chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 17 years old female patient. On 11-APR-2013 the patient was vaccinated with GARDASIL (dose, route, indication and lot number were not provided) first dose. No other concomitant medications were reported. The medical assistant noted that the patient was administered with the first and second doses of GARDASIL (dose, route, indication and lot number not provided) on 11-APR-2013 and 10-MAY-2013, respectively. No adverse effect reported. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Facial pain, Infection, Oral herpes, Pain
Clinical narrative: This spontaneous report was received from a 60 year old female patient who is also a pharmacist via a company representative regarding herself. No medical history was reported. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (lot#, expiry not reported), subcutaneously. No concomitant medications were reported. On an unknown date, the patient experienced a reaction on her lips similar to cold sores, lingering spots above the top lip and shooting pain up the side of the face. One of the reactions became infected with pus and came to a head. The Pharmacist reported that she started the use of ABREVA and stated this did not work well for her. The Pharmacist stated that, after ABREVA (unspecified dose, frequency and manufacturer) failed to work for her, she began therapy with doxycycline (unspecified dose, frequenct and manufacturer) and LYRICA (unspecified dose, frequenct and manufacturer) and both medications worked well. Patient sought medical attention (office visit on an unspecified date). The patient was recovering from the events. Additional information has been requested.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: Patient states arm hurt next day. Also that her elbow still persists to hurt to this day 5/24/13. Patient would like a follow up call.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Cellulitis, Erythema, Infection, Pyrexia
Clinical narrative: Pt called said was running fever and redness was spreading told pt to get to dr tonight. Diagnosed with cellulitis infection. Dr put on KEFLEX and BACTRIM for infection.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Blister, Injection site erythema, Injection site swelling, Injection site vesicles
Clinical narrative: Swelling with yellowish blisters in (R) thigh - raised large erythematous patch - in thigh.
Age: 1.07
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Rash papular, Scab, Secretion discharge, Skin lesion
Clinical narrative: 15 lesions over neck, face, right ear and left distal forearm. Scabbed, healing, papular lesions some w/ yellow, crusted discharge.
Age: 16.0
Sex: F
Vaccine: HEPA, TDAP, YF
Symptoms: Acupuncture, Asthenia, Blood test, Dizziness, Fatigue
Clinical narrative: Pt had acupuncture after immunization. Patient developed dizziness, nausea, fatigue, weakness that was prolonged over 4 hrs - enough for patient to go to ER. At ER blood drawn patient fainted. Got IV fluids and ZOFRAN. Dxed by ER at "vaccine reaction".
Age: 16.0
Sex: F
Vaccine: HEPA, TDAP, YF
Symptoms: Nausea, Syncope, Vaccination complication
Clinical narrative: Pt had acupuncture after immunization. Patient developed dizziness, nausea, fatigue, weakness that was prolonged over 4 hrs - enough for patient to go to ER. At ER blood drawn patient fainted. Got IV fluids and ZOFRAN. Dxed by ER at "vaccine reaction".
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site mass
Clinical narrative: Patient received ZOSTAVAX on 5/13/13. Patient presented to pharmacy on 5/19/13 complaining of a 2" long erythematic line at the site of injection. Area feels lumpy to patient. No itching, no fever, area not warm to touch, not painful.
Age: 3.0
Sex: M
Vaccine: DTAP
Symptoms: Gait disturbance, Injection site erythema, Injection site swelling, Injection site warmth, Irritability
Clinical narrative: Woke up with entire left thigh (where vaccine was injected) completely swollen, red, and hot to the touch. Patient was limping when walking. He was very lethargic all day as well as overly fussy. Two days later, he is still having the same symptoms.
Age: 3.0
Sex: M
Vaccine: DTAP
Symptoms: Lethargy
Clinical narrative: Woke up with entire left thigh (where vaccine was injected) completely swollen, red, and hot to the touch. Patient was limping when walking. He was very lethargic all day as well as overly fussy. Two days later, he is still having the same symptoms.
Age: 20.0
Sex: M
Vaccine: HEP
Symptoms: Pruritus, Swelling face, Urticaria
Clinical narrative: HIVES, ITCHING, FACIAL SWELLING.
Age: 22.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Vaccination site pain, Vaccination site swelling
Clinical narrative: Extreme swelling and redness at site of vaccine along with soreness and itching and burning. Took ibuprofen on 5/24/2013 for soreness.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Gait disturbance, Injection site pain, Injection site swelling
Clinical narrative: Pt started complaining of right thigh pain, mother noticed some limping, and swelling. Mother applied ice to effected area, pt slept. Did not have any issues over night, this morning patient continued to limp, and thigh got more swollen extending towards knee.
