chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 15.0
Sex: M
Vaccine: HPV4
Symptoms: Dizziness, Ear pain, Headache, Otitis media
Clinical narrative: This spontaneous report as received from a physician refers to a 15 year old male patient with allergic rhinitis and migraine and no drug reactions or allergies, who on 09-APR-2013, was vaccinated intramuscularly with the first 0.5 ml dose of GARDASIL (lot # H021861, Exp. Date: 09-OCT-2015). Concomitant therapies included BENAZAQUINE, fluticasone and sumatriptan. The physician reported that on 09-APR-2013, the patient experienced headaches with increased severity and dizziness. It was stated that acetaminophen and ibuprofen did not bring the patient relief. On 15-MAY-2013, the patient was seen for dizziness and left ear pain and was treated for otitis media with floxacin drops, which brought temporary relief. On 10-JUN-2013, the patient was vaccinated with the second dose of GARDASIL (lot # H021861, Exp. Date: 09-OCT-2015). At a follow up visit on 25-JUN-2013, the patient's parents reported that the patient's dizziness had not resolved since the first dose of GARDASIL and that his headaches had increased in frequency and severity. It was also reported that the sumatriptan for his headaches was less effective. No lab diagnostics studies were performed. At the time of the report the patient had not recovered from headaches and dizziness and the outcome regarding left ear pain was unknown. The relatedness for headaches, dizziness and left ear pain and GARDASIL was unknown. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a physician via office manager refers to a patient of unknown age. On 04-JUN-2013, the patient was vaccinated with a dose of RECOMBIVAX HB, (lot # H015537, expiry date JUL-2015), with the same lot of improperly stored RECOMBIVAX HB. Concomitant medications were not reported. No adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 46.0
Sex: M
Vaccine: HPV4
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 46 year old male patient with a history of recurring HPV who about a month ago in approximately May 2013, was vaccinated with the first dose of GARDASIL (dose, route and lot number not reported). The medical assistant reported that the patient had had a history of recurring HPV since before GARDASIL was administered and she did not specify if any HPV outbreaks had occurred since GARDASIL was administered. No adverse effects were reported. Additional information has been requested.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Electroencephalogram abnormal, Nuclear magnetic resonance imaging normal, Partial seizures
Clinical narrative: Onset of partial complex epilepsy 5/7/13, five days after vaccination.
Age: 0.53
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Pt had swelling (+) redness to both legs after pt. received vaccines. Legs were also hot to touch from injection site to bottom of feet. Ice cold compression. BENADRYL and MOTRIN for Tx.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a physician via office manager refers to a patient of unknown age. On 23-APR-2013, the patient was vaccinated with a dose of RECOMBIVAX HB, (lot # H015537, expiry date JUL-2015), with the same lot of improperly stored RECOMBIVAX HB. Concomitant medications were not reported. No adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a physician via office manager refers to a patient of unknown age. On 01-MAY-2013, the patient was vaccinated with a dose of VAQTA, (lot # H019104, expiry date 19-JUL-2015), which was exposed to 31 degree Fahrenheit. Concomitant medications were not reported. No adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity
Clinical narrative: Information has been received from a 67 year-old female consumer with no pertinent medical history and with allergy to aspirin reporting on herself. On approximately 13-JUN-2013 ("two weeks ago"), the patient was placed on therapy with PNEUMOVAX 23 (dose, route and lot # not reported). Concomitant medications included ranitidine and pantoprazole 40 mg. It was reported that, on 13-JUN-2013 (two weeks ago), the patient experienced severe pain in her right arm after receiving PNEUMOVAX 23. No treatment for the pain was reported. No lab test were performed. The patient sought a medical attention by a phone call to her doctor. At the time of the report, the patient was recovering from the pain in her arm. Relatedness for severe pain in her arm was not reported for PNEUMOVAX 23. Additional information is not expected.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a physician via office manager refers to a patient of unknown age. On 27-APR-2013, the patient was vaccinated with a dose of RECOMBIVAX HB, lot # H015537, expiry date JUL-2015), with the same lot of improperly stored RECOMBIVAX HB. Concomitant medications were not reported. No adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a physician via office manager refers to a patient of unknown age. On 16-APR-2013, the patient was vaccinated with a dose of RECOMBIVAX HB, (lot # H015537, expiry date JUL-2015), with the same lot of improperly stored RECOMBIVAX HB. Concomitant medications were not reported. No adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a physician via office manager refers to a patient of unknown age. On 08-JUN-2013, the patient was vaccinated with a dose of VAQTA, (lot # H019104, expiry date 19-JUL-2015), which was exposed to 31 degree Fahrenheit. Concomitant medications were not reported. No adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a physician via office manager refers to a patient of unknown age. On 06-JUN-2013, the patient was vaccinated with a dose of VAQTA, (lot # H019104, expiry date 19-JUL-2015), which was exposed to a 31 degree Fahrenheit. Concomitant medications were not reported. No adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: PPV
Symptoms: Basophil percentage decreased, Blood culture negative, C-reactive protein increased, Cellulitis, Gait disturbance
Clinical narrative: Redness, swelling of left lower extremity from mid thigh to knee. Fever at home not documented at office. Also had limping. Patient had received PCV13 4/17/2013.
