PNEUMOVAX 23 was supported with in-house expiry data. No adverse effects reported. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a physician via market research program conducted by agency refers to a female patient of unknown age. On an unknown date in 2012, the patient was vaccinated with a dose of ZOSTAVAX. On 31-MAY-2015, the patient subsequently developed shingles. The patient began VALTREX. The outcome of the event was reported as recovering/resolving. The reporter considered the event to be related to ZOSTAVAX. Additional information has been requested.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthritis, Oedema peripheral, Pain in extremity
Clinical narrative: This spontaneous report as received from a pharmacist refers to a male patient of unknown age with no drug allergies. The patient's concurrent conditions and medical history were not reported. On 28-AUG-2014, the patient was vaccinated with a dose of ZOSTAVAX lot # J007208, expiration date: 20-SEP-2014 (also reported as 18-FEB-2015) 0.65 ml, subcutaneously, to prevent shingles. No concomitant medications were reported. The pharmacist reported, that on an unknown date after administration of ZOSTAVAX, the patient developed pain (unspecified location) and edema on his leg (unspecified leg). The patient was seen by an unspecified physician on an unspecified date, and was given ibuprofen to treat the pain. The pharmacist reported, that ibuprofen "only helped a little". The patient tried to use "alternative medicine like acupuncture" to relieve the edema but "it didn't help". The reporter also mentioned, that the patient was diagnosed with arthritis (date unknown). It was not known whether the diagnosis occurred before or after the patient received ZOSTAVAX. The outcome of the events was reported as not recovered/not resolved. The relatedness between the events and ZOSTAVAX was not provided. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: FLU3
Symptoms: Areflexia, Diplopia, Fatigue, Guillain-Barre syndrome, Lumbar puncture
Clinical narrative: Resulted in Guillain-Barre Syndrome. I had full body paralysis, fatigue, ventilator required, double vision, and loss of reflexes.
Age: 24.0
Sex: F
Vaccine: FLU3
Symptoms: Mechanical ventilation, Nerve conduction studies, Paralysis
Clinical narrative: Resulted in Guillain-Barre Syndrome. I had full body paralysis, fatigue, ventilator required, double vision, and loss of reflexes.
Age: 18.0
Sex: M
Vaccine: HPV9
Symptoms: Dizziness, Immediate post-injection reaction, Nausea, Pallor
Clinical narrative: Patient became lightheaded immediately after vaccine was given, even thought patient was given juice prior to vaccine administration.  Became very pale and nauseated, although did not vomit.  Patient continued to lay in supine position with legs elevated for 20 minutes. After 20 minutes, patient sat up for another 5 minutes and then left the office without another incident.
Age: 79.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Induration, Pain in extremity, Peripheral swelling
Clinical narrative: Red, swollen, hard, painful, spreading to entire upper arm, and down to elbow by the next day.
Age: 65.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Rash generalised
Clinical narrative: Pimple-like rash on entire body per patient's description - Benadryl administered over weekend - Medrol Dosepak prescribed on 06/09/2015.
Age: 65.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Blister, Purulent discharge, Rash
Clinical narrative: Pimple-like rash on entire body per patient's description - Benadryl administered over weekend - Medrol Dosepak prescribed on 06/09/2015.
Age: 65.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Rash generalised
Clinical narrative: Had the PREVNAR 13 shot and the very next morning I broke out with a rash of over 300 bumps some were pussy somewhere blistery.
Age: 65.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Blister, Purulent discharge, Rash
Clinical narrative: Had the PREVNAR 13 shot and the very next morning I broke out with a rash of over 300 bumps some were pussy somewhere blistery.
Sex: F
Vaccine: PPV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Information has been received from a currently 58 year old female nurse practitioner with unspecified chronic lung condition referring to herself. It was reported that the patient had been vaccinated with a total of 4 doses of PNEUMOVAX 23 (strength, dose, route and lot # not reported) on unspecified date. No adverse effects reported. Additional information is not expected because the reporter was not consented to be contacted.
