chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: AM of 5/7/14 pt. noticed 3 inch by 2 inch area of swelling around injection site. It was itchy and hot to the touch. It was also painful. Ice was used and provided some relief.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Cough, Dyspnoea, Wheezing
Clinical narrative: Within 5 min. after adm of vaccines pt. began coughing and wheezing, c/o difficulty breathing. 4 puffs albuterol adm. via inhaler, 12.5 mg BENADRYL given PO, Epi. 0.15 mg Adm SQ x 1. Noted improvement in breathing immediate. Pt transferred to ED for observation.
Age: 50.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to a 50 year old female patient with hypertension, pre-diabetes, hyperlipidemia, depression and b-complex deficiencies. No other medical conditions reported. The patient has no drug reactions or allergies known. No laboratory diagnostic studies were performed. On 22-APR-2014 the patient was vaccinated with ZOSTAVAX (lot #: J013453, Expiration date: 24-JAN-2015), 0.65 ml, subcutaneous injection, once to prevent shingles (dose number and anatomical location not reported). Concomitant therapies included carvedilol, bupropion hydrochloride and hydroxyzine (strength, dose, formulation, frequency route and duration unspecified). On 23-APR-2014 (reported as the next morning), the patient experienced a "huge bright red" area at the injection site that was hot to the touch. The reporter also stated that she just talked to the patient and at the moment (approximately on 23-APR-2014) there was a very small red area and it was no longer hot to the touch, so it was almost gone. The outcome of the adverse events was reported as recovering/resolving. Therapy was not given for the adverse event. Additional information has been requested.
Age: 50.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site reaction
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to a 50 year old female patient with hypertension, pre-diabetes, hyperlipidemia, depression and b-complex deficiencies. No other medical conditions reported. The patient has no drug reactions or allergies known. No laboratory diagnostic studies were performed. On 22-APR-2014 the patient was vaccinated with ZOSTAVAX (lot #: J013453, Expiration date: 24-JAN-2015), 0.65 ml, subcutaneous injection, once to prevent shingles (dose number and anatomical location not reported). Concomitant therapies included carvedilol, bupropion hydrochloride and hydroxyzine (strength, dose, formulation, frequency route and duration unspecified). On 23-APR-2014 (reported as the next morning), the patient experienced a "huge bright red" area at the injection site that was hot to the touch. The reporter also stated that she just talked to the patient and at the moment (approximately on 23-APR-2014) there was a very small red area and it was no longer hot to the touch, so it was almost gone. The outcome of the adverse events was reported as recovering/resolving. Therapy was not given for the adverse event. Additional information has been requested.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Received ZOSTAVAX on 2/7/14. Diagnosed with shingles 5/5/14.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site swelling, Nausea, Pyrexia, Vomiting
Clinical narrative: Within 24 hours of MCV4 ran fever of 103, nausea/vomiting, arm swollen and red at injection site. Parent states reaction to pertussis containing vaccine much worse. All four of her children cannot tolerate pertussis. Saw PMD - ordered BENADRYL, fluids and rest.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Pt here today for vaccines, DTaP, IPV, MMR and should of been Varicella, but student gave ZOSTAVAX instead, pt at time of vaccine did not experience any adverse reaction.
Age: 0.18
Sex: M
Vaccine: DTAPHEPBIP, HIBV, RV5
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Patient was seen in the clinic for a 2 month well-child check. He was inadvertently given a dose of MENACTRA (meningococcal) vaccine instead of PREVNAR (pneumococcal) vaccine. No adverse reaction has been reported.
Age: 0.52
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Ecchymosis, Induration, Lipoatrophy
Clinical narrative: Pt seen on 04/07/14 for WCC. Received HIB and PREVNAR in (R) superolateral thigh. RTC yesterday (04/28/14) with dimpling of fat in an area approx 6 cm x 2 cm. Flesh colored to ecchymotic at times. Mild induration in center.
Age: 76.0
Sex: F
Vaccine: TDAP
Symptoms: Gravitational oedema, Injection site erythema, Injection site swelling, Myalgia
Clinical narrative: Had vaccine 2d ago. Felt some local pain in muscle after 6 hrs then noted redness/swelling yesterday at site and below 18 1/2 x 12 cm. Edematous dependent with biceps and no induration or firmness. Denies pain at time of examination. Full range of arm no neurological or circulation deficits. Denies nausea, headache, diarrhea. Cool pack, or TYLENOL and prn antihistamine if needed. Return ASAP prn.
Age: 0.49
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC13, RV5
Symptoms: Abdominal X-ray, Decreased appetite, Muscle spasms, Ultrasound abdomen, Vomiting projectile
Clinical narrative: Projectile vomiting, decreased appetite, cramping.