Age: 5.0
Sex: F
Vaccine: PPV
Symptoms: Haematocrit normal, Haemoglobin normal, Injection site erythema, Injection site swelling, Lymphocyte percentage decreased
Clinical narrative: Redness, swelling of left lower extremity from mid thigh to knee. Fever at home not documented at office. Also had limping. Patient had received PCV13 4/17/2013.
Age: 5.0
Sex: F
Vaccine: PPV
Symptoms: Monocyte percentage increased, Neutrophil percentage, Platelet count normal, Pyrexia, White blood cell disorder
Clinical narrative: Redness, swelling of left lower extremity from mid thigh to knee. Fever at home not documented at office. Also had limping. Patient had received PCV13 4/17/2013.
Age: 5.0
Sex: F
Vaccine: PPV
Symptoms: X-ray limb abnormal
Clinical narrative: Redness, swelling of left lower extremity from mid thigh to knee. Fever at home not documented at office. Also had limping. Patient had received PCV13 4/17/2013.
Age: 22.0
Sex: M
Vaccine: MNQ
Symptoms: Urticaria
Clinical narrative: Patient notices hives on upper body and arms on 6/30/13 (Sunday). Called our pharmacy on 7/1/13 to report hives: the hives are improving. Patient has not taken anything for hives. Recommended BENADRYL 25mg up to QID. Pt also said he was out of town over the weekend and said he had spent time in the hotel's pool.
Age: 1.16
Sex: F
Vaccine: FLU3, HIBV, PNC13
Symptoms: Body temperature increased, Convulsion
Clinical narrative: 09/20/2011 Severe. Had temp of 103F and seizures 1 week after vaccine.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: Redness at inj. site.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Injection site reaction, Injection site vesicles, Rash erythematous
Clinical narrative: Erythematous rash at site of (L) shoulder area surrounded by small blisters. GM used to give him BENADRYL x 2 days. This rash lasted for 4 days. No residuals left.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a physician via office manager refers to a patient of unknown age. On 29-APR-2013, the patient was vaccinated with a dose of RECOMBIVAX HB, (lot # H015537, expiry date JUL-2015), with the same lot of improperly stored RECOMBIVAX HB. Concomitant medications were not reported. No adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Local swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age. On 21-JUN-2013 the patient was vaccinated with a dose of ZOSTAVAX, 0.65 ml, subcutaneous. On 24-JUN-2013, the patient presented to the pharmacy with her left arm extremely swollen and red. At the time of the report, the patient had not yet seen a physician. No treatment was provided at this time. No lab diagnostic studies were performed. The patient sought medical attention by visiting the pharmacist. The outcome of left arm extremely swollen and red was reported as not recovered/not resolved. The causal relationship was not reported. Additional information has been requested.
Sex: M
Vaccine: PPV, VARZOS
Symptoms: Injection site rash
Clinical narrative: This spontaneous report was received from a male physician (reporting on himself) of unknown age. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (Lot # not reported) (dose, and route not reported). Other suspect therapies included PNEUMOVAX23 (Lot #, dose and route not reported); given on the same day as ZOSTAVAX. Concomitant therapy was not reported. On an unknown date the patient developed a rash around injection site after receiving ZOSTAVAX. The outcome of rash around injection site after receiving ZOSTAVAX was reported as recovered on an unknown date. Additional information has been requested.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Injection site rash, Rash
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age with hypertension and type II Diabetes. Drug reactions/allergies were not reported. On Friday 21-JUN-2013, the patient was vaccinated with ZOSTAVAX (lot number reported J001692; expiration date 08-MAY-2014), subcutaneous in the left arm. Concomitant therapies included atenolol, losartan potassium (+) hydrochlorothiazide (manufacturer unknown), metformin, glipizide, amlodipine and VICODIN. On 22-JUN-2013, the morning after receiving ZOSTAVAX the patient developed a rash, located around the injection site (left arm) and the rash travels up her arm and around to her back. On Sunday 23-JUN-2013, the patient visited the emergency room (ER) and was prescribed VICODIN. The patient visited her physician and was diagnosed with shingles and prescribed VALTREX. The outcome of the patient developed a rash the morning after receiving ZOSTAVAX, located around the injection site (left arm) and the rash traveled up her arm and around to her back was unknown. Additional information has been requested.