Age: 1.01
Sex: F
Vaccine: HIBV, MMR, PNC13, VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a Licensed Practical Nurse referring to a 12 month old female patient without pre-existing allergies, birth defects, medical conditions and no illness at time of vaccination. On 17-APR-2015 at 11:00, the patient was vaccinated with her first dose of (Merck) VARIVAX (lot # K003420, subcutaneous in the right thigh (RT), dose, expired date were unspecified). Concomitant vaccines administered on the same day included MMR II, PREVNAR, and LIQUID PEDVAXHIB. The patient was given (Merck) VARIVAX which had been noticed that freezer temperature was above recommended temperature for safety storage. No adverse reaction occurred. Sibling's experience has been captured in MARRS# 1504USA018771. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker and refers to a patient of unknown age and gender. The patient's medical history and current condition were not reported. On 27-MAY-2015, the patient was vaccinated with an expired dose of VARIVAX (lot # H020601, expiry date: 13-NOV-2014, route of administration and dose number were not reported). No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to an unspecified number of patients of unknown age and gender. On unspecified date the patients were vaccinated with doses of improperly stored LIQUID PEDVAXHIB (strength, dosage, frequency and route unspecified) (lot # reported as J007097 with expiration date of 14-MAR-2016 and lot# K008873 with expiration of 06-FEB-2017). The temperature excursion for LIQUID PEDVAXHIB was unsupported with in-house stability data and the initial temperature excursion was on 15-OCT-2014. No adverse event was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HEPA, HPV9, MNQ, TDAP
Symptoms: Syncope
Clinical narrative: Information has been received from a registered nurse via field employee referring to an 11 year old female patient. The patient was not pregnant. Information about concurrent condition and medical history was not provided. On an unknown date, the patient was vaccinated with one dose of GARDASIL 9 (lot number, expiration date and dose number were unknown, 0.5 ml, intramuscular). Other suspect therapies included VAQTA (lot number, dose and route were unknown). Concomitant therapies included Tdap and MENACTRA. On 04-JUN-2015, the patient experienced syncope. The patient sought medical attention via office visit. The outcome of syncope was unknown. The causality between the event and suspect therapies was unspecified. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: This spontaneous report as received from a pharmacist via a field representative refers to 2 unspecified female patients of an unknown age. Pertinent medical history, drug reactions and concomitant medication were not specified by the reporter. On an unknown date, the patients were vaccinated with ZOSTAVAX vial (dose, route of administration, lot# and expiration date were not reported) for shingles prevention. On an unknown date, the patients experienced a stronger than normal injection site redness, the size of a quarter. It was not specified if any treatment was given for the adverse event. The outcome of injection site redness was not reported. Causality assessment between the event of injection site redness and ZOSTAVAX was not provided. Product quality complaint (PQC) was not involved. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site mass, Injection site swelling
Clinical narrative: Information has been received from an office manager via a company representative referring to 7 patients of unknown age and gender. No concurrent or historical conditions were provided. They were not pregnant. On unknown dates, the patients were vaccinated with ZOSTAVAX, dose was reported as "recommended dose", subcutaneously for prevention of shingles (lot# was L006382 and expiration date 25-MAY-2016, strength unknown). There was no concomitant medication reported. On unknown dates, the patients experienced swollen lump and redness at the injection site after receiving ZOSTAVAX. The patient sought medical attention via phone calls. The outcome of the events was unknown. The causality between the events and ZOSTAVAX was not reported. Additional information has been requested.
Age: 58.0
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 58 year old adult patient of unknown gender. No information about medical history, concurrent conditions was reported for the patient. On 06-NOV-2013 the patient was vaccinated with first dose of RECOMBIVAX HB strength 10/1.0 Micrograms (MCRG)/ML (dose, route unspecified) and second dose of RECOMBIVAX HB (dose, route unspecified) on 24-MAR-2015 (inappropriate schedule of drug administration). No adverse effect was reported. The outcome events reported was unknown. No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse concerning an unspecified number of patients. On unknown dates, the patient(s) were vaccinated with two improperly stored doses of ROTATEQ (dose, strength and lot # were not reported, oral). No adverse events were reported. This is one of several reports received from same source. Additional information has been requested.
Age: 6.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site abscess, Injection site erythema
Clinical narrative: Red abscess around injection site.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Hyperaesthesia, Induration, Mass, Skin irritation
Clinical narrative: Sensitivity after injection, 2in Red irritated area, warm to touch, hard lump.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin warm
Clinical narrative: Sensitivity after injection, 2in Red irritated area, warm to touch, hard lump.
Age: 37.0
Sex: M
Vaccine: HEP
Symptoms: Asthenia, Back pain, Coordination abnormal, Electromyogram, Fatigue
Clinical narrative: Physical weakness, ears ringing, back ache, tingling and numbness in hands and feet, lumps and numbness in throat, trouble walking with coordination. Diagnosed with Guillain Barre Syndrome 8-28-12, Hospitalized 9-4-12 thru 9-8-15 for IVg treatments.  Physical Therapy Sept 24, 2012 thru November to walk again. Continue to have symptoms of fatigue, fuzzy hands, off and on weekly sometimes it subsides for a month then worse again.  Worse March 2015 saw Dr. and discussed residual weakness of GBS and possible Chronic Fatigue Syndrome and possible depression etc.