Age: 35.0
Sex: F
Vaccine: HEP
Symptoms: Anxiety, Dizziness, Dyspnoea, Headache, Hyperhidrosis
Clinical narrative: Within 15 minutes after receiving vaccine, pt sxs included nausea, dizziness, HA, feeling anxious, shaky, SOB, sweating, shallow rapid breathing, SOB tumors, BP 130/100, 160/104, P-120 R 20-22. Transported to ED by EMTs.
Age: 35.0
Sex: F
Vaccine: HEP
Symptoms: Hypopnoea, Nausea, Respiratory rate increased, Tremor
Clinical narrative: Within 15 minutes after receiving vaccine, pt sxs included nausea, dizziness, HA, feeling anxious, shaky, SOB, sweating, shallow rapid breathing, SOB tumors, BP 130/100, 160/104, P-120 R 20-22. Transported to ED by EMTs.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Dyspnoea, Hypoaesthesia oral
Clinical narrative: 30 mins after vaccine felt numbness on tip of tongue and slight shortness of breath. Took inhaler and nasal spray, helped "a little bit". Also c/o general weakness. Also took BENADRYL.
Sex: F
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to her daughter of unknown age. On an unknown date, the patient was vaccinated with a dose of GARDASIL (dose, route and lot # not reported) that was improperly stored. The physician stated that this dose was administered by the dose and route recommended in the prescribing information. No adverse events were reported. Additional information has been requested.
Age: 0.8
Sex: M
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 9 month old patient. On an unknown date in February 2013, when the patient was 9 months old was mistakenly administered a dose of VAQTA (dose, route and frequency were not reported). It was reported that the patient was now 2 years old. No adverse effects reported. No further information was provided. Additional information is not expected.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site reaction
Clinical narrative: This spontaneous report as received from a pharmacist refers to an unspecified number of patients of unknown age and gender. On an unknown date the patients were vaccinated with ZOSTAVAX. Dose, route, lot number and dose number were not reported. On an unknown date the patients experienced injection site reactions after administration of ZOSTAVAX. The outcome of the patients were unknown. Reporter causality assessment was not reported. All telephone attempts to obtain follow up information have been unsuccessful. Additional information has been requested. This case copy from 1404USA010523. A new case was created to correct the initial aware date of initial version from 17-APR-2014 to 16-APR-2014. All the information has been transferred to 1405USA002543.
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. On 05-MAY-2014 the patient was vaccinated with ZOSTAVAX (lot # J001003, exp. date 24-APR-2014) 0.65 ml subcutaneous. The patient received an expired dose of ZOSTAVAX. No adverse effect reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date the patients were vaccinated with VARIVAX (lot#, dose, strength and route unknown). On an unknown date the (Oka/Merck) VARIVAX was exposed to temperature excursions on 6F for 8 hours and/or 10F for 11.5 hours. No adverse events were reported. This is one of several reports received from the same reporter. Additional information is not expected.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date the patients were vaccinated with PROQUAD (lot#, dose, strength and route unknown). On an unknown date the PROQUAD was exposed to temperature excursions on 6F for 8 hours and/or 10F for 11.5 hours. No adverse events were reported. This is one of several reports received from the same reporter. Additional information is not expected.
Sex: F
Vaccine: VARZOS
Symptoms: Blood creatine increased, Blood glucose increased, Electromyogram, Glomerular filtration rate decreased, Herpes zoster
Clinical narrative: This spontaneous report as received from a female patient of unknown age with arthritis in spine, leaky valve and "blood pressure" refers to herself. In July 2013 the patient had already had a case of shingles. During that case of the shingles, she also had a sinus infection, where she was treated with KEFLEX. patient also stated that many years ago, she had hives after taking an unspecified "sulfa" product. On 06-AUG-2013 the patient was vaccinated with a dose of ZOSTAVAX (route, dose and lot# were unknown). Concomitant therapies included INDERAL LA, amlodipine besylate, hydrochlorothiazide, TRIBENZOR, meloxicam, tramadol hydrochloride and VALIUM. On 16-APR-2014, the patient was again diagnosed with the shingles on her right backside. The patient was treated with generic RELAFEN. The patient mentioned that a week before the second shingles case, she went through Electromyography (EMG) and conduction velocities (CV) tests in the lumbar area of the spine. She thought this could be a correlation. The patient said that her recent blood tests (on an unknown date of 2014) show estimated glomerular filtration rate (eGFR) was lower, creatine was high and glucose was higher than usual. The outcome of events was unknown. The ZOSTAVAX was not reintroduced. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Nerve conduction studies
Clinical narrative: This spontaneous report as received from a female patient of unknown age with arthritis in spine, leaky valve and "blood pressure" refers to herself. In July 2013 the patient had already had a case of shingles. During that case of the shingles, she also had a sinus infection, where she was treated with KEFLEX. patient also stated that many years ago, she had hives after taking an unspecified "sulfa" product. On 06-AUG-2013 the patient was vaccinated with a dose of ZOSTAVAX (route, dose and lot# were unknown). Concomitant therapies included INDERAL LA, amlodipine besylate, hydrochlorothiazide, TRIBENZOR, meloxicam, tramadol hydrochloride and VALIUM. On 16-APR-2014, the patient was again diagnosed with the shingles on her right backside. The patient was treated with generic RELAFEN. The patient mentioned that a week before the second shingles case, she went through Electromyography (EMG) and conduction velocities (CV) tests in the lumbar area of the spine. She thought this could be a correlation. The patient said that her recent blood tests (on an unknown date of 2014) show estimated glomerular filtration rate (eGFR) was lower, creatine was high and glucose was higher than usual. The outcome of events was unknown. The ZOSTAVAX was not reintroduced. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacy student refers to an unspecified number of patients. On an unknown date the patients were vaccinated with doses of M-M-R II (dose, route and indication not reported) separately. Pharmacy student stated an unspecified number of patients may have received M-M-R II that was transported via pneumatic tube system for an unspecified time in the past. Pharmacy student stated pneumatic tube system used to transport vaccines, namely M-M-R II, when urgent and the duration of transit is less than 30 minutes. Pharmacy student stated no further specific time and temperature conditions at time of call. No adverse effects reported. Additional information has been requested.