Sex: M
Vaccine: HEPA
Symptoms: Hepatitis A antibody negative
Clinical narrative: This spontaneous report was received from a office administrator refers to a male patient of unknown age. Two years ago, in 2011, the patient was vaccinated with a dose of hepatitis a vaccine, inactivated (manufacturer unknown) as routine immunization. No other co-suspect therapy was reported. Concomitant medications were not provided. Patient recently approximately June 2013, had hepatitis A titers before a mission trip which were negative. At the time of the report, the outcome of the event was unknown. The patient did not receive any treatment for the event. The patient sought unspecified medical attention. Additional information is not expected.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Purulent discharge, Scab, Skin lesion
Clinical narrative: This spontaneous report as received from a physician refers to a 50 year old female patient with none pertinent medical history or drug reaction allergies. On 23-MAY-2013 the patient was vaccinated with a dose of ZOSTAVAX (lot # H021459, expiration date 30-APR-2014) (dose and route not reported). Concomitant therapies included vitamin D (unspecified) and drospirenone, YAZ. On 11-JUN-2013 the patient developed 2 lesions on her inner elbow. On 21-JUN-2013 the patient had lesions in different stages of development ranging from lesions with yellow fluid leaking out to lesions that were scabbed over. The patient was seen by this physician in the office on 22-JUN-2013 and this physician noted that the patient had lesions which were very itchy mainly on her bilateral arms, a few on the right leg and abdomen and one on her left temple. This physician also noted that the patient had a fever on 22-JUN-2012, the day of the office appointment. The patient sought medical attention and this physician prescribed the patient Aveeno bath, ACYCLOVIR and ZYRTEC. Laboratory diagnostic studies were not performed. At the time of the report, the patient's outcome was not recovered. Additional information has been requested.
Age: 52.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a 52 year old male physician via a field representative refers to himself. On an unknown date in June 2011 (about two years ago) the patient was vaccinated with a dose of ZOSTAVAX (dose, route and lot # not reported). On 13-JUN-2013 the patient had developed shingles after receiving ZOSTAVAX. At the time of reporting, the patient had not recovered from shingles. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Pharyngitis streptococcal
Clinical narrative: This spontaneous report was received from a pharmacist refers to a pediatric patient of unknown age. On an unknown date, the patient was vaccinated with the second dose of VARIVAX (Merck) (route, dose and lot # not reported). No other co-suspect therapy was reported. Concomitant medications were not provided. The pharmacist reported that a few days later the patient developed a "strept-throat like infection", for which they were given CEFTIN. The outcome of patient was reported as not recovered/not resolved. It was also reported that the patient sought medical attention visiting the office. Additional information has been requested.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Induration, Pruritus, Upper extremity mass
Clinical narrative: This spontaneous report as received from a pharmacist via a field representative refers to a 75 year old female patient. On 03-JUN-2013 the patient was vaccinated with a dose of ZOSTAVAX, 0.65 ml, subcutaneous (lot # not reported). On 15-JUN-2013, the patient experienced a hard, approximately 2 inch red, itchy, lump on the injection arm. No treatment was given for the event and no lab diagnostics studies were performed. The patient saw the pharmacist and did not seek medical attention. At the time of reporting, the patient's outcome was unknown. Additional information has been requested.
Age: 16.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Asthenia, Dizziness, Hypoaesthesia
Clinical narrative: This spontaneous report as received from a physician via a field representative refers to a 16 years old male patient. The patient had no known drug allergy and no pertinent medical history. In June 2013 the patient was vaccinated with the second dose of GARDASIL (lot# H02002) (no expiration date given), injection, route unknown, (dose unspecified). Concomitant therapies included over the counter allergy medication. After the vaccination, the patient started to feel dizzy, one minute later the patient was sleeping/snoring. Physician administered an EPIPEN to patient. Physician then evaluated/monitored patient for one hour after the dizzy and sleeping/snoring began. Patient was fully recovered and attended school the next day on an unspecified date in June 2013. Upon internal review, dizzy and sleeping/snoring were considered to be medically important events. Additional information has been requested.
Age: 16.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Dizziness, Snoring, Sudden onset of sleep
Clinical narrative: This spontaneous report as received from a physician via a field representative refers to a 16 years old male patient. The patient had no known drug allergy and no pertinent medical history. In June 2013 the patient was vaccinated with the second dose of GARDASIL (lot# H02002) (no expiration date given), injection, route unknown, (dose unspecified). Concomitant therapies included over the counter allergy medication. After the vaccination, the patient started to feel dizzy, one minute later the patient was sleeping/snoring. Physician administered an EPIPEN to patient. Physician then evaluated/monitored patient for one hour after the dizzy and sleeping/snoring began. Patient was fully recovered and attended school the next day on an unspecified date in June 2013. Upon internal review, dizzy and sleeping/snoring were considered to be medically important events. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site inflammation, Injection site pruritus, Injection site rash, Injection site vesicles
Clinical narrative: Around injection site a softball sized, raised lump with the center containing a silver dollar sized rough patch. The area was hot to the touch and itched some. Occurred approx 24 hrs after admin. Treatment provided was BACTRIM DS 1 BID x 10d - after 2 days treatment area was improving per pt.