Age: 0.33
Sex: F
Vaccine: DTAPIPV, HIBV, PNC13, RV5
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Given vaccine outside manufacturer licensing age.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Abasia, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Swelling on right thigh, felt warm to touch, pt not walking, complaining of pain. At 6:00 pm swelling got worse extending to knee. Pt slept overnight with no issues, on 05/23/2013 pt did not walk at all and complained of pain. On 05/22/2013 mother brought pt to see provider Benadryl recommended.
Age: 0.51
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Abnormal faeces, Crying, Faeces hard, Irritability, Vomiting projectile
Clinical narrative: Fussy later in afternoon day of visit. Given Tylenol. Next day not quite herself. Forceful vomiting 30hrs after shots after eating. 6-10x. Whimpering. ? Lethargic. Taken to ER. Tolerated Pedialyte there and d/c to home. One BM since shots hard and sticky.
Age: 11.0
Sex: F
Vaccine: TD
Symptoms: Loss of consciousness
Clinical narrative: Patient passed out - patient laid on floor by nurses, legs put up, cold towel to head, pulse 80, BP 100/80.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Breath holding, Hypotonia, Moaning, Pain, Pallor
Clinical narrative: Breath holding episode, pt became pale and limp. 5 min post episode still pale and moaning in pain referred directly to ER.
Sex: F
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers a patient of unknown demographics. On an unknown date in August 2012, the patient was vaccinated with a dose of improperly stored GARDASIL (Lot number, expiry date, route and dose were not reported). The medical assistant reported that the vaccine was exposed to temperature of 26 F(Fahrenheit) for a total of 135 hours. No adverse effects reported. Follow-up received. Medical assistant stated that other 104 children received GARDASIL. Follow up information has been received from the medical assistant regarding an unknown age, female patient with no pertinent medical history reported. On 21-AUG-2012 the patient was vaccinated with a dose of GARDASIL (lot number and expiration date not reported) (intramuscular on the left arm dose not reported). On 18-MAR-2013 the patient received another dose of GARDASIL (lot number and expiration date not reported) (intramuscular on the right arm, dose not reported). It was reported that the patient did not seek medical attention. This is one of the several reports from the same source. Additional information is not expected.
Age: 0.51
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Injection site pain, Pyrexia, X-ray limb
Clinical narrative: (R) leg pain at site of injection. Fever 101.3 rectal.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Pain in extremity, Pruritus, Skin warm
Clinical narrative: Approx. 1 wk after immunization back of arm (L) sore, hot to touch, slightly itchy. Symptoms progressed to front of arm with 4 blisters. Areas hot and painful. Reaction occurred when pt out of state on vacation. Pt seen today by Dr. Better now per pt. ZPAK ordered by Dr.
Age: 13.0
Sex: M
Vaccine: HEPA, HIBV, HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown demographics. On an unknown date, the patient was vaccinated with a dose of improperly stored GARDASIL (Lot number, expiry date, route and dose were not reported) and Liquid PEDVAXHIB (Lot number, expiry date, route and dose were not reported). Medical assistant reported that both vaccines were exposed to temperature of 26 F (Fahrenheit) for a total of 135 hours. No adverse effects reported. Follow-up received. Medical assistant stated other 104 children received GARDASIL and other 18 children received Liquid PEDVAXHIB vaccine. Follow up information has been received from the medical assistant regarding a 13 years old, male patient with no pertinent medical history reported. On 17-OCT-2012 the patient was vaccinated with GARDASIL (lot number and expiration date not reported) (intramuscular on the right arm, dose not reported). Other suspect therapies included Liquid PEDVAXHIB (lot number and expiration date not reported) (intramuscular on the left arm, dose not reported). Concomitant medications included Hepatitis A vaccine (manufacturer unknown) (lot number and expiration date not reported) (intramuscular on the right arm, dose not reported). It was reported that the patient did not seek medical attention. This is one of the several reports from the same source. Additional information is not expected.
Age: 13.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers a patient of unknown demographics. On an unknown date, the patient was vaccinated with a dose of improperly stored GARDASIL (Lot number, expiry date, route and dose were not reported). The medical assistant reported that the vaccine was exposed to temperature of 26 F for a total of 135 hours. No adverse effects reported. Follow-up received. Medical assistant stated that other 104 children received GARDASIL. Follow up information has been received from the medical assistant regarding a 13 years old, female patient with no pertinent medical history reported. On 15-NOV-2012 the patient was vaccinated with GARDASIL (lot number and expiration date not reported) (intramuscular on the right arm, dose not reported). Concomitant medications included Hepatitis A vaccine (manufacturer unknown) (lot number and expiration date not reported) (intramuscular on the left arm, dose not reported). It was reported that the patient did not seek medical attention. This is one of the several reports from the same source. Additional information is not expected.