Age: 46.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: General symptom
Clinical narrative: Initial report received on 02-MAY-2014 from a consumer who is the patient. A 46 year(s) old female was vaccinated intramuscularly with ADACEL, batch C4030AA into the left gluteal on 06 February 2012. On the same day, she began experiencing injection site pain, stiffness from the waist down, sweating, fever and fatigue. At an unspecified time, the symptoms extended to blisters in mouth, elevated blood pressure, her hair fell out, fatigue worsened, raspy voice, mental anxiety, thought processes were affected, arthritis type symptoms to the point she couldn't move on some days, tingling of feet, blurred vision, headaches, left sided weakness, swelling of legs intermittently, insomnia and increased heart rate which continue today. The patient has a history of antibiotic allergy. The patient denied illness at the time of vaccination. Concomitant medications were not reported. Laboratory tests and corrective treatments were not reported. The patient has seen her own physician and is being referred for evaluation to an infectious disease doctor, vascular doctor, hematologist and will be setting up an appointment to see a neurologist. The reporter filed a report with VAER and was given a "temporary number for her VAERS of E-79615." The patient outcome was not recovered. Documents held by sender: None.
Age: 46.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Alopecia, Anxiety, Arthritis, Blood pressure increased, Dysphonia
Clinical narrative: Initial report received on 02-MAY-2014 from a consumer who is the patient. A 46 year(s) old female was vaccinated intramuscularly with ADACEL, batch C4030AA into the left gluteal on 06 February 2012. On the same day, she began experiencing injection site pain, stiffness from the waist down, sweating, fever and fatigue. At an unspecified time, the symptoms extended to blisters in mouth, elevated blood pressure, her hair fell out, fatigue worsened, raspy voice, mental anxiety, thought processes were affected, arthritis type symptoms to the point she couldn't move on some days, tingling of feet, blurred vision, headaches, left sided weakness, swelling of legs intermittently, insomnia and increased heart rate which continue today. The patient has a history of antibiotic allergy. The patient denied illness at the time of vaccination. Concomitant medications were not reported. Laboratory tests and corrective treatments were not reported. The patient has seen her own physician and is being referred for evaluation to an infectious disease doctor, vascular doctor, hematologist and will be setting up an appointment to see a neurologist. The reporter filed a report with VAER and was given a "temporary number for her VAERS of E-79615." The patient outcome was not recovered. Documents held by sender: None.
Age: 46.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Fatigue, Headache, Heart rate increased, Hemiparesis, Hyperhidrosis
Clinical narrative: Initial report received on 02-MAY-2014 from a consumer who is the patient. A 46 year(s) old female was vaccinated intramuscularly with ADACEL, batch C4030AA into the left gluteal on 06 February 2012. On the same day, she began experiencing injection site pain, stiffness from the waist down, sweating, fever and fatigue. At an unspecified time, the symptoms extended to blisters in mouth, elevated blood pressure, her hair fell out, fatigue worsened, raspy voice, mental anxiety, thought processes were affected, arthritis type symptoms to the point she couldn't move on some days, tingling of feet, blurred vision, headaches, left sided weakness, swelling of legs intermittently, insomnia and increased heart rate which continue today. The patient has a history of antibiotic allergy. The patient denied illness at the time of vaccination. Concomitant medications were not reported. Laboratory tests and corrective treatments were not reported. The patient has seen her own physician and is being referred for evaluation to an infectious disease doctor, vascular doctor, hematologist and will be setting up an appointment to see a neurologist. The reporter filed a report with VAER and was given a "temporary number for her VAERS of E-79615." The patient outcome was not recovered. Documents held by sender: None.
