chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction, Rash vesicular
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 53 year old female patient. The patient's current conditions or medical history were not reported. On 18-FEB-2014, the patient was vaccinated with ZOSTAVAX vial dry SD 0.65 ml subcutaneously (lot J011882, exp date 04-JAN-2014). Concomitant medications included lisinopril (manufacturer unknown) and KLONOPIN. On 19-FEB-2014, the patient developed a few bumps around injection site that looked like shingles rash. The patient had had several cases of shingles and she identified those bumps as shingles-like rash. The patient did not reported any pain. At the time of the report the patient was not recovered from bumps around injection site that looked like shingles rash. The patient called the office to sough for medical attention and did not received treatment for the events. No lab diagnostics were performed. Additional information has been requested.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Abdominal rash, red swollen hot injection site, headache, chills, lethargy.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Lethargy, Rash
Clinical narrative: Abdominal rash, red swollen hot injection site, headache, chills, lethargy.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Local swelling
Clinical narrative: Large red mark on upper left arm. Swelling followed. Large hard baseball size swelling. This lasted 6 days. Redness still there after 7 days. Swelling gone!
Age: 0.21
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Crying
Clinical narrative: Mom called at 2:50 pm on 2-25-14 stating baby has been crying non stop. Unable to soothe him. Tried rocking, giving bottle, walking. Mom gave TYLENOL at 11:30 AM. Took to ER.
Age: 12.0
Sex: M
Vaccine: FLU3, MNQ, TDAP
Symptoms: Back pain, Blood culture positive, Culture urine positive, Haematuria, Pyrexia
Clinical narrative: Pt awoke at 6:30 a.m. on 2/25/14 with a lower backache, and had "bright red" hematuria. Pt's mom reported 100.8 degree F fever mid-afternoon. Urine became progressively lighter through 2/25 but remained blood-tinged. Visited Urgent Care at 6:30 pm. Treated with amoxicillin, 1000 mg bid x 7 days. Sx resolved by 2/27/14.
Age: 1.01
Sex: F
Vaccine: HIBV, MMR, PNC13
Symptoms: Blister, Excoriation, Scab, Skin lesion, Varicella virus test
Clinical narrative: Lots lesions on scalp - started as blisters then excoriated - crusty.
Age: 6.0
Sex: F
Vaccine: FLU3, HEPA, IPV, MMR
Symptoms: Headache, Pallor, Somnolence, Syncope, Vomiting
Clinical narrative: Per dad about 10 mins. after receiving immunizations she became pale and fainted for about 1 min. When she woke up she was drowsy, vomiting, HA. Pt was referred to her PCP for eval of having a history of syncope episodes. Dismissed home is stable condition.
Age: 71.0
Sex: M
Vaccine: PPV
Symptoms: Asthenia, Mobility decreased, Pain in extremity, Pyrexia, Rash erythematous
Clinical narrative: Rec'd shot at 2:00 p.m. 02/25/14. Arm pain noon 02/26/14. Red rash around vaccination and fever 100 degrees 7 p.m. 2/26/14. Weakness 2/26 and 2/27. Fever at 101.7 at 7:00 p.m. 02/27/14; took Tylenol. No fever at 6:00 a.m. 02/28/14; arm still very tight. upper arm still very sore.
Age: 71.0
Sex: M
Vaccine: PPV
Symptoms: Vaccination site reaction
Clinical narrative: Rec'd shot at 2:00 p.m. 02/25/14. Arm pain noon 02/26/14. Red rash around vaccination and fever 100 degrees 7 p.m. 2/26/14. Weakness 2/26 and 2/27. Fever at 101.7 at 7:00 p.m. 02/27/14; took Tylenol. No fever at 6:00 a.m. 02/28/14; arm still very tight. upper arm still very sore.
Age: 42.0
Sex: F
Vaccine: FLU4
Symptoms: Allergy test, Chest pain, Conjunctivitis, Cough, Dyspnoea
Clinical narrative: Dry cough, shortness of breath, chest pain, headache, conjunctivitis. Dry cough - 3 hours after, shortness of breath/chest pain 4 hours after, headache and conjunctivitis 5 hours after injection.
Age: 42.0
Sex: F
Vaccine: FLU4
Symptoms: Headache, Skin test
Clinical narrative: Dry cough, shortness of breath, chest pain, headache, conjunctivitis. Dry cough - 3 hours after, shortness of breath/chest pain 4 hours after, headache and conjunctivitis 5 hours after injection.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: Sore to the touch around injection site months after administration.
Age: 55.0
Sex: M
Vaccine: FLU4
Symptoms: Confusional state, Dizziness, Hyperhidrosis, Loss of consciousness, Swelling
Clinical narrative: Slight bump (immediate). Larger bump (approximately 3 mins). Dizziness (approximately 4 mins). Diaphoresis (approximately 4 mins). Loss of consciousness (approximately 5 mins) for 15 sec. Confusion (approximately 5 mins) for 10 sec. Pt ok (approximately 7 mins)
Age: 4.0
Sex: F
Vaccine: DTAPHEPBIP, MMRV
Symptoms: Cough, Eye swelling, Increased upper airway secretion, Ocular hyperaemia, Sneezing
Clinical narrative: Within minutes of receiving vaccines pt began sneezing repeatedly, had throat secretions and sl cough. Over next 15 min hives developed, bloodshot eyes with periorbital swelling. EPIPEN administered and pt taken to ER.