Age: 37.0
Sex: F
Vaccine: HPV4
Symptoms: Alopecia, Alopecia areata
Clinical narrative: Hair loss - likely alopecia areata.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: Patient calls pharmacy & states she has a rash visible at site of vaccine injection (over triceps muscle of left arm). Pt advised to contact Primary Care Provider. As per vaccine administrator's follow-up with MD on 5/24/13, pt never contacted office; office to follow-up with pt.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Chest discomfort, Dyspnoea, Injection site rash, Rash generalised
Clinical narrative: Rash on arms, chest neck and face. Raised bumps around injection site and difficulty breathing tightness in chest.
Age: 0.87
Sex: F
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: High fever (over 103).
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site cellulitis
Clinical narrative: 5/24/13 Cellulitis - Lt upper arm, Afebrile Rx given - KEFLEX 500 BID 10 days started today.
Age: 14.0
Sex: M
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown demographics. On an unknown date, the patient was vaccinated with a dose of improperly stored GARDASIL (Lot number, expiry date, route and dose were not reported). The medical assistant reported that the vaccine was exposed to temperature of 26F (Fahrenheit) for a total of 135 hours. No adverse effects reported. Follow-up received. Medical assistant stated that other 104 children received GARDASIL. Follow up information has been received from the medical assistant regarding a 14 years old, male patient with no pertinent medical history reported. On 16-OCT-2012 the patient was vaccinated with GARDASIL (lot number and expiration date not reported) (intramuscular on the right arm, dose not reported). On 18-FEB-2013 the patient received another dose of GARDASIL (lot number and expiration date not reported) (intramuscular on the left arm, dose not reported). It was reported that the patient did not seek medical attention. This is one of the several reports from the same source. Additional information is not expected.
Age: 16.0
Sex: M
Vaccine: HEPA, HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers a patient of unknown demographics. On an unknown date, the patient was vaccinated with a dose of improperly stored GARDASIL (Lot number, expiry date, route and dose were not reported). The medical assistant reported that the vaccine was exposed to temperature of 26 F (Fahrenheit) for a total of 135 hours. No adverse effects reported. Follow-up received. Medical assistant stated that other 104 children received GARDASIL. Follow up information has been received from the medical assistant regarding a 16 years old, male patient with no pertinent medical history reported. On 15-NOV-2012 the patient was vaccinated with GARDASIL (lot number and expiration date not reported) (intramuscular on the left arm, dose not reported). Concomitant medications included Hepatitis A Vaccine (manufacturer unknown) (intramuscular in the right arm, dose not reported). It was reported that the patient did not seek medical attention. This is one of the several reports from the same source. This is an amended report the adverse event codification was updated. Additional information is not expected.
Age: 1.14
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Irritability, Pyrexia, Rash pustular
Clinical narrative: Irritability, low grade fevers and 6 pustules appeared on 5/19/13.
Age: 12.0
Sex: M
Vaccine: HPV4
Symptoms: Rash maculo-papular, Rash pruritic
Clinical narrative: The day after getting the HPV vaccine (5/20/13) patient developed a maculopapular rash on sun exposed areas of skin on arms and legs. The rash was mildly itchy.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Feeling hot, Inflammation
Clinical narrative: Inflammation, warmth and redness persisting still 4 days post vaccination.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Dyspnoea, Heart rate increased, Hypertension, Local swelling, Pyrexia
Clinical narrative: Large 8 in wide swollen blotch. Rapid pulse - 130 BPM. Short of breath. High fever -103. BP 175/135 within 6 hrs.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Rash macular
Clinical narrative: Large 8 in wide swollen blotch. Rapid pulse - 130 BPM. Short of breath. High fever -103. BP 175/135 within 6 hrs.
Age: 43.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Pt was admin TD 1/10 of the dose a SQ to see if she is allergic to it as it was admin she started complaining of burning redness, swelling at the site. Dr wanted a ice pack on the site which helped and pt left at stable condition. She was given 1/10 dose of Td reported a reaction to previous Tdap on 10/10/08.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site oedema, Injection site pain
Clinical narrative: 5-23-13 injection site redness, edema, tenderness measuring 2.5 x 1 inches. Given 1 tsp BENADRYL and Amoxicillin called to pharmacy. Mother instructed to give BENADRYL, TYLENOL, antibiotic and apply ice to area.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site erythema, Pruritus, Urticaria
Clinical narrative: 5-23-13 Patient has red, itchy, welt size of 50 cents piece told to do BENADRYL, TYLENOL and ice to area. 5-24-13 Patient came into clinic 4.5 x 4 inch red area surrounding inj site c/o itching. Doxy called to pharmacy.