Age: 46.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Injection site pain, Insomnia, Local swelling, Mental impairment, Mobility decreased
Clinical narrative: Initial report received on 02-MAY-2014 from a consumer who is the patient. A 46 year(s) old female was vaccinated intramuscularly with ADACEL, batch C4030AA into the left gluteal on 06 February 2012. On the same day, she began experiencing injection site pain, stiffness from the waist down, sweating, fever and fatigue. At an unspecified time, the symptoms extended to blisters in mouth, elevated blood pressure, her hair fell out, fatigue worsened, raspy voice, mental anxiety, thought processes were affected, arthritis type symptoms to the point she couldn't move on some days, tingling of feet, blurred vision, headaches, left sided weakness, swelling of legs intermittently, insomnia and increased heart rate which continue today. The patient has a history of antibiotic allergy. The patient denied illness at the time of vaccination. Concomitant medications were not reported. Laboratory tests and corrective treatments were not reported. The patient has seen her own physician and is being referred for evaluation to an infectious disease doctor, vascular doctor, hematologist and will be setting up an appointment to see a neurologist. The reporter filed a report with VAER and was given a "temporary number for her VAERS of E-79615." The patient outcome was not recovered. Documents held by sender: None.
Age: 46.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Musculoskeletal stiffness, Oral mucosal blistering, Paraesthesia, Pyrexia, Vision blurred
Clinical narrative: Initial report received on 02-MAY-2014 from a consumer who is the patient. A 46 year(s) old female was vaccinated intramuscularly with ADACEL, batch C4030AA into the left gluteal on 06 February 2012. On the same day, she began experiencing injection site pain, stiffness from the waist down, sweating, fever and fatigue. At an unspecified time, the symptoms extended to blisters in mouth, elevated blood pressure, her hair fell out, fatigue worsened, raspy voice, mental anxiety, thought processes were affected, arthritis type symptoms to the point she couldn't move on some days, tingling of feet, blurred vision, headaches, left sided weakness, swelling of legs intermittently, insomnia and increased heart rate which continue today. The patient has a history of antibiotic allergy. The patient denied illness at the time of vaccination. Concomitant medications were not reported. Laboratory tests and corrective treatments were not reported. The patient has seen her own physician and is being referred for evaluation to an infectious disease doctor, vascular doctor, hematologist and will be setting up an appointment to see a neurologist. The reporter filed a report with VAER and was given a "temporary number for her VAERS of E-79615." The patient outcome was not recovered. Documents held by sender: None.
Age: 85.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site vesicles, Injection site warmth
Clinical narrative: Patient reported on 5/1/14 that the injection site became red and sore on 4/30/14.  On 5/1/14, blisters appeared near the injection site and the area continued to be red, sore and warm to the touch. Patient applied a cold compress to the area and took oral acetaminophen for the pain and swelling.
Age: 85.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site vesicles, Injection site warmth
Clinical narrative: Patient reported on 5/1/14 that the injection site became red and sore on 4/30/14.  On 5/1/14, blisters appeared near the injection site and the area continued to be red, sore and warm to the touch. Patient applied a cold compress to the area and took oral acetaminophen for the pain and swelling.
Age: 1.53
Sex: M
Vaccine: DTAP, MMR, VARCEL
Symptoms: Hypersomnia, Irritability, Pyrexia, Rash generalised, Rash morbilliform
Clinical narrative: Day 1-9: fussiness and irritability, more than usual even for a toddler. Day 9&10: fever. Day 11: slept 5 hours longer than normal in a 24-hour period. Day 13&14: measles-like rash all over body, sent 10 photos and 2 videos to doctor, who confirmed it looked like the rash that is typical from MMR vaccine and is not contagious.
Age: 22.0
Sex: M
Vaccine: HEP, VARCEL
Symptoms: Erythema, Local swelling, Pruritus
Clinical narrative: LOCAL READNESS, SWELLING, ITCHING.