Age: 4.0
Sex: F
Vaccine: DTAPHEPBIP, MMRV
Symptoms: Urticaria
Clinical narrative: Within minutes of receiving vaccines pt began sneezing repeatedly, had throat secretions and sl cough. Over next 15 min hives developed, bloodshot eyes with periorbital swelling. EPIPEN administered and pt taken to ER.
Age: 4.0
Sex: M
Vaccine: DTAP, MMR
Symptoms: Injection site erythema, Urticaria
Clinical narrative: Welt occurred within few minutes. Left thigh was red to a reaction of MMR.
Age: 1.14
Sex: M
Vaccine: HIBV, MMR, PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: Rash with erythema, warmth, tenderness, and swelling to left thigh where he received Hib and PCV 13. Recommended Ibuprofen 5ml Q 6 h overnight then as needed for discomfort. Recheck Monday if not fine.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Swelling, Tenderness
Clinical narrative: Redness, swelling, tenderness.
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Dizziness, Injection site erythema, Pain in extremity
Clinical narrative: Extremely dizzy 13 hrs. after injection (4:30 A.M.) symptom lasted approx. 10 minutes. Arm very sore. Redness in injection area. No treatment.
Age: 11.0
Sex: M
Vaccine: FLU3, MNQ, TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site inflammation
Clinical narrative: Redness with induration 5 x 6 cm and inflammation. On (R) deltoid region.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a unspecified number of patients of unknown demographics. The patients current conditions or medical history were not reported. On an unknown date, between January-February 2014, the patients were vaccinated with 28 doses (unspecified) of VAQTA (dose and route were not reported) lot #s: H010659 expiry 01-MAR-2015; H012669 expiry 17-APR-2015; H019104 expiry 19-JUL-2015; J000366 expiry 22-AUG-2015; J005713 expiry 25-OCT-2015 that had been stored in January 2014 (starting 16-JAN-2014) at 30 F minimum for a total of 112 hours. No adverse effect reported. This is one of several reports from the same source: 1403USA000542, 1403USA001589, 1403USA001588, 1402USA001586. Additional information has been requested.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Seizure like phenomena
Clinical narrative: Seizure-like activity after shots (day after) that has persisted but improving.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown demographics. The patient's current conditions or medical history were not reported. On an unknown date, between January-February 2014, the patients were vaccinated with 17 doses (unspecified) of RECOMBIVAX HB (dose and route were not reported) lot's: H017304 expiry 11-JUL-2015; H020604 expiry 10-FEB-2015, that had been stored in January 2014 (starting 16-JAN-2014) at 30 F minimum for a total of 112 hours. No adverse effect reported. This is one of several reports from the same source. 1403USA000542, 1403USA001589, 1403USA001586, 1403USA011587. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown demographics. The patient's current conditions or medical history were not reported. On an unknown date, between January-February 2014, the patients were vaccinated with 31 doses (unspecified) of PEDVAXHIB 0.5 ml intramuscular, lot #'s: J005668 expiry 12-MAY-2015; J009134 expiry 15-APR-2016; J009713 expiry 19-MAY-2016, that had been stored in January 2014 (starting 16-JAN-2014) at 30 F minimum for a total of 112 hours. No adverse effect reported. This is one of several reports from the same source: 1403USA001589, 1403USA001586, 1403USA001588, 1403USA001587. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown demographics. The patient's current conditions or medical history were not reported. On an unknown date, between January-February 2014, the patient was vaccinated with one dose of PNEUMOVAX 23 lot # H012650 expiration date 27-FEB-2014 (dose and route were not reported) that had been stored in January 2014 (starting 16-JAN-2014) at 30 F minimum for a total of 112 hours. No adverse effect reported. This is one of several reports from the same source. 1403USA000542, 1403USA001589, 1403USA001588, 1403USA001587. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site erythema, Injection site nodule, Injection site swelling, Injection site warmth
Clinical narrative: Patient had a grapefruit size knot on arm where injection was and was bright red, very hot and swollen. To this day, a knot is still there but smaller.
Age: 20.0
Sex: M
Vaccine: TYP
Symptoms: Chest discomfort, Chills, Dizziness, Feeling abnormal, Throat irritation
Clinical narrative: Patient felt dizzy, lite headed with chills, tingly-spicy throat, shaking, spacy, tight upper chest, denied SOB, hives or rash...transported to urgent care.
Age: 20.0
Sex: M
Vaccine: TYP
Symptoms: Tremor
Clinical narrative: Patient felt dizzy, lite headed with chills, tingly-spicy throat, shaking, spacy, tight upper chest, denied SOB, hives or rash...transported to urgent care.