Age: 0.34
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC13, RV1
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: None stated.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site cellulitis
Clinical narrative: Patient developed cellulitis at injection site next day following injection. Patient started on course of antibiotics 2 days after injection. Patient showed great improvement after 1 1/2 days of antibiotic course.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood test, Computerised tomogram, Muscle strain, Nerve injury, Skin burning sensation
Clinical narrative: This spontaneous report was received from a 76 year old female consumer (reporting on herself) with no pertinent medical history. In July 2011 the patient was vaccinated with a dose of ZOSTAVAX (lot # not reported) (dose and route not reported). Concomitant therapies included Hydrocodin and gabapentin. In January 2013 the patient experienced a sensation going along her breast to her back, she thought it was a pulled muscle. However a few days later she started to feel a burning sensation on her skin. She felt nerve damage under her right breast traveling to her lower back (a piercing sensation). No blisters or itching on her skin just the "burning" patient did not sought medical attention and an unspecified treatment was given. Laboratory diagnostic studies included CT scan, X-ray and blood work (results not reported). At the time of the report the patient's outcome was unknown. Additional information has been requested.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: X-ray
Clinical narrative: This spontaneous report was received from a 76 year old female consumer (reporting on herself) with no pertinent medical history. In July 2011 the patient was vaccinated with a dose of ZOSTAVAX (lot # not reported) (dose and route not reported). Concomitant therapies included Hydrocodin and gabapentin. In January 2013 the patient experienced a sensation going along her breast to her back, she thought it was a pulled muscle. However a few days later she started to feel a burning sensation on her skin. She felt nerve damage under her right breast traveling to her lower back (a piercing sensation). No blisters or itching on her skin just the "burning" patient did not sought medical attention and an unspecified treatment was given. Laboratory diagnostic studies included CT scan, X-ray and blood work (results not reported). At the time of the report the patient's outcome was unknown. Additional information has been requested.
Age: 16.0
Sex: M
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a patient of unknown demographics. On an unknown date, the patient was vaccinated with a dose of improperly stored GARDASIL (Lot number, expiry date, route and dose were not reported) and LIQUID PEDVAXHIB (Lot number, expiry date, route and dose were not reported). Medical assistant reported that both vaccines were exposed to temperature of 26 F (Fahrenheit) for a total of 135 hours. No adverse effects reported. Follow-up received. Certified Medical assistant stated other 104 children received GARDASIL and other 18 children received LIQUID PEDVAXHIB. Follow up information has been received from the certified medical assistant regarding a 15 years old, male patient with no pertinent medical history reported. On 27-AUG-2012 the patient was vaccinated with a dose of GARDASIL (lot number and expiration date not reported) (intramuscular on the right arm, dose not reported). Other suspect therapies included LIQUID PEDVAXHIB (lot number and expiration date not reported) (intramuscular on the left arm, dose not reported). On 18-MAR-2013 the patient received another dose of GARDASIL (lot number and expiration date not reported) (intramuscular on the left arm, dose not reported). It was reported that the patient did not seek medical attention. This is one of the several reports from the same source. Additional information is not expected.
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse and Office Manager refers to a female patient of unknown age. Medical history and concomitant medications were not reported. On 08-APR-2013 the patient was vaccinated with ZOSTAVAX lot # J000433, expiration date 11-APR-2014 (dose, and route were not reported). On an unknown date in 2013, after vaccination, the patient experienced reaction on the injection site (deltoid area), which was red, with swelling and heat. The patient was diagnosed with cellulitis and was treated with KEFLEX. The outcome of events was reported as recovered/resolved. The relatedness between events and ZOSTAVAX was not reported. The Licensed Practical Nurse stated that pharmacy had ZOSTAVAX vaccine with the Lot number J000444. This is one of several reports from the same source. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown demographics. On an unknown date, the patient was vaccinated with a dose of improperly stored GARDASIL (Lot number, expiry date, route and dose were not reported). The medical assistant reported that the vaccine was exposed to temperature of 26 F(Fahrenheit)for a total of 135 hours. No adverse effects reported. Follow-up received. Medical assistant stated that other 104 children received GARDASIL. Follow up information has been received from the medical assistant regarding an 11 years old, female patient with no pertinent medical history reported. On 16-NOV-2012 the patient was vaccinated with a dose of GARDASIL (lot number and expiration date not reported) (intramuscular on the right arm, dose not reported). On 15-APR-2013 the patient received another dose of GARDASIL (lot number and expiration date not reported) (intramuscular on the left arm, dose not reported). It was reported that the patient did not seek medical attention. This is one of the several reports from the same source.