Age: 37.0
Sex: M
Vaccine: HEP
Symptoms: Feeling abnormal, Gait disturbance, Guillain-Barre syndrome, Hypoaesthesia, Immunoglobulin therapy
Clinical narrative: Physical weakness, ears ringing, back ache, tingling and numbness in hands and feet, lumps and numbness in throat, trouble walking with coordination. Diagnosed with Guillain Barre Syndrome 8-28-12, Hospitalized 9-4-12 thru 9-8-15 for IVg treatments.  Physical Therapy Sept 24, 2012 thru November to walk again. Continue to have symptoms of fatigue, fuzzy hands, off and on weekly sometimes it subsides for a month then worse again.  Worse March 2015 saw Dr. and discussed residual weakness of GBS and possible Chronic Fatigue Syndrome and possible depression etc.
Age: 37.0
Sex: M
Vaccine: HEP
Symptoms: Lumbar puncture, Neurological examination, Pain, Paraesthesia, Pharyngeal hypoaesthesia
Clinical narrative: Physical weakness, ears ringing, back ache, tingling and numbness in hands and feet, lumps and numbness in throat, trouble walking with coordination. Diagnosed with Guillain Barre Syndrome 8-28-12, Hospitalized 9-4-12 thru 9-8-15 for IVg treatments.  Physical Therapy Sept 24, 2012 thru November to walk again. Continue to have symptoms of fatigue, fuzzy hands, off and on weekly sometimes it subsides for a month then worse again.  Worse March 2015 saw Dr. and discussed residual weakness of GBS and possible Chronic Fatigue Syndrome and possible depression etc.
Age: 37.0
Sex: M
Vaccine: HEP
Symptoms: Sensation of foreign body, Tinnitus, Walking aid user
Clinical narrative: Physical weakness, ears ringing, back ache, tingling and numbness in hands and feet, lumps and numbness in throat, trouble walking with coordination. Diagnosed with Guillain Barre Syndrome 8-28-12, Hospitalized 9-4-12 thru 9-8-15 for IVg treatments.  Physical Therapy Sept 24, 2012 thru November to walk again. Continue to have symptoms of fatigue, fuzzy hands, off and on weekly sometimes it subsides for a month then worse again.  Worse March 2015 saw Dr. and discussed residual weakness of GBS and possible Chronic Fatigue Syndrome and possible depression etc.
Age: 24.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site pain, Joint crepitation, Musculoskeletal stiffness, Pain
Clinical narrative: Slight pain in my left shoulder after injection; was told it was normal and was going to subside after a week or so. As time passed, about a month to two months, pain grew and my shoulder got stiff with limited range of motion. Could hear cracks when moved and very painful to move in certain places. Gets worse when sleeping and especially when waking up. Told my doctor about it after three months and he didn't think anything of it and brushed it off. I didn't get it checked out again because I was managing it with ibuprofen and joint vitamins. As of today (06/11/2015), it's a lot better but not healed all the way. Still take vitamins and ibuprofen for the pain when it's discomforting.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse concerning a patient of unknown age and gender. On an unknown date, the patient was vaccinated with one improperly stored dose of GARDASIL (dose, strength, lot# and route were not reported). No adverse events were reported. This is one of several reports from the same source. Additional information has been requested.