Age: 11.0
Sex: F
Vaccine: HPV4, HPV4, MNQ, TDAP
Symptoms: Blood test, Erythema, Fatigue, Headache, Loss of consciousness
Clinical narrative: This spontaneous report as received from a consumer refers to an approximately 11 years old female patient, the reporter's daughter. Patient's current condition included hypothyroidism. No drug reactions or allergies were reported. In January, March and July 2012 the patient was vaccinated with doses of GARDASIL injection (location and exact route were not specified); dose 1, dose 2 and dose 3 (lot number 672652/0022AE, expiration date 28-SEP-2014), as recommended by physician. Lot numbers 08408A, expiration date 14-OCT-2013, and 12618A, expiration date 11-NOV-2013, are invalid for GARDASIL. Concomitant medications included SINGULAIR. In December 2012 (also reported as by December 2012), the patient was feeling yucky all the time, had passed out, experienced migraines almost every day, her cheeks were scalding red and was tired all the time. After passing out the patient was taken to an Emergency Room at a Medical Centre (date unspecified), but was not admitted. The patient was later seen by a neurologist (date unspecified), who prescribed gabapentin for headaches. The patient had blood tests performed (dates and results not specified). The outcome of the events was reported as not recovered, the patient's condition did not improve (it was also reported that therapy was not reintroduced). The relatedness between the events and GARDASIL was not reported. Upon internal review the event of had passed out was considered medically significant. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4, HPV4, MNQ, TDAP
Symptoms: Malaise, Migraine
Clinical narrative: This spontaneous report as received from a consumer refers to an approximately 11 years old female patient, the reporter's daughter. Patient's current condition included hypothyroidism. No drug reactions or allergies were reported. In January, March and July 2012 the patient was vaccinated with doses of GARDASIL injection (location and exact route were not specified); dose 1, dose 2 and dose 3 (lot number 672652/0022AE, expiration date 28-SEP-2014), as recommended by physician. Lot numbers 08408A, expiration date 14-OCT-2013, and 12618A, expiration date 11-NOV-2013, are invalid for GARDASIL. Concomitant medications included SINGULAIR. In December 2012 (also reported as by December 2012), the patient was feeling yucky all the time, had passed out, experienced migraines almost every day, her cheeks were scalding red and was tired all the time. After passing out the patient was taken to an Emergency Room at a Medical Centre (date unspecified), but was not admitted. The patient was later seen by a neurologist (date unspecified), who prescribed gabapentin for headaches. The patient had blood tests performed (dates and results not specified). The outcome of the events was reported as not recovered, the patient's condition did not improve (it was also reported that therapy was not reintroduced). The relatedness between the events and GARDASIL was not reported. Upon internal review the event of had passed out was considered medically significant. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4, HPV4, MNQ, TDAP
Symptoms: Arthralgia, Blood thyroid stimulating hormone, Epstein-Barr virus test, Full blood count, Headache
Clinical narrative: This spontaneous report as received from a consumer refers to an approximately 11 years old female patient, the reporter's daughter. Patient's current condition included hypothyroidism. No drug reactions or allergies were reported. In January, March and July 2012 the patient was vaccinated with doses of GARDASIL injection (location and exact route were not specified); dose 1, dose 2 and dose 3 (lot number 672652/0022AE, expiration date 28-SEP-2014), as recommended by physician. Lot numbers 08408A, expiration date 14-OCT-2013, and 12618A, expiration date 11-NOV-2013, are invalid for GARDASIL. Concomitant medications included SINGULAIR. In December 2012 (also reported as by December 2012), the patient was feeling yucky all the time, had passed out, experienced migraines almost every day, her cheeks were scalding red and was tired all the time. After passing out the patient was taken to an Emergency Room at a Medical Centre (date unspecified), but was not admitted. The patient was later seen by a neurologist (date unspecified), who prescribed gabapentin for headaches. The patient had blood tests performed (dates and results not specified). The outcome of the events was reported as not recovered, the patient's condition did not improve (it was also reported that therapy was not reintroduced). The relatedness between the events and GARDASIL was not reported. Upon internal review the event of had passed out was considered medically significant. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4, HPV4, MNQ, TDAP
Symptoms: Hypothyroidism, Laboratory test, Lethargy, Malaise, Red blood cell sedimentation rate
Clinical narrative: This spontaneous report as received from a consumer refers to an approximately 11 years old female patient, the reporter's daughter. Patient's current condition included hypothyroidism. No drug reactions or allergies were reported. In January, March and July 2012 the patient was vaccinated with doses of GARDASIL injection (location and exact route were not specified); dose 1, dose 2 and dose 3 (lot number 672652/0022AE, expiration date 28-SEP-2014), as recommended by physician. Lot numbers 08408A, expiration date 14-OCT-2013, and 12618A, expiration date 11-NOV-2013, are invalid for GARDASIL. Concomitant medications included SINGULAIR. In December 2012 (also reported as by December 2012), the patient was feeling yucky all the time, had passed out, experienced migraines almost every day, her cheeks were scalding red and was tired all the time. After passing out the patient was taken to an Emergency Room at a Medical Centre (date unspecified), but was not admitted. The patient was later seen by a neurologist (date unspecified), who prescribed gabapentin for headaches. The patient had blood tests performed (dates and results not specified). The outcome of the events was reported as not recovered, the patient's condition did not improve (it was also reported that therapy was not reintroduced). The relatedness between the events and GARDASIL was not reported. Upon internal review the event of had passed out was considered medically significant. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4, HPV4, MNQ, TDAP
Symptoms: Thyroid function test, Urine analysis
Clinical narrative: This spontaneous report as received from a consumer refers to an approximately 11 years old female patient, the reporter's daughter. Patient's current condition included hypothyroidism. No drug reactions or allergies were reported. In January, March and July 2012 the patient was vaccinated with doses of GARDASIL injection (location and exact route were not specified); dose 1, dose 2 and dose 3 (lot number 672652/0022AE, expiration date 28-SEP-2014), as recommended by physician. Lot numbers 08408A, expiration date 14-OCT-2013, and 12618A, expiration date 11-NOV-2013, are invalid for GARDASIL. Concomitant medications included SINGULAIR. In December 2012 (also reported as by December 2012), the patient was feeling yucky all the time, had passed out, experienced migraines almost every day, her cheeks were scalding red and was tired all the time. After passing out the patient was taken to an Emergency Room at a Medical Centre (date unspecified), but was not admitted. The patient was later seen by a neurologist (date unspecified), who prescribed gabapentin for headaches. The patient had blood tests performed (dates and results not specified). The outcome of the events was reported as not recovered, the patient's condition did not improve (it was also reported that therapy was not reintroduced). The relatedness between the events and GARDASIL was not reported. Upon internal review the event of had passed out was considered medically significant. Additional information has been requested.