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age and gender. On 30-JUN-2008 the patient was vaccinated with the first dose of GARDASIL (Lot # not reported) (dose, route not reported), on 04-JAN-2012 the patient was vaccinated with the second dose of GARDASIL (Lot # not reported) (dose, route not reported) and on 20-May-2013 the patient was vaccinated with the third dose of GARDASIL (Lot # not reported) (dose, route not reported). No adverse effect reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Viral titre decreased
Clinical narrative: This spontaneous report was received from a pharmacist concerning to unspecified patients at their facility, that then and in the past may had received a dose of M-M-R II (lot number not reported) (dose and route not reported), and had low rubella titers. Those patients were immunized with M-M-R II prior to being discharged from the hospital on an unspecified date. Concomitant therapy was not reported. The outcome of low rubella titers was unknown. Additional information has been unspecified.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Paraesthesia
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 74 year old female patient with hypertension. Drug reactions/allergies were not reported. On approximately May 2011, (two years ago), the patient was vaccinated with ZOSTAVAX (lot number, dose, route and expiration date were not reported) at unspecified clinic. Concomitant therapies included NEXIUM and unspecified medication for hypertension. In April 2013, (about one month), the patient was diagnosed with shingles. The patient had "tingles" in her fingers. The patient was treated with acyclovir. The patient sought medical attention, by an office visit to unspecified physician. The outcome of shingles and "tingles" in her fingers was reported as recovering. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a patient of unknown demographics. On an unknown date, the patient was vaccinated with a dose of improperly stored GARDASIL (Lot number, expiry date, route and dose were not reported). The medical assistant reported that the vaccine was exposed to temperature of 26 F (Fahrenheit) for a total of 135 hours. No adverse effects reported. Follow-up received. Certified Medical assistant stated that other 104 children received GARDASIL. Follow up information has been received from the certified medical assistant regarding an unknown age (previously reported as child), female patient with no pertinent medical history reported. On 18-MAR-2013 the patient was vaccinated with GARDASIL (lot number and expiration date not reported) (intramuscular on the right arm, dose not reported). It was reported that the patient did not seek medical attention. This is one of the several reports from the same source. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a female patient of unknown age. On 02-OCT-2009, the patient was vaccinated with the first 0.5 ml dose of GARDASIL (Lot # not reported) IM and on 22-MAY-2013, the patient received the second 0.5 ml dose of GARDASIL (Lot # not reported) IM. No adverse effect was reported. Additional information has been requested.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: Patient developed red around the injection site. She was offered Benadryl, which she refused. Then, she was offered Zyrtec, which she took in front of the pharmacist.
Age: 75.0
Sex: M
Vaccine: PPV
Symptoms: Blood test, Bronchitis, Diarrhoea, Injection site swelling
Clinical narrative: Severe diarrhea for 20 hrs. Swelling at site of injection / severe reaction. Acute bronchitis.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Injection site rash, Pain in extremity, Pruritus
Clinical narrative: Pt broke out in rash at injection site, right ankle and left leg itchy and a little painful. Did not go to dr. Occurred day after injection. Talked with pt on 5-25-13. Still itchy.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain, Pruritus, Swelling
Clinical narrative: Swollen, sore, itchy red patch approx 2"x3" in size. Swelling & itching subsided about 05/25/13. Currently still pinkish.
Age: 36.0
Sex: M
Vaccine: HEP
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a physician and an office manager at the physician's office via a company representative refers to a 36 year old male patient. "Around 3 days ago", on approximately 13-MAY-2013 the patient was vaccinated with hepatitis b vaccine (manufacturer unknown) (lot # reported as 9722404, expiry date 16-JUN-2012) (strength and total daily dose not reported). It was reported that the adult dose of hepatitis b vaccine (manufacturer unknown) the patient received was expired. The physician was unsure of the brand name and manufacturer of the hepatitis B vaccine. The patient was not experiencing any known symptoms. No adverse effect was reported. It was unspecified whether the patient sought for medical attention. The outcome was unknown. It was also reported that the patient received a dose of VAQTA instead of a dose of adult VAQTA on 13-MAY-2013 (Related ID: 1305USA012913).