Age: 16.0
Sex: M
Vaccine: HPV9
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Information has been received from a consumer referring to a 16 year old male patient. Information regarding concurrent conditions and medical history was not provided. On an unknown date the patient was vaccinated with a dose of GARDASIL 9 (dose, dose, number, lot #, route and application site were not reported) (inappropriate schedule of drug administration). The caller mentioned that the patient was not within the indicated age range on the date of administration. Concomitant therapy was not reported. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Appendicectomy, Appendix disorder, Blood test, Computerised tomogram, Culture urine
Clinical narrative: GARDASIL administered Friday afternoon. Passed out with seizure Saturday afternoon. Hospitalized with appendix attack, numbness of all limbs, rash all over, fever, dizziness. Appendix removed following Monday, released Tuesday. Still having trouble walking, numbness still in feet, aches all over, very fatigued.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Electrocardiogram, Fatigue, Gait disturbance, Hypoaesthesia
Clinical narrative: GARDASIL administered Friday afternoon. Passed out with seizure Saturday afternoon. Hospitalized with appendix attack, numbness of all limbs, rash all over, fever, dizziness. Appendix removed following Monday, released Tuesday. Still having trouble walking, numbness still in feet, aches all over, very fatigued.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Loss of consciousness, Pain, Pyrexia, Rash generalised, Seizure
Clinical narrative: GARDASIL administered Friday afternoon. Passed out with seizure Saturday afternoon. Hospitalized with appendix attack, numbness of all limbs, rash all over, fever, dizziness. Appendix removed following Monday, released Tuesday. Still having trouble walking, numbness still in feet, aches all over, very fatigued.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Ultrasound scan, Urine analysis
Clinical narrative: GARDASIL administered Friday afternoon. Passed out with seizure Saturday afternoon. Hospitalized with appendix attack, numbness of all limbs, rash all over, fever, dizziness. Appendix removed following Monday, released Tuesday. Still having trouble walking, numbness still in feet, aches all over, very fatigued.
Age: 0.2
Sex: U
Vaccine: VARCEL
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a physician and refers to a 2 month old patient of an unknown gender. Concurrent conditions, medical history and allergies were not reported. On 27-MAY-2015, the patient was vaccinated a dose of VARIVAX (Merck) injection, 0.5 ml once, subcutaneous, (lot# reported as L001333), which was administered outside the prescribing information to the 2 month old of the patient. No adverse effects were reported. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP
Symptoms: Dysphagia, Oropharyngeal pain, Wheezing
Clinical narrative: Difficulty swallowing sore throat. Within 15 min of shots given. Given prednisone 10mg-4 tabs, Diphenhydramine HCl elixir-2 tsp. Wheezing-albuterol 2.5mg. Was examined by NP and monitored in the office for over an hour.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Dyspnoea, Hypoaesthesia, Incomplete course of vaccination, Pain in extremity, Pyrexia
Clinical narrative: My healthy 12 year old, and in healthy I mean: "never missing 1 day of school" daughter took GARDASIL 1st shot and within 40 days had unexplained illness, including: fever, difficult breathing, leg numbness and aches and pains. It was bad enough we took her to the emergency room. The ER couldn't find the problem but we are clear now on the cause. No more second or third shots of GARDASIL for us.
Age: 26.0
Sex: F
Vaccine: MMR
Symptoms: Back pain, Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: (R) upper arm redness, tenderness, warmth and back ache.
Age: 62.0
Sex: M
Vaccine: TDAP
Symptoms: Ear discomfort, Ear infection, Tinnitus
Clinical narrative: Pressure inside ear. Felt like ear infection "hissing" sensation in ear like swimmers ear. Lastn 30 min. (10 episodes). Resolved during night. (symptoms gone by 6/9/15).
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Anaphylactic reaction, Blood pressure decreased, Hypotension, Intensive care, Urticaria
Clinical narrative: This spontaneous report was received from a physician referring to a 15 year old female patient. There was no description of medical history or concurrent conditions. On 24-Nov-2014 the patient was vaccinated with the second dose of GARDASIL (dose and route of administration were not provided). On 08-DEC-2014, the patient developed a severe case of hives and went into anaphylaxis. Then, the patient was admitted to the Intensive Care Unit of an unspecified hospital. Additionally, on an unknown date, the patient experienced blood pressure decreased during hospitalization and was treated with unspecified vasopressor medication. The patient was discharged from the hospital, on an unspecified date and she was recovered of the anaphylactic vaccine reaction and blood pressure decreased. On an unspecified date, the patient was seen by an unknown allergist who determined that GARDASIL may have caused the hives and anaphylaxis. The causality between the blood pressure decreased and therapy with GARDASIL was not reported. The physician considered anaphylaxis reaction and blood pressure decreased Life Threatening. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Vaccination complication
Clinical narrative: This spontaneous report was received from a physician referring to a 15 year old female patient. There was no description of medical history or concurrent conditions. On 24-Nov-2014 the patient was vaccinated with the second dose of GARDASIL (dose and route of administration were not provided). On 08-DEC-2014, the patient developed a severe case of hives and went into anaphylaxis. Then, the patient was admitted to the Intensive Care Unit of an unspecified hospital. Additionally, on an unknown date, the patient experienced blood pressure decreased during hospitalization and was treated with unspecified vasopressor medication. The patient was discharged from the hospital, on an unspecified date and she was recovered of the anaphylactic vaccine reaction and blood pressure decreased. On an unspecified date, the patient was seen by an unknown allergist who determined that GARDASIL may have caused the hives and anaphylaxis. The causality between the blood pressure decreased and therapy with GARDASIL was not reported. The physician considered anaphylaxis reaction and blood pressure decreased Life Threatening. Additional information has been requested.