Age: 1.02
Sex: M
Vaccine: FLU4, HEPA, MMR, VARCEL
Symptoms: Injection site pustule, Injection site rash
Clinical narrative: Pox developed at injection site.
Age: 22.0
Sex: M
Vaccine: JEV1, MNQ, RAB, TYP
Symptoms: Erythema, Local swelling, Pain in extremity
Clinical narrative: Pt felt a pain inside his arm above the elbow at 1010am, he states he felt this pain a few times and then saw some swelling and redness to his arm.  PT was given a Motrin and a Zyrtec prescribed by provider and also a ice pack was applied to the area.
Age: 0.19
Sex: M
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Abdominal pain, Crying, Decreased appetite, Dehydration, Hypotonia
Clinical narrative: Sx began Wednesday night with crying, pulling up of legs, late Wednesday night pt. Began to vomit.  From 8:30am-1pm on Thursday pt. Screamed, not eating and then fell asleep from 1pm-6pm.  Mom woke child up at 6pm and reports that child was limp, took to ER.  Reports that child was dehydrated.
Age: 0.19
Sex: M
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Screaming, Vomiting
Clinical narrative: Sx began Wednesday night with crying, pulling up of legs, late Wednesday night pt. Began to vomit.  From 8:30am-1pm on Thursday pt. Screamed, not eating and then fell asleep from 1pm-6pm.  Mom woke child up at 6pm and reports that child was limp, took to ER.  Reports that child was dehydrated.
Age: 20.0
Sex: F
Vaccine: TYP
Symptoms: Abdominal pain upper, Dizziness, Feeling hot, Headache, Musculoskeletal chest pain
Clinical narrative: On day of vaccine developed headache and felt warm. The next morning felt dizzy, nausea, vomited twice and had pain in mid epigastric region and lower anterior ribs.
Age: 20.0
Sex: F
Vaccine: TYP
Symptoms: Nausea, Vomiting
Clinical narrative: On day of vaccine developed headache and felt warm. The next morning felt dizzy, nausea, vomited twice and had pain in mid epigastric region and lower anterior ribs.
Age: 59.0
Sex: M
Vaccine: FLU4
Symptoms: Audiogram abnormal, Deafness, Ear congestion, Tinnitus
Clinical narrative: Rapid hearing loss, severely plugged ears, tinnitus. Audiogram on 01/13/2014 showed marked hearing loss. After 9 days with no improvement MD prescribed 8 day Prednisone treatment. After 6 weeks, no marked improvement except some of the plugged sensation resolved in right ear; left ear unchanged.
Age: 3.0
Sex: F
Vaccine: DTAP, FLU4, HEP, HIBV
Symptoms: Rash generalised, Somnolence
Clinical narrative: Broke out in a rash, starting on arm and progessing to all of body.
Age: 20.0
Sex: F
Vaccine: HEP, TDAP
Symptoms: Blood pressure decreased, Dizziness, Heart rate decreased, Immediate post-injection reaction, Nausea
Clinical narrative: Immediately after administration of vaccine, patient reported feeling light headed.  Raised head of bed slightly, leaned back and placed ice pack on back of neck.  Noticed pale color.  Took blood pressure (77/44, pulse 44).  Went to get provider for assistance. FNP came to room, noted poor color, raised legs to above level of heart, had head of bed lowered, and requested additional ice pack be placed on chest.  Blood pressure re-checked, 97/68, 82. Color slowly returned.  Over about 15 minutes color continued to improve and more talkative, reported decrease in nausea and lightheaded feeling.  Slowly sat patient up with bed in low position.  Once standing, reported feeling ok.  Was discharged from clinic by PCM with brother to drive home.  Patient left clinic in good condition, talking and joking.
Age: 20.0
Sex: F
Vaccine: HEP, TDAP
Symptoms: Pallor
Clinical narrative: Immediately after administration of vaccine, patient reported feeling light headed.  Raised head of bed slightly, leaned back and placed ice pack on back of neck.  Noticed pale color.  Took blood pressure (77/44, pulse 44).  Went to get provider for assistance. FNP came to room, noted poor color, raised legs to above level of heart, had head of bed lowered, and requested additional ice pack be placed on chest.  Blood pressure re-checked, 97/68, 82. Color slowly returned.  Over about 15 minutes color continued to improve and more talkative, reported decrease in nausea and lightheaded feeling.  Slowly sat patient up with bed in low position.  Once standing, reported feeling ok.  Was discharged from clinic by PCM with brother to drive home.  Patient left clinic in good condition, talking and joking.
Age: 24.0
Sex: F
Vaccine: FLU3
Symptoms: Rash, Tuberculin test
Clinical narrative: Rash appeared 8-9 hours post immunization of both the PPD and the seasonal influenza.
Age: 11.0
Sex: M
Vaccine: FLU4, HPV4, MNQ, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient with swelling, redness and tenderness to entire left deltoid area.