Age: 73.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Body temperature increased, Chills, Injection site erythema, Oedema peripheral, Skin warm
Clinical narrative: This spontaneous report was received from a registered nurse concerning an approximately 73 year old female patient with no drug reactions or allergies. The medical history of the patient included adhesive capsulitis of the right shoulder, cholecystectomy and rotator cuff tear (everything resolved on an unknown date). On 17-MAY-2013, the patient was vaccinated with 0.5 milliliter (ml) of PNEUMOVAX23 (lot number and expiry date reported as J001180 and 18-AUG-2014 respectively), intramuscularly. The patient received ZOSTAVAX (lot number, expiry date, dose and route unspecified) as well on the same day as the PNEUMOVAX23 (on 17-MAY-2013). Concomitant therapies included vitamins (unspecified) (reported as multivitamins). On 17-MAY-2013, the patient experienced swelling of the arm, arm was warm to touch, large reddened area at injection site about 10 centimeters (cm), chills and a temperature of 102 or 103 (units unspecified) after receiving PNEUMOVAX23. The patient sought medical attention (called to doctor office on 20-MAY-2013). Patient was told by the physician to take some ibuprofen and to put ice on the area. No lab tests were performed. The patient was recovering from all the events. The relatedness for all the events was unknown for PNEUMOVAX23 and ZOSTAVAX. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Smear cervix abnormal
Clinical narrative: This spontaneous report as received from a registered nurse via a company representative refers to 3 patients of unknown age. On an unknown date the patients were vaccinated with GARDASIL (lot number, expiry date, route, site unspecified). On an unknown date "within the last month" approximately in April 2013, the patients presented with abnormal Pap smear test after finishing the GARDASIL series. The patients had not sought medical attention. No treatment was given. No laboratory diagnostics studies were performed. The outcome of the event was unknown. This is one of several patients from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: This spontaneous report as received from a registered nurse via a company representative refers to a patient of unknown age. On an unknown date the patient was vaccinated with GARDASIL (lot number, expiry date, route, site unspecified). On an unknown date 'within the last month" approximately in April 2013, the patient experienced had syncope on both first and second dose of GARDASIL vaccination. The outcome of syncope was unknown. This is one of several patients from the same source. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Clostridium difficile infection, Confusional state, Erythema, Gastrointestinal disorder, Injection site erythema
Clinical narrative: This spontaneous report as received from a consumer referring to herself, a female patient of unknown age. On 01-JUN-2012 the patient was vaccinated with PNEUMOVAX23 (injection, route, dose and lot number unknown). Then within 15 minutes her arm began to hurt and was "killing her", within 1-2 hours of receiving the vaccine her arm swelled, and turned red and hot "all the way to her hand" from the injection site. On 02-JUN-2012 (reported as the next day) she was hospitalized for an unspecified length of time. She was confused, and treated with various steroids and antibiotics. During hospitalization patient then developed a condition where the lining of her intestines began shedding, the condition was abbreviated with "DIFF", and may have been caused by her use of unspecified antibiotics during her hospital stay (approximately on 02-JUN-2012). The patient explained that she has been in and out of hospital care since receiving the vaccine with various related issues. The patient's most recent hospital visit occurred the day before yesterday. The patient still had a scab on her arm from the vaccination with PNEUMOVAX23 that still becomes painful on a sporadic basis (approximately on 01-JUN-2012). Unspecified tests were performed. The outcome of the adverse events were not reported. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling, Injection site warmth, Laboratory test, Oedema peripheral, Pain in extremity
Clinical narrative: This spontaneous report as received from a consumer referring to herself, a female patient of unknown age. On 01-JUN-2012 the patient was vaccinated with PNEUMOVAX23 (injection, route, dose and lot number unknown). Then within 15 minutes her arm began to hurt and was "killing her", within 1-2 hours of receiving the vaccine her arm swelled, and turned red and hot "all the way to her hand" from the injection site. On 02-JUN-2012 (reported as the next day) she was hospitalized for an unspecified length of time. She was confused, and treated with various steroids and antibiotics. During hospitalization patient then developed a condition where the lining of her intestines began shedding, the condition was abbreviated with "DIFF", and may have been caused by her use of unspecified antibiotics during her hospital stay (approximately on 02-JUN-2012). The patient explained that she has been in and out of hospital care since receiving the vaccine with various related issues. The patient's most recent hospital visit occurred the day before yesterday. The patient still had a scab on her arm from the vaccination with PNEUMOVAX23 that still becomes painful on a sporadic basis (approximately on 01-JUN-2012). Unspecified tests were performed. The outcome of the adverse events were not reported. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Skin warm