Age: 62.0
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from the registered nurse concerning to an approximately 62 year old patient of unknown gender. Patient's concurrent conditions and relevant medical history was not reported. On 02-FEB-2015, the patient was vaccinated with improperly stored dose of PNEUMOVAX 23 (lot number: K0054202 with unknown expiration date) (dose, route and frequency unspecified). Concomitant medications were not reported. No adverse event was reported. The outcome of the event was unknown. The causality of the events with pneumococcal vaccine, was not reported. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to a patient of unknown age and gender. Medical history and concurrent conditions were not provided. On 04-JUN-2015, the patient was vaccinated with an improperly stored dose of PROQUAD lot number reported as L004005, expiry date 05-AUG-2016 (dose and route were not reported). No adverse effects reported and no Product Quality Complaints (PQC) involved. There was no concomitant medication provided. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Patient developed acute Herpes Zoster following administration of ZOSTAVAX. Patient treated with VALTREX and pain medication.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Rash
Clinical narrative: Injection given 6/9/15, patient noticed rash on arms and legs only the following morning on 6/10/2015. Patient had to work on 6/10, came to pharmacy 6/11/15 complaining of rash and itching. Told pt to contact physician immediately.
Age: 59.0
Sex: F
Vaccine: TDAP
Symptoms: Ear discomfort, Ear pain
Clinical narrative: Dull pain in inner ear- Patient thought it felt like an ear infection (pressure). lasted 24 hours.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. On an unknown dates the patients were vaccinated with improperly stored doses of VARIVAX (Merck) (dose, frequency and route of administration were not reported). No adverse effects reported. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: HEPA, MMRV, PNC13
Symptoms: Varicella
Clinical narrative: Developed chicken pox. BACTROBAN to affected area by topical route 3 x day for 7 days.
Sex: U
Vaccine: DTAPIPV
Symptoms: Nonspecific reaction
Clinical narrative: This case was reported by a nurse and described the occurrence of nonspecific reaction in a child patient who received KINRIX (batch number KB75Z, expiry date 20th March 2017). On an unknown, the patient received KINRIX. On an unknown date, an unknown time after receiving KINRIX, the patient experienced nonspecific reaction. On an unknown date, the outcome of the nonspecific reaction was unknown. It was unknown if the reporter considered the nonspecific reaction to be related to KINRIX. Additional informations received: No further information was reported regarding the event. 3 pediatric patients returned with moderate reactions to KINRIX. Nurse was not sure if it is a coincidence or a bad batch.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a currently 7 months old patient of unknown gender. On an unknown date in 2015, the patient was vaccinated with improperly stored PEDVAXHIB of lot # K008878 with expiry date 23-MAR-2017 (via the correct route as per the prescribing information). On 25-FEB-2015, the vaccine was improperly exposed to 21.72F for 40 minutes for 1 cycle. There were no known adverse effect reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 1.39
Sex: M
Vaccine: DTAP, HIBV, PNC13
Symptoms: Insomnia, Irritability, Pruritus, Pyrexia, Rash
Clinical narrative: Hives started 6/6/15 approximately noon, more by 10 pm that night. Went to ED 6/7/15 0057. Was given 1 oral dose of steroids and RX for 15 mg qd x 5 d. 6/10/15 still has hives and had fever T 100.1 6/9/15 no respiratory distress. Received 15 month shots yesterday. Now starting at 1600) has skin colored raised areas essentially all over. Mom states itching at them and fussy. Will not sleep. Was given ATARAX at 2200 and TYLENOL at 2300 without relief. Spoke with her pediatric nurse practitioner and was told to bring child to them on Sunday. Mother states that since he became fussy, she brought him here. This history is provided by the mother. Patient is a 16 mos male presenting with rash. This is a new problem. The current episode stated today. The onset was sudden.