Age: 47.0
Sex: F
Vaccine: FLUR3
Symptoms: Blood glucose normal, Blood pressure increased, Dizziness, Feeling abnormal, Hypoaesthesia oral
Clinical narrative: Suddenly felt nauseous, lips were numb, head felt dizzy, just felt miserable, nurse assisted me...fellow coworkers took blood pressure 138/90 (norm is 100/60), blood sugar 135 (had eaten bologna sandwich and half a bagel with peach tea) this happened at work, I'm new, an RN.  They saw red botched on my skin.
Age: 47.0
Sex: F
Vaccine: FLUR3
Symptoms: Nausea, Rash macular
Clinical narrative: Suddenly felt nauseous, lips were numb, head felt dizzy, just felt miserable, nurse assisted me...fellow coworkers took blood pressure 138/90 (norm is 100/60), blood sugar 135 (had eaten bologna sandwich and half a bagel with peach tea) this happened at work, I'm new, an RN.  They saw red botched on my skin.
Age: 55.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Swelling around injection site; tender to touch; warm to touch and very sore.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Erythema, Local swelling, Skin warm
Clinical narrative: Pt arms swollen w/redness and warm to touch. Treated w/PO OTC Benadryl, Tylenol and Motrin.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Autoimmune disorder, Immediate post-injection reaction, Immunology test, Local swelling, Rash
Clinical narrative: Right after the vaccination, I began to swell in my feet and face. Then, I developed rashes and hives. I still have these affects after 10 months I now have developed an auto immune disorder. I take herbs to help w/the symptoms of each. I never signed a paper before taking this. It was pushed to take it.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Swelling face, Urticaria
Clinical narrative: Right after the vaccination, I began to swell in my feet and face. Then, I developed rashes and hives. I still have these affects after 10 months I now have developed an auto immune disorder. I take herbs to help w/the symptoms of each. I never signed a paper before taking this. It was pushed to take it.
Age: 55.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Chills, Hyperhidrosis, Joint crepitation, Muscle contracture
Clinical narrative: Chills, sweats (fever), nausea, vomiting within 6-8 hrs after vaccine. Lasted 5-6 days then mild within 1 1/2 wks. Fingers contracted. Joints started to ache six months later with crackling of neck and spine and knee joints for 3 months still present.
Age: 55.0
Sex: F
Vaccine: TDAP
Symptoms: Nausea, Pyrexia, Vomiting
Clinical narrative: Chills, sweats (fever), nausea, vomiting within 6-8 hrs after vaccine. Lasted 5-6 days then mild within 1 1/2 wks. Fingers contracted. Joints started to ache six months later with crackling of neck and spine and knee joints for 3 months still present.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Fatigue, Myalgia, Somnolence
Clinical narrative: PNEUMOVAX vacc was administered on Thurs 2/27/14 around 1:45 pm; Thurs evening pt. experienced muscle pain/joint pains along rt side of body, no headache, extreme fatigue and felt very sleepy.
Age: 49.0
Sex: M
Vaccine: HEPAB, TYP
Symptoms: Blister, Confusional state, Headache, Injection site pain, Musculoskeletal stiffness
Clinical narrative: 3/5/14 at 1500 Employee reports received TWINRIX and Typhoid vaccination for foreign travel on 2/17/14; 3 to 4 days later started with hot spots and soreness, progressing from (R) shoulder down to hand, rash on neck, upper back and (R) arm, developed blisters, "felt like skin was on fire" irritated by slightest touch, clothing, headaches, stiffness in neck and shoulder, intermittent dizziness and confusion, denies fever, SOB, denies seeking medical treatment, advised to follow up with primary doctor. Reports has an appointment with MD on 3/6/14.
Age: 49.0
Sex: M
Vaccine: HEPAB, TYP
Symptoms: Pain in extremity, Rash, Skin burning sensation, Skin irritation, Skin warm
Clinical narrative: 3/5/14 at 1500 Employee reports received TWINRIX and Typhoid vaccination for foreign travel on 2/17/14; 3 to 4 days later started with hot spots and soreness, progressing from (R) shoulder down to hand, rash on neck, upper back and (R) arm, developed blisters, "felt like skin was on fire" irritated by slightest touch, clothing, headaches, stiffness in neck and shoulder, intermittent dizziness and confusion, denies fever, SOB, denies seeking medical treatment, advised to follow up with primary doctor. Reports has an appointment with MD on 3/6/14.
Age: 70.0
Sex: M
Vaccine: PPV
Symptoms: Chills, Headache, Injection site swelling, Pain, Pyrexia
Clinical narrative: 5 hours after vaccine administration, he developed fever to 101.6, chills, swelling (no redness) at site, headaches and general body aches.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pain, Pyrexia
Clinical narrative: The patient developed redness, swelling at the injection site. The patient had aches and fever and the site was warm to the touch.