Clinical narrative: This spontaneous report as received from a consumer referring to herself, a female patient of unknown age. On 01-JUN-2012 the patient was vaccinated with PNEUMOVAX23 (injection, route, dose and lot number unknown). Then within 15 minutes her arm began to hurt and was "killing her", within 1-2 hours of receiving the vaccine her arm swelled, and turned red and hot "all the way to her hand" from the injection site. On 02-JUN-2012 (reported as the next day) she was hospitalized for an unspecified length of time. She was confused, and treated with various steroids and antibiotics. During hospitalization patient then developed a condition where the lining of her intestines began shedding, the condition was abbreviated with "DIFF", and may have been caused by her use of unspecified antibiotics during her hospital stay (approximately on 02-JUN-2012). The patient explained that she has been in and out of hospital care since receiving the vaccine with various related issues. The patient's most recent hospital visit occurred the day before yesterday. The patient still had a scab on her arm from the vaccination with PNEUMOVAX23 that still becomes painful on a sporadic basis (approximately on 01-JUN-2012). Unspecified tests were performed. The outcome of the adverse events were not reported. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: MNQ, TDAP, VARCEL, MNQ, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report as received from a Medical Assistant refers to a 19 year old female patient with no pertinent medical history and no drug reactions or allergies. On 07-MAY-2013 the patient was vaccinated with the second dose of VARIVAX (merck) (lot # H018791, expiration date 15-OCT-2014) 0.5 ml, subcutaneous in the right arm for going to college. Other suspect therapies included MENACTRA in the right arm and tetanus toxoid (manufacturer unknown) (lot # and exp date unspecified) in the left arm administered on the same date (dose and therapy route unspecified for both). Concomitant medication included unspecified thyroid medication 50 mcg once a day. On 08-MAY-2013, the patient experienced at the site of injection redness, itchy, swelling the size of a 50 cent piece and there were areas that looked like it was developing pustules around the injection site. The patient also had on 07-MAY-2013 a Tuberculosis (TB) test done in the left forearm. Patient sought medical attention by visiting the office, she received treatment with oral BENADRYL. Laboratory tests were not performed. At the time of the report the outcome of pustules around the injection site, injection site redness, itchy, and swelling was reported as recovered. Medical assistant requested a lot check. This is one of several reports from the same source. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: MNQ, TDAP, VARCEL, MNQ, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site pustule, Injection site swelling, Mycobacterium tuberculosis complex test
Clinical narrative: This spontaneous report as received from a Medical Assistant refers to a 19 year old female patient with no pertinent medical history and no drug reactions or allergies. On 07-MAY-2013 the patient was vaccinated with the second dose of VARIVAX (merck) (lot # H018791, expiration date 15-OCT-2014) 0.5 ml, subcutaneous in the right arm for going to college. Other suspect therapies included MENACTRA in the right arm and tetanus toxoid (manufacturer unknown) (lot # and exp date unspecified) in the left arm administered on the same date (dose and therapy route unspecified for both). Concomitant medication included unspecified thyroid medication 50 mcg once a day. On 08-MAY-2013, the patient experienced at the site of injection redness, itchy, swelling the size of a 50 cent piece and there were areas that looked like it was developing pustules around the injection site. The patient also had on 07-MAY-2013 a Tuberculosis (TB) test done in the left forearm. Patient sought medical attention by visiting the office, she received treatment with oral BENADRYL. Laboratory tests were not performed. At the time of the report the outcome of pustules around the injection site, injection site redness, itchy, and swelling was reported as recovered. Medical assistant requested a lot check. This is one of several reports from the same source. Additional information has been requested.
Age: 68.0
Sex: M
Vaccine: PPV
Symptoms: Chills, Hot flush, Pain, Pyrexia
Clinical narrative: Body aches, chills, hot flash & fever. Lasted about 4 hours. No treatment, I just let it run it's course.
Age: 21.0
Sex: F
Vaccine: HEP
Symptoms: Headache, Injection site pain
Clinical narrative: DONOR HAD PAIN AT SITE AND HEADACHE 5/10 PAIN FOR TWO DAYS AFTER. HEADACHE RESOLVED WTIH NO TREATMENT.
Age: 13.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Convulsion, Dyskinesia
Clinical narrative: This spontaneous report as received, via field employee, from a physician refers to a 13 year old female patient. In approximately May 2012, reported as one year ago, the patient was vaccinated with GARDASIL (dose, lot number and expiration date were not reported) dose 1, intramuscular. In approximately May 2012, reported as one year ago, after receiving the first dose of GARDASIL, the patient experienced involuntary hand movements once a day, for an unspecified period of time. On an unspecified date, in approximately 2013, reported as recently at an unspecified timeframe, the patient received a second dose of GARDASIL, (dose, lot number and expiration date were not reported). On an unknown date, in approximately 2013, (72 hours after vaccination with second dose of GARDASIL) the patient experienced seizure. The patient sought medical attention with a neurologist visit (unspecified Health Care Professional (HCP)) and received unspecified treatment. The outcome of involuntary hand movements once a day and seizure was reported as recovering/resolving. Upon internal review the event seizure was considered as medically significant. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Feeling cold, Hypoaesthesia, Incomplete course of vaccination
Clinical narrative: This spontaneous report as received, via field employee, from a physician refers to a 13 year old female patient. In approximately May 2012, reported as one year ago, the patient was vaccinated with GARDASIL (dose, lot number and expiration date were not reported) dose 1, intramuscular. In approximately May 2012, reported as one year ago, after receiving the first dose of GARDASIL, the patient experienced involuntary hand movements once a day, for an unspecified period of time. On an unspecified date, in approximately 2013, reported as recently at an unspecified timeframe, the patient received a second dose of GARDASIL, (dose, lot number and expiration date were not reported). On an unknown date, in approximately 2013, (72 hours after vaccination with second dose of GARDASIL) the patient experienced seizure. The patient sought medical attention with a neurologist visit (unspecified Health Care Professional (HCP)) and received unspecified treatment. The outcome of involuntary hand movements once a day and seizure was reported as recovering/resolving. Upon internal review the event seizure was considered as medically significant. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Convulsion, Dyskinesia