Age: 1.39
Sex: M
Vaccine: DTAP, HIBV, PNC13
Symptoms: Respiratory distress, Skin discolouration, Skin swelling, Urticaria
Clinical narrative: Hives started 6/6/15 approximately noon, more by 10 pm that night. Went to ED 6/7/15 0057. Was given 1 oral dose of steroids and RX for 15 mg qd x 5 d. 6/10/15 still has hives and had fever T 100.1 6/9/15 no respiratory distress. Received 15 month shots yesterday. Now starting at 1600) has skin colored raised areas essentially all over. Mom states itching at them and fussy. Will not sleep. Was given ATARAX at 2200 and TYLENOL at 2300 without relief. Spoke with her pediatric nurse practitioner and was told to bring child to them on Sunday. Mother states that since he became fussy, she brought him here. This history is provided by the mother. Patient is a 16 mos male presenting with rash. This is a new problem. The current episode stated today. The onset was sudden.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Right arm at injection site, area warm swollen and sore. 3 inches in diameter. Pt is applying ice, to injection site area.
Age: 5.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of injection site erythema in a 5-year-old female patient who received KINRIX (batch number KB75Z, expiry date 20th March 2017). On an unknown date, the patient received KINRIX .5 ml. On 14th May 2015, an unknown time after receiving KINRIX, the patient experienced injection site erythema and injection site warmth. On an unknown date, the outcome of the injection site erythema and injection site warmth were unknown. It was unknown if the reporter considered the injection site erythema and injection site warmth to be related to KINRIX. Additional information received: There were also 2 other patients who experienced the same side effects.
Age: 22.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from the registered nurse concerning to an approximately 22 year old patient of unknown gender. Patient's concurrent conditions and relevant medical history was not reported. On 26-FEB-2015, the patient was vaccinated with improperly stored dose of GARDASIL (lot number: J012212 with expiration date of 18-FEB-2016)(dose, route and frequency unspecified). Concomitant medications were not reported. No adverse event was reported. The outcome of the event was unknown. The causality of the events with GARDASIL was not reported. This is one of the several reports from the same reporter.  Additional information has been requested.
Sex: U
Vaccine: DTAPIPV
Symptoms: Nonspecific reaction
Clinical narrative: This case was reported by a nurse and described the occurrence of nonspecific reaction in a child patient who received KINRIX (batch number KB75Z, expiry date 20th March 2017). On an unknown date, the patient received KINRIX. On an unknown date, an unknown time after receiving KINRIX, the patient experienced nonspecific reaction. On an unknown date, the outcome of the nonspecific reaction was unknown. It was unknown if the reporter considered the nonspecific reaction to be related to KINRIX. Additional information received: No further information was reported regarding the event. 3 pediatric patients returned with moderate reactions to KINRIX. Nurse was not sure if it is coincidence or a bad batch.
Sex: U
Vaccine: DTAPIPV
Symptoms: Nonspecific reaction
Clinical narrative: This case was reported by a nurse and described the occurrence of nonspecific reaction in a child patient who received KINRIX (batch number KB75Z, expiry date 20th March 2017). On an unknown date, the patient received KINRIX. On an unknown date, an unknown time after receiving KINRIX, the patient experienced nonspecific reaction. On an unknown date, the outcome of the nonspecific reaction was unknown. It was unknown if the reporter considered the nonspecific reaction to be related to KINRIX. Additional information received: No further information was reported regarding the event. 3 pediatric patient returned with moderate reactions to KINRIX. Nurse as not sure if it is a coincidence or a bad batch.
Age: 68.0
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from the registered nurse concerning to an approximately 68 year old patient of unknown gender. Patient's concurrent conditions and relevant medical history was not reported. On 22-DEC-2014, the patient was vaccinated with improperly stored dose of PNEUMOVAX 23 (lot number: K005402 with unknown expiration date) (dose, route and frequency unspecified). Concomitant medications were not reported. No adverse event was reported. The outcome of the event was unknown. The causality of the events with PNEUMOVAX 23 was not reported. This is one of the several reports from the same reporter. Additional information has been requested.
Age: 65.0
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from the registered nurse concerning to an approximately 65 year old patient of unknown gender. Patient's concurrent conditions and relevant medical history was not reported. On 03-FEB-2015, the patient was vaccinated with improperly stored dose of PNEUMOVAX 23 (lot number: K005402 with unknown expiration date) (dose, route and frequency unspecified). Concomitant medications were not reported. No adverse event was reported. The outcome of the event was unknown. The causality of the events with PNEUMOVAX 23. This is one of the several reports from the same reporter. Additional information has been requested.