Age: 41.0
Sex: F
Vaccine: VARZOS
Symptoms: Abortion spontaneous, Activities of daily living impaired, Exposure during pregnancy, Uterine dilation and curettage
Clinical narrative: This spontaneous retrospective pregnancy report was received from an approximately 41 years old female pharmacist, regarding herself. Patient had no relevant medical history and no drug reactions/allergies. On an unknown date the patient was vaccinated with ZOSTAVAX (dose and frequency unknown). Patient's concomitant medication was not reported. On an unknown date the patient had a miscarriage in 2013 (approximately) (medically significant), D and C procedure (medically significant) and she took off of work for two weeks after her miscarriage (disability). It was reported that, about a year ago the patient was 3 months pregnant (last menstrual period approximately February 2013 and estimated delivery date was approximately November 2013) and had a miscarriage (approximately 2013). The reporter states that during her pregnancy, she administered ZOSTAVAX to an unspecified amount of patients. She reported that she went to an unspecified emergency room on an unspecified date where it was discovered that she has a miscarriage. The reporter also stated that she took off work for two weeks after her miscarriage and that during that time, she had a dilatation and curettage (D and C) procedure. Laboratory studies were not performed. Patient was not hospitalized. Product quality complaint was not involved. The outcome of the events was unknown. The reporter's causality assessment was not provided. Upon internal review, the event of miscarriage was considered to be medically significant. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Urticaria, Vomiting
Clinical narrative: Hives on legs...by the next morning it was all over her body.  By the third day my daughter was vomiting.
Age: 8.0
Sex: F
Vaccine: MMR
Symptoms: Fall, Hypotonia
Clinical narrative: Patient received MMR vaccine only, as patient was walking out to the check out desk patient whispered to her mother and she fell limp in her mother's arms.  The patient immediately opened her eyes when PHN called out her name, a cool compress was applied to the forehead and the back of the neck, EMS was notified per mother and the EMS was in the clinic within less than 5 minutes.  Ems assessed the patient and recommended she be transported to hospital for evaluation.  The patient did not hit her head or any other part of her body when she fell limp, she was in her mother's arms.  The patient and her mother/EMS left the clinic at exactly 11:30 AM
Age: 0.26
Sex: F
Vaccine: DTAP, HIBV, MMR
Symptoms: Emotional distress, Irritability, Pyrexia
Clinical narrative: Inconsolability and fever.  Fever started 5/2/14 and lasted 3 days.  Inconsolability and fussiness started on 5/5 and have been present for 4 days.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia, Eye pain, Eyelid oedema, Neck pain, Pain in extremity
Clinical narrative: Swollen eyelids, eye pain, neck pain, scalp pain, left arm and left leg paresthesia, sore arm lasted three days, self-limited, four days later, had joint pains in shoulders, ankles, knees still ongoing.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Pain of skin, Paraesthesia
Clinical narrative: Swollen eyelids, eye pain, neck pain, scalp pain, left arm and left leg paresthesia, sore arm lasted three days, self-limited, four days later, had joint pains in shoulders, ankles, knees still ongoing.
Age: 4.0
Sex: U
Vaccine: DTP
Symptoms: Convulsion, Hemiparesis
Clinical narrative: Initial report received from a healthcare professional (physician) via Merck (reference number 1-11130268781) on 29 April 2014. An unidentified 4 year old with no reported medical history or concomitant medications, developed uncontrollable seizures and left sided weakness following vaccination with DTP (manufacturer reported as Sanofi Aventis, batch, date of administration, route and site not reported). The patient has had seizures ever since then. The physician of the patient was unknown to the physician. No additional information was reported. The patient outcome is not recovered. Note: This case was forwarded by Merck, who was not able to provide the name for the physician who reported the event. Since the contact information from the reporter is not sufficient to obtain an address or phone number, no additional follow-up requests can be sent. Documents held by sender: None.