Age: 69.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site warmth
Clinical narrative: Around injection site a softball sized, raised lump with the center containing a silver dollar sized rough patch. The area was hot to the touch and itched some. Occurred approx 24 hrs after admin. Treatment provided was BACTRIM DS 1 BID x 10d - after 2 days treatment area was improving per pt.
Age: 69.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site mass, Injection site pruritus, Injection site warmth
Clinical narrative: Around injection site a softball sized, raised lump with the center containing a silver dollar sized rough patch. The area was hot to the touch and itched some. Occurred approx 24 hrs after admin. Treatment provided was BACTRIM DS 1 BID x 10d - after 2 days treatment area was improving per pt.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 60 year old female patient. On approximately 10-JUN-2013, ("approximately two weeks ago") the patient was vaccinated with ZOSTAVAX refrigerated vial 19400 PFU (lot # J000493, expiration date 14-APR-2014) 0.65 ml/once, subcutaneous. Concomitant medications included ibuprofen (unspecified) (also reported as treatment). On 22-JUN-2013, the patient presented in store location after administration of ZOSTAVAX with complaints of redness at injection site, hot and tender to touch sensitivity with enlargement noted. Pharmacist provided ibuprofen (unspecified) as treatment. The outcome of redness at injection site, and, hot and tender to touch sensitivity with enlargement was not reported. The relationship between ZOSTAVAX and the events was not reported. Patient did not seek medical attention. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 60 year old female patient. On approximately 10-JUN-2013, ("approximately two weeks ago") the patient was vaccinated with ZOSTAVAX refrigerated vial 19400 PFU (lot # J000493, expiration date 14-APR-2014) 0.65 ml/once, subcutaneous. Concomitant medications included ibuprofen (unspecified) (also reported as treatment). On 22-JUN-2013, the patient presented in store location after administration of ZOSTAVAX with complaints of redness at injection site, hot and tender to touch sensitivity with enlargement noted. Pharmacist provided ibuprofen (unspecified) as treatment. The outcome of redness at injection site, and, hot and tender to touch sensitivity with enlargement was not reported. The relationship between ZOSTAVAX and the events was not reported. Patient did not seek medical attention. Additional information has been requested.
Age: 57.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Pruritus, Rash, Secretion discharge, Viral test negative
Clinical narrative: This spontaneous report as received from a physician and a medical assistant refers to a 57-year-old female patient with diabetes, hypertension, anemia, hypothyroidism and allergy to sulfa. On 05-JUN-2013 the patient was vaccinated with a dose of ZOSTAVAX (lot # H012578, expiration date 28-SEP-2013) subcutaneously. Concomitant therapies included CYMBALTA, diclofenac, gabapentin, levothyroxine sodium, lisinopril, magnesium oxide, RITALIN, pilocarpine and tramadol hydrochloride. The patient saw the primary care physician on 21-JUN-2013, at which time she had red spots on her abdomen that started two days prior (approximately on 19-JUN-2013). The patient was prescribed VALTREX. On 24-JUN-2013, the patient came back to the unspecified physician's office with the same red spots on her abdomen and an additional outbreak on her left wrist. At that time, the unspecified physician took a culture of the spots and sent the culture out for further evaluation. The unspecified physician believed the red spots were shingles. Treatment was rendered for the event. The event did not resolve at the time of this report. Patient sought medical attention for the event. Causality was not reported. Additional information has been requested.
Age: 57.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Culture, Erythema, Herpes zoster
Clinical narrative: This spontaneous report as received from a physician and a medical assistant refers to a 57-year-old female patient with diabetes, hypertension, anemia, hypothyroidism and allergy to sulfa. On 05-JUN-2013 the patient was vaccinated with a dose of ZOSTAVAX (lot # H012578, expiration date 28-SEP-2013) subcutaneously. Concomitant therapies included CYMBALTA, diclofenac, gabapentin, levothyroxine sodium, lisinopril, magnesium oxide, RITALIN, pilocarpine and tramadol hydrochloride. The patient saw the primary care physician on 21-JUN-2013, at which time she had red spots on her abdomen that started two days prior (approximately on 19-JUN-2013). The patient was prescribed VALTREX. On 24-JUN-2013, the patient came back to the unspecified physician's office with the same red spots on her abdomen and an additional outbreak on her left wrist. At that time, the unspecified physician took a culture of the spots and sent the culture out for further evaluation. The unspecified physician believed the red spots were shingles. Treatment was rendered for the event. The event did not resolve at the time of this report. Patient sought medical attention for the event. Causality was not reported. Additional information has been requested.