Age: 5.0
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from the registered nurse concerning to an approximately 5 year old patient of unknown gender. Patient's concurrent conditions and relevant medical history was not reported. On 10-APR-2015, the patient was vaccinated with improperly stored MMR II (lot number: K001230 with unknown expiration date (dose, route and frequency unspecified). Concomitant medications were not reported. No adverse event was reported. The outcome of the event was unknown. The causality of the events with MMR II was not reported. This is one of the several reports from the same reporter. Additional information has been requested.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site rash
Clinical narrative: Information has been received from a pharmacist referring to a 50 year old female patient with pertinent medical history of high blood pressure and high cholesterol. Information regarding drug allergies was unspecified by the reporter. On 04-JUN-2015 the patient was vaccinated with ZOSTAVAX (lot#, expiration date, dose and route not reported). Concomitant therapies included simvastatin (manufacturer unknown) and lisinopril (manufacturer unknown). On 05-JUN-2015, the patient experienced a red, hard rash around the unspecified injection site area described as "it was about 3 inches across the injection area and it was getting larger". The patient sought medical attention by seeing the pharmacist on an unknown date. No lab diagnostics studies were performed and no treatment was given for the event. Outcome of the event was not recovered. Causality assessment was not reported. This is one of two reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B surface antibody negative
Clinical narrative: Information has been received from a certified medical assistant concerning a female patient of unknown age. Pertinent medical history or drug allergies/drug reactions were not reported. On an unspecified dates, the patient was vaccinated with the first, second and third dose of hepatitis b vaccine (manufacturer unknown), (lot number, expiration date, dose, strength, frequency and dose were not reported). Concomitant medication was not reported. It was reported that on an unknown date, the patient had titers drawn and the results came back negative for hepatitis B. The reporter also stated that a fourth dose of hepatitis B vaccine (manufacturer unknown) was administered on an unspecified date. At the time of reporting, the outcome of the hepatitis B surface antibody negative was unknown. Additional information is not expected since no permission for follow up was given.
Age: 1.01
Sex: F
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Rash
Clinical narrative: Rash to back and spreading to face.
Sex: F
Vaccine: HPV4
Symptoms: Exposure during pregnancy, Pregnancy test positive
Clinical narrative: This spontaneous prospective pregnancy report as received from a registered nurse refers to a currently 21 years old female patient. The patient's medical history and concurrent conditions were not reported. Concomitant therapies included SYNTHROID. In approximately April 2015 (reported as about 3 weeks ago), the patient was vaccinated with an unspecified dose in series of GARDASIL. The patient was determined to be pregnant by an unspecified blood test given on an unspecified date. The patient's last menstrual period was on 10-APR-2015. Estimated date of conception was approximately 24-APR-2015 and estimated due date on 15-JAN-2016. The pregnancy outcome was outcome pending. The patient sought an unspecified type of medical attention. Additional information has been requested.
Age: 13.0
Sex: M
Vaccine: MMRV
Symptoms: Erythema, Pain, Pruritus, Swelling
Clinical narrative: Swollen, red, painful, itchy, about 2-3 inches in diameter.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. On unspecified dates approximately in 2015, patients may have received doses of GARDASIL lot # K009482, expiration date: 16-MAR-2017 and lot # K007858, expiration date: 02-MAR-2017 (dose and route of administration were not reported) which were improperly stored at 12.9 Celsius degree for 90 hours on unspecified dates during the time frame of April 2015 to May 2015. There was no known adverse effects. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. On 12-MAY-2015, the patients was vaccinated with a dose of (Merck) PROQUAD lot # K020747, expiration date: 30-APR-2016 (dose and route were not reported, that underwent temperature excursion of 25 Fahrenheit (F) for 41 hours. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Dysphagia, Injection site erythema, Injection site rash, Paraesthesia oral
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 75 year old female patient. Patient's pertinent medical history and drug reactions/allergies were not reported. On 07-JUN-2015 the patient was vaccinated with ZOSTAVAX (lot # K018173, expiry date:10-JAN-2016) dose 1 (reported as single dose), subcutaneous in the right arm. Concomitant medications were unspecified. Patient reported that she experienced tingling of her lips (paresthesia oral) and mild trouble while swallowing 30 minutes after administration of ZOSTAVAX vaccine on 07-JUN-2015. On an unspecified date in June 2015, patient developed redness and a rash around the injection site of the right arm. Patient sought medical attention and went to the pharmacy on 09-JUN-2015. No lab diagnostic studies were performed. No treatment was provided for the adverse events. Outcome of the events were reported as not recovered. Causal relationship of the events with respect to therapy with ZOSTAVAX was not reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Premature menopause
Clinical narrative: This literature report as received from a physician through a published journal articles. Physician was concerned about safety of GARDASIL (dose, route and lot number were unspecified) after reading two journal articles stated that GARDASIL has been show to cause premature ovarian failure. Physician stated that he had no information and no access to specific patient information. Action taken with the therapy and outcome of event was not reported. The reporter considered premature ovarian failure to be related to GARDASIL. No product quality complaint involved. Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from the registered nurse concerning to an approximately 4 year old patient of unknown gender. Patient's concurrent conditions and relevant medical history was not reported. On 17-MAR-2015, the patient was vaccinated with improperly stored dose of MMR II (lot number: K001230 with unknown expiration date) (dose, route and frequency unspecified). Concomitant medications were not reported. No adverse event was reported. The outcome of the event was unknown. The causality of the events with MMR II was not reported. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to patients of unknown demography. No concurrent condition, medical history or allergy/drug reactions were reported. The nurse reported that on an unspecified date, an unspecified number of patients received improperly stored (Merck) PROQUAD injection (strength, dose, route and lot number or batch number unspecified). No concomitant medications were reported. No other symptoms were reported. The outcome of the event was unknown. There were no product quality complaints (PQC) involved. The reporter's causality assessment was not provided. Additional information has been requested.