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 unspecified number of patients of unknown demographics. The patient's current conditions or medical history were not reported. On an unknown date, between January-February 2014, the patients were vaccinated with 7 doses (unspecified) of GARDASIL (dose and route were not reported) lot numbers:H015555 expiry 13-APR-2015: H021608 expiry 13-AUG-2015: H021861 expiry 09-OCT-2015, that had been stored in January 2014 (starting 16-JAN-2014) at 30 F minimum for a total of 112 hours. No adverse effect reported. This is one of several reports from the same source: 1403USA000542, 1403USA001586, 1403USA001588, 1402USA001587. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Ophthalmic herpes zoster
Clinical narrative: This spontaneous report as received from a pharmacist, via company representative, refers to a male patient of unknown age. About a year ago, in 2013, the patient was vaccinated with ZOSTAVAX (dose, route and lot number were not reported). Concomitant medications were not reported. On an unknown date the patient experienced shingles of an unspecified eye. Pharmacist reported that "recently", on an unknown date, patient went into the pharmacy to have an unspecified antiviral prescription filled due to the shingles of an unspecified eye. The outcome of shingles of an unspecified eye was not reported. The relationship between ZOSTAVAX and the event was not reported. Patient was seen by an unspecified physician on an unspecified date. 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 medical assistant refers to an unspecified number of patients. Medical assistant reported that an unspecified number of patients were administered doses of M-M-R II (lot#, expiration date, dose, frequency, route and indication not reported) from 27-JAN-2014 to 24-FEB-2014 after being exposed to temperatures outside of the prescribing information that were not supported. No adverse events were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified number of patients. Medical assistant reported that an unspecified number of patients were administered doses of LIQUID PEDVAXHIB (lot #, expiry date, dose, frequency, route and indication not reported) from 27-JAN-2014 to 24-FEB-2014 after being exposed to temperatures outside of the prescribed information that were not supported. No adverse events were reported. This is one of several reports received from the same source. Addition information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse, concerning a patient of unknown age and gender. On an unknown date, a dose of VARIVAX (Merck), 1350U, (total dose, route, lot number and expiry date were not provided) which was exposed to 6 degrees F for possibly 66 hours, was administered to an unspecified patient. Co-suspect therapy and concomitant medications were not provided. No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified number of patients. Medical assistant reported that an unspecified number of patients were administered doses of oral ROTATEQ (lot #, expiry date, dose, frequency, route and indication not reported) from 27-JAN-2014 to 24-FEB-2014 after being exposed to temperatures outside of the prescribing information that were not supported. No adverse events were reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 1.83
Sex: F
Vaccine: DTAP, HEPA, HIBV, PNC13
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: At injection site: redness, warmth, hard, swollen.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Delivery, Exposure during pregnancy, Pregnancy test urine positive
Clinical narrative: This spontaneous prospective pregnancy report as received from a Registered Nurse refers to a 25 year old female patient with allergic reaction to bee sting, drug reactions/allergies to oxycodone and with no medical history, who on 16-SEP-2011 the patient was vaccinated with her first dose of GARDASIL (lot # 668262/0841AA, Exp date: 18-APR-2013) 0.5 ml, intramuscularly. Other suspect therapies included vaccination of influenza virus vaccine (manufacturer unknown) (dose, lot# unspecified) on an unknown date. Concomitant therapies included MAXALT, PRILOSEC and ZYRTEC. The nurse reported that the patient received the first dose of GARDASIL and then requested to be on birth control pills. The standard policy of the office was to do a urine pregnancy test prior to the patient receiving birth control pills and the patient performed it on 16-SEP-2011. The patient was found to be positive for pregnancy. No treatment was given for AE. The patient was in the office to seek medical attention. Follow up information has been received from a certified pediatric nurse (CPN) reporting the patient on 16-SEP-2011 was vaccinated with the first dose of GARDASIL (lot number 668262/0841AA). Other medications used in this pregnancy included ZYRTEC 10 mg daily for the treatment of allergies, MAXALT 10 mg as needed, and PRILOSEC 20 mg once a day. Follow up information as received from a Registered Nurse refers to a 25 year old female patient who became pregnant with LMP of 02-AUG-2011 and EDD of 08-MAY-2012. Initial exposure to GARDASIL was at 6 week(s). The patient delivered an infant of unknown gender. The infant was normal and with no congenital anomaly. The outcome of the event was reported as recovered/resolved. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Abnormal behaviour, Convulsion, Dizziness, Electroencephalogram abnormal, Fatigue