Age: 24.0
Sex: M
Vaccine: ANTH
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Patient given anthrax vaccination instead of typhoid vaccination, IM L deltoid 0.5 mg. Patient experienced no adverse reactions. Patient contacted and informed.
Age: 56.0
Sex: M
Vaccine: VARCEL
Symptoms: Bladder pain, Bruxism, Erectile dysfunction, Functional gastrointestinal disorder, Herpes simplex
Clinical narrative: This spontaneous report was received from a 56 year old male patient regarding himself. The patient's medical history included appendicitis. Patient had no drug allergies. The patient reported that on 15-MAR-1995 someone may have broken into his house and gave him an injection of either VARIVAX (Merck) (lot #, expiry not reported) or a horse medication in his buttock. On 23-MAR-1995, the patient experienced intestine failure, malabsorption problems, loose teeth, teeth grinding, lip peeling, ridges on his toenails, impotency, bladder pain and sores. The patient sought medical attention-went to the emergency room for a day. The patient believed he had an undiagnosed condition as a result of this shot. The patient did not have a primary care physician. An Electron microscopy test was performed on the mouth sore: and results confirmed herpes simplex. Patient was given unspecified antibiotic for treatment. The outcome of intestine failure, herpes simplex, malabsorption problems, loose teeth, teeth grinding, lip peeling, ridges on his toenails, impotency, bladder pain and sores was reported as not recovered. Additional information has been requested.
Age: 56.0
Sex: M
Vaccine: VARCEL
Symptoms: Laboratory test abnormal, Lip exfoliation, Loose tooth, Malabsorption, Microscopy
Clinical narrative: This spontaneous report was received from a 56 year old male patient regarding himself. The patient's medical history included appendicitis. Patient had no drug allergies. The patient reported that on 15-MAR-1995 someone may have broken into his house and gave him an injection of either VARIVAX (Merck) (lot #, expiry not reported) or a horse medication in his buttock. On 23-MAR-1995, the patient experienced intestine failure, malabsorption problems, loose teeth, teeth grinding, lip peeling, ridges on his toenails, impotency, bladder pain and sores. The patient sought medical attention-went to the emergency room for a day. The patient believed he had an undiagnosed condition as a result of this shot. The patient did not have a primary care physician. An Electron microscopy test was performed on the mouth sore: and results confirmed herpes simplex. Patient was given unspecified antibiotic for treatment. The outcome of intestine failure, herpes simplex, malabsorption problems, loose teeth, teeth grinding, lip peeling, ridges on his toenails, impotency, bladder pain and sores was reported as not recovered. Additional information has been requested.
Age: 56.0
Sex: M
Vaccine: VARCEL
Symptoms: Nail ridging, Stomatitis
Clinical narrative: This spontaneous report was received from a 56 year old male patient regarding himself. The patient's medical history included appendicitis. Patient had no drug allergies. The patient reported that on 15-MAR-1995 someone may have broken into his house and gave him an injection of either VARIVAX (Merck) (lot #, expiry not reported) or a horse medication in his buttock. On 23-MAR-1995, the patient experienced intestine failure, malabsorption problems, loose teeth, teeth grinding, lip peeling, ridges on his toenails, impotency, bladder pain and sores. The patient sought medical attention-went to the emergency room for a day. The patient believed he had an undiagnosed condition as a result of this shot. The patient did not have a primary care physician. An Electron microscopy test was performed on the mouth sore: and results confirmed herpes simplex. Patient was given unspecified antibiotic for treatment. The outcome of intestine failure, herpes simplex, malabsorption problems, loose teeth, teeth grinding, lip peeling, ridges on his toenails, impotency, bladder pain and sores was reported as not recovered. Additional information has been requested.
Age: 72.0
Sex: M
Vaccine: PPV
Symptoms: Cardiac disorder, Chest discomfort, Hyperhidrosis, Injection site warmth, Intensive care
Clinical narrative: This spontaneous report was received from a certified medical assistant concerning a 72 year old male patient. There were no drug reactions or allergies at that time but currently refers to PNEUMOVAX23. Approximately on an unknown date in 1998 (reported as 10-15 years ago), the patient was vaccinated with a dose of PNEUMOVAX23 (25/0.5) (lot number, expiry date and route unspecified, typical dose). No concomitant medications were reported. Approximately on an unknown date in 1998 (reported as that day), the patient experienced injection site warmness, profuse sweating and chest tightness in the middle of the night after the vaccination. The patient sought medical attention for the same and on that unspecified night the patient went to a hospital and was admitted in the intensive care unit (ICU) where a heart issue (unspecified) was determined. It was unspecified if any lab tests were performed. On an unknown date, the patient recovered from all the reported events. The relatedness for the events was unknown for PNEUMOVAX23. Additional information has been requested.