Sex: U
Vaccine: FLUX, FLUX
Symptoms: Anaphylactic reaction
Clinical narrative: This case was reported by a consumer via a sales representative and described the occurrence of anaphylaxis in a subject of unspecified age and gender who was vaccinated with Influenza vaccine (manufacturer unspecified). A physician or other health care professional has not verified this report. The subject was not sensitive to latex. A few years ago, the subject received unspecified dose of Influenza vaccine (unknown route, injection site and batch number). At an unspecified time after vaccination with Influenza vaccine, the subject experienced anaphylaxis. This case was assessed as medically serious by GSK. At the time of reporting the outcome of the event was unspecified.
Age: 2.0
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from the registered nurse concerning to an approximately 2 year old patient of unknown gender. Patient's concurrent conditions and relevant medical history was not reported. On 12-DEC-2014, the patient was vaccinated with improperly stored doses of MMR II (lot number: J014813 with unknown expiration date) (dose, route and frequency unspecified). Concomitant medications were not reported. No adverse event was reported. The outcome of the event was unknown. The causality of the events with MMR II was not reported. This is one of the several reports from the same reporter. Additional information has been requested.
Age: 0.4
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from the registered nurse concerning to an approximately 4 month old patient of unknown gender. Patient's concurrent conditions and relevant medical history was not reported. On 04-NOV-2014, the patient was vaccinated with improperly stored dose of ROTATEQ (lot number: J012522 with expiration date of 31-JAN-2015) (dose, route and frequency unspecified). Concomitant medications were not reported. No adverse event was reported. The outcome of the event was unknown. The causality of the events with ROTATEQ was not reported. This is one of the several reports from the same reporter. Additional information has been requested.
Age: 0.57
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from the registered nurse concerning to an approximately 6 month old patient of unknown gender. Patient's concurrent conditions and relevant medical history was not reported. On 06-JAN-2015, the patient as vaccinated with improperly stored dose of oral, ROTATEQ (lot number: J012522 with expiration date of 31-JAN-2015) (dose, route and frequency unspecified). Concomitant medications were not reported. No adverse event was reported. The outcome of the event was unknown. The causality of the events with oral, ROTATEQ was not reported. This is one of the several reports from the same reporter. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site cellulitis, Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: THE INJECTION SITE WAS HARD, RED AND HOT TO THE TOUCH.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Axillary mass, Erythema, Injection site erythema, Injection site nodule, Injection site warmth
Clinical narrative: Arm hurt, red and hot place to elbow on arm, large knot formed at injection site, muscle aches, lymph nodes underneath arms welled, armpit has two knots and is red.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Lymphadenopathy, Myalgia, Pain in extremity
Clinical narrative: Arm hurt, red and hot place to elbow on arm, large knot formed at injection site, muscle aches, lymph nodes underneath arms welled, armpit has two knots and is red.
Age: 13.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Dizziness, Muscular weakness
Clinical narrative: Lightheadedness, muscular weakness.
Age: 30.0
Sex: F
Vaccine: TDAP, TYP, YF
Symptoms: Influenza, Nasopharyngitis, Urticaria
Clinical narrative: Wk long course of symptoms began 24 hrs after immunization on Monday. Tuesday - Thursday- Flu; Sunday - Tuesday - Hives across body; Thursday/Friday - Sm cold.