Clinical narrative: This spontaneous report as received, via field employee, from a physician refers to a 13 year old female patient. In approximately May 2012, reported as one year ago, the patient was vaccinated with GARDASIL (dose, lot number and expiration date were not reported) dose 1, intramuscular. In approximately May 2012, reported as one year ago, after receiving the first dose of GARDASIL, the patient experienced involuntary hand movements once a day, for an unspecified period of time. On an unspecified date, in approximately 2013, reported as recently at an unspecified timeframe, the patient received a second dose of GARDASIL (dose, lot number and expiration date were not reported). On an unknown date, in approximately 2013, (72 hours after vaccination with second dose of GARDASIL the patient experienced seizure. The patient sought medical attention with a neurologist visit (unspecified Health Care Professional (HCP)) and received unspecified treatment. The outcome of involuntary hand movements once a day and seizure was reported as recovering/resolving. Upon internal review the event seizure was considered as medically significant. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Feeling cold, Hypoaesthesia, Incomplete course of vaccination
Clinical narrative: This spontaneous report as received, via field employee, from a physician refers to a 13 year old female patient. In approximately May 2012, reported as one year ago, the patient was vaccinated with GARDASIL (dose, lot number and expiration date were not reported) dose 1, intramuscular. In approximately May 2012, reported as one year ago, after receiving the first dose of GARDASIL, the patient experienced involuntary hand movements once a day, for an unspecified period of time. On an unspecified date, in approximately 2013, reported as recently at an unspecified timeframe, the patient received a second dose of GARDASIL (dose, lot number and expiration date were not reported). On an unknown date, in approximately 2013, (72 hours after vaccination with second dose of GARDASIL the patient experienced seizure. The patient sought medical attention with a neurologist visit (unspecified Health Care Professional (HCP)) and received unspecified treatment. The outcome of involuntary hand movements once a day and seizure was reported as recovering/resolving. Upon internal review the event seizure was considered as medically significant. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Convulsion, Dyskinesia
Clinical narrative: This spontaneous report as received from a physician refers to a male patient of unknown age. On an unknown date the patient was vaccinated with GARDASIL (dose and lot# unknown), intramuscular. On an unknown date the patient experienced unspecified coldness and numbness after received the GARDASIL. Therapy with GARDASIL was discontinued.No treatment was given to the events. It was unknown if the patient had sought medical attention. The events were resolved in 15 minutes and the patient is fully recovered on an unknown date. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Feeling cold, Hypoaesthesia, Incomplete course of vaccination
Clinical narrative: This spontaneous report as received from a physician refers to a male patient of unknown age. On an unknown date the patient was vaccinated with GARDASIL (dose and lot# unknown), intramuscular. On an unknown date the patient experienced unspecified coldness and numbness after received the GARDASIL. Therapy with GARDASIL was discontinued.No treatment was given to the events. It was unknown if the patient had sought medical attention. The events were resolved in 15 minutes and the patient is fully recovered on an unknown date. Additional information has been requested.
Age: 86.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Anaemia, Asthenia, Death, Palpable purpura, Sepsis
Clinical narrative: This spontaneous report was received from a physician via a company representative concerning an 86 year old female patient with diabetes, hypertension, lumbar spondylosis, hyperlipidemia and chronic allergies. Patient's medical history included elevated c-reactive protein and elevated eosinophil levels. On 11-MAR-2013, the patient was vaccinated with a dose of ZOSTAVAX (lot number, expiry date, dose and route unspecified). Concomitant therapies included PRAVACHOL (20 milligrams), KLOR-CON 10 milligrams(mg), hydrochlorothiazide (dose unspecified), SOMA (350 mg), atenolol (50 mg) and amitriptyline hydrochloride (50 mg). On 31-MAR-2013, the patient experienced palpable purpura and vasculitis covering her body two weeks after receiving ZOSTAVAX. Her physician advised her to immediately go to the hospital. The patient was admitted to the hospital (name unspecified) on 31-MAR-2013 and was given medication to treat her condition (prednisone-dosage unspecified). The patient was discharged on 02-APR-2013. Approximately on an unknown date in April 2013, upon returning home the patient developed a urinary tract infection, and experienced profound weakness and anemia. The patient was readmitted to the unspecified hospital for these symptoms on 18-APR-2013. Upon discharge (exact date unspecified in 2013) the patient was sent to a rehabilitation center (unspecified) where she remained until two days before her death. The events were not resolved at the time of reporting. On 11-MAY-2013, the patient died due to sepsis. It was unknown if the autopsy was done. The physician noted that blood work that was taken from the patient directly preceding vaccination indicated that she had elevated C-reactive protein levels directly before she received the vaccine which may have been an indicator of the declining conditions of the patient. The relatedness for the events was unknown for ZOSTAVAX. The reporter considered the events to be life threatening. Additional information has been requested.