Age: 1.3
Sex: M
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: This spontaneous report as received from a registered nurse, also reported as a physician, via a company representative refers to a 15 month old male patient with no drug reactions/allergies. The patient's medical history included chicken pox at the age of 7 months. On 07-JUN-2013 the patient was vaccinated with VARIVAX (Merck). The dose number, strength, lot number and expiry date were not reported. The patient did not take concomitant medications. On 14-JUN-2013 the patient experienced chicken pox. The patient saw a doctor at the office and was treated with an unspecified dose of BENADRYL and Calamine lotion (dose and manufacturer not specified). No lab diagnostic tests were performed. The outcome of chicken pox and causality were not reported. Additional information has been requested.
Age: 0.82
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Pyrexia, Somnolence
Clinical narrative: Initial report was received from a consumer on 21 June 2013. A 9 month old male patient received a second dose of DAPTACEL, sanofi pasteur, lot number unknown (route, site, and side of administration not reported), and a second dose of ACTHIB, sanofi pasteur, lot number unknown (route, site and side of administration not reported) on 01 August 2008. On the same day, the patient experienced fever of 104 degrees Fahrenheit (40 degrees Celsius) and could not be awakened and had to be put in a cool bath to wake up. The patient's outcome was not reported. This case is linked to case 2013-07180. Documents held by sender: None.
Age: 97.0
Sex: F
Vaccine: VARZOS
Symptoms: Vomiting
Clinical narrative: This spontaneous report as received from a physician via company representative refers to a 97 year old female patient. On an unknown date the patient was vaccinated with ZOSTAVAX (lot number not provided) (route: injection). The patient experienced vomiting after receiving ZOSTAVAX. The outcome of vomiting was unknown. The patient saw the doctor for seeking medical attention. Additional information is not expected.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a physician via office manager refers to a patient of unknown age. On 14-MAY-2013, the patient was vaccinated with a dose of VAQTA, (lot # H010659, expiry date MAR-2015), which was exposed to 31 degree Fahrenheit. Concomitant medications were not reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a physician via office manager refers to a patient of unknown age. On 14-MAY-2013, the patient was vaccinated with a dose of VAQTA, (lot # H010659, expiry date MAR-2015), which was exposed to 31 degree Fahrenheit. Concomitant medications were not reported. No adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a physician via office manager refers to a patient of unknown age. On 28-MAY-2013, the patient was vaccinated with a dose of VAQTA, (lot # H010659, expiry date MAR-2015), which was exposed to 31 degree Fahrenheit. Concomitant medications were not reported. No adverse effects were reported. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a physician via office manager refers to a patient of unknown age. On 24-MAY-2013, the patient was vaccinated with a dose of VAQTA, (lot # H010659, expiry date MAR-2015), which was exposed to 31 degree Fahrenheit. Concomitant medications were not reported. No adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a physician via office manager refers to a patient of unknown age. On 20-MAY-2013, the patient was vaccinated with a dose of VAQTA, (lot # H010659, expiry date MAR-2015), which was exposed to 31 degree Fahrenheit. Concomitant medications were not reported. No adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a physician via office manager refers to a patient of unknown age. On 30-APR-2013, the patient was vaccinated with a dose of VAQTA, (lot # H010659, expiry date MAR-2015), which was exposed to 31 degree Fahrenheit. Concomitant medications were not reported. No adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Urticaria
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX, 0.65 ml one shot administered by the pharmacist. On an unknown date the patient developed a "wheel reaction" at the injection site after receiving the dose of ZOSTAVAX. This "wheel reaction" was defined as redness and swelling. No rash was involved. The reaction went away after an unspecified length of time. The pharmacist stated that he believed that the "wheel reaction" for this patient might have been attributed to the manner in which he was administering ZOSTAVAX (administration method not specified). It was not specified whether the patient sought medical attention for the injection site reaction because it was assumed but not confirmed that the reaction took place in the presence of the administering pharmacist, upon administration of ZOSTAVAX. The outcome of "wheel reaction" at the injection site defined as redness and swelling was reported as recovered/resolved. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist refers to a patient of unknown age and gender. On 27-JUN-2013, the patient was vaccinated with a dose of ZOSTAVAX (lot # 672676/0069AE, expiry: 03-APR-2013) subcutaneously which had expired. The pharmacist did not know the day of the month on which the ZOSTAVAX expired. No adverse effects reported. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of drug administration, Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacy technician refers to a female patient of unknown age. On an unknown dates, the patient was vaccinated with two doses of ZOSTAVAX vaccine within a little over 1 year time (dose, route, lot number were not reported). No adverse effects were reported. The patient's outcome was not reported. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood test, Dehydration, Dizziness, Electrocardiogram normal, Laboratory test normal