Age: 2.0
Sex: M
Vaccine: FLU3
Symptoms: Abnormal behaviour, Aphasia
Clinical narrative: Initial case received from the patient's mother on 01 May 2014. A 2-year-old male patient, with no reported medical history and no reported concomitant drug, had received 2 doses of FLUZONE in 2005 (batch number U1746AA, expiry date 30-JUN-2006) at his own HCP. Since time of vaccination in 2005, the patient has "not been the same". It was stated that the patient was talking prior to the vaccination and that after vaccination he did not talk. The patient's outcome was reported as unknown. Documents held by sender: none.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site pruritus
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown demographics. No information about medical history concurrent conditions and concomitant medications was reported. The reported stated that she held a ZOSTAVAX clinic and 9 out of 11 patients were administered ZOSTAVAX lot number K000456, expiration date 15-DEC-2014, dose single dose, route SQ. One patient developed an itchy patch few inches from the injection site. At the time of report none of the patients had required medical treatment. The outcome of developed an itchy patch few inches from the injection site is unknown. The patient sought medical attention. No product quality complaint was involved. This case is linked to the case 1405USA003395 via same reporter link. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to 8 patients of unknown demographics. No information about medical history concurrent conditions and concomitant medications was reported. The reported stated that she held a ZOSTAVAX clinic and 9 out of 11 patients were administered ZOSTAVAX lot number K000456, expiration date 15-DEC-2014, dose single dose, route SQ for vaccination. Eight patients developed redness, swelling and induration at injection site, redness on an unknown date. At the time of report none of the patients had required medical treatment. The outcome of redness, swelling and induration at injection site is unknown. The patient sought medical attention. No product quality complaint was involved. This case is linked to the case 1405USA003862 via same reporter link. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date unspecified number of patients were vaccinated with RECOMBIVAX HB (dose of 0.5 ml once, intramuscular) (lot and expiration date not reported) that were stored at 11C for an unspecified time period. No concomitant medications were reported. No adverse effects reported. The reporter stated refrigerator consistently was reading in range between 36 and 46F (2 to 8C) for month of March 2014. Additional information has been requested.
Sex: F
Vaccine: MMR
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a female patient of unknown age. On 03-MAY-2014 the patient was administered a dose of MMR II (HSA; lot # 0183AE; expiry date 18-JAN-2014) subcutaneously that had been properly stored, but expired. The dose (0.5 ml) was the patient's first dose of MMR II. No adverse events were reported. Additional information has been reported.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a health worker refers to unspecified patients of unknown age. On an unknown date the patients were vaccinated with PROQUAD (dose and lot# not reported). It was reported that the temperature excursion of -13C up to 808 hours to VARIVAX which was supported. Multiple individuals had been vaccinated post excursion. And no individuals had been vaccinated post excursion. And no individual had reported any adverse effects post vaccination. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. On 30-APR-2014, the patient was vaccinated with a dose of improperly stored ZOSTAVAX (dose and Lot# not reported). No symptoms were reported. Additional information has been requested.
Sex: U
Vaccine: PNC13
Symptoms: Abdominal pain, Coeliac disease
Clinical narrative: This is a spontaneous report from a contactable pharmacist. A patient of unspecified age, ethnicity and gender received PREVNAR 13, via an unspecified route of administration, on an unspecified date at 0.5 ml, single. The patient medical history and concomitant medications were not reported. The patient experienced celiac disease and abdominal pain on an unspecified date. The outcome of the reported events was unknown at the time of this report. The reporting pharmacist questioned about the ingredients of PREVNAR 13.
Age: 63.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Fatigue, Headache, Pyrexia
Clinical narrative: Patient resported symptoms of fever (103 degrees), extreme fatigue, and severe headaches.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unknown number of patients. No further information regarding the patients was available. On an unknown date the patients were vaccinated with improperly stored GARDASIL. Strength, dose, route and lot number were not provided. GARDASIL was exposed to a temperature between 46.5F and a highest of 48F for a total 45 hours and 5 minutes from 10-APR-2014 to 02-MAY-2014: Out of range for 2 hours from 10-APR-2014 to 11-APR-2014; out of range for 10 hours and 15 minutes on 12-APR-2014; out of range for 12 hours and 25 minutes on 13-APR-2014; out of range for 1.5 hours on 14-APR-2014; out of range for 9.5 hours on 01-MAY-2014; out of range for 9 hours and 25 minutes on 02-MAY-2014. No adverse effects were reported. This is one of several reports received from the same reporter (other case IDs: 1405USA004215, 1405USA004216 and 1405USA002823). Additional information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: Antibody test negative, Exposure during pregnancy
Clinical narrative: This spontaneous prospective pregnancy report as received from a consumer refers to a female patient of unknown age. Relevant medical history and concomitant medication were not provided. On an unknown date the patient was vaccinated with VARIVAX (Merck) 2 doses. Lot number, dose, route and frequency were not provided. On an unknown date the patient's antibody titers were negative. The patient was now 8 months pregnant. No problems were reported. The pregnancy outcome was pending. The outcome of antibody titers were negative was reported as not recovered/not resolved. The reporter causality was unknown. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Pain in extremity
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with PNEUMOVAX 23. On an unknown date the patient experienced sore arm after administration of PNEUMOVAX. Causality was not reported. The outcome of the event is unknown. No further information provided. Additional information has been requested.