Clinical narrative: This spontaneous report was received from the mother of the patient, concerning her 11 year old daughter with ADHD (Attention deficit/hyperactivity disorder). The patient had allergy to LAMICTAL. It was reported that the patient was not pregnant. On 15-DEC-2010, the patient was vaccinated with the first dose of GARDASIL, (dose, route and lot number were not reported). On 26-FEB-2011, the patient received the second dose of GARDASIL (dose, route and lot number were not reported) and on 23-JUN-2011, the patient received the third dose of GARDASIL (dose, route and lot number were not reported). There were no concomitant medications. On 20-AUG-2011, after the patient received the third shot of GARDASIL, the patient experienced seizures, muscle pains, headaches and blurred vision. It was reported that the patient was also using other medication (dosage, frequency, manufacturer unspecified) for the seizures because the patient was still having them to this day. The patient was not recovered from this. The patient did not develop side effects until after receiving the third shot of GARDASIL. Blood work and CAT scan were performed on an unspecified date, the results were not provided. At the time of the report, the patient had not recovered. The patient sought medical attention, she saw the doctor. Upon internal review the event of seizures was considered to be medically significant. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Headache, Myalgia, Vision blurred
Clinical narrative: This spontaneous report was received from the mother of the patient, concerning her 11 year old daughter with ADHD (Attention deficit/hyperactivity disorder). The patient had allergy to LAMICTAL. It was reported that the patient was not pregnant. On 15-DEC-2010, the patient was vaccinated with the first dose of GARDASIL, (dose, route and lot number were not reported). On 26-FEB-2011, the patient received the second dose of GARDASIL (dose, route and lot number were not reported) and on 23-JUN-2011, the patient received the third dose of GARDASIL (dose, route and lot number were not reported). There were no concomitant medications. On 20-AUG-2011, after the patient received the third shot of GARDASIL, the patient experienced seizures, muscle pains, headaches and blurred vision. It was reported that the patient was also using other medication (dosage, frequency, manufacturer unspecified) for the seizures because the patient was still having them to this day. The patient was not recovered from this. The patient did not develop side effects until after receiving the third shot of GARDASIL. Blood work and CAT scan were performed on an unspecified date, the results were not provided. At the time of the report, the patient had not recovered. The patient sought medical attention, she saw the doctor. Upon internal review the event of seizures was considered to be medically significant. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Blood test, Computerised tomogram, Convulsion, Headache, Myalgia
Clinical narrative: This spontaneous report was received from the mother of the patient, concerning her 11 year old daughter with ADHD (Attention deficit/hyperactivity disorder). The patient had allergy to LAMICTAL. It was reported that the patient was not pregnant. On 15-DEC-2010, the patient was vaccinated with the first dose of GARDASIL, (dose, route and lot number were not reported). On 26-FEB-2011, the patient received the second dose of GARDASIL (dose, route and lot number were not reported) and on 23-JUN-2011, the patient received the third dose of GARDASIL (dose, route and lot number were not reported). There were no concomitant medications. On 20-AUG-2011, after the patient received the third shot of GARDASIL, the patient experienced seizures, muscle pains, headaches and blurred vision. It was reported that the patient was also using other medication (dosage, frequency, manufacturer unspecified) for the seizures because the patient was still having them to this day. The patient was not recovered from this. The patient did not develop side effects until after receiving the third shot of GARDASIL. Blood work and CAT scan were performed on an unspecified date, the results were not provided. At the time of the report, the patient had not recovered. The patient sought medical attention, she saw the doctor. Upon internal review the event of seizures was considered to be medically significant. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Vision blurred
Clinical narrative: This spontaneous report was received from the mother of the patient, concerning her 11 year old daughter with ADHD (Attention deficit/hyperactivity disorder). The patient had allergy to LAMICTAL. It was reported that the patient was not pregnant. On 15-DEC-2010, the patient was vaccinated with the first dose of GARDASIL, (dose, route and lot number were not reported). On 26-FEB-2011, the patient received the second dose of GARDASIL (dose, route and lot number were not reported) and on 23-JUN-2011, the patient received the third dose of GARDASIL (dose, route and lot number were not reported). There were no concomitant medications. On 20-AUG-2011, after the patient received the third shot of GARDASIL, the patient experienced seizures, muscle pains, headaches and blurred vision. It was reported that the patient was also using other medication (dosage, frequency, manufacturer unspecified) for the seizures because the patient was still having them to this day. The patient was not recovered from this. The patient did not develop side effects until after receiving the third shot of GARDASIL. Blood work and CAT scan were performed on an unspecified date, the results were not provided. At the time of the report, the patient had not recovered. The patient sought medical attention, she saw the doctor. Upon internal review the event of seizures was considered to be medically significant. Additional information has been requested.