Clinical narrative: Client became lightheaded, dizzy and nauseated very shortly after injection. Juice given, cool cloths applied to head and neck. Needed to move to BR via WC, placed on bed with cool pack behind neck and knees elevated. Pulse 60 BP 114/76. Alert and oriented and speaking throughout incident. Client has had pacemaker x 8 yrs - due to be replaced. Stated sx's are similar to sxs she had prior to pacemaker. Family doctor notified of event. She recommended evaluation at ER. Friend came and drove her to ER for evaluation. Tuesday, June 25, 2013 at 3:05pm. Phone call received from patient. RN spoke with her. She was seen in the ER. They checked blood work, did an EKG and a pacemaker check. They've determined that she is dehydrated. The EKG and pacemaker check were both normal. She is home now forcing fluids. The ER will be notifying her Cardiologist of this incident.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea
Clinical narrative: Client became lightheaded, dizzy and nauseated very shortly after injection. Juice given, cool cloths applied to head and neck. Needed to move to BR via WC, placed on bed with cool pack behind neck and knees elevated. Pulse 60 BP 114/76. Alert and oriented and speaking throughout incident. Client has had pacemaker x 8 yrs - due to be replaced. Stated sx's are similar to sxs she had prior to pacemaker. Family doctor notified of event. She recommended evaluation at ER. Friend came and drove her to ER for evaluation. Tuesday, June 25, 2013 at 3:05pm. Phone call received from patient. RN spoke with her. She was seen in the ER. They checked blood work, did an EKG and a pacemaker check. They've determined that she is dehydrated. The EKG and pacemaker check were both normal. She is home now forcing fluids. The ER will be notifying her Cardiologist of this incident.
Age: 63.0
Sex: M
Vaccine: PPV
Symptoms: Blindness unilateral, Eye swelling, Laboratory test, Pain, Swelling
Clinical narrative: Extreme swelling of left shoulder, severe pain, swelling inside left eye. Loss of vision left eye.
Age: 63.0
Sex: M
Vaccine: PPV
Symptoms: X-ray
Clinical narrative: Extreme swelling of left shoulder, severe pain, swelling inside left eye. Loss of vision left eye.
Age: 0.4
Sex: F
Vaccine: RV5
Symptoms: Irritability, Lethargy, Tremor
Clinical narrative: This spontaneous report was received from a mother refers to approximately 5 month old daughter. On an unknown date in MAR-2013, the patient was vaccinated with a dose of ROTATEQ, (lot number, expiry date was not reported, route was oral). The mother stated that the child had two experienced with the ROTATEQ medication. The first event occurred on an unknown date in MAR-2013, when after 3 doses the child became extremely uncontrollable with shaking, irritable and lethargic. The second event occurred on an unknown date in MAY-2013 where the child displayed irritability for two to three days. The mother stated that the symptoms began to dissipate after the third day and the child appeared to be herself. The mother stated that her concerns were for potential future vaccine medications that might cause potential harm. There was no treatment rendered for the events. On an unknown date, the patient recovered from the events. The patient sought medical attention. Additional information has been requested.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Rash under left axilla. No itching, fever. No HA.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Headache, Joint range of motion decreased, Pain, Pain in extremity
Clinical narrative: Patient complains of left arm throbbing, left arm pain 10/10, loss of range of motion, and headache.  Pertinent negatives include hives, dyspnea, palpitations, dizziness, nausea, vomiting, warmth or redness at injection site.
Age: 1.02
Sex: M
Vaccine: HEPA, HIBV, MMR, PPV, VARCEL
Symptoms: Pain, Pyrexia, Rash, Somnolence
Clinical narrative: Mild rash, low-grade fever, sleeping issues (will not sleep for more than 20 min incraments), and acting in pain.
Age: 0.48
Sex: F
Vaccine: HEP, HIBV, IPV, PNC, RV1, TDAP
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: No adverse reactions, however infant patient was given Tdap instead of DTaP.
Age: 14.0
Sex: F
Vaccine: MNQ
Symptoms: Fatigue, Headache, Musculoskeletal stiffness, Pyrexia
Clinical narrative: Fever for one day post vaccine.  Headache and tired one day post vaccine and lasting for at least 5 days.  Stiff neck started 3 days after- paraspinal.
Age: 39.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Cellulitis, Erythema, Immediate post-injection reaction, Nerve injury, Throat irritation
Clinical narrative: Immediate itchy throat and reddening of entire arm. Sent to employee health then immediately to Emergency Room where counter active IV's where administered.