Age: 64.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: This spontaneous report was received from a 64 year old male patient with no drug allergies/reactions. The patient's pertinent medical history included muscular dystrophy. On 22-APR-2014 the patient was vaccinated with ZOSTAVAX for prevention of shingles. Concomitant medications were none. On 22-APR-2014 the patient experienced no adverse reaction. On 02-MAY-2014, patient noticed that the injection site was red with a bump on the inside and the site feels itchy. No product quality complain (PQC) reported. The lab diagnostics studies were none. The outcome of the injection site was red with a bump on the inside and the site feels itch was reported as not recovered (reported as adverse event did not improve). The causality was not reported. The patient did not sought medical attention. Additional information has been requested.
Age: 64.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: This spontaneous report was received from a 64 year old male patient with no drug allergies/reactions. The patient's pertinent medical history included muscular dystrophy. On 22-APR-2014 the patient was vaccinated with ZOSTAVAX for prevention of shingles. Concomitant medications were none. On 22-APR-2014 the patient experienced no adverse reaction. On 02-MAY-2014, patient noticed that the injection site was red with a bump on the inside and the site feels itchy. No product quality complain (PQC) reported. The lab diagnostics studies were none. The outcome of the injection site was red with a bump on the inside and the site feels itch was reported as not recovered (reported as adverse event did not improve). The causality was not reported. The patient did not sought medical attention. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a health worker refers to unspecified patients of unknown age. On an unknown date the patients were vaccinated with VARIVAX (Merck) (dose and lot# not reported). It was reported that the temperature excursion of -13c up to 808 hours to VARIVAX (Merck) which was supported. Multiple individuals had been vaccinated post excursion. And no individual had reported any adverse effects post vaccination. This is one of the several reports from the same reporter. Additional information has been requested.
Age: 50.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 50 year old patient who was scheduled to receive MMR II. On 23-APR-2014 the patient was inadvertently vaccinated with one dose of PROQUAD (Merck), 0.5 ml (dose number, route and lot # not reported), due to an error on the part of the staff at the physicians office. There was no error in the product labeling and no confusion about what was listed on the label. No PQC and no adverse effects reported. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash
Clinical narrative: This spontaneous report as received from a field employee via pharmacist refers to an approximately 68 year old female patient with diabetes. No drug reactions or allergies, no other medical history was provided by the reporter. On an unknown date the patient was vaccinated with ZOSTAVAX (route of administration, anatomical location, lot number not reported). No concomitant medications were reported. On an unknown date the patient experienced shingles after receiving ZOSTAVAX. The patient's husband informed reporter on 27-APR-2014 that the patient experienced a good dose of shingles. Lab diagnostic studies were not provided by the reporter. It was reported that the patient received multiple unspecified prescriptions for treatment of pain and rash, from unspecified healthcare provider. The outcome of shingles/good dose of shingles and pain was not reported. The patient sought medical attention via contacting unspecified healthcare provider. The relatedness between events and ZOSTAVAX was not reported. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to unspecified number of patients of unknown demographics. No information about medical history concurrent conditions and concomitant medications was reported. The reporter stated that on an unknown date the patient was vaccinated with PROQUAD, strength-0.5 ml, subcutaneous that was improperly stored. The reporter also stated that PROQUAD and reached a high temperature of 14F for a total of about 42 hours from 01-APR-2014 to 04-APR-2014. No adverse effects reported. The outcome of events reported is unknown. No product quality complaint was involved. This case is linked to the other case 1405USA004206 via same patient link. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to unspecified number of patients of unknown demographics. No information about medical history concurrent conditions and concomitant medications was reported. The reporter stated that on an unknown date the patients were vaccinated with VARIVAX (Merck) that was improperly stored. The reporter also stated that VARIVAX (Merck) reached a high temperature of 14F for a total of about 42 hours from 01-APR-2014 to 04-APR-2014. No adverse effects reported. The outcome of events reported is unknown. No product quality complaint was involved. This case is linked to the other case 1405USA004041 via same patient link. Additional information has been requested.