Age: 31.0
Sex: U
Vaccine: VARCEL
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from other health professional via company representative refers to a 31 year old patient of unknown gender. On 28-FEB-2014 the patient was accidentally vaccinated with VARIVAX injection 0.5 milliliter (ML)/one shot with lot # 1408AA that has expired on 16-SEP-2013. No adverse experiences were reported. The outcome of administered an expired VARIVAX and no adverse experiences was unknown. No further adverse event (AE) information was reported. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Menorrhagia
Clinical narrative: This spontaneous report as received from a Medical Assistant refers to a female patient. The medical assistant reported that an unspecified patient's mother reported to her that the daughter of the mother's friend experienced heavy menstrual bleeding after receiving GARDASIL (dose, frequency and route not reported). The patient's outcome was unknown. This is one of several cases from the same source. Additional information has been requested.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Neuralgia
Clinical narrative: This spontaneous report as received from a consumer refers to herself a 74 year old female patient with allergy to "mycin" medication and unspecified antibiotics. The patient's medical history included shingles 3 times prior to having the vaccine. In 2006 the patient was vaccinated with ZOSTAVAX (dose/frequency as directed; route and lot number were not provided). Concomitant therapies included TOPAMAX. In 2014 the patient experienced shingles related neuralgia. The patient talked to her physician and the event was treated with capsaicin. The outcome of shingles related neuralgia was reported as not recovered/not resolved. The relatedness was not provided. Additional information is not expected.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: This spontaneous report as received from a registered nurse via a company representative refers to a 67 years old female patient with no medical history and drug reactions or allergies. On an unknown date in 2007 the patient was vaccinated with a dose of ZOSTAVAX (dose, frequency and lot number not reported). Concomitant therapies included AMBIEN also reported as 'AMBIAN', PROTONIX also reported as 'PROTOICS', an unspecified inhaler and unspecified creams. On 26-FEB-2014 the patient experienced rash that has been diagnosed as a mild case of shingles. The outcome of the event was reported as not recovered. The patient sought medical attention by the office visit. The relatedness between ZOSTAVAX and the event was not reported. Additional information has been requested.
Age: 1.04
Sex: M
Vaccine: MMR
Symptoms: Blood immunoglobulin G increased, Blood immunoglobulin M increased, Measles, Rash
Clinical narrative: This spontaneous report was received from a physician refers to a 12 month old male patient with routine vaccine. The patient did not have any pertinent medical history, drug allergies. The patient had fever one week prior to receiving M-M-R II. On 13-FEB-2014, the patient was vaccinated with M-M-R II, 0.5 ml, subcutaneous. On 17-FEB-2014 (reported as 4 days later), the patient had an rash which was diagnosed as measles, when physician tested IgG and IgM which were found to be positive. The patient contacted physician. No treatment was provided for the event. The outcome of measles was unknown. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4, UNK
Symptoms: Adverse event, Exposure during pregnancy, Human chorionic gonadotropin positive
Clinical narrative: Information has been received from a consumer for GARDASIL, a Pregnancy Registry product, concerning her granddaughter (who she adopted) 17 year old with no pertinent medical history and no allergies who on 31-AUG-2011 was vaccinated with the second dose of GARDASIL and was pregnant. Also, another vaccine was given on that same date, but consumer did not known which one. After the vaccine administration her granddaughter had exam (results not provided) and urine test which confirmed she was pregnant. Consumer stated her granddaughter was not experiencing any problems, was healthy. The patient sought unspecified medical attention (she was in the office). No treatment was given for the treatment of the adverse event. It was reported that the date of LMP was on 10-JUN-2011. EDD was on 16-MAR-2012. Follow up information has been received. There has been no response to any attempts for outcome. The case is lost to follow up. Pregnancy outcome was reported as lost to follow up. No further information is available.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Bursitis, Connective tissue disorder, Iliotibial band syndrome, Musculoskeletal discomfort, X-ray
Clinical narrative: This spontaneous report was received from a consumer refers to herself as a 67 year old female patient of unknown age. The patient pertinent medical history included arthritis. On an unknown date in October 2013, the patient was vaccinated with ZOSTAVAX one single injection. Concomitant medications included AFLURIA and unspecified blood pressure drugs. On an unknown date in early November 2013, the patient experienced discomfort in her hips and was diagnosed with bursitis. On an unknown date in November 2013, the patient experienced problem with connective tissue. She also reported that her bones are fine. On an unknown date in November 2013, the patient experienced IT bands are knotted. The patient sought medical attention. The patient was treated with physical therapy and unspecified cortisone injection, which she says have not helped. On an unknown date, the patient had an X-ray. The outcome of the events was reported as not recovered. The reporter did not provide the causality between the event and the suspect drug. Additional information is not expected.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Exposure during pregnancy, Pregnancy test urine positive
Clinical narrative: Information has been received from a consumer, for GARDASIL, a Pregnancy Registry product, concerning her 16 year old granddaughter with a history of attention deficit/hyperactivity disorder (ADHD) and no drug reactions or allergies who was vaccinated with the first and second dose of GARDASIL (Lot# not reported) in approximately 2010 (reported as "about a year ago") and on 20-OCT-2011 (reported as "2 weeks ago"), respectively (lot# and route not reported). Concomitant therapy included medroxyprogesterone acetate. After the patient received her second shot of GARDASIL and had just found out that she was pregnant. On an unspecified day she had 3 urine tests performed and only one of them came back positive for pregnancy. The patient also had ultrasound performed (result not reported). Therapy with GARDASIL had been discontinued by the given physician. On 04-NOV-2011 the patient would go to the OB/GYN office to seek medical attention. The patient's last menstrual period (LMP) was on 22-JUN-2011 and her estimate delivery date (EDD) was on 08-MAR-2012. Follow up information has been received from a physician concerning the patient who was seen for an initial obstetric visit at her organization on 01-NOV-2011. The physician had reviewed the patient's medical chart. Prior to 01-NOV-2011, the patient had never been seen here. The physician's office had not administered any vaccines for this patient as of 01-NOV-2011. Additional information has been requested.