Age: 39.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Thrombosis
Clinical narrative: Immediate itchy throat and reddening of entire arm. Sent to employee health then immediately to Emergency Room where counter active IV's where administered.
Age: 39.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Cellulitis, Disability, Erythema, Immediate post-injection reaction, Nerve injury
Clinical narrative: Immediate itchy throat and reddening of entire arm. Sent to employee health then immediately to Emergency Room where counter active IV's where administered.
Age: 39.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Throat irritation, Thrombosis
Clinical narrative: Immediate itchy throat and reddening of entire arm. Sent to employee health then immediately to Emergency Room where counter active IV's where administered.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a pharmacist refers to a female patient of unknown age with is a renal dialysis patient. On 17-JUN-2013, the patient was vaccinated with a dose of ZOSTAVAX (lot #, expiry not reported), 0.65 ml, subcutaneously. On an unknown date in 2013, the patient had been diagnosed with shingles. Patient sought medical attention-evaluated by an unspecified physician. The outcome of shingles was unknown. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin swelling, Skin warm
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 61 year old female patient with no known drug allergies. On 28-JUN-2013, the patient was vaccinated with a dose of ZOSTAVAX (lot # J000432, expiry: 10-APR-2014) subcutaneously. Late on 29-JUN-2013 to early 30-JUN-2013, the patient experienced a small mosquito type bump, which was warm to touch. Patient called pharmacist to report and did not seek medical attention. Pharmacist suggested patient use TYLENOL, for discomfort, to which patient replied that it was not that bad. Laboratory diagnostics studies performed were none. The outcome of patient experienced a small mosquito type bump, which was warm to touch was unknown. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Injection site rash
Clinical narrative: This spontaneous report as received from a health worker refers to a patient of unknown age. On an unknown date the patient was vaccinated with GARDASIL (route, dose and lot # were unknown). On an unknown date the patient experienced a rash at the injection site. The outcome of the event was unknown. Additional information has been requested.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Biopsy skin, Pruritus, Rash generalised, Skin burning sensation
Clinical narrative: Shortly after getting shingles vaccine (approx 4 yrs ago), I began experiencing rashes on my arms, torso, thighs and legs. Skin was itchy and felt like it was on fire.
Age: 2.0
Sex: F
Vaccine: FLU3
Symptoms: Febrile convulsion
Clinical narrative: Febrile seizure - 48 hours after vaccine given.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Rash, Skin discolouration, Varicella
Clinical narrative: This spontaneous report as received from a 62 year old female patient Registered Nurse and reporting on herself. The patient's medical history included breast cancer. On 08-MAY-2013 the patient was vaccinated with ZOSTAVAX, (dose, route, lot number and exp. date not provided). Concomitant therapies included CELEXA and ATIVAN. On 14-MAY-2013, patient developed a spot, with itching, that she initially thought to be a bug bite, however the patient's arms broke out with rash and she saw physician assistant on 15-MAY-2013. The physician assistant did not believe the rash was as vaccine-related and prescribed an unspecified ointment and TAGAMET for the itching, initially. TAGAMET was ineffective and ATARAX was prescribed, for the itching. On 19-MAY-2013, patient sought medical attention in Emergency Room at hospital and was diagnosed with classic chickenpox. The patient was discharged that same day and was treated with ACYCLOVIR. The patient reported she had discoloration from the rash from an unspecified date in 2013 and itching persisted. At the time of the report the patient did not recover from classic chickenpox and discoloration from the rash. Additional information has been requested.
Age: 26.0
Sex: U
Vaccine: TD
Symptoms: Bradycardia, Dysstasia, Fall, Hyperhidrosis, Nausea
Clinical narrative: Td given 9:00 AM - seated in waiting area. Attempted to stand - nausea, diaphoresis, fell forward into aisle shelving. Remained conscious. EMS arrived. Bradycardia - heart rate 40's with attempts to stand. Transport ambulance to hospital.
Age: 77.0
Sex: F
Vaccine: MMR
Symptoms: Arthralgia, Dizziness, Joint swelling, Local swelling, Paraesthesia
Clinical narrative: Given MMR vaccine on 6/11/13. Patient noted that after a few weeks she experienced occasional dizziness, pain in knees x 2d (increased with squatting), mild swelling in both hands, intermittent paresthesias of fingertips, swelling (R) hand > (L), also slightly swollen (R) wrist. Symptoms worse in AM. No abscess at wound site. Symptoms resolved mostly.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a Nurse Practitioner refers to a 11 year old female patient. On 13-SEP-2012, the patient was vaccinated with first dose of GARDASIL (lot #, expiry not reported) 0.5 ml, intramuscularly and on 01-JUL-2013, the patient was vaccinated with GARDASIL (lot #, expiry not reported) dose 2, 0.5 ml, intramuscularly. No adverse effect reported. Additional information has been requested.