Age: 82.0
Sex: F
Vaccine: FLUX
Symptoms: Abasia, Adverse drug reaction, Asthenia, Blood electrolytes decreased, Blood potassium decreased
Clinical narrative: This consumer report (initial receipt 24-Feb-2014) concerns an 82 year old female patient who had a medical history of COPD (chronic obstructive pulmonary disease) and emphysema for the past 17 years and allergies to clindamycin, sulfa drugs and pethidine. Concomitant medications included fluticasone/salmeterol, an unspecified nebuliser, oxygen and albuterol/ipratropium. On an unspecified date around the second week of Dec-2013, the patient received an unspecified flu shot (manufacturer and batch number not specified) one shot via injection. The vaccination was a booster flu shot for patients over 65. About one week and a half later, the patient became sick with an unspecified infection which was some kind of bug that felt similar to the flu. The infection made her so weak that she was unable to walk. It was never determined whether the infection was viral or bacterial but when the patient was admitted to hospital on the 27-Dec-2013, a hospital X-ray found that the illness was not pneumonia. While she was hospitalised, she was administered an unspecified dosage and frequency of moxifloxacin via IV (intravenous) which made her so sick she thought she would die. The moxifloxacin caused severe burning in her veins which she reported to a nurse but was told nothing could be done about it. The patient vomited every day whilst receiving the moxifloxacin and was still vomiting on the 30-Dec-2013 when the moxifloxacin IV was stopped and she was discharged. She commenced moxifloxacin 400mg orally daily on discharge but only took one of the three tablets that she was prescribed due to worsening side effects. Around the 07-Jan-2014, the patient was hospitalised for a day and a half and received unspecified treatment. Whilst in hospital, it was found that her electrolytes were completely depleted and she had no potassium or sodium. She had experienced many ongoing and worsening side effects. She had experienced severe dizziness such that she had to be helped to use the bathroom because she was too dizzy to stand. She also developed worsening astronomical pains in her arms and shoulders as well as burning and muscle weakness in her arms and shoulders which has begun spreading into her legs. Her arms were so weak that she could not use them and could not even lift a gallon of milk. Her pulse was generally staying over 120 and sometimes was lower but not lower than 110. She also experienced bruising and severe shortness of breath. She never had the degree of shortness of breath that she had been experiencing since Dec-2013 around the time that she became ill and was given moxifloxacin. She spoke with medical professionals whilst hospitalised and pharmacists. Outcome was not reported.
Age: 82.0
Sex: F
Vaccine: FLUX
Symptoms: Blood sodium decreased, Burning sensation, Chest X-ray normal, Contusion, Dizziness
Clinical narrative: This consumer report (initial receipt 24-Feb-2014) concerns an 82 year old female patient who had a medical history of COPD (chronic obstructive pulmonary disease) and emphysema for the past 17 years and allergies to clindamycin, sulfa drugs and pethidine. Concomitant medications included fluticasone/salmeterol, an unspecified nebuliser, oxygen and albuterol/ipratropium. On an unspecified date around the second week of Dec-2013, the patient received an unspecified flu shot (manufacturer and batch number not specified) one shot via injection. The vaccination was a booster flu shot for patients over 65. About one week and a half later, the patient became sick with an unspecified infection which was some kind of bug that felt similar to the flu. The infection made her so weak that she was unable to walk. It was never determined whether the infection was viral or bacterial but when the patient was admitted to hospital on the 27-Dec-2013, a hospital X-ray found that the illness was not pneumonia. While she was hospitalised, she was administered an unspecified dosage and frequency of moxifloxacin via IV (intravenous) which made her so sick she thought she would die. The moxifloxacin caused severe burning in her veins which she reported to a nurse but was told nothing could be done about it. The patient vomited every day whilst receiving the moxifloxacin and was still vomiting on the 30-Dec-2013 when the moxifloxacin IV was stopped and she was discharged. She commenced moxifloxacin 400mg orally daily on discharge but only took one of the three tablets that she was prescribed due to worsening side effects. Around the 07-Jan-2014, the patient was hospitalised for a day and a half and received unspecified treatment. Whilst in hospital, it was found that her electrolytes were completely depleted and she had no potassium or sodium. She had experienced many ongoing and worsening side effects. She had experienced severe dizziness such that she had to be helped to use the bathroom because she was too dizzy to stand. She also developed worsening astronomical pains in her arms and shoulders as well as burning and muscle weakness in her arms and shoulders which has begun spreading into her legs. Her arms were so weak that she could not use them and could not even lift a gallon of milk. Her pulse was generally staying over 120 and sometimes was lower but not lower than 110. She also experienced bruising and severe shortness of breath. She never had the degree of shortness of breath that she had been experiencing since Dec-2013 around the time that she became ill and was given moxifloxacin. She spoke with medical professionals whilst hospitalised and pharmacists. Outcome